The Utilization of 32 Full Factorial Design (FFD) for Optimization of Lincomycin Hydrochloride (LNH) Loaded Nanogel Involving; Design of Experiments (DoE) an Advanced Approach
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced.
Dissolution Enhancement of BCS Class 4 Dssrugs Using Quality by Design Approa...inventionjournals
Solid dispersion is one of the vastly accepted and practically economical processes in bioavailability enhancement study. The present investigation deals mostly with increase in solubility and dissolution rate of BCS class 4 drugs for enhancement of oral bioavailability. For the same solid dispersion were prepared and analyzed for appropriate concentration of drug polymer ratio by phase solubility analysis. The solvent evaporation study widely accepted due to its efficient solid dispersion in lesser efforts. The study designs were prepared with specific concentration of drug and polymer ratio with the help of high throughput model i.e. Central Composite Design (by Design Expert trial copy) by specific design of experiment with full factorial design (DOE). The fixed variables were concentration of polymers and dependant variables were dissolution and permeability across bio-membrane in in-vitro model. The prepared dispersion investigated for dissolution and permeability improvement using USP Type II apparatus and modified everted gut sac model which leads to improvement of quality of whole formulation with Quality by design efficiently.
Application of COSMO-RS-DARE as a Tool for Testing Consistency of Solubility ...Maciej Przybyłek
Coumarin is a naturally occurring lactone-type benzopyrone with various applications in the pharmaceutical, food, perfume, and cosmetics industries. This hydrophobic compound is poorly soluble in water but dissolves well in protic organic solvents such as alcohols. Despite the extensive use of coumarin, there are only a few reports documenting its solubility in organic solvents, and some reported data are incongruent, which was the direct impulse for this study. To resolve this problem, a theoretical congruency test was formulated using COSMO-RS-DARE for the determination of intermolecular interaction parameters, which allowed for the identification of outliers as suspicious datasets. The perfect match between back-computed values of coumarin solubility and the experimental ones confirms the reliability of the formulated theoretical approach and its adequacy for testing solubility data consistency. As the final approval, the temperature-related coumarin solubility in seven neat alcohols was determined experimentally. Four solvents (methanol, ethanol, 1-propanol, and 2-propanol) were used for reproducibility purposes, and an additional three (1-butanol, 1-pentanol, and 1-octanol) were used to extend the information on the homologous series. The consistency of this extended solubility dataset is discussed in terms of the comparison of remeasured solubility values with the ones already published and within the series of structurally similar solvents. The proposed procedure extends the range of applicability of COSMO-RS-DARE and provides a real and useful tool for consistency tests of already published solubility data, allowing for the approval/disapproval of existing data and filling gaps in datasets. Linear regressions utilizing a 2D molecular descriptor, SpMin2_Bhm, or the distance between solute and solvent in the Hansen solubility space, Ra, were formulated for the estimation of COMSO-RS-DARE integration parameters.
Experimental and Machine-Learning-Assisted Design of Pharmaceutically Accepta...Maciej Przybyłek
Deep eutectic solvents (DESs) are commonly used in pharmaceutical applications as excellent solubilizers of active substances. This study investigated the tuning of ibuprofen and ketoprofen solubility utilizing DESs containing choline chloride or betaine as hydrogen bond acceptors and various polyols (ethylene glycol, diethylene glycol, triethylene glycol, glycerol, 1,2-propanediol, 1,3-butanediol) as hydrogen bond donors. Experimental solubility data were collected for all DES systems. A machine learning model was developed using COSMO-RS molecular descriptors to predict solubility. All studied DESs exhibited a cosolvency effect, increasing drug solubility at modest concentrations of water. The model accurately predicted solubility for ibuprofen, ketoprofen, and related analogs (flurbiprofen, felbinac, phenylacetic acid, diphenylacetic acid). A machine learning approach utilizing COSMO-RS descriptors enables the rational design and solubility prediction of DES formulations for improved pharmaceutical applications.
Formulation and Development of Modified Release Biphasic Compressed Tablet of...ijtsrd
Quick slow drug delivery system involves the use of compressed core, consisting of sustained release tablet, which is coated by compression over the whole surface with fast dispersible formulation. Propranolol hydrochloride, a non selective beta adrenergic blocker has widely used in the treatment of hypertension and angina pectoris with frequent administration. Aim of present study was to develop press coated tablet system to achieve quick slow release of the drug are the main purposes of biphasic drug delivery system to avoid frequent administration with increasing patient compliance and therapeutic efficacy. In this study immediate layer which was prepared using croscarmellose sodium, crospovidone and sodium starch glycol ate which was compressed on core tablet prepared by using HPMC and Ethyl cellulose. Results showed that the immediate layer dissolved within four minutes and core tablet releases drug for 12 hrs in controlled manner with zero order release kinetics. Mrs. Poonam Jaykar Patil | Dr. Durgacharan A. Bhagwat | Ms. Rutuja Rajendra Shah | Dr. Jhon I. D’souza "Formulation and Development of Modified Release Biphasic Compressed Tablet of Propranolol Hydrochloride" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-1 , December 2020, URL: https://www.ijtsrd.com/papers/ijtsrd38190.pdf Paper URL : https://www.ijtsrd.com/pharmacy/other/38190/formulation-and-development-of-modified-release-biphasic-compressed-tablet-of-propranolol-hydrochloride/mrs-poonam-jaykar-patil
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Dissolution Enhancement of BCS Class 4 Dssrugs Using Quality by Design Approa...inventionjournals
Solid dispersion is one of the vastly accepted and practically economical processes in bioavailability enhancement study. The present investigation deals mostly with increase in solubility and dissolution rate of BCS class 4 drugs for enhancement of oral bioavailability. For the same solid dispersion were prepared and analyzed for appropriate concentration of drug polymer ratio by phase solubility analysis. The solvent evaporation study widely accepted due to its efficient solid dispersion in lesser efforts. The study designs were prepared with specific concentration of drug and polymer ratio with the help of high throughput model i.e. Central Composite Design (by Design Expert trial copy) by specific design of experiment with full factorial design (DOE). The fixed variables were concentration of polymers and dependant variables were dissolution and permeability across bio-membrane in in-vitro model. The prepared dispersion investigated for dissolution and permeability improvement using USP Type II apparatus and modified everted gut sac model which leads to improvement of quality of whole formulation with Quality by design efficiently.
Application of COSMO-RS-DARE as a Tool for Testing Consistency of Solubility ...Maciej Przybyłek
Coumarin is a naturally occurring lactone-type benzopyrone with various applications in the pharmaceutical, food, perfume, and cosmetics industries. This hydrophobic compound is poorly soluble in water but dissolves well in protic organic solvents such as alcohols. Despite the extensive use of coumarin, there are only a few reports documenting its solubility in organic solvents, and some reported data are incongruent, which was the direct impulse for this study. To resolve this problem, a theoretical congruency test was formulated using COSMO-RS-DARE for the determination of intermolecular interaction parameters, which allowed for the identification of outliers as suspicious datasets. The perfect match between back-computed values of coumarin solubility and the experimental ones confirms the reliability of the formulated theoretical approach and its adequacy for testing solubility data consistency. As the final approval, the temperature-related coumarin solubility in seven neat alcohols was determined experimentally. Four solvents (methanol, ethanol, 1-propanol, and 2-propanol) were used for reproducibility purposes, and an additional three (1-butanol, 1-pentanol, and 1-octanol) were used to extend the information on the homologous series. The consistency of this extended solubility dataset is discussed in terms of the comparison of remeasured solubility values with the ones already published and within the series of structurally similar solvents. The proposed procedure extends the range of applicability of COSMO-RS-DARE and provides a real and useful tool for consistency tests of already published solubility data, allowing for the approval/disapproval of existing data and filling gaps in datasets. Linear regressions utilizing a 2D molecular descriptor, SpMin2_Bhm, or the distance between solute and solvent in the Hansen solubility space, Ra, were formulated for the estimation of COMSO-RS-DARE integration parameters.
