This document describes the development of an emulgel formulation of the drug piroxicam for transdermal delivery. Piroxicam is an anti-inflammatory drug that has oral side effects. The researchers developed emulgel formulations using different combinations of oil, emulsifiers, gelling agents and other excipients. They used a 32 factorial design to study the effect of emulsifier concentration and gelling agent concentration on drug release. A total of 18 formulations were developed and evaluated for drug content, globule size, viscosity and in vitro drug release. The optimized formulations showed controlled drug release over 8 hours and good skin permeation in studies compared to the marketed gel formulation.
This document describes the development of an emulgel formulation of the drug piroxicam to improve its skin penetration compared to current marketed products. Piroxicam emulgel formulations were prepared using different combinations of oil, emulsifiers, gelling agents and other excipients according to a 32 full factorial design to study the effect of emulsifier and gelling agent concentration on drug release. 18 formulations were developed using two types of carbomer with varying concentrations of emulsifiers and gelling agent. The formulations were characterized and evaluated for drug content, globule size, in vitro drug release, and other properties. The optimized formulations with lower carbomer and higher emulsifier concentration provided higher skin permeation of piroxicam over
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).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
This thesis submitted by Deepak Chandra Sharma examines the formulation and evaluation of an Apremilast emulgel for topical drug delivery. The objectives are to study the drug and polymer compatibility, prepare the emulgel using different polymers, and evaluate the formulations. Eight emulgel formulations were created using various gelling agents like carbopol 934, HPMC K4M, xanthan gum and sodium CMC. Pre-formulation studies such as melting point, solubility, partition coefficient and calibration curves were conducted on the drug. Compatibility studies using FTIR showed no interactions between the drug and polymers. The emulgels were then evaluated for physical appearance, pH, viscosity, drug content
1. The document discusses microemulgel, which combines the benefits of microemulsions and gels to improve drug delivery. Microemulgel allows for higher drug solubility and skin penetration compared to other topical formulations.
2. The review evaluates the preparation and characteristics of microemulsions and microemulgel. Microemulsions are isotropic mixtures of oil, water, and surfactants that can solubilize drugs and penetrate the skin. Incorporating microemulsions into gels creates microemulgel, providing a dual-benefit delivery system.
3. Microemulgel has advantages over other topical formulations like good consistency, emolliency, longer shelf
This document discusses emulgels as a drug delivery system. It begins by outlining the contents to be covered, including the purpose and rationale of using emulgels. Some key advantages are avoiding first-pass metabolism and improving patient compliance. Important constituents and preparation methods are described. Characterization studies discussed include rheology, spreadability, drug content and skin irritation testing. In vitro drug release kinetics and stability studies are also evaluated. The conclusion states that emulgels provide benefits like spreadability and adhesion over other delivery systems and can effectively deliver hydrophobic drugs in a gel base.
formulation and evaluation of microbeadsgurleen kaur
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
This document presents information on emulgels, which are emulsions gelled with a gelling agent to provide a new platform for topical drug delivery. Emulgels can incorporate hydrophobic drugs and improve their bioavailability. The document discusses the advantages of emulgels, different types based on the emulsion and drug, and the formulation process. Key steps in developing an emulgel include preparing the emulsion and gel base separately and then combining them. Excipients commonly used and evaluation methods like physical characterization, drug content, and stability testing are also summarized. Several commercial emulgel products are presented as examples. The conclusion states that emulgels can be a better topical delivery system than conventional options due to
This document describes the development of an emulgel formulation of the drug piroxicam to improve its skin penetration compared to current marketed products. Piroxicam emulgel formulations were prepared using different combinations of oil, emulsifiers, gelling agents and other excipients according to a 32 full factorial design to study the effect of emulsifier and gelling agent concentration on drug release. 18 formulations were developed using two types of carbomer with varying concentrations of emulsifiers and gelling agent. The formulations were characterized and evaluated for drug content, globule size, in vitro drug release, and other properties. The optimized formulations with lower carbomer and higher emulsifier concentration provided higher skin permeation of piroxicam over
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).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
This thesis submitted by Deepak Chandra Sharma examines the formulation and evaluation of an Apremilast emulgel for topical drug delivery. The objectives are to study the drug and polymer compatibility, prepare the emulgel using different polymers, and evaluate the formulations. Eight emulgel formulations were created using various gelling agents like carbopol 934, HPMC K4M, xanthan gum and sodium CMC. Pre-formulation studies such as melting point, solubility, partition coefficient and calibration curves were conducted on the drug. Compatibility studies using FTIR showed no interactions between the drug and polymers. The emulgels were then evaluated for physical appearance, pH, viscosity, drug content
1. The document discusses microemulgel, which combines the benefits of microemulsions and gels to improve drug delivery. Microemulgel allows for higher drug solubility and skin penetration compared to other topical formulations.
2. The review evaluates the preparation and characteristics of microemulsions and microemulgel. Microemulsions are isotropic mixtures of oil, water, and surfactants that can solubilize drugs and penetrate the skin. Incorporating microemulsions into gels creates microemulgel, providing a dual-benefit delivery system.
3. Microemulgel has advantages over other topical formulations like good consistency, emolliency, longer shelf
This document discusses emulgels as a drug delivery system. It begins by outlining the contents to be covered, including the purpose and rationale of using emulgels. Some key advantages are avoiding first-pass metabolism and improving patient compliance. Important constituents and preparation methods are described. Characterization studies discussed include rheology, spreadability, drug content and skin irritation testing. In vitro drug release kinetics and stability studies are also evaluated. The conclusion states that emulgels provide benefits like spreadability and adhesion over other delivery systems and can effectively deliver hydrophobic drugs in a gel base.
formulation and evaluation of microbeadsgurleen kaur
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
This document presents information on emulgels, which are emulsions gelled with a gelling agent to provide a new platform for topical drug delivery. Emulgels can incorporate hydrophobic drugs and improve their bioavailability. The document discusses the advantages of emulgels, different types based on the emulsion and drug, and the formulation process. Key steps in developing an emulgel include preparing the emulsion and gel base separately and then combining them. Excipients commonly used and evaluation methods like physical characterization, drug content, and stability testing are also summarized. Several commercial emulgel products are presented as examples. The conclusion states that emulgels can be a better topical delivery system than conventional options due to
The document describes the development of calcium alginate beads for oral delivery of the antibiotic ceftriaxone sodium. Twelve formulations of calcium alginate beads were developed using an ionotropic gelation method. The optimized formulation achieved high drug entrapment efficiency (>75%) and provided sustained drug release over 10-18 hours. Scanning electron microscopy indicated the coated optimized beads had a smooth surface and fewer pores, slowing the drug release rate compared to uncoated beads. The calcium alginate beads have potential as a drug delivery system for oral administration of ceftriaxone sodium.
Microemulsion based emulgel a novel topical drug delivery systemNitin Mori
This document describes the development of a microemulsion-based emulgel as a novel topical drug delivery system. It begins with an introduction to topical drug delivery and the advantages of microemulsions. It then discusses the anatomy and physiology of skin as the site of drug delivery. Key points include that microemulsions can solubilize both hydrophilic and hydrophobic drugs, enhance skin permeability, and are thermodynamically stable. The document proposes that a microemulsion-based emulgel could provide controlled drug release through the combined advantages of microemulsions and gels. It then provides details on formulating the microemulsion and emulgel components, and evaluating parameters like viscosity, pH
Formulation and Evaluation of Nimodipine Tablet by Liquisolid Techniqueijtsrd
Liquisolid technique is novel concept of the drug delivery via the oral route. This technique is applied to poorly water soluble , water insoluble or lipophilic drugs. According to the new formulation method of liquisolid compact, liquid medication such as solution or suspensions of water insoluble drug in suitable non volatile solvent can be converted into acceptably flowing and compressible powders by blending with selected powder excipients. The present work endeavour is directed towards the development of liquisolid compact for production of immediate release tablet of water insoluble Nimodipine. Liquisolid compacts were prepared by using polyethylene glycol 300 as the liquid vehicle or non volatile solvent. Crospovidone was used as a superdisintegrating agent and PVP K30 as a binder. Microcrystalline cellulose was used as a absorbing carrier and silicone dioxide as adsorbing coating material. The prepared liquisolid system were evaluated for their micromeretic properties and possible drug excipients interaction . The FTIR spectra study ruled out any interaction between the drug and excipients in preparation of Nimodipine liquisolid compact. The in vitro dissolution study confirmed enhance drug release from liquisolid compacts by using USP type I basket in 0.5 SLS in water. The selected optimal formula released 93.86 of its content in 30 min which is showing immediate release. The results showed that use of superdisintegrants had remarkable impact on the release rate of Nimodipine from Liquisolid compact, enhancing the release rate of the drug from liquisolid compact. Neha Durge | Kirti Parida ""Formulation and Evaluation of Nimodipine Tablet by Liquisolid Technique"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd23863.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/23863/formulation-and-evaluation-of-nimodipine-tablet-by-liquisolid-technique/neha-durge
This research article describes the formulation and evaluation of gel formulations containing an aqueous extract of Mimosa pudica for anti-inflammatory activity. Different gel formulations were prepared using carbopol 940, hydroxypropyl methylcellulose, and sodium carboxymethylcellulose as polymers. The gels were evaluated for characteristics such as drug content, physical appearance, pH, extrudability, and spreadability. The carbopol 940 gel formulation was found to be transparent, homogenous, and have the highest spreadability. This formulation showed significant inhibition of carrageenan-induced paw edema in rats, indicating anti-inflammatory effects.
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).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
The document describes the formulation and evaluation of Ritonavir floating tablets. It discusses Ritonavir's properties and uses floating drug delivery systems to prolong its release rate in the stomach. Several polymers like HPMC K4M, HPMC K15M, Eudragit RSPO and ethyl cellulose were used to formulate the tablets. The tablets were evaluated for parameters like weight variation, thickness, hardness, drug content and in vitro buoyancy and dissolution studies. The results showed that the floating tablets were able to prolong the release of Ritonavir in the stomach.
The document discusses the formulation and evaluation of solid dispersions of the drug carvedilol to improve its solubility and dissolution rate. Carvedilol was selected as it has low aqueous solubility and bioavailability. Solid dispersions were prepared using different carriers like poloxamer 407, mannitol, and PEG 4000 via solvent evaporation method. The dispersions were evaluated for dissolution rate and the best formulation was selected based on the evaluation studies. Stability studies were also proposed to be conducted on the best formulation.
This document summarizes emulgels, which are a combination of gels and emulsions used for topical drug delivery. Emulgels allow both hydrophilic and hydrophobic drugs to be incorporated and released in a controlled manner. They have advantages over other topical formulations like better stability, higher drug loading, and simpler production. An emulgel is prepared by dispersing an emulsion (either oil-in-water or water-in-oil) into a gel base. Key components include aqueous materials, oils, emulsifiers, gelling agents, and penetration enhancers. Emulgels combine the benefits of gels and emulsions for topical drug delivery.
Formulation development and invitro evaluation of lamotrigine fast dissolving...SriramNagarajan19
The present study was to formulate and evaluate oral fast dissolving Oral tablet containing Lamotrigine. Present study reveals that all the nine formulated tablet showed satisfactory tablet parameters. It can be concluded that, Oral fast dissolving tablet -containing Lamotrigine can be prepared by direct compression method. 10% CCS (FV) tablet exhibited required disintegration time and dissolution time. The drug release was about 98.7 % in 15min. The accelerated stability studies of the optimized F5 formulation indicates that the formulated oral fast dissolving tablet were unaffected after 3 months storage under accelerated conditions as there were no signs of visually distinguishable changes in appearance, disintegration time and cumulative percentage of drug release. From the present investigation it can be concluded that oral fast dissolving tablet formulation can be a potential novel drug dosage form for pediatric, geriatric and also for general population.
The document describes the formulation and characterization of a clarithromycin emulgel for topical drug delivery. Various formulations of clarithromycin emulgel were prepared using different gelling agents like Carbopol 934, Carbopol 940 and HPMCK4M. The formulations were evaluated for physical appearance, pH, viscosity, drug content and in vitro drug release. Formulation F1 showed optimum results with maximum drug content of 91.6% and sustained drug release of 74.47% over 12 hours. Thus, the developed clarithromycin emulgel using Carbopol 934 as gelling agent can be considered as a potential formulation for topical delivery of clarithromycin.
Dissolution enhancement of glimepiride by solid dispersion technique.Santosh Adhikari
Dissolution Enhancement of Glimepiride by Solid Dispersion Technique.
Priyanka Shrestha1*, Shiva Kumar Bhandari1, SM Ashraful Islam1, and Santosh Adhikari2.
1Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, Bangladesh.
2Department of Pharmacy, Rajiv Gandhi University of Health Science, Banglore-560 041.
Formulation and evaluation ofmetformin HCl micro beads by ionotropic gelation...Sagar Savale
The Metformin HCL Micro Beads is formulated by the Ionotropic Gelation Method. The CMC is a Swellable
polymer is responsible for the Sustained release action or activity. A combination of CMC (Carboxy Methyl
Cellulose) and Sodium Alginate shows better sustained release activity. The PreparedSustained released Micro
Beadsis Evaluated In terms of bulk density, tapped density, angle of repose, Carr’s Index, Swelling Index, Drug
Content, % Encapsulation Efficiency and vitro study. The result associated in Optimized batch is good to
Satisfactory and having a good free flowing property. The Drug Content and % Encapsulation Efficiency values are
within the pharmacopeia limit. The in vitro Dissolution studies shows Maximum percentage of release of drug
(71.15) with in end of 4 Hours.
Development and evaluation of xyloglucan matrix release tabs contaning glipizidesukesh
The document describes a research project that developed and evaluated matrix release tablets containing the drug glipizide using xyloglucan as a polymer. Xyloglucan was extracted from tamarind kernels and used to prepare different tablet formulations. Tablets were evaluated for dissolution, drug release, and other parameters. The best formulation was F1, which released 99% of the drug in a prolonged manner and could be used for extended release of glipizide.
This document discusses using hot melt extrusion (HME) technology to improve the dissolution and bioavailability of the poorly water soluble drug efavirenz (Efv) through the formation of solid dispersions with hydrophilic polymers and surfactants. Efv solid dispersions were prepared by HME using Kollidon VA64 polymer and various surfactants at 10% weight. Dissolution and permeability studies showed improved results for formulations containing PEG 4000 and sorbiton monolaurate surfactants. Pharmacokinetic studies in rats found the PEG 4000 formulation increased the extent of Efv absorption by 106.98% compared to non-HME controls. The study demonstrates HME can enhance the
This document discusses using gelatin beads as a sustained release drug delivery system. Gelatin beads can provide sustained release of drugs over time by taking advantage of their large surface area and diffusion properties. The document describes preparing and evaluating propranolol HCl loaded gelatin beads using natural polymers gelatin and fish gelatin crosslinked with glutaraldehyde. The beads were evaluated for loading efficiency, yield, in vitro drug release, and stability over 3 months of accelerated conditions. Overall, the document proposes that gelatin beads can serve as a biocompatible drug delivery system for sustained drug release.
Formulation and characterization of epigallocatechin gallate nanoparticlesRamkumar Ponnuraj
This document describes the formulation and characterization of Epigallocatechin gallate (EGCG) nanoparticles. EGCG was encapsulated in chitosan nanoparticles using ionic gelation with sodium tripolyphosphate to improve its bioavailability. Different ratios of EGCG to chitosan were tested, and a 1:0.5 ratio showed the highest drug loading and encapsulation efficiency. The resulting nanoparticles were spherical with a size range of 198-385 nm. In vitro drug release and characterization studies demonstrated the nanoparticles were a promising delivery system for EGCG with improved absorption.
The document summarizes the development of an extended release formulation of bupropion hydrochloride tablets. The objectives were to develop a stable, cost-effective ER formulation and compare it to marketed products. Various ER tablet formulations were prepared using different concentrations of coating polymers and evaluated for drug release. Formulations F9 and F10, which used 8% coating of ethylcellulose 15cps, showed comparable release to the reference product over 16 hours. The developed formulation met the objectives of providing a once-daily ER tablet for bupropion hydrochloride.
Formulation, characterization and invitro evaluation of aceclofenacemulgel fo...SriramNagarajan17
This document summarizes the formulation, characterization, and in vitro evaluation of aceclofenac emulgel for topical application. Eight aceclofenac emulgel formulations were prepared using a factorial design with variables including gelling agent, light liquid paraffin, and emulsifying agent. The formulations were evaluated for properties such as appearance, pH, viscosity, spreadability, and drug content. In vitro drug permeation studies showed that formulation F7 had the highest permeation, with 89.97% cumulative drug release after 12 hours. Kinetic analysis indicated F7 followed Higuchi diffusion, indicating drug release was diffusion mediated. Thus, F7 was selected as the optimized aceclofenac emulgel formulation for
Formulation and Evaluation of Microspheres Containing Aceclofenacpharmaindexing
This document describes research into formulating and evaluating microspheres containing the drug aceclofenac. Microspheres were prepared using hydroxypropyl methylcellulose (HPMC) and eudragit polymers via a solvent evaporation method. Infrared spectroscopy showed no chemical interactions between the drug and polymers. Drug entrapment efficiency was 72.32% for one formulation. In vitro drug release studies found 89.59% of the drug was released from one formulation over 12 hours. Scanning electron microscopy images showed the microspheres were spherical and smooth. The researchers concluded HPMC and eudragit are suitable carriers for preparing aceclofenac microspheres with improved bioavailability.
The document discusses how the media product draws from and develops conventions of the horror genre. It examines films like Insidious, Paranormal Activity, Cabin in the Woods, and The Woman in Black to inform decisions around genre, location, camera techniques, sound, costumes, lighting, and other mise-en-scene elements. References were made to establish tension, atmosphere, and verify authentic sounds that would make the film feel like a conventional horror movie.
The role of microbial testing in ensuring sterility of aseptically filled sterile pharmaceutical products is discussed. Microbial testing plays a key role from product development through finished product testing. During product development, tests are used to evaluate ingredients, packaging, and establish formulation and manufacturing parameters. In-process monitoring includes testing ingredients, water systems, environmental surfaces and personnel, and pre-filtration bioburden. Finished product testing includes sterility tests, though sterility assurance is primarily achieved through validated manufacturing processes rather than finished product testing alone.
The document describes the development of calcium alginate beads for oral delivery of the antibiotic ceftriaxone sodium. Twelve formulations of calcium alginate beads were developed using an ionotropic gelation method. The optimized formulation achieved high drug entrapment efficiency (>75%) and provided sustained drug release over 10-18 hours. Scanning electron microscopy indicated the coated optimized beads had a smooth surface and fewer pores, slowing the drug release rate compared to uncoated beads. The calcium alginate beads have potential as a drug delivery system for oral administration of ceftriaxone sodium.
Microemulsion based emulgel a novel topical drug delivery systemNitin Mori
This document describes the development of a microemulsion-based emulgel as a novel topical drug delivery system. It begins with an introduction to topical drug delivery and the advantages of microemulsions. It then discusses the anatomy and physiology of skin as the site of drug delivery. Key points include that microemulsions can solubilize both hydrophilic and hydrophobic drugs, enhance skin permeability, and are thermodynamically stable. The document proposes that a microemulsion-based emulgel could provide controlled drug release through the combined advantages of microemulsions and gels. It then provides details on formulating the microemulsion and emulgel components, and evaluating parameters like viscosity, pH
Formulation and Evaluation of Nimodipine Tablet by Liquisolid Techniqueijtsrd
Liquisolid technique is novel concept of the drug delivery via the oral route. This technique is applied to poorly water soluble , water insoluble or lipophilic drugs. According to the new formulation method of liquisolid compact, liquid medication such as solution or suspensions of water insoluble drug in suitable non volatile solvent can be converted into acceptably flowing and compressible powders by blending with selected powder excipients. The present work endeavour is directed towards the development of liquisolid compact for production of immediate release tablet of water insoluble Nimodipine. Liquisolid compacts were prepared by using polyethylene glycol 300 as the liquid vehicle or non volatile solvent. Crospovidone was used as a superdisintegrating agent and PVP K30 as a binder. Microcrystalline cellulose was used as a absorbing carrier and silicone dioxide as adsorbing coating material. The prepared liquisolid system were evaluated for their micromeretic properties and possible drug excipients interaction . The FTIR spectra study ruled out any interaction between the drug and excipients in preparation of Nimodipine liquisolid compact. The in vitro dissolution study confirmed enhance drug release from liquisolid compacts by using USP type I basket in 0.5 SLS in water. The selected optimal formula released 93.86 of its content in 30 min which is showing immediate release. The results showed that use of superdisintegrants had remarkable impact on the release rate of Nimodipine from Liquisolid compact, enhancing the release rate of the drug from liquisolid compact. Neha Durge | Kirti Parida ""Formulation and Evaluation of Nimodipine Tablet by Liquisolid Technique"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd23863.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/23863/formulation-and-evaluation-of-nimodipine-tablet-by-liquisolid-technique/neha-durge
This research article describes the formulation and evaluation of gel formulations containing an aqueous extract of Mimosa pudica for anti-inflammatory activity. Different gel formulations were prepared using carbopol 940, hydroxypropyl methylcellulose, and sodium carboxymethylcellulose as polymers. The gels were evaluated for characteristics such as drug content, physical appearance, pH, extrudability, and spreadability. The carbopol 940 gel formulation was found to be transparent, homogenous, and have the highest spreadability. This formulation showed significant inhibition of carrageenan-induced paw edema in rats, indicating anti-inflammatory effects.
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).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
The document describes the formulation and evaluation of Ritonavir floating tablets. It discusses Ritonavir's properties and uses floating drug delivery systems to prolong its release rate in the stomach. Several polymers like HPMC K4M, HPMC K15M, Eudragit RSPO and ethyl cellulose were used to formulate the tablets. The tablets were evaluated for parameters like weight variation, thickness, hardness, drug content and in vitro buoyancy and dissolution studies. The results showed that the floating tablets were able to prolong the release of Ritonavir in the stomach.
The document discusses the formulation and evaluation of solid dispersions of the drug carvedilol to improve its solubility and dissolution rate. Carvedilol was selected as it has low aqueous solubility and bioavailability. Solid dispersions were prepared using different carriers like poloxamer 407, mannitol, and PEG 4000 via solvent evaporation method. The dispersions were evaluated for dissolution rate and the best formulation was selected based on the evaluation studies. Stability studies were also proposed to be conducted on the best formulation.
This document summarizes emulgels, which are a combination of gels and emulsions used for topical drug delivery. Emulgels allow both hydrophilic and hydrophobic drugs to be incorporated and released in a controlled manner. They have advantages over other topical formulations like better stability, higher drug loading, and simpler production. An emulgel is prepared by dispersing an emulsion (either oil-in-water or water-in-oil) into a gel base. Key components include aqueous materials, oils, emulsifiers, gelling agents, and penetration enhancers. Emulgels combine the benefits of gels and emulsions for topical drug delivery.
Formulation development and invitro evaluation of lamotrigine fast dissolving...SriramNagarajan19
The present study was to formulate and evaluate oral fast dissolving Oral tablet containing Lamotrigine. Present study reveals that all the nine formulated tablet showed satisfactory tablet parameters. It can be concluded that, Oral fast dissolving tablet -containing Lamotrigine can be prepared by direct compression method. 10% CCS (FV) tablet exhibited required disintegration time and dissolution time. The drug release was about 98.7 % in 15min. The accelerated stability studies of the optimized F5 formulation indicates that the formulated oral fast dissolving tablet were unaffected after 3 months storage under accelerated conditions as there were no signs of visually distinguishable changes in appearance, disintegration time and cumulative percentage of drug release. From the present investigation it can be concluded that oral fast dissolving tablet formulation can be a potential novel drug dosage form for pediatric, geriatric and also for general population.
The document describes the formulation and characterization of a clarithromycin emulgel for topical drug delivery. Various formulations of clarithromycin emulgel were prepared using different gelling agents like Carbopol 934, Carbopol 940 and HPMCK4M. The formulations were evaluated for physical appearance, pH, viscosity, drug content and in vitro drug release. Formulation F1 showed optimum results with maximum drug content of 91.6% and sustained drug release of 74.47% over 12 hours. Thus, the developed clarithromycin emulgel using Carbopol 934 as gelling agent can be considered as a potential formulation for topical delivery of clarithromycin.
Dissolution enhancement of glimepiride by solid dispersion technique.Santosh Adhikari
Dissolution Enhancement of Glimepiride by Solid Dispersion Technique.
Priyanka Shrestha1*, Shiva Kumar Bhandari1, SM Ashraful Islam1, and Santosh Adhikari2.
1Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, Bangladesh.
2Department of Pharmacy, Rajiv Gandhi University of Health Science, Banglore-560 041.
Formulation and evaluation ofmetformin HCl micro beads by ionotropic gelation...Sagar Savale
The Metformin HCL Micro Beads is formulated by the Ionotropic Gelation Method. The CMC is a Swellable
polymer is responsible for the Sustained release action or activity. A combination of CMC (Carboxy Methyl
Cellulose) and Sodium Alginate shows better sustained release activity. The PreparedSustained released Micro
Beadsis Evaluated In terms of bulk density, tapped density, angle of repose, Carr’s Index, Swelling Index, Drug
Content, % Encapsulation Efficiency and vitro study. The result associated in Optimized batch is good to
Satisfactory and having a good free flowing property. The Drug Content and % Encapsulation Efficiency values are
within the pharmacopeia limit. The in vitro Dissolution studies shows Maximum percentage of release of drug
(71.15) with in end of 4 Hours.
Development and evaluation of xyloglucan matrix release tabs contaning glipizidesukesh
The document describes a research project that developed and evaluated matrix release tablets containing the drug glipizide using xyloglucan as a polymer. Xyloglucan was extracted from tamarind kernels and used to prepare different tablet formulations. Tablets were evaluated for dissolution, drug release, and other parameters. The best formulation was F1, which released 99% of the drug in a prolonged manner and could be used for extended release of glipizide.
This document discusses using hot melt extrusion (HME) technology to improve the dissolution and bioavailability of the poorly water soluble drug efavirenz (Efv) through the formation of solid dispersions with hydrophilic polymers and surfactants. Efv solid dispersions were prepared by HME using Kollidon VA64 polymer and various surfactants at 10% weight. Dissolution and permeability studies showed improved results for formulations containing PEG 4000 and sorbiton monolaurate surfactants. Pharmacokinetic studies in rats found the PEG 4000 formulation increased the extent of Efv absorption by 106.98% compared to non-HME controls. The study demonstrates HME can enhance the
This document discusses using gelatin beads as a sustained release drug delivery system. Gelatin beads can provide sustained release of drugs over time by taking advantage of their large surface area and diffusion properties. The document describes preparing and evaluating propranolol HCl loaded gelatin beads using natural polymers gelatin and fish gelatin crosslinked with glutaraldehyde. The beads were evaluated for loading efficiency, yield, in vitro drug release, and stability over 3 months of accelerated conditions. Overall, the document proposes that gelatin beads can serve as a biocompatible drug delivery system for sustained drug release.
Formulation and characterization of epigallocatechin gallate nanoparticlesRamkumar Ponnuraj
This document describes the formulation and characterization of Epigallocatechin gallate (EGCG) nanoparticles. EGCG was encapsulated in chitosan nanoparticles using ionic gelation with sodium tripolyphosphate to improve its bioavailability. Different ratios of EGCG to chitosan were tested, and a 1:0.5 ratio showed the highest drug loading and encapsulation efficiency. The resulting nanoparticles were spherical with a size range of 198-385 nm. In vitro drug release and characterization studies demonstrated the nanoparticles were a promising delivery system for EGCG with improved absorption.
The document summarizes the development of an extended release formulation of bupropion hydrochloride tablets. The objectives were to develop a stable, cost-effective ER formulation and compare it to marketed products. Various ER tablet formulations were prepared using different concentrations of coating polymers and evaluated for drug release. Formulations F9 and F10, which used 8% coating of ethylcellulose 15cps, showed comparable release to the reference product over 16 hours. The developed formulation met the objectives of providing a once-daily ER tablet for bupropion hydrochloride.
Formulation, characterization and invitro evaluation of aceclofenacemulgel fo...SriramNagarajan17
This document summarizes the formulation, characterization, and in vitro evaluation of aceclofenac emulgel for topical application. Eight aceclofenac emulgel formulations were prepared using a factorial design with variables including gelling agent, light liquid paraffin, and emulsifying agent. The formulations were evaluated for properties such as appearance, pH, viscosity, spreadability, and drug content. In vitro drug permeation studies showed that formulation F7 had the highest permeation, with 89.97% cumulative drug release after 12 hours. Kinetic analysis indicated F7 followed Higuchi diffusion, indicating drug release was diffusion mediated. Thus, F7 was selected as the optimized aceclofenac emulgel formulation for
Formulation and Evaluation of Microspheres Containing Aceclofenacpharmaindexing
This document describes research into formulating and evaluating microspheres containing the drug aceclofenac. Microspheres were prepared using hydroxypropyl methylcellulose (HPMC) and eudragit polymers via a solvent evaporation method. Infrared spectroscopy showed no chemical interactions between the drug and polymers. Drug entrapment efficiency was 72.32% for one formulation. In vitro drug release studies found 89.59% of the drug was released from one formulation over 12 hours. Scanning electron microscopy images showed the microspheres were spherical and smooth. The researchers concluded HPMC and eudragit are suitable carriers for preparing aceclofenac microspheres with improved bioavailability.
The document discusses how the media product draws from and develops conventions of the horror genre. It examines films like Insidious, Paranormal Activity, Cabin in the Woods, and The Woman in Black to inform decisions around genre, location, camera techniques, sound, costumes, lighting, and other mise-en-scene elements. References were made to establish tension, atmosphere, and verify authentic sounds that would make the film feel like a conventional horror movie.
The role of microbial testing in ensuring sterility of aseptically filled sterile pharmaceutical products is discussed. Microbial testing plays a key role from product development through finished product testing. During product development, tests are used to evaluate ingredients, packaging, and establish formulation and manufacturing parameters. In-process monitoring includes testing ingredients, water systems, environmental surfaces and personnel, and pre-filtration bioburden. Finished product testing includes sterility tests, though sterility assurance is primarily achieved through validated manufacturing processes rather than finished product testing alone.
This document is a bibliography or list of references for a publication. It contains over 35 references to journal articles, books, and other sources on topics related to pharmaceutical formulations, herbal medicines, and microbiology. The references are listed in alphabetical order by first author's last name and include information such as title, journal, year, and page numbers to cite the sources. The bibliography covers formulations such as gels, extracts of various plants and herbs, and their antimicrobial activities.
The document discusses how the media product draws from and develops conventions of the horror genre. It examines films like Insidious, Paranormal Activity, Cabin in the Woods, and The Woman in Black to inform decisions around genre, location, camera techniques, sound, costumes, lighting, and more. Reference materials like sound effect websites were also consulted to replicate techniques used in similar horror films.
This document discusses USP 797 regulations regarding environmental quality control for sterile compounding facilities. It outlines the need for regular air and surface sampling to test for microbial contamination where sterile compounds are prepared. Facilities must determine the risk levels of the compounds they produce to ensure sampling frequency and action levels meet USP 797 guidelines. If contamination exceeds allowed levels, facilities must take steps to eliminate the issue and re-sample to confirm. Outsourcing environmental sampling to qualified labs can help facilities achieve and maintain compliance.
The student used a basic video camera to film their short film because it was suitable for the angles, shots, and scale of their project. During pre-production they used Blogger to organize documents and Celtex to write the script. They filmed with a digital camera and used Blogger, Final Cut, PowerPoint, Word, Prezzi, and voice recorders for post-production and evaluation. The technology choices were made because the equipment was easy, fast, and simple enough to achieve their vision. The student learned how to use new technologies like cameras, bloggers, and editing software through completing this project.
Think and wonder, wonder and think. The document discusses developing student creativity through best practices such as explicitly teaching creativity, embedding it in lessons and assignments, and using tools to develop divergent and convergent thinking skills. It also addresses developing a creative mindset in students.
The document discusses guidelines issued by the FDA and Europe in 2004 regarding aseptic processing and sterile drug production. It outlines the importance of process control and describes how media fills are used to simulate aseptic filling processes to evaluate contamination levels. Key aspects of designing an effective media fill process are highlighted, including mimicking the actual aseptic process as closely as possible and using an appropriate growth medium to support the growth of a wide range of microorganisms.
This document provides a review of emulgels as a topical drug delivery system. Emulgels combine the advantages of gels and emulsions to allow both hydrophilic and hydrophobic drugs to be delivered through the skin. They consist of an emulsion incorporated into a gel base. This overcomes limitations of conventional gels which cannot effectively deliver hydrophobic drugs. Emulgels provide better stability, drug loading, and controlled release compared to other topical systems. They are easier and cheaper to produce than vesicular systems. The document discusses the skin as a barrier to drug delivery, factors influencing absorption, and methods to enhance penetration. It also outlines the key constituents of emulgels and their advantages for topical drug
Disinfectants and sterilization methods. rev.09302013Eka Selvina
This document provides guidance on disinfectants and sterilization methods. It defines key terms and discusses various classes of chemical disinfectants like aldehydes, halogen compounds, quaternary ammonium compounds, phenolics, acids/alkalis, heavy metals and alcohols. It also covers sterilization methods such as steam autoclaving, dry heat, radiation and vapors/gases. Tables provide summaries of practical disinfectants and their characteristics, potential applications and examples of proprietary disinfectants. The document aims to assist in selecting appropriate disinfectants and sterilization methods.
This guidance from the FDA provides recommendations for the types of information and data that should be submitted to validate sterilization processes for human and veterinary drug products. It outlines the key elements needed to characterize terminal sterilization processes like moist heat and validate their ability to reliably produce sterile products. These include descriptions of the process and product, thermal qualification studies, microbiological efficacