(6)6 sy comparative efficacy of four ayurvedic antidiabetic formulations in a...Kiran Kumar
1) The study evaluated the efficacy of four Ayurvedic antidiabetic formulations (A, B, C, D) in lowering blood glucose and lipid levels in alloxan-induced diabetic rabbits.
2) Formulation A showed the earliest onset of action at 8 hours and was the most effective at reducing blood glucose levels over a sustained period, compared to the other formulations and tolbutamide.
3) Formulation A also significantly lowered lipid levels and was the most effective antihyperlipidemic agent among the four formulations tested.
Fabrication and evaluation of a stable flurbiprofen hydrogelpharmaindexing
This study aimed to fabricate and evaluate a stable 6% flurbiprofen hydrogel for topical delivery. Flurbiprofen hydrogel was prepared using carbopol 940 as the thickening agent. Stability studies were conducted over 28 days at different temperatures (2-40°C, 25°C, 40°C) by assessing parameters like liquefaction, color, phase separation, centrifugation and pH. The hydrogel showed no changes in these parameters, and pH values remained stable. Drug content of the hydrogel was 76.3% flurbiprofen. In vitro drug release studies found 79.46% of drug was released after 8 hours, indicating the formulation was stable for topical use.
Formulation and invivo evaluation of mucoadhesive microspheres embedded clero...SriramNagarajan19
In this study an attempt was made to prepare mucoadhesive microcapsules of Clerodendrum phlomidis extract using alginate polymers for prolonged release. Encapsulation of extract into sodium alginate polymer was done by ionic-gelation technique. In vivo testing of the mucoadhesive microcapsules in diabetic albino rats demonstrated significant antidiabetic effect of extract. The hypoglycemic effect obtained by mucoadhesive microcapsules was for more than 16 h whereas plain CP extract produced an antidiabetic effect for only 4 h suggesting that mucoadhesive microcapsules are a valuable system for the long term delivery of CP extract. In-vivo data obtained over a 120-h period indicate that CP extract loaded alginate microspheres from batch F7 showed the better glycemic control than control and a commercial brand of the drug.
A new analytical method development and validation for the simultaneus estima...SriramNagarajan19
A simple and selective LC method is described for the determination of Albuterol and Ipratropium Bromide in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 80 volumes of methanol and 20 volumes of water with detection of 239 nm. Linearity was observed in the range 36-84 µg /ml for Albuterol (r2 =0.996) and 6-14 µg /ml for Ipratropium Bromide (r2 =0.997) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim.
The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.
Formulation and evaluation of gastroretentive ciprofloxacin hcl effervescent ...Sagar Savale
Ciprofloxacin HCL is an effervescent Tablet is made by Wet Granulation Method. Ciprofloxacin is a broad
spectrum Fluroquinolon antibiotics. Is mainly used for various Bacterial Infections. In this tablet bitter taste
was masked by saccharine as sweeting agent furthermore the effervescent effect of citric acid, tartaric acid
and sodium bicarbonate lead to Effervescent activity by realising the CO2 Molecule. Tablets are rapidly
dissolved and rapidly absorbed and give maximum activity. The Prepared Effervescent Tablet is Evaluated
In terms of bulk density, tapped density, angle of repose, Carr’s Index and, hardness test, weight variation
test, friability test and in vitro study. The result associated in Optimized batch is good to Satisfactory and
having a good free flowing property. The hardness, weight variation, and friability these values are within
the pharmacopeia limit. The in vitro Dissolution studies show Maximum percentage of release of drug
(99.26) with in end of 5 min.
NOVEL SIMULTANEOUS SEPARATION AND QUANTITATIVE DETERMINATION OF FOUR SARTANS...Dr. Ravi Sankar
The core AIM of the present study is to develop a novel, rapid, precise and accurate RP-HPLC method for simultaneous separation and quantification of Hydrochlorothiazide along with four sartans Telmisartan(TELM), Losartan(LOSA), Olmesartan(OLME) and Valsartan(VALS).
To develop Novel methods for separation and quantification of all the above said drugs on single chromatographic system without any minor changes in detection wavelength and mobile phase composition.
This document discusses in vitro-in vivo correlation (IVIVC) which aims to establish a relationship between a drug product's in vitro dissolution profile and its in vivo performance. It defines IVIVC and describes the different levels (A, B, C) based on the strength of correlation. A Level A correlation allows using the in vitro dissolution curve as an alternative to in vivo studies for quality control. It is the most informative for regulatory purposes. Level B uses mean dissolution time comparisons while Level C correlates a single dissolution time point to a pharmacokinetic parameter.
Expt. 8 Hypoglycemic effect of insulin in rabbitVISHALJADHAV100
This experiment aims to evaluate the hypoglycemic effect of insulin in rabbits at different time intervals. Healthy rabbits weighing 1800-3000 grams were fasted for 18 hours before being injected with 1 unit per ml of insulin. Blood glucose levels were measured initially and then every hour for 5 hours post-injection. Insulin caused blood glucose levels to decrease over time, demonstrating its ability to lower blood sugar as it stimulates glucose uptake into cells. The mean percentage decrease in glucose at each interval determined the hypoglycemic potency of insulin over the study period.
(6)6 sy comparative efficacy of four ayurvedic antidiabetic formulations in a...Kiran Kumar
1) The study evaluated the efficacy of four Ayurvedic antidiabetic formulations (A, B, C, D) in lowering blood glucose and lipid levels in alloxan-induced diabetic rabbits.
2) Formulation A showed the earliest onset of action at 8 hours and was the most effective at reducing blood glucose levels over a sustained period, compared to the other formulations and tolbutamide.
3) Formulation A also significantly lowered lipid levels and was the most effective antihyperlipidemic agent among the four formulations tested.
Fabrication and evaluation of a stable flurbiprofen hydrogelpharmaindexing
This study aimed to fabricate and evaluate a stable 6% flurbiprofen hydrogel for topical delivery. Flurbiprofen hydrogel was prepared using carbopol 940 as the thickening agent. Stability studies were conducted over 28 days at different temperatures (2-40°C, 25°C, 40°C) by assessing parameters like liquefaction, color, phase separation, centrifugation and pH. The hydrogel showed no changes in these parameters, and pH values remained stable. Drug content of the hydrogel was 76.3% flurbiprofen. In vitro drug release studies found 79.46% of drug was released after 8 hours, indicating the formulation was stable for topical use.
Formulation and invivo evaluation of mucoadhesive microspheres embedded clero...SriramNagarajan19
In this study an attempt was made to prepare mucoadhesive microcapsules of Clerodendrum phlomidis extract using alginate polymers for prolonged release. Encapsulation of extract into sodium alginate polymer was done by ionic-gelation technique. In vivo testing of the mucoadhesive microcapsules in diabetic albino rats demonstrated significant antidiabetic effect of extract. The hypoglycemic effect obtained by mucoadhesive microcapsules was for more than 16 h whereas plain CP extract produced an antidiabetic effect for only 4 h suggesting that mucoadhesive microcapsules are a valuable system for the long term delivery of CP extract. In-vivo data obtained over a 120-h period indicate that CP extract loaded alginate microspheres from batch F7 showed the better glycemic control than control and a commercial brand of the drug.
A new analytical method development and validation for the simultaneus estima...SriramNagarajan19
A simple and selective LC method is described for the determination of Albuterol and Ipratropium Bromide in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 80 volumes of methanol and 20 volumes of water with detection of 239 nm. Linearity was observed in the range 36-84 µg /ml for Albuterol (r2 =0.996) and 6-14 µg /ml for Ipratropium Bromide (r2 =0.997) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim.
The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.
Formulation and evaluation of gastroretentive ciprofloxacin hcl effervescent ...Sagar Savale
Ciprofloxacin HCL is an effervescent Tablet is made by Wet Granulation Method. Ciprofloxacin is a broad
spectrum Fluroquinolon antibiotics. Is mainly used for various Bacterial Infections. In this tablet bitter taste
was masked by saccharine as sweeting agent furthermore the effervescent effect of citric acid, tartaric acid
and sodium bicarbonate lead to Effervescent activity by realising the CO2 Molecule. Tablets are rapidly
dissolved and rapidly absorbed and give maximum activity. The Prepared Effervescent Tablet is Evaluated
In terms of bulk density, tapped density, angle of repose, Carr’s Index and, hardness test, weight variation
test, friability test and in vitro study. The result associated in Optimized batch is good to Satisfactory and
having a good free flowing property. The hardness, weight variation, and friability these values are within
the pharmacopeia limit. The in vitro Dissolution studies show Maximum percentage of release of drug
(99.26) with in end of 5 min.
NOVEL SIMULTANEOUS SEPARATION AND QUANTITATIVE DETERMINATION OF FOUR SARTANS...Dr. Ravi Sankar
The core AIM of the present study is to develop a novel, rapid, precise and accurate RP-HPLC method for simultaneous separation and quantification of Hydrochlorothiazide along with four sartans Telmisartan(TELM), Losartan(LOSA), Olmesartan(OLME) and Valsartan(VALS).
To develop Novel methods for separation and quantification of all the above said drugs on single chromatographic system without any minor changes in detection wavelength and mobile phase composition.
This document discusses in vitro-in vivo correlation (IVIVC) which aims to establish a relationship between a drug product's in vitro dissolution profile and its in vivo performance. It defines IVIVC and describes the different levels (A, B, C) based on the strength of correlation. A Level A correlation allows using the in vitro dissolution curve as an alternative to in vivo studies for quality control. It is the most informative for regulatory purposes. Level B uses mean dissolution time comparisons while Level C correlates a single dissolution time point to a pharmacokinetic parameter.
Expt. 8 Hypoglycemic effect of insulin in rabbitVISHALJADHAV100
This experiment aims to evaluate the hypoglycemic effect of insulin in rabbits at different time intervals. Healthy rabbits weighing 1800-3000 grams were fasted for 18 hours before being injected with 1 unit per ml of insulin. Blood glucose levels were measured initially and then every hour for 5 hours post-injection. Insulin caused blood glucose levels to decrease over time, demonstrating its ability to lower blood sugar as it stimulates glucose uptake into cells. The mean percentage decrease in glucose at each interval determined the hypoglycemic potency of insulin over the study period.
The main objective of the present research work is to formulate the Clopidogrel Fast Dissolving tablets. Clopidogrel, an antiplatelet drug, belongs to BCS Class-II and used to control Heart attack, Hypertension by inhibiting Platelet activation and aggregation .The Fast Dissolving tablets of Clopidogrel were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrant by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50%, t90% were selected as dependent variables. Totally nine formulations were designed and evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, and in-vitro drug release. From the Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the in-vitro dissolution profiles of all formulations were fitted into different Kinetic models, the statistical parameters like intercept (a), slope (b) and regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations was verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines, the formulation (F5) containing combination of 15% Crospovidone and 15% Croscarmellose, is the most similar formulation (similarity factor f2=91.3936, dissimilarity factor f1= 1.203& No significant difference, t= -0.00062) to marketed product (PLAVIX-75). The selected formulation (F1) follows First order, Higuchi’s kinetics, mechanism of drug release found to be Fickian Diffusion (n= 0.226).
The main aim of present research study is to formulate the floating tablets of Labetalol HCl using 32 factorial design. Labetalol HCl, non selective α, -β- adreno receptor antagonist, Indicated for treatment of Hypertension/moderate Heart Failure. The Floating tablets of Labetalol HCl were prepared employing different concentrations of HPMCK4M and sodium bicarbonate in different combinations by Direct Compression technique. The concentration of HPMCK4M and sodium bicarbonate required to achieve desired drug release was selected as independent variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables. 9 formulations were designed and are evaluated for hardness, friability, thickness, % drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all the formulation were found to be within the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept, slope & regression coefficient were calculated. Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations. According to SUPAC guidelines the formulation (F8) containing combination of 20% HPMCK4M and 3.75% sodium bicarbonate, is the most identical formulation which meets the objective of work. The selected formulation (F8) follows Higuchi’s kinetics, and the mechanism of drug release was found to be NonFickian Diffusion (n= 1.033, Super Case-II transport).
Design expert software assisted development and evaluation of cefpodoxime pro...Makrani Shaharukh
This document describes a study that developed and evaluated sustained release matrix tablets of the antibiotic drug Cefpodoxime Proxetil using natural polymers like karaya gum and acacia gum. 32 factorial designs were used to optimize the tablet formulations and evaluate the effect of polymer concentration on tablet properties like hardness and drug release. Tablets were prepared by direct compression and evaluated for drug-polymer compatibility, pre-compression parameters, post-compression parameters, in-vitro drug release, release kinetics, and stability. The optimized formulation F5 showed sustained drug release over 12 hours and maintained stability over time, indicating these matrix tablets could improve the oral bioavailability of Cefpodoxime Proxetil.
This document provides details on establishing in vitro-in vivo correlations (IVIVC) for drug products. It discusses the need for and importance of IVIVCs, including reducing human studies, serving as a surrogate for in vivo bioavailability, and assisting with quality control. The document outlines the objectives and purposes of IVIVCs, as well as factors that can affect developing a predictable IVIVC. It also describes different types and levels of correlations and provides a case study example. Overall, the document provides a comprehensive overview of establishing IVIVCs to correlate in vitro dissolution tests to in vivo performance of drug products.
Ijpar 14 618 ashaSynthesis and screening of new 2-(2-oxoindoline-3-ylidene)-n...pharmaindexing
This document describes the synthesis and characterization of new 2-(2-oxoindoline-3-ylidene)-N-phenyl hydrazine carbothioamide derivatives and evaluation of their antimicrobial activity. It involves a three step synthesis of the derivatives from aryl amines, including purification and characterization of intermediates and final compounds. The compounds were characterized using physical methods like melting point and spectroscopy. The compounds were evaluated for antibacterial activity against four bacteria and antifungal activity against two fungi using disk diffusion assays. Some of the compounds showed good antimicrobial activity.
This document discusses in vitro-in vivo correlation (IVIVC), which aims to establish relationships between a drug product's in vitro dissolution or release characteristics and the drug's in vivo performance. It defines IVIVC and describes the various approaches and levels (A, B, C) of establishing correlations. Level A correlation provides the strongest direct relationship between in vitro dissolution and in vivo absorption. The document also covers the need for IVIVC, methods for developing correlations, and applications of IVIVC in reducing human studies and setting dissolution specifications.
This document discusses in vitro-in vivo correlation (IVIVC), which establishes a relationship between a drug's biological effects and physicochemical properties. It defines IVIVC, explains its importance in reducing bioequivalence testing and supporting formulation development, and outlines the different levels and types of IVIVC models. The document also covers IVIVC development, validation, applications in drug delivery, and examples of software used to analyze IVIVC.
A new precise accurate and reliable validated method for the determination of Capecitabine was developed by using
reverse phase high performance liquid chromatography in pharmaceutical dosage forms. Spectrophotometer
determination was carried out at an absorption maximum of 240nm by using methanol. The linearity was over the
concentration range of 20-120 μg/ml with correlation coefficient 0.999. Chromatographic separation was carried
out by using a mobile phase of methanol: Acetonitrile: water (80:20:80 V/V) on Waters 2487 dual absorbance
column in an isocratic mode at a flow rate of 1.1 ml/min with UV detection at 240 nm. The developed methods were
found to be precise and accurate for the estimation of Capecitabine in pharmaceutical dosage forms and could be
used for routine analysis.
Keywords: Capecitabine, RP-HPLC, Spectrophotometry, Waters 2487 dual absorbance detector, Nova pack 300 ×
3.9mm 5μ as column, 240nm
1) The study established a Level A in vitro-in vivo correlation (IVIVC) for immediate release acyclovir tablets using the Wagner-Nelson method.
2) In vitro dissolution testing found 96% of the drug dissolved within 45 minutes for both the test and reference formulations.
3) In vivo absorption studies in 36 subjects found about 90% absorption of the drug within 1 hour for both formulations.
4) A time scaling factor of 6.66 was used to correlate the in vitro and in vivo data. The IVIVC model showed good predictability with %PE for AUC and Cmax within acceptable limits.
This document discusses concepts related to in vivo-in vitro correlation (IVIVC) including definitions, approaches, applications, limitations, and uses of dissolution as a surrogate for bioavailability. It describes the Biopharmaceutics Classification System (BCS) which categorizes drugs based on solubility and permeability. The expectations for establishing IVIVC are discussed for different BCS classes. The document also covers topics such as quantitative IVIVC levels, dissolution methodologies for immediate and extended release products, acceptance criteria, and apparatus used for dissolution testing.
Development and Evaluation of Enteric Coated Herbal Drug Delivery System for ...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
The document discusses in-vitro in-vivo correlation (IVIVC) which relates the dissolution of a drug from a dosage form to its absorption in vivo. It provides different levels or stages of IVIVC from simple point-to-point correlations to more complex models incorporating pharmacokinetic parameters. Common dissolution models are also summarized, including zero-order, first-order, Hixson-Crowell, and Higuchi models. Establishing IVIVC can help reduce bioequivalence studies and ensure consistent performance of drug products.
Formulation and evaluation of metformin and rosuvastatin bilayered tabletsSriramNagarajan17
This document describes the formulation and evaluation of bilayer tablets containing metformin hydrochloride as the sustained release layer and rosuvastatin as the immediate release layer. Various formulations of each layer were prepared using different polymers, excipients, and manufacturing methods. The metformin layer was prepared by wet granulation while the rosuvastatin layer used direct compression. Physicochemical properties of granules and tablets were evaluated. Standard calibration curves were developed for both drugs to enable drug content analysis. The optimized formulations demonstrated desired drug release profiles with the metformin layer providing sustained release over 12 hours and the rosuvastatin layer releasing completely within 1 hour.
Clinical significance of bioequivalence and biowaiversNagaraju Ravouru
1. The document discusses the clinical significance of bioequivalence studies and biowaivers. Bioequivalence studies are conducted to show that generic drug products are equivalent to innovator products in terms of rate and extent of absorption.
2. Biowaivers allow approval of drug applications without conducting in vivo bioequivalence testing based on evidence of equivalence from other factors. The Biopharmaceutics Classification System provides guidelines for biowaivers for certain drug products based on solubility and permeability characteristics.
3. There are limitations to biowaivers such as they are not applicable to locally acting or modified release drug products, or those with a narrow therapeutic index. Biowaivers can help reduce unnecessary exposure of subjects to
This document discusses in vitro-in vivo correlations (IVIVCs). It defines IVIVC as a predictive mathematical model relating an in vitro property (e.g. dissolution rate) to an in vivo response (e.g. absorption rate). The document outlines the significance of IVIVCs in reducing bioequivalence studies and supporting biowaivers. It describes different levels of IVIVC (A, B, C) and parameters that can be correlated (dissolution rate to absorption rate; percent dissolved to percent absorbed). The document provides examples of IVIVC case studies and concludes that current regulatory guidelines only apply to oral dosage forms, while further research is needed to develop IVIVCs for other drug products.
Formulation and in vitro evaluation of fast melting tablets of FexofenadineSriramNagarajan18
This document describes the formulation and in vitro evaluation of fast melting tablets containing fexofenadine hydrochloride. Fourteen batches of rapid dispersible tablets were prepared using different superdisintegrants (cross povidone, cross carmellose sodium, and sodium starch glycolate) at various concentrations, either alone or in combination, by direct compression method. Preformulation studies including solubility, drug-polymer compatibility via FTIR, and evaluation of tablet properties such as hardness, friability, drug content uniformity, wetting time, disintegration time, and dissolution were performed. The results showed that formulations containing superdisintegrants in certain concentrations produced tablets with desirable properties and rapid disintegration, indicating their potential
Biopharmaceutical Classification System (BCS)Suraj Khali
The Biopharmaceutical Classification System (BCS) classifies drug compounds based on their solubility and permeability properties. The BCS can be used to predict in vivo pharmacokinetics and determine when a waiver for bioavailability and bioequivalence studies may be requested. BCS Class I drugs that are highly soluble and permeable are most suitable for oral administration as they are rapidly dissolved and absorbed. The BCS aids in drug development by using solubility and permeability measurements to predict in vivo drug performance and guide biowaiver considerations.
Development and formulation of metoprolol succinate extended release tablets ...srirampharma
The document summarizes the preformulation characterization of metoprolol succinate extended release tablets. Key tests included determining the drug's percentage compressibility, stability in water and buffers, solubility, and compatibility with excipients. The percentage compressibility of 13.94% supported use of direct compression. Stability studies showed no degradation in water, buffer, or HCl. Compatibility by physical mixing and IR spectroscopy found no interactions between the drug and excipients. Solubility in water was determined to be 95896μg/ml. The results supported formulation development of metoprolol succinate ER tablets by direct compression.
A comparative bioavailability study of aceclofenac products in healthy human ...Alexander Decker
This study compared the bioavailability of two branded formulations of the drug aceclofenac - Drug A and Drug B. 18 healthy volunteers participated in a randomized crossover study where they received a single 100mg dose of either Drug A or Drug B with a 1 week washout period in between. Blood samples were taken up to 24 hours after dosing and aceclofenac plasma concentrations were measured using HPLC. Pharmacokinetic parameters like Cmax, Tmax, AUC, and t1/2 were calculated and compared between the two drugs to determine bioequivalence. The results found that the Cmax, AUC, and t1/2 were similar between Drug A and Drug B, suggesting the two formulations are bioequivalent
The main objective of the present research work is to formulate the Clopidogrel Fast Dissolving tablets. Clopidogrel, an antiplatelet drug, belongs to BCS Class-II and used to control Heart attack, Hypertension by inhibiting Platelet activation and aggregation .The Fast Dissolving tablets of Clopidogrel were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrant by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50%, t90% were selected as dependent variables. Totally nine formulations were designed and evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, and in-vitro drug release. From the Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the in-vitro dissolution profiles of all formulations were fitted into different Kinetic models, the statistical parameters like intercept (a), slope (b) and regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations was verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines, the formulation (F5) containing combination of 15% Crospovidone and 15% Croscarmellose, is the most similar formulation (similarity factor f2=91.3936, dissimilarity factor f1= 1.203& No significant difference, t= -0.00062) to marketed product (PLAVIX-75). The selected formulation (F1) follows First order, Higuchi’s kinetics, mechanism of drug release found to be Fickian Diffusion (n= 0.226).
The main aim of present research study is to formulate the floating tablets of Labetalol HCl using 32 factorial design. Labetalol HCl, non selective α, -β- adreno receptor antagonist, Indicated for treatment of Hypertension/moderate Heart Failure. The Floating tablets of Labetalol HCl were prepared employing different concentrations of HPMCK4M and sodium bicarbonate in different combinations by Direct Compression technique. The concentration of HPMCK4M and sodium bicarbonate required to achieve desired drug release was selected as independent variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables. 9 formulations were designed and are evaluated for hardness, friability, thickness, % drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all the formulation were found to be within the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept, slope & regression coefficient were calculated. Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations. According to SUPAC guidelines the formulation (F8) containing combination of 20% HPMCK4M and 3.75% sodium bicarbonate, is the most identical formulation which meets the objective of work. The selected formulation (F8) follows Higuchi’s kinetics, and the mechanism of drug release was found to be NonFickian Diffusion (n= 1.033, Super Case-II transport).
Design expert software assisted development and evaluation of cefpodoxime pro...Makrani Shaharukh
This document describes a study that developed and evaluated sustained release matrix tablets of the antibiotic drug Cefpodoxime Proxetil using natural polymers like karaya gum and acacia gum. 32 factorial designs were used to optimize the tablet formulations and evaluate the effect of polymer concentration on tablet properties like hardness and drug release. Tablets were prepared by direct compression and evaluated for drug-polymer compatibility, pre-compression parameters, post-compression parameters, in-vitro drug release, release kinetics, and stability. The optimized formulation F5 showed sustained drug release over 12 hours and maintained stability over time, indicating these matrix tablets could improve the oral bioavailability of Cefpodoxime Proxetil.
This document provides details on establishing in vitro-in vivo correlations (IVIVC) for drug products. It discusses the need for and importance of IVIVCs, including reducing human studies, serving as a surrogate for in vivo bioavailability, and assisting with quality control. The document outlines the objectives and purposes of IVIVCs, as well as factors that can affect developing a predictable IVIVC. It also describes different types and levels of correlations and provides a case study example. Overall, the document provides a comprehensive overview of establishing IVIVCs to correlate in vitro dissolution tests to in vivo performance of drug products.
Ijpar 14 618 ashaSynthesis and screening of new 2-(2-oxoindoline-3-ylidene)-n...pharmaindexing
This document describes the synthesis and characterization of new 2-(2-oxoindoline-3-ylidene)-N-phenyl hydrazine carbothioamide derivatives and evaluation of their antimicrobial activity. It involves a three step synthesis of the derivatives from aryl amines, including purification and characterization of intermediates and final compounds. The compounds were characterized using physical methods like melting point and spectroscopy. The compounds were evaluated for antibacterial activity against four bacteria and antifungal activity against two fungi using disk diffusion assays. Some of the compounds showed good antimicrobial activity.
This document discusses in vitro-in vivo correlation (IVIVC), which aims to establish relationships between a drug product's in vitro dissolution or release characteristics and the drug's in vivo performance. It defines IVIVC and describes the various approaches and levels (A, B, C) of establishing correlations. Level A correlation provides the strongest direct relationship between in vitro dissolution and in vivo absorption. The document also covers the need for IVIVC, methods for developing correlations, and applications of IVIVC in reducing human studies and setting dissolution specifications.
This document discusses in vitro-in vivo correlation (IVIVC), which establishes a relationship between a drug's biological effects and physicochemical properties. It defines IVIVC, explains its importance in reducing bioequivalence testing and supporting formulation development, and outlines the different levels and types of IVIVC models. The document also covers IVIVC development, validation, applications in drug delivery, and examples of software used to analyze IVIVC.
A new precise accurate and reliable validated method for the determination of Capecitabine was developed by using
reverse phase high performance liquid chromatography in pharmaceutical dosage forms. Spectrophotometer
determination was carried out at an absorption maximum of 240nm by using methanol. The linearity was over the
concentration range of 20-120 μg/ml with correlation coefficient 0.999. Chromatographic separation was carried
out by using a mobile phase of methanol: Acetonitrile: water (80:20:80 V/V) on Waters 2487 dual absorbance
column in an isocratic mode at a flow rate of 1.1 ml/min with UV detection at 240 nm. The developed methods were
found to be precise and accurate for the estimation of Capecitabine in pharmaceutical dosage forms and could be
used for routine analysis.
Keywords: Capecitabine, RP-HPLC, Spectrophotometry, Waters 2487 dual absorbance detector, Nova pack 300 ×
3.9mm 5μ as column, 240nm
1) The study established a Level A in vitro-in vivo correlation (IVIVC) for immediate release acyclovir tablets using the Wagner-Nelson method.
2) In vitro dissolution testing found 96% of the drug dissolved within 45 minutes for both the test and reference formulations.
3) In vivo absorption studies in 36 subjects found about 90% absorption of the drug within 1 hour for both formulations.
4) A time scaling factor of 6.66 was used to correlate the in vitro and in vivo data. The IVIVC model showed good predictability with %PE for AUC and Cmax within acceptable limits.
This document discusses concepts related to in vivo-in vitro correlation (IVIVC) including definitions, approaches, applications, limitations, and uses of dissolution as a surrogate for bioavailability. It describes the Biopharmaceutics Classification System (BCS) which categorizes drugs based on solubility and permeability. The expectations for establishing IVIVC are discussed for different BCS classes. The document also covers topics such as quantitative IVIVC levels, dissolution methodologies for immediate and extended release products, acceptance criteria, and apparatus used for dissolution testing.
Development and Evaluation of Enteric Coated Herbal Drug Delivery System for ...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
The document discusses in-vitro in-vivo correlation (IVIVC) which relates the dissolution of a drug from a dosage form to its absorption in vivo. It provides different levels or stages of IVIVC from simple point-to-point correlations to more complex models incorporating pharmacokinetic parameters. Common dissolution models are also summarized, including zero-order, first-order, Hixson-Crowell, and Higuchi models. Establishing IVIVC can help reduce bioequivalence studies and ensure consistent performance of drug products.
Formulation and evaluation of metformin and rosuvastatin bilayered tabletsSriramNagarajan17
This document describes the formulation and evaluation of bilayer tablets containing metformin hydrochloride as the sustained release layer and rosuvastatin as the immediate release layer. Various formulations of each layer were prepared using different polymers, excipients, and manufacturing methods. The metformin layer was prepared by wet granulation while the rosuvastatin layer used direct compression. Physicochemical properties of granules and tablets were evaluated. Standard calibration curves were developed for both drugs to enable drug content analysis. The optimized formulations demonstrated desired drug release profiles with the metformin layer providing sustained release over 12 hours and the rosuvastatin layer releasing completely within 1 hour.
Clinical significance of bioequivalence and biowaiversNagaraju Ravouru
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Development and formulation of metoprolol succinate extended release tablets ...srirampharma
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A comparative bioavailability study of aceclofenac products in healthy human ...Alexander Decker
This study compared the bioavailability of two branded formulations of the drug aceclofenac - Drug A and Drug B. 18 healthy volunteers participated in a randomized crossover study where they received a single 100mg dose of either Drug A or Drug B with a 1 week washout period in between. Blood samples were taken up to 24 hours after dosing and aceclofenac plasma concentrations were measured using HPLC. Pharmacokinetic parameters like Cmax, Tmax, AUC, and t1/2 were calculated and compared between the two drugs to determine bioequivalence. The results found that the Cmax, AUC, and t1/2 were similar between Drug A and Drug B, suggesting the two formulations are bioequivalent
A comparative bioavailability study of aceclofenac products in healthy human ...Alexander Decker
This study compared the bioavailability of two branded aceclofenac drug formulations (Drug A and Drug B) in 18 healthy human subjects. Blood samples were collected over 24 hours and aceclofenac plasma concentrations were measured using validated HPLC. Key pharmacokinetic parameters like Cmax, Tmax, AUC, and half-life were calculated and found to be comparable between the two drugs. A statistical analysis found the 90% confidence intervals for AUC and Cmax ratios were within the 80-125% range specified by FDA guidelines, demonstrating the two drugs are bioequivalent. Therefore, this study concluded the two aceclofenac formulations have similar rates and extents of absorption.
Abstract:
The Chronopharmacotherapy the drug administration is synchronised with circadian rhythms Formulation development of Microspheres is more reliable formulation as compare to single type dosage formulation due to it avoids dose dumping, as per required drug release profile is achieved For microspheres many polymers are used such as albumin, gelatine, starch, Eudragit, Polyacrylamide (“PAM”) these material loading capacity is high. Micro sponges which are Spherical are called as micro-balloons. Due to its hollow structure it shows good floating properties. In these systems use of Carbon-dioxide (CO2) as gas generating system which are used for floating purpose. The objective of present investigation is to prepared and evaluate a floating pulsatile drug delivery system of Aceclofenac. The strategy adopted for microspheres containing Aceclofenac as a material were prepared by emulsion solvent diffusion technique. Drug and polymer were mixed in dichloromethane and ethanol at 1:1 ratio. The drug and polymer solution were poured in water 50% W/V polyvinyl alcohol maintained at 30-40 C and the solution was stir at 500rpm using mechanical stirrer, The microspheres obtain were washed repeatedly with water until free from poly vinyl alcohol. The developed formulations were evaluated yield of floating microspheres particle size and shape, drug entrapment efficiency in-vitro evolution of floating ability, in-vitro drug release study. On the basis of these evolution parameters it was found that optimised floating pulsatile release formulation F7 showed higher drug entrapment efficiency floating time 6.8 minutes and the drug and polymer 32 1:3 ratio the particle size was increased.
Key Words: Chronopharmacotherapy, Floating pulsatile drug delivery, Aceclofenac.
Ameliorating Effect of Frankincense on Red Blood Cells of Alloxan Induced-Dia...inventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
EFFECT OF DIFFERENT CHROMATOGRAPHIC FRACTION AQUEOUS AND ALCOHOLIC EXTRACTS O...Jing Zang
In recent studies Teucrium polium(T. polium ) was known as a hypoglycemic plants. But further research is needed to better understand the effect of Teucrium polium and biological active part of it. The purpose of this investigation is to examine the effect of different chromatographic fractions of aqueous and alcoholic extract of this plant on the level of insulin secretion and glucose content in hyperglycemic rat model. Also, our aim is determination of biological active fraction of aqueous and alcoholic extract of this plant. This study was carried out on the 36 rats. Hyperglycemia induced by administrating of 50 mg/kg alloxan intraperitoneally and glucose level was monitored for hyperglycemic status. Hyperglycemic was confirmed by blood glucose measurement. In each experiment 100 grams of Teucrium polium aerial parts powder were boiled with 2 Litter of distilled water for 36 h. The decoction preparation was then filtered through a gauz cloth followed by filtration through filter paper. The extract was evaporated to one-fifth of its original volume and kept at 4oC until its use. Determination of different fraction aqueous extract effect of Teucrium polium on glucose level and insulin secretion was carried out. Blood was collected from the tail of the rats. Then glucose and insulin level was evaluated. The hyperglycemic animals showed significant decrease in the blood glucose level in rats administered with fourth fraction compared with other factions. Administration of fourth fraction Teucrium polium aerial parts extract cause increase in insulin levels in alloxan-treated rats. Results suggest that treatment of fourth fraction Teucrium polium aerial parts extract may be useful in preventing the increase of glucose level in hyperglycemic rats. The interesting phenomenon of our results has shown that fourth fraction given parenterally possesses a hypoglycemic effect in alloxan hyperglycemic rats. Fourth fraction was found biological active and to be responsive to glucose challenge as evidenced by increase in insulin secretion.
Formulation and Evaluation of Moxifloxacin Loaded Alginate Chitosan Nanoparti...pharmaindexing
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Formulation and In-Vitro Evaluation of Fluconazole Loaded Microsponge Gel For...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.
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International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
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Hepatoprotective Effect of Cestrum parqui L. aerial parts and Phytochemical ...Jing Zang
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The objective of the present study was to evaluate the phytochemistry, acute toxicity and glucose lowering potential of hydromethanolic roots extract (HMREt) of Rauwolfia serpentina. The qualitative analysis of HMREt showed the presence of many important phyto-constituents except anthraquinones, carbohydrates and saponins whereas quantitatively it found rich in total phenols. In acute toxicity study, orally administrated HMREt from 5-250 mg/ kg was observed safe and non-sedative while its doses from 500-2500 mg/kg were found sedative and induced mortalities (17-100%) within 4 hours of administration. The median lethal dose (LD50) of same extract was calculated as 1412.54 mg / kg (log LD50 = 3.15 mg/ kg) from log doses verses probit graph. The HMREt in doses of 50, 100 and 150 mg/kg induced significant percent decrease in blood glucose level at 30, 60 and 120 minutes in normo-hyperglycemic test mice as compared to control and negative control groups (p<0.05). The results concluded that HMREt has glucose lowering potential either by developing glucose tolerance or by pancreatic action in normo-hyperglycemic mice.
The study evaluated the long-term effects of administering silibinin, epigallocatechin, quercetin, or rutin on the absorption and tissue distribution of zinc, copper, and iron in rats. The results showed that all flavonoids increased serum and tissue levels of the trace elements compared to controls. Specifically, the flavonoids increased absorption of all three elements and their availability in brain, kidney, and liver tissues. However, the effects varied between flavonoids, with epigallocatechin generally having the greatest effect on iron absorption and tissue levels. The study suggests long-term intake of high-dose flavonoid supplements could increase absorption and tissue accumulation of some trace elements.
In the present study, a gastro retentive micro particulate system was formulated with different Polymers by using
solvent evaporation technique. A series of 8 formulations was prepared based on 23 Design of experiments. The
formulated microspheres were evaluated flow characteristics, Practical yield (up to 80 %) and Encapsulation
efficiency (up to 94%). Scanning electron Microscopy confirmed their porous and spherical structure and the
particles were of the Size range of (65-525 μm). The release of drug at 1 hour and 8 hours’ time points were
taken as the measurable parameters for running the DOE experiments. According to design space Hollow
Microspheres formulated with Drug in the range of 50 to 70 mg/unit, Ethyl cellulose 7 cps in the range of 145 to
150 mg/unit and HPMC 5 cps in the range of 0.4 to 2 mg/unit were observed to have the best floating
characteristics and in vitro dissolution profile as per the preset target product profile. Stability studies showed no
significant change in the drug content in the formulations at 3 months accelerated condition. In this study
concluded that a micro particulate floating dosage form of an anti-infective drug can be successfully designed to
give controlled release and improved oral bioavailability.
KEYWORDS
Gastro retentive system, Ciprofloxacin Hcl, Ethyl Cellulose 7 cps, HPMC 5cps, Hollow microspheres.
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Topical Delivery of Fenoprofen Proliposomes: Preparation, Evaluation and In V...inventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Validated stability indicating RP-HPLC method for the simultaneous determinat...pharmaindexing
Validated stability indicating RP-HPLC method for the simultaneous determination of ofloxacin, ornidazole, clobetasol propionate, terbinafine hydrochloride, methyl paraben, propyl paraben in bulk and pharmaceutical dosage form
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Therapeutic Effects of Albendazole on Disposition Kinetics of Florfenicol in Goats
1. Abstract of Applied Sciences and Engineering, 2016, Vol.7
DOI: 10.18488/journal.1001/2016.7/1001.7
7th
International Scientific Conference on Applied
Sciences and Engineering
27-28 February, 2016
Flora Grand Hotel, Dubai
Conference Website: www.scihost.org
8
Paper ID: 24/16/ 7
th
ISCASE
Therapeutic Effects of Albendazole on Disposition Kinetics
of Florfenicol in Goats
Muhammad Ahsan Naeem1
--- Bilal Aslam2
--- Muhammad Mudassar Ashraf3
--- Ijaz Javed4
1,2,3,4
Institute of Pharmacy, Physiology and Pharmacology, Faculty of Veterinary Science,
University of Agriculture, Faisalabad.
Abstract
Effect of albendazole on the pharmacokinetics of florfenicol was investigated in ten
healthy adult goats. In each experiment, after restraining the animal, a single dose of
florfenicol was administered intramuscularly. After wash out period of 7 days, florfenicol
along with albendazole suspension was administered orally. Blood samples were
collected in plastic centrifuge tubes. Prior to drug administration, a control blood sample
was collected in each experiment. Following drug administration, blood samples were
drawn at half hourly interval up to 4 hours followed by hourly interval up to 8 hours and
thereafter, at 10 and 12 hours. Blood samples were centrifuged and serum was
separated and stored at -20°C until analysis. The concentration of florfenicol in serum
samples was determined by using high performance liquid chromatography HPLC
technique. The results of present study indicated that albendazole significantly
(P<0.05) increased or decreased the pharmacokinetic parameters of florfenicol after
their concurrent administration i.e. decreased peak serum concentration Cmax (4.22 ±
0.32 to 3.3 ± 0.21 µg mL-1
), extrapolated zero time drug concentration B (5.29 ± 0.46 to
4.85 ±0.51 µg mL-1
), elimination half-life t1/2 β (6.56 ± 0.94 to 5.06 ± 0.77 hours) and
increased volume of distribution Vd (4.05 ± 0.35 to 4.49 ± 0.4 L kg-1
) and total body
clearance CLB (0.47 ± 0.04 to 0.69 ± 0.06 mL min-1
kg-1
). As florfenicol is metabolized
by the same cytochrome P450 isoenzymes (CYP1A1 and CYP1A2) which are induced
by albendazole, the change in pharmacokinetics parameters of florfenicol may be
attributed to its drug action with albendazole. Thus it may be conceived that the
change in pharmacokinetic parameters is due to rapid elimination of florfenicol when
given concurrently with albendazole to healthy adult goats which in turn may be due to
induction of CYP3A4 isoenzyme by albendazole.
Keywords: Florfenicol, Albendazole, Cytochrome, Disposition kinetics, Clearance and volume of
distribution