Experimental and Machine-Learning-Assisted Design of Pharmaceutically Accepta...Maciej Przybyłek
Deep eutectic solvents (DESs) are commonly used in pharmaceutical applications as excellent solubilizers of active substances. This study investigated the tuning of ibuprofen and ketoprofen solubility utilizing DESs containing choline chloride or betaine as hydrogen bond acceptors and various polyols (ethylene glycol, diethylene glycol, triethylene glycol, glycerol, 1,2-propanediol, 1,3-butanediol) as hydrogen bond donors. Experimental solubility data were collected for all DES systems. A machine learning model was developed using COSMO-RS molecular descriptors to predict solubility. All studied DESs exhibited a cosolvency effect, increasing drug solubility at modest concentrations of water. The model accurately predicted solubility for ibuprofen, ketoprofen, and related analogs (flurbiprofen, felbinac, phenylacetic acid, diphenylacetic acid). A machine learning approach utilizing COSMO-RS descriptors enables the rational design and solubility prediction of DES formulations for improved pharmaceutical applications.
Formulation and Development of Modified Release Biphasic Compressed Tablet of...ijtsrd
Quick slow drug delivery system involves the use of compressed core, consisting of sustained release tablet, which is coated by compression over the whole surface with fast dispersible formulation. Propranolol hydrochloride, a non selective beta adrenergic blocker has widely used in the treatment of hypertension and angina pectoris with frequent administration. Aim of present study was to develop press coated tablet system to achieve quick slow release of the drug are the main purposes of biphasic drug delivery system to avoid frequent administration with increasing patient compliance and therapeutic efficacy. In this study immediate layer which was prepared using croscarmellose sodium, crospovidone and sodium starch glycol ate which was compressed on core tablet prepared by using HPMC and Ethyl cellulose. Results showed that the immediate layer dissolved within four minutes and core tablet releases drug for 12 hrs in controlled manner with zero order release kinetics. Mrs. Poonam Jaykar Patil | Dr. Durgacharan A. Bhagwat | Ms. Rutuja Rajendra Shah | Dr. Jhon I. D’souza "Formulation and Development of Modified Release Biphasic Compressed Tablet of Propranolol Hydrochloride" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-1 , December 2020, URL: https://www.ijtsrd.com/papers/ijtsrd38190.pdf Paper URL : https://www.ijtsrd.com/pharmacy/other/38190/formulation-and-development-of-modified-release-biphasic-compressed-tablet-of-propranolol-hydrochloride/mrs-poonam-jaykar-patil
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Influence of Biofield Treatment on Physicochemical Properties of Hydroxyethyl...albertdivis
Hydroxyethyl cellulose (HEC) and hydroxypropyl cellulose (HPC) are widely explored as excipients to improve the solubility of poorly water soluble drugs and to improve self-life of dosage form. This work is an attempt to modulate the physicochemical properties of these cellulose derivatives using biofield treatment.
Ultra performance liquid chromatographic method for simultaneous quantificati...Ratnakaram Venkata Nadh
Plerixafor (PLX) injections are administered to patients with cancers of lymphocytes
(non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main
objective of the current study was to develop a short reverse phase chromatographic
method for the simultaneous quantification of PLX and its impurities, in an injection
formulation, to reduce the time required for these quality tests. Furthermore, the
present work describes the role of nonalkyl branched nonquaternary ion pair reagent
in improving the peak shape and reducing column equilibration time. The separation
of PLX and its related substances is pH dependent (optimum pH = 2.50) and was
achieved on an octadecylsilyl (C18) column. The method was validated for its intended
purpose in accordance with the current regulatory guidelines for validation. The
proposed method can be applied for quality control, release, and stability analyses of
active pharmaceutical ingredient, PLX, as well as finished products, PLX injections
Recent Advancement and Patents of the Lipid Polymer Hybrid Nanoparticlespeertechzpublication
In recent years, robustness and surface engineering of dosage form made improvement in
pharmacokinetics with decrease in dose of drug. Specifi city with adherence of ligands has now become
the reality as surface modifi cation can easily deceive phagocytic system. Lipid molecules ensures the
release of drug at lymphatic system, entrapment of polymeric nanoparticles in lipoidal core led to the
avoidance of disadvantage of low entrapment effi ciency if use of hydrophobic drug with hydrophobic
polymer becomes essential. Various studies have been published and the best formulations with optimal
In vitro and In vivo results are highlighted in this paper. In this review most advanced researches and
accepted patents were discussed so to act as a medium for getting everything regarding lipid polymer
hybrid particles under one umbrella.
In recent years, robustness and surface engineering of dosage form made improvement in pharmacokinetics with decrease in dose of drug. Specificity with adherence of ligands has now become the reality as surface modifi cation can easily deceive phagocytic system. Lipid molecules ensures the
release of drug at lymphatic system, entrapment of polymeric nanoparticles in lipoidal core led to the
avoidance of disadvantage of low entrapment effi ciency if use of hydrophobic drug with hydrophobic polymer becomes essential. Various studies have been published and the best formulations with optimal In vitro and In vivo results are highlighted in this paper. In this review most advanced researches and accepted patents were discussed so to act as a medium for getting everything regarding lipid polymer hybrid particles under one umbrella.
Nanoparticles consists of organic and inorganic materials. Nanocrystals are aggregates of atoms that combine into a “cluster” and are pure drug crystals with sizes in the nanometer range stabilized or surrounded by a thin coating of surfactant. Todays nanocrystal formulation preparation method characterised as “bottom up” “top down” and “bottom up” spray drying methods. The majority of nanocrystal medicinal products are presently approved for oral ingestion and treatment of disorders other than cancer. Smurti Magar | Prof. Santosh Waghmare | Dr. Hemant Kamble "Nanocrystals-As Drug Delivery System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-3 , April 2022, URL: https://www.ijtsrd.com/papers/ijtsrd49563.pdf Paper URL: https://www.ijtsrd.com/humanities-and-the-arts/other/49563/nanocrystalsas-drug-delivery-system/smurti-magar
Piroxicam Nanostructured Lipid Carrier Drug Delivery SystemYogeshIJTSRD
Objective Nanostructured lipid carrier NLC based topical gel of Piroxicam PXM was formulated with the aim of controlled release action and to reduce systemic side effect for the treatment of an arthritic condition. Methods NLCs developed using high pressure homogenization method and optimized using a 32 factorial design with response surface methodology using design expert software. NLCs were characterized for particle size, zeta potential analysis, drug entrapment efficiency, and in vitro drug release studies to select the optimized formulation. The NLCs were suitably gelled and evaluated with respect to homogeneity, pH, viscosity, gel strength, spread ability, rheological characteristics, drug content, in vitro diffusion, and stability study. Safety of the NLC based gel was assessed using primary skin irritation studies, and efficacy was confirmed using carrageen an induced rat paw edema model. Results NLCs formulation comprising 2 of lipid 60 40 and surfactant 1.50 was confirmed as an optimized batch having a particle size 138.2±3.60 nm with polydispersibility index value 0.344±0.034. The zeta potential value indicates good physical stability. Based on the results from the in vitro release study it was shown that the formed gels had the ability to extend release of PXM for 24 h and showing percentage drug release of 90.92 ±1.96 at the end of 24 h. Skin irritation studies revealed that the optimized gel formulation shows no erythema, edema, or ulceration. Conclusion The overall results of the present study clearly indicated promising potentials of NLC based gel for delivering PXM topically over the conventional gel. Dr. G. Jagadish | Dr. Rita Mourya | Dr. Amith Nayak "Piroxicam Nanostructured Lipid Carrier Drug Delivery System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd39912.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/39912/piroxicam-nanostructured-lipid-carrier-drug-delivery-system/dr-g-jagadish
Intermolecular Interactions as a Measure of Dapsone Solubility in Neat Solven...Maciej Przybyłek
Dapsone is an effective antibacterial drug used to treat a variety of conditions. However, the aqueous solubility of this drug is limited, as is its permeability. This study expands the available solubility data pool for dapsone by measuring its solubility in several pure organic solvents: N-methyl-2-pyrrolidone (CAS: 872-50-4), dimethyl sulfoxide (CAS: 67-68-5), 4-formylmorpholine (CAS: 4394-85-8), tetraethylene pentamine (CAS: 112-57-2), and diethylene glycol bis(3-aminopropyl) ether (CAS: 4246-51-9). Furthermore, the study proposes the use of intermolecular interactions as molecular descriptors to predict the solubility of dapsone in neat solvents and binary mixtures using machine learning models. An ensemble of regressors was used, including support vector machines, random forests, gradient boosting, and neural networks. Affinities of dapsone to solvent molecules were calculated using COSMO-RS and used as input for model training. Due to the polymorphic nature of dapsone, fusion data are not available, which prohibits the direct use of COSMO-RS for solubility calculations. Therefore, a consonance solvent approach was tested, which allows an indirect estimation of the fusion properties. Unfortunately, the resulting accuracy is unsatisfactory. In contrast, the developed regressors showed high predictive potential. This work documents that intermolecular interactions characterized by solute–solvent contacts can be considered valuable molecular descriptors for solubility modeling and that the wealth of encoded information is sufficient for solubility predictions for new systems, including those for which experimental measurements of thermodynamic properties are unavailable.
Experimental and Theoretical Insights into the Intermolecular Interactions in...Maciej Przybyłek
Solubility is not only a crucial physicochemical property for laboratory practice but also provides valuable insight into the mechanism of saturated system organization, as a measure of the interplay between various intermolecular interactions. The importance of these data cannot be overstated, particularly when dealing with active pharmaceutical ingredients (APIs), such as dapsone. It is a commonly used anti-inflammatory and antimicrobial agent. However, its low solubility hampers its efficient applications. In this project, deep eutectic solvents (DESs) were used as solubilizing agents for dapsone as an alternative to traditional solvents. DESs were composed of choline chloride and one of six polyols. Additionally, water–DES mixtures were studied as a type of ternary solvents. The solubility of dapsone in these systems was determined spectrophotometrically. This study also analyzed the intermolecular interactions, not only in the studied eutectic systems, but also in a wide range of systems found in the literature, determined using the COSMO-RS framework. The intermolecular interactions were quantified as affinity values, which correspond to the Gibbs free energy of pair formation of dapsone molecules with constituents of regular solvents and choline chloride-based deep eutectic solvents. The patterns of solute–solute, solute–solvent, and solvent–solvent interactions that affect solubility were recognized using Orange data mining software (version 3.36.2). Finally, the computed affinity values were used to provide useful descriptors for machine learning purposes. The impact of intermolecular interactions on dapsone solubility in neat solvents, binary organic solvent mixtures, and deep eutectic solvents was analyzed and highlighted, underscoring the crucial role of dapsone self-association and providing valuable insights into complex solubility phenomena. Also the importance of solvent–solvent diversity was highlighted as a factor determining dapsone solubility. The Non-Linear Support Vector Regression (NuSVR) model, in conjunction with unique molecular descriptors, revealed exceptional predictive accuracy. Overall, this study underscores the potency of computed molecular characteristics and machine learning models in unraveling complex molecular interactions, thereby advancing our understanding of solubility phenomena within the scientific community.
SiO2@FeSO4 nano composite: A recoverable nano-catalyst for eco-friendly synth...Iranian Chemical Society
Various aldoximes and ketoximes synthesis of corresponding aldehydes and ketones in the presence of SiO2@FeSO4 nano composite as recoverable nano catalyst and NH2OH·HCl. The SiO2@FeSO4 nano composite system was carried out between 10 to 15 min in oil bath (70-80 °C) under solvent-free condition in excellent yields in addition this protocol can be used for industrial scales. This method offers some advantages in term of clean reaction conditions, easy work-up procedure, short reaction time, applied to convert α-diketones to α-diketoximes (as longer than other carbonyl compounds), α,β-unsaturated aldehydes and ketones to corresponding oximes and suppression of any side product. So we think that NH2OH•HCl/SiO2@FeSO4 nano composite system could be considered a new and useful addition to the present methodologies in this area. Structure of products and nano composite elucidation was carried out by 1H NMR, 13C NMR, FT-IR, scanning electron microscopy (SEM).
A New Low Cost Biosorbent for a Cationic Dye TreatmentIJEAB
The aim of our study consists to investigate the adsorption of Methylene Blue from aqueous solution by a new biosorbent prepared from Papaya seed. Adsorption behavior of the cationic dye was analyzed by variation of solution pH, contact time, adsorbent dose, and temperature. Adsorption isotherms were studied according to the Langmuir and Freundlich Model, and adsorption kinetics according to pseudo first and second order. Results show that the maximum adsorption is obtained at ambient temperature with the yield of 98.82% and was reached in first 20min (pH = 10, adsorbent dose of 100 mg in 50 mL). The Langmuir isotherm shows a correlation coefficient of 99.4% higher than 95.4%obtained for Freundlich model and the adsorption kinetic model follow a pseudo-second order with a maximum adsorption capacity of 52.28 mg/g.
Software Used In Formulation Design Process- Minor Project [Bachelor].pdfRAHUL PAL
In the field of formulations, various software tools are commonly used to streamline and optimize the development process. One such software is formulation management software, which helps in creating and managing formulations by allowing scientists to input ingredient quantities, calculate costs, and analyze ingredient interactions. Additionally, simulation software like computational fluid dynamics (CFD) programs are utilized to model and predict how formulations will behave under different conditions, aiding in the design of efficient manufacturing processes. Furthermore, statistical analysis software plays a crucial role in analyzing experimental data and optimizing formulations based on statistical models, ensuring that the final product meets desired specifications. Overall, these software tools enhance productivity, accuracy, and efficiency in the formulation development workflow.
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
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Influence of Biofield Treatment on Physicochemical Properties of Hydroxyethyl...albertdivis
Hydroxyethyl cellulose (HEC) and hydroxypropyl cellulose (HPC) are widely explored as excipients to improve the solubility of poorly water soluble drugs and to improve self-life of dosage form. This work is an attempt to modulate the physicochemical properties of these cellulose derivatives using biofield treatment.
Ultra performance liquid chromatographic method for simultaneous quantificati...Ratnakaram Venkata Nadh
Plerixafor (PLX) injections are administered to patients with cancers of lymphocytes
(non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main
objective of the current study was to develop a short reverse phase chromatographic
method for the simultaneous quantification of PLX and its impurities, in an injection
formulation, to reduce the time required for these quality tests. Furthermore, the
present work describes the role of nonalkyl branched nonquaternary ion pair reagent
in improving the peak shape and reducing column equilibration time. The separation
of PLX and its related substances is pH dependent (optimum pH = 2.50) and was
achieved on an octadecylsilyl (C18) column. The method was validated for its intended
purpose in accordance with the current regulatory guidelines for validation. The
proposed method can be applied for quality control, release, and stability analyses of
active pharmaceutical ingredient, PLX, as well as finished products, PLX injections
Recent Advancement and Patents of the Lipid Polymer Hybrid Nanoparticlespeertechzpublication
In recent years, robustness and surface engineering of dosage form made improvement in
pharmacokinetics with decrease in dose of drug. Specifi city with adherence of ligands has now become
the reality as surface modifi cation can easily deceive phagocytic system. Lipid molecules ensures the
release of drug at lymphatic system, entrapment of polymeric nanoparticles in lipoidal core led to the
avoidance of disadvantage of low entrapment effi ciency if use of hydrophobic drug with hydrophobic
polymer becomes essential. Various studies have been published and the best formulations with optimal
In vitro and In vivo results are highlighted in this paper. In this review most advanced researches and
accepted patents were discussed so to act as a medium for getting everything regarding lipid polymer
hybrid particles under one umbrella.
In recent years, robustness and surface engineering of dosage form made improvement in pharmacokinetics with decrease in dose of drug. Specificity with adherence of ligands has now become the reality as surface modifi cation can easily deceive phagocytic system. Lipid molecules ensures the
release of drug at lymphatic system, entrapment of polymeric nanoparticles in lipoidal core led to the
avoidance of disadvantage of low entrapment effi ciency if use of hydrophobic drug with hydrophobic polymer becomes essential. Various studies have been published and the best formulations with optimal In vitro and In vivo results are highlighted in this paper. In this review most advanced researches and accepted patents were discussed so to act as a medium for getting everything regarding lipid polymer hybrid particles under one umbrella.
Nanoparticles consists of organic and inorganic materials. Nanocrystals are aggregates of atoms that combine into a “cluster” and are pure drug crystals with sizes in the nanometer range stabilized or surrounded by a thin coating of surfactant. Todays nanocrystal formulation preparation method characterised as “bottom up” “top down” and “bottom up” spray drying methods. The majority of nanocrystal medicinal products are presently approved for oral ingestion and treatment of disorders other than cancer. Smurti Magar | Prof. Santosh Waghmare | Dr. Hemant Kamble "Nanocrystals-As Drug Delivery System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-3 , April 2022, URL: https://www.ijtsrd.com/papers/ijtsrd49563.pdf Paper URL: https://www.ijtsrd.com/humanities-and-the-arts/other/49563/nanocrystalsas-drug-delivery-system/smurti-magar
Piroxicam Nanostructured Lipid Carrier Drug Delivery SystemYogeshIJTSRD
Objective Nanostructured lipid carrier NLC based topical gel of Piroxicam PXM was formulated with the aim of controlled release action and to reduce systemic side effect for the treatment of an arthritic condition. Methods NLCs developed using high pressure homogenization method and optimized using a 32 factorial design with response surface methodology using design expert software. NLCs were characterized for particle size, zeta potential analysis, drug entrapment efficiency, and in vitro drug release studies to select the optimized formulation. The NLCs were suitably gelled and evaluated with respect to homogeneity, pH, viscosity, gel strength, spread ability, rheological characteristics, drug content, in vitro diffusion, and stability study. Safety of the NLC based gel was assessed using primary skin irritation studies, and efficacy was confirmed using carrageen an induced rat paw edema model. Results NLCs formulation comprising 2 of lipid 60 40 and surfactant 1.50 was confirmed as an optimized batch having a particle size 138.2±3.60 nm with polydispersibility index value 0.344±0.034. The zeta potential value indicates good physical stability. Based on the results from the in vitro release study it was shown that the formed gels had the ability to extend release of PXM for 24 h and showing percentage drug release of 90.92 ±1.96 at the end of 24 h. Skin irritation studies revealed that the optimized gel formulation shows no erythema, edema, or ulceration. Conclusion The overall results of the present study clearly indicated promising potentials of NLC based gel for delivering PXM topically over the conventional gel. Dr. G. Jagadish | Dr. Rita Mourya | Dr. Amith Nayak "Piroxicam Nanostructured Lipid Carrier Drug Delivery System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd39912.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/39912/piroxicam-nanostructured-lipid-carrier-drug-delivery-system/dr-g-jagadish
Intermolecular Interactions as a Measure of Dapsone Solubility in Neat Solven...Maciej Przybyłek
Dapsone is an effective antibacterial drug used to treat a variety of conditions. However, the aqueous solubility of this drug is limited, as is its permeability. This study expands the available solubility data pool for dapsone by measuring its solubility in several pure organic solvents: N-methyl-2-pyrrolidone (CAS: 872-50-4), dimethyl sulfoxide (CAS: 67-68-5), 4-formylmorpholine (CAS: 4394-85-8), tetraethylene pentamine (CAS: 112-57-2), and diethylene glycol bis(3-aminopropyl) ether (CAS: 4246-51-9). Furthermore, the study proposes the use of intermolecular interactions as molecular descriptors to predict the solubility of dapsone in neat solvents and binary mixtures using machine learning models. An ensemble of regressors was used, including support vector machines, random forests, gradient boosting, and neural networks. Affinities of dapsone to solvent molecules were calculated using COSMO-RS and used as input for model training. Due to the polymorphic nature of dapsone, fusion data are not available, which prohibits the direct use of COSMO-RS for solubility calculations. Therefore, a consonance solvent approach was tested, which allows an indirect estimation of the fusion properties. Unfortunately, the resulting accuracy is unsatisfactory. In contrast, the developed regressors showed high predictive potential. This work documents that intermolecular interactions characterized by solute–solvent contacts can be considered valuable molecular descriptors for solubility modeling and that the wealth of encoded information is sufficient for solubility predictions for new systems, including those for which experimental measurements of thermodynamic properties are unavailable.
Experimental and Theoretical Insights into the Intermolecular Interactions in...Maciej Przybyłek
Solubility is not only a crucial physicochemical property for laboratory practice but also provides valuable insight into the mechanism of saturated system organization, as a measure of the interplay between various intermolecular interactions. The importance of these data cannot be overstated, particularly when dealing with active pharmaceutical ingredients (APIs), such as dapsone. It is a commonly used anti-inflammatory and antimicrobial agent. However, its low solubility hampers its efficient applications. In this project, deep eutectic solvents (DESs) were used as solubilizing agents for dapsone as an alternative to traditional solvents. DESs were composed of choline chloride and one of six polyols. Additionally, water–DES mixtures were studied as a type of ternary solvents. The solubility of dapsone in these systems was determined spectrophotometrically. This study also analyzed the intermolecular interactions, not only in the studied eutectic systems, but also in a wide range of systems found in the literature, determined using the COSMO-RS framework. The intermolecular interactions were quantified as affinity values, which correspond to the Gibbs free energy of pair formation of dapsone molecules with constituents of regular solvents and choline chloride-based deep eutectic solvents. The patterns of solute–solute, solute–solvent, and solvent–solvent interactions that affect solubility were recognized using Orange data mining software (version 3.36.2). Finally, the computed affinity values were used to provide useful descriptors for machine learning purposes. The impact of intermolecular interactions on dapsone solubility in neat solvents, binary organic solvent mixtures, and deep eutectic solvents was analyzed and highlighted, underscoring the crucial role of dapsone self-association and providing valuable insights into complex solubility phenomena. Also the importance of solvent–solvent diversity was highlighted as a factor determining dapsone solubility. The Non-Linear Support Vector Regression (NuSVR) model, in conjunction with unique molecular descriptors, revealed exceptional predictive accuracy. Overall, this study underscores the potency of computed molecular characteristics and machine learning models in unraveling complex molecular interactions, thereby advancing our understanding of solubility phenomena within the scientific community.
SiO2@FeSO4 nano composite: A recoverable nano-catalyst for eco-friendly synth...Iranian Chemical Society
Various aldoximes and ketoximes synthesis of corresponding aldehydes and ketones in the presence of SiO2@FeSO4 nano composite as recoverable nano catalyst and NH2OH·HCl. The SiO2@FeSO4 nano composite system was carried out between 10 to 15 min in oil bath (70-80 °C) under solvent-free condition in excellent yields in addition this protocol can be used for industrial scales. This method offers some advantages in term of clean reaction conditions, easy work-up procedure, short reaction time, applied to convert α-diketones to α-diketoximes (as longer than other carbonyl compounds), α,β-unsaturated aldehydes and ketones to corresponding oximes and suppression of any side product. So we think that NH2OH•HCl/SiO2@FeSO4 nano composite system could be considered a new and useful addition to the present methodologies in this area. Structure of products and nano composite elucidation was carried out by 1H NMR, 13C NMR, FT-IR, scanning electron microscopy (SEM).
A New Low Cost Biosorbent for a Cationic Dye TreatmentIJEAB
The aim of our study consists to investigate the adsorption of Methylene Blue from aqueous solution by a new biosorbent prepared from Papaya seed. Adsorption behavior of the cationic dye was analyzed by variation of solution pH, contact time, adsorbent dose, and temperature. Adsorption isotherms were studied according to the Langmuir and Freundlich Model, and adsorption kinetics according to pseudo first and second order. Results show that the maximum adsorption is obtained at ambient temperature with the yield of 98.82% and was reached in first 20min (pH = 10, adsorbent dose of 100 mg in 50 mL). The Langmuir isotherm shows a correlation coefficient of 99.4% higher than 95.4%obtained for Freundlich model and the adsorption kinetic model follow a pseudo-second order with a maximum adsorption capacity of 52.28 mg/g.
A review on solid lipid nanoparticles : A modern formulation approach in drug delivery system
Similar to The Utilization of 32 Full Factorial Design (FFD) for Optimization of Lincomycin Hydrochloride (LNH) Loaded Nanogel Involving; Design of Experiments (DoE) an Advanced Approach (20)
Software Used In Formulation Design Process- Minor Project [Bachelor].pdfRAHUL PAL
In the field of formulations, various software tools are commonly used to streamline and optimize the development process. One such software is formulation management software, which helps in creating and managing formulations by allowing scientists to input ingredient quantities, calculate costs, and analyze ingredient interactions. Additionally, simulation software like computational fluid dynamics (CFD) programs are utilized to model and predict how formulations will behave under different conditions, aiding in the design of efficient manufacturing processes. Furthermore, statistical analysis software plays a crucial role in analyzing experimental data and optimizing formulations based on statistical models, ensuring that the final product meets desired specifications. Overall, these software tools enhance productivity, accuracy, and efficiency in the formulation development workflow.
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosome An Non-Ionic Surfactant Vesicles.pptxRAHUL PAL
Niosomes are novel drug delivery systems that have garnered significant interest in the pharmaceutical field. They are essentially vesicles composed of non-ionic surfactants and cholesterol, forming a bilayer structure similar to liposomes. However, unlike liposomes, which are composed of phospholipids, niosomes are formed by self-assembly of non-ionic surfactants in aqueous media. This unique composition offers several advantages such as improved drug solubility, stability, and biocompatibility.
The introduction of niosomes as drug carriers has revolutionized the field of drug delivery due to their ability to encapsulate both hydrophilic and hydrophobic drugs. This versatility allows for targeted and controlled release of therapeutics, enhancing their efficacy while minimizing side effects.
Moreover, the surface of niosomes can be modified to achieve specific targeting of drugs to desired sites within the body, thus enhancing therapeutic outcomes and reducing systemic toxicity.
Overall, niosomes hold great promise in the pharmaceutical industry and continue to be a subject of intense research for their potential applications in various fields including cancer therapy, gene delivery, and vaccine development.
𝐎𝐫𝐚𝐥 𝐏𝐚𝐩𝐞𝐫 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 (𝐈𝐑𝐓𝐄𝐂 𝟐.𝟎-𝟐𝟎𝟐𝟒); The Curre...RAHUL PAL
Targeted drug delivery systems are employed to administer pharmaceutical medication,
facilitating the precise delivery of drugs to specific diseased areas. Several drug delivery
systems utilise carriers such as antibodies, transdermal patches, biodegradable polymers,
nanoparticles (NPs), liposomes, niosomes, and microspheres. Niosomes, on the other hand,
represent a promising and innovative category of vesicular systems. Niosomes are vesicles
formed by hydrating a combination of nonionic surfactants and cholesterol. These non-ionic
surfactant vesicles serve as carriers for both amphiphilic and lipophilic drugs. In the drug
delivery system using niosomes, the medication is enclosed within a vesicle. Niosomes in
tuberculosis (TB) possess biodegradable and biocompatible properties, are non-immunogenic,
and demonstrate versatility in their structural composition. It’s a serious and potentially deadly
infectious disease caused by a bacteria called Mycobacterium tuberculosis. In the recent
update, WHO still estimates 9.9 million new TB cases in 2022 at the latest. Involvement of
niosomes improves the treatment of TB with much more advanced technology and an advanced
drug nanocarrier with better treatment. The main highlights of this review paper are to
summarise the structure, compositions, preparation methods, and ICH stability guidelines for
the formulation of niosomes and their applications in TB with their several stages of treatment
by niosomal formulations.
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
THE CURRENT STATUS IN MUCOSAL DRUG DELIVERY SYSTEM (MDDS) AND FUTURE PROSPECT...RAHUL PAL
This systematic review aims to provide a comprehensive overview of the current status of
mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery.
MDDS have gained significant attention in recent years due to their potential to enhance drug
absorption, improve therapeutic efficacy, and minimize systemic side effects. This review
critically evaluates the existing literature on MDDS, including various mucosal routes such as
oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges
associated with MDDS, such as formulation development, stability, and regulatory
considerations. Furthermore, this review highlights emerging technologies and innovative
strategies that hold promise for the future of MDDS. Overall, this systematic review provides
valuable insights into the current landscape of MDDS and offers recommendations for future
research and development in this field.
Design of Experiments (DoE) manipulation in the formulation and optimization ...RAHUL PAL
Introduction: In India, the regulatory body for catechu is the Food Safety and Standards Authority of
India (FSSAI). The FSSAI is responsible for regulating the manufacture, sale, and distribution of food in
India, including catechu. The FSSAI has set standards for the purity and quality of catechu, and it also
monitors the market for adulterated catechu. The FDA (The Food and Drug Administration) is
responsible for regulating the safety and efficacy of drugs and dietary supplements in the United States
(US). The FDA has not approved catechu as a drug or dietary supplement, but it does regulate catechu as
a food additive. The FDA has set limits on the amount of catechu that can be added to food
Objective: The primary objective of this research was to involvement of design of experiments (DoE)
manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried
extract of Senegalia catechu enhanced through statistical analysis.
Methodology: The dried extract of Senegalia catechu was collected and identified at the botanical
herbarium garden. Subsequently, it underwent a drying process and was ground into a powder.
Determination of Partition coefficient of Known and Unknown drug.pdfRAHUL PAL
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.pptRAHUL PAL
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition Coefficient Determination (Pharmaceutics Practical).pptxRAHUL PAL
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)RAHUL PAL
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
The Utilization of Response Surface Methodology (RSM) In the Optimization of ...RAHUL PAL
The objective of the current studies to enhance the formulation of DS-loaded liposomes through the utilization of Response surface methodology (RSM) and involving the computation approach for their validation.
Investigational outcome represents the perceived responses were in related with the desired values and this represents the relationship of the RSM for optimization of % DR and % EE in DS loaded liposomal preparations.
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...RAHUL PAL
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
Research Article Published: "Optimization and formulation of dox loaded lipos...RAHUL PAL
Doxorubicin (DOX) is a potent anticancer drug, but it is also associated with significant side effects, such as cardiotoxicity. Liposomal encapsulation of DOX can help to reduce these side effects and improve the drug's efficacy.
There are a number of different factors that can affect the optimization and formulation of DOX-loaded liposomes, including:
Lipid composition: The type and ratio of lipids used to form the liposomes can affect their size, stability, and drug encapsulation efficiency. Some commonly used lipids for DOX liposomes include hydrogenated soy phosphatidylcholine (HSPC), cholesterol, and distearoylphosphatidylglycerol (DSPG).
Drug loading method: There are a number of different methods for loading DOX into liposomes. Some common methods include the ammonium sulfate gradient method, the remote loading method, and the ethanol injection method. The choice of loading method can affect the drug encapsulation efficiency and stability of the liposomes.
Liposome size: The size of the liposomes can affect their circulation time in the body and their ability to target specific tissues. Smaller liposomes tend to have a longer circulation time and are better able to penetrate tumors.
Surface modification: Liposomes can be surface-modified with various ligands to improve their targeting and delivery properties. For example, liposomes can be conjugated with antibodies to target specific cancer cells.
The optimization of DOX-loaded liposomes is typically carried out using a quality by design (QbD) approach. QbD is a systematic approach to drug development that focuses on identifying and controlling the critical quality attributes (CQAs) of the drug product. The CQAs of DOX-loaded liposomes may include particle size, drug encapsulation efficiency, stability, and in vitro and in vivo performance.
Nucleic Acid Based Therapeutics Delivery.pdfRAHUL PAL
Nucleic acid-based therapeutics (NATs) are a promising new class of drugs that have the potential to treat a wide range of diseases, including cancer, genetic disorders, and infectious diseases. NATs work by directly targeting the genetic material of cells, either to alter gene expression or to repair damaged DNA or RNA.
However, delivering NATs to cells can be challenging. Nucleic acids are large and fragile molecules, and they can be easily degraded by enzymes in the body. Additionally, NATs need to be able to cross the cell membrane and enter the cytoplasm in order to function.
Nucleic acid-based therapeutics delivery is a rapidly evolving field, and new delivery systems are being developed all the time. As delivery systems improve, NATs are becoming more and more viable as treatments for a wide range of diseases.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Lincomycin Hydrochloride (LNH) Loaded Nanogel Involving; Design of Experiments (DoE) an Advanced Approach
1. _____________________________________________________________________________________________________
++
Lecturer;
#
Assistant Professor;
*Corresponding author: E-mail: palsrahul330@gmail.com;
Adv. Res., vol. 24, no. 6, pp. 272-281, 2023
Advances in Research
Volume 24, Issue 6, Page 272-281, 2023; Article no.AIR.110951
ISSN: 2348-0394, NLM ID: 101666096
The Utilization of 32
Full Factorial
Design (FFD) for Optimization of
Lincomycin Hydrochloride (LNH)
Loaded Nanogel Involving; Design
of Experiments (DoE) an Advanced
Approach
Rahul Pal a*, Prachi Pandey a, Devanand Jha b++,
Prottay Dutta c#, Subhashree Sahoo c#,
Rishabh Gupta d#, Mohammad Rizwan e#,
Madhuri Sahdev Keskar f#, Vikash Kumar g++
and Himmat Singh Chawra a
a Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur,
Rajasthan, 303121, India.
b Department of Pharmacology, Dhanarua School of Nursing & Paramedics, Aryabhatta
Knowledge University (AKU), Patna, 804451, India.
c Department of Pharmacy, Usha Martin University, Ranchi, Jharkhand, 835103, India.
d Department of Pharmacy, Jagannath University, Jaipur, Rajasthan, 303901, India.
e Department of Pharmaceutical Science, Sir J. C. Bose Technical Campus, Bhimtal,
Kumaun University, Nainital, 263136, India.
f Department of Pharmaceutics, Rajgad, Dnyanpeeth's College of Pharmacy, Savitribai,
Phule Pune University, Bhor, Pune, 412206, India.
g Department of Pharmaceutical Chemistry, Sai Baba Institute of Pharmaceutical, India.
Authors’ contributions
This work was carried out in collaboration among all authors. All authors read and approved the final
manuscript.
Article Information
DOI: 10.9734/AIR/2023/v24i61009
2. Pal et al.; Adv. Res., vol. 24, no. 6, pp. 272-281, 2023; Article no.AIR.110951
273
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Received: 14/10/2023
Accepted: 19/12/2023
Published: 21/12/2023
ABSTRACT
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced.
Conclusion: The nanogels containing drugs were tested for drug release, PDI, and particle size.
The standardized formulation, ER12, was achieved successfully. Consequently, it was determined
that LNH can be formulated as nanogels that can maintain drug release for 24 hours. This shows
potential for improved drug delivery in topical treatments, surpassing the effectiveness of traditional
therapy formulations.
Keywords: Design of experiments; optimization; formulations; nanogel; lincomycin; infection;
antibiotics; lincosamide; response surface methodology; advance vehicles.
1. INTRODUCTION
Lincomycin hydrochloride (LNH) is a broad-
spectrum antibiotic with limited oral bioavailability
and poor penetration into target tissues.
Nanogels, due to their unique properties like
sustained release, site-specific delivery, and
enhanced bioavailability, offer a promising
approach for improving the therapeutic efficacy of
lincomycin hydrochloride. Streptococcal
gangrene is a rare but serious condition caused
by Group a Streptococcus (GAS) bacteria [1-2]. It
is characterized by rapid tissue death and
destruction, often accompanied by severe pain
and fever. LNH is a member of the lincosamide
class, functioning as an antibiotic. Its efficacy
against GAS bacteria has been demonstrated,
making it a valuable option for treating
streptococcal gangrene. LNH belongs to the BCS
Class III classification. This means it has high
solubility in aqueous solutions but low
permeability across biological membranes,
including the intestinal wall. LNH is a salt with
hygroscopic properties, which implies that it has
the ability to absorb moisture from the
surrounding air [3-5].
Consequently, it is crucial to store LNH in a
container that is tightly sealed to prevent any
moisture from entering. In addition, LNH exhibits
solubility in aqueous solutions within a pH range
of 4-8. The chemical structure of LNH can be
observed in Fig. 1 as below followings.
The physicochemical properties of LNH
discussed in the below Table 1 as followings:
Nanogels are three-dimensional, cross-linked
polymeric networks with sizes ranging between
10-1000 nanometers. They are a specific class of
Original Research Article
3. Pal et al.; Adv. Res., vol. 24, no. 6, pp. 272-281, 2023; Article no.AIR.110951
274
nanomaterials characterized by their high water
content, swelling ability, and tunable properties
[6]. Nanogels, as robust nanoparticles, offer a
promising solution for controlled drug delivery
applications. Their unique chemical composition
and formulations make them suitable for
delivering both hydrophilic and hydrophobic
drugs, ensuring effectiveness and safety. By
utilizing functionalized nanoparticles as drug
carriers, nanogels enable the controlled release
of drugs and other active materials at specific
sites. This advanced drug delivery system
demonstrates enhanced drug release and
improved drug penetration, positioning it as a
promising option for the topical administration of
LNH in the management of streptococcal
gangrene [7-9].
Fig. 1. The chemical (Molecular) structure
representation of LNH with IUPAC
Table 1. The physicochemical properties of
LNH
Sr. No. Property Value
01. Molecular Weight 406.99 g/mol
02. Melting Point 165-167 °C
03. Boiling Point Decomposes
04. Log P -0.5
05. Water Solubility 1.0 mg/mL
06. pKa 7.7
DoE provides a structured and efficient
methodology for optimizing the formulation
process. A 32 FFD is a type of DoE that
investigates the impact of multiple factors and
their interactions on the desired response. This
approach can be advantageous for optimizing
LNH-loaded nanogels due to its ability to:
• Analyze the main effects and interactions
of various formulation factors on the
nanogel properties.
• Decrease the quantity of experimental runs
necessary when compared to traditional
one-factor-at-a-time experiments.
• Develop a statistically robust model that
can predict the nanogel properties based
on the selected formulation factors [6-10].
The pharmaceutical industry places significant
importance on the selection and optimization of
formulation and process variables. DoE has
become an invaluable tool for efficiently handling
quality risks. It starts by setting clear objectives
and concentrates on improving our
comprehension of product and process
parameters. The 32 FFD is a widely employed
design style in DoE, enabling us to systematically
estimate main effects and interactions [11].
Moreover, the application of optimization
techniques further enhances the predictability of
dosage forms. RSM is a widely recognized DoE
tool that maximizes the extraction of valuable
information from well-designed experiments [12-
13].
The main goal or objective of this research work
to used Factorial Design at 32 level in the
optimization as well as the formulation of LNH-
loaded nanogel and validate with statistical
analysis data validation. The LNH nanogel
formulate by the using two different techniques
for the using of statistics as ANOVA for the
current study.
2. MATERIALS AND METHODS
2.1 Chemicals and Agents
Mylan laboratory Ltd kindly provided a gift
sample of Lincomycin Hydrochloride (LNH). SD
Fine Chemicals Ltd supplied Chitosan,
Polyvinyl alcohol (PVA), Dichloromethane,
Triethanolamine, Di-sodium hydrogen
orthophosphate, Glycerine Propylene glycol, and
Potassium dihydrogen orthophosphate.
Research Institute, Mumbai provided Carbopol
and Methanol. Qualigens fine chemicals supplied
Sodium hydroxide pellets, and Leo chem. R.D
fine chemicals limited, Mumbai supplied
Disodium Hydrogen Phosphate.
2.2 Preparation of Clindamycin Nanogel
LNH nanogels were prepared utilizing the
Nanoprecipitation method [9-13], employing
Chitosan and Tween 80 as stabilizing agents. To
achieve maximum stability and avoid clumping or
settling, the drug and polymer were combined in
glycerol while being constantly stirred on a
magnetic stirrer, ensuring optimal results. This
resulted in complete dissolution of the drug and
polymer, and the formation of nanoparticles
4. Pal et al.; Adv. Res., vol. 24, no. 6, pp. 272-281, 2023; Article no.AIR.110951
275
through the Nanoprecipitation method. For the
preparation of the nanogel, the Dispersion
method was employed using Carbopol 934,
which was soaked in water for several hours to
allow for swelling [14-16]. The Carbopol, which
had become swollen, was subsequently
positioned on a magnetic stirrer to continue the
stirring process. In order to improve penetration,
PEG was introduced into the Carbopol mixture,
along with either the equivalent amount of the
drug or the separate nanoparticulate system.
Furthermore, triethanolamine was included in the
nanogel mixture to ensure the pH of the
formulation remained stable. Ultimately, the
formation of the nanogels was achieved.
2.3 Utilization of Design Expert for
Optimization
This procedure underwent optimization studies
with utilization of 3² FFD (Design Expert Software
Trial version 10.0.7), resulting in 9 runs. The
independent variables chosen were the
concentration of Chitosan (R1) and Carbopol 934
(R2). The dependent variables included PS (P1),
PDI (P2), and % DR (P3). The formulations was
labeled with ER1, ER2, and ER3 & ER9, with 4
control formulations provided by the model. For
the optimization studies, three different
concentrations of the polymer (5.5, 11, and 16
mg) were selected. These studies demonstrate
how the responses change when both factors are
altered simultaneously [15-18]. The experiment
was carried out at three distinct levels: -1, 0, and
+1, which corresponded to low, medium, and
high concentrations, respectively. The
optimization results are presented in Table. 2 and
Table. 3 as follows:
The Table. 02 and Table. 03 display the values of
the independent variables, both in coded and
actual forms with briefly.
2.4 Data Optimization
The current optimization study: involved the
utilization of Design Expert software to perform
various response surface methodology (RSM)
computations. Multiple linear regression analysis
(MLRA) techniques were employed to generate
polynomial models with interaction for all the
response variables [19].
To assess the impact of the independent
variables: on the responses, the researchers
utilized the statistical technique known as
Analysis of Variance (ANOVA) through the
implementation of Design Expert software
(version 10.0.7). In order to establish statistical
significance, a significance level of p < 0.05 was
adopted.
To visualize the variance in the response
surface: Three-dimensional plots were created
to visualize the measured responses. These
plots prove to be highly valuable when examining
the influence of two factors on the response
concurrently, as they offer a graphical depiction
of how independent variables affect the
responses [20-21].
3. RESULTS AND DISCUSSION
3.1 The Production of Polynomial
Equation
This interactive polynomial terms generate by the
statistical model for each response can be
represented by the following equations:
Y = α0 + α1R + α2P + α3RP + α4R2 + α5P2 Equation (1)
In this equation, the variable Y is used to
represent the independent variable. The
coefficient β0 corresponds to the arithmetic mean
response of the nine runs, while α 1 represents
the estimated coefficient for factor R. The main
effects of factors R and P provide insight into the
average outcome when these factors are
individually altered from their lower to higher
values. On the other hand, the interaction terms
(RP) illustrate how the response changes when
both factors are simultaneously modified [22].
The data acquired from the Department of
Energy (DoE) indicates a strong correlation
between the chosen independent variables and
particle size, PDI, and %DR. Analysing the
polynomial equations allows for various
conclusions to be drawn based on the
mathematical signs they exhibit. Specifically,
positive and negative signs indicate synergistic
and antagonistic effects, respectively.
P1 – (PS) = 429.79 –47.17 R –29.21 P + 2.21 RP + 48.19 R2
+ 14.18P2 Equation (02)
P2– (PDI) = 0.54–0.017R –0.066P –0.19RP –0.078 R2
+0.088P2 Equation (03)
P3 – (%DR) = 63.52+ 6.26R + 10.89P –5.88RP + 6.29 R2 +
4.76 P2 Equation (04)
Where, R= Chitosan Con. and P= Carbopol 934
conc. for the formulation.
The average result is mainly affected by the
amount of R and P, showing how the variables
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Table 2. The values of independent variables in the coded form
Independent
Variables
ER1 ER2 ER3 ER4 ER5 ER6 ER7 ER8 ER9 ER10 ER11 ER12 ER13
R1 -1 -1 0 1 0 1 -1 1 -1 0 1 1 -1
R2 0 -1 0 1 -1 0 -1 -1 1 1 1 -1 1
Table 3. The values of coded and actual independent variable
Coded Value Actual Value (mg)
-- R1 R2
-1 5.5 0.03
0 11 0.08
1 16 0.12
change from lower to higher values. The
interaction coefficients (RP) demonstrate how
the response changes when both variables are
modified at the same time. According to the
polynomial equation, when the polymer
concentration and gelling agent increase, the
particle size of the formulation decreases and
shows a PDI of less than 0.5 nm [23-25].
Additionally, the percentage of DR also
increases.
3.2 Statistical Analysis of Data
ANOVA was utilized to identify insignificant
factors. The data was analyzed using Design-
Expert Software (version 11.0). It was evident
from the obtained data that the p-value was less
than 0.05 (p<0.05) for all the dependent
variables. The Model F values for PS, PDI, and
%DR were 14.01 (P1), 16.67 (P2), and 12.47
(P3) respectively, indicating the significance of
the model. R-Squared serves as a measure of
goodness-of-fit for linear regression
models, representing the percentage of
variance in the dependent variable
explained collectively by the independent
variables [26].
The using of 32 factorial design tom identifies the
independent variables have a significance effect
on the dependent variables. They also used for
the determination of increasing the polymer and
drug con. When might increasing size in PS, PDI
as well as LNH con. for the more accuracy. The
design also identifies the interaction between the
independent variables, that’s meaning the effect
of one variable depends on the level of the
other.
Table 4. The ANOVA values for the models model-F value of PS (P1) [25-26]
Ingredients Sum of
squares
df Mean
Square
value p-value Probability
>F
Models 23020.04 4.9 4909.03 13.12 0.0361
R-CHITOSAN 12489.19 0.08 12489.19 39.91 0.0089
P- CARBOPOL934 5460.17 1 5460.17 15.93 0.0282
RP 20.25 1 20.25 0.059 0.8236
R2 4834.72 1 4834.72 14.11 0.0330
P2 346.72 1 346.72 1.01 0.3886
Remaining Value 1031.22 3.4 334.71 -- --
Final Values 26037.35 7.8 -- -- --
Table 5. The ANOVA for models indicating-Squared value Model-F value of PS [27]
Standard Deviation 19.53 R2
Value 0.9479
Total Mean 472.44 Adjustable R2
0.9804
CV% 3.92 Predictable R2
0.5368
-- 11869.57 Precision 11.415
3.3 Generation of 3D Response Surface
Plots
The 3D plots were utilized to analyze the
measured responses and identify any changes
in the response surface. This plots proved to a
valuable in examining the impact of two factors
on the response simultaneously. The surface
plots generated aligned with the polynomial
term, providing insights into the influence of
6. Pal et al.; Adv. Res., vol. 24, no. 6, pp. 272-281, 2023; Article no.AIR.110951
277
Chitosan concentration (R1) and carbopol 934
concentration (R2) on the responses [26-29].
The impact of independent variables on the
dependent variables is illustrated through the 3D
plots displayed in Fig. 02 to 06. The Fig. 03
focuses on presenting the 3D response plots for
particle size (P1), revealing a decrease in
particle size as the concentration of Chitosan
increases and the concentration of carbopol 934
decreases. Likewise, the counter plots in Fig. 02
also exhibit a decrease in particle size with an
increase in the concentration of the polymer and
gelling agent [30].
Table 6. The ANOVA for quadratic models of PDI (P2) [26-28]
Ingredients Sum of
Square
df Mean Square F Value p-value Probability
>F
Models 0.12 4.8 0.036 17.61 0.0216
R-CHITOSAN 3.054E-004 1 2.054E-003 1.35 0.3416
P-CARBOPOL 934 0.019 1 0.019 12.10 0.0401
RP 0.084 1 0.083 53.79 0.0066
R2 8.778E-004 1 8.778E-004 6.78 0.0882
P2 0.018 1 0.018 11.42 0.0431
Remaining Value 4.611E-003 3 1.537E-003
Final Values 2703.32 8.3 -- -- --
Table 7. The ANOVA for models indicating R2
Value Model-F value of PDI [29]
Standard Deviation 0.039 R2
Value 0.9652
Total Mean 0.54 Adjustable R2
Value 0.9073
CV% 7.25 Predictable R2
Value 0.6317
-- 0.049 Precision 12.381
Table 8. The ANOVA for quadratic models model-F value of % DR (P3) [28-29]
Ingredients Sum of
squares
df Mean Square F-Value p-value Probability
>F
Models 1291.12 5.1 259.23 13.42 0.0421
R-CHITOSAN 234.03 1 232.02 12.17 0.0341
P-
CARBOPOL934
836.15 1 836.15 40.39 0.0079
RP 96.33 1 96.33 4.65 0.1199
R2 80.35 1 80.35 3.88 0.1434
P2 48.29 1 47.28 2.38 0.2269
Remaining
Value
64.12 2.9 21.72 -- --
Final Values 1254.23 7.9 -- -- --
Fig. 2. The schematic representation of counter plot: RP1: The Counter plot for PS; RP2: The
counter plot for the PDI
7. Pal et al.; Adv. Res., vol. 24, no. 6, pp. 272-281, 2023; Article no.AIR.110951
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Fig. 3. The schematic representation of 3D response surface of PS (Particle Size)
Table 9. The ANOVA for models indicating R2
Value Model-F value of % DR [27]
Standard Deviation 4.66 R2
Value 0.9531
Total Mean 62.66 Adjustable R2
Value 0.9665
CV% 8.19 Predictable R2
Value 0.4671
833.43 Precision 12.54
Fig. 4. The PDI is shown on the Surface plot, which demonstrates the impact of Chitosan and
Carbopol 934 Concentration
The response plots in 3D for PDI (P2) depicted
in Fig. 05 demonstrate a decrease in PDI with a
notable increase in the concentration of polymer
and gelling agent.
The 3D response plots for the percentage of
drug release %DR of (P3) are shown in Fig. 05
and Fig. 06. The graphs demonstrate that
increasing the concentration of Chitosan and
carbopol 934 initially leads to a notable increase
in %DR. This can be attributed to the
combination of the same concentration of
polymer and gelling agent, resulting in a higher
overall polymer concentration [29-31].
Chitosan had different impacts on the drug
release percentage (% DR). Initially, when the
concentration of Chitosan in the formulation
decreased, there was a decrease in % DR.
However, when the concentration remained
unchanged, there was an increase in the
percentage of drug release [31]. This can be
8. Pal et al.; Adv. Res., vol. 24, no. 6, pp. 272-281, 2023; Article no.AIR.110951
279
attributed to the combined effect of the polymer
and gelling agent concentration, which had a
stronger influence on the drug release
percentage.
Fig. 5. The Response Surface Plots of
Chitosan and Carbopol 934 for % DR are
presented in a 3D format
Fig. 6. The Contour Plots for % DR provide a
visual representation of the impact of two
factors on the response
The formulation 12 (ER12), which exhibited a
favorable PDI range, was chosen as the
optimized formulation for evaluation studies
based on the highest drug release achieved
from a 32 FFD with 2 factors and 3 levels [32].
4. CONCLUSION
The Design Expert software was utilized to
analyze the response surface of a 3-level FD
with 13 runs in a quadratic model. The
formulations were developed using a 3² full
factorial design, allowing for the concurrent
evaluation of two formulation variables and their
interaction. The utilization of 32 FFD combined
with advanced approaches can significantly
improve the development and optimization of
LNH-loaded nanogels. This can lead to the
production of nanogels with superior properties
and enhanced therapeutic efficacy for various
clinical applications.
The comparison of these variables took place
across three levels: high, medium, and low. An
examination of the impact of these factors on the
dependent variables, specifically PS (P1), PDI
(P2), and % DR (P3), was conducted through
the utilization of a polynomial equation. The
significant findings derived from the 3² FFD
yielded valuable insights that greatly contributed
to the successful advancement of LNH Nanogel
for topical administration. Through a comparison
of the observed and projected outcomes, it
became apparent that the RSM effectively
optimized the formulation of LNH Nanogel,
resulting in the desired PS and DR
characteristics. Optimization, a sophisticated
experimental process commonly employed in
nanoparticle development, enables the creation
of robust preparation techniques that
consistently yield the desired product
characteristics. Factorial designs, widely utilized
for optimization purposes, help identify the key
factors influencing the output and determine the
optimal levels of these variables for achieving an
improved and desired dosage form.
COMPETING INTERESTS
Authors have declared that no competing
interests exist.
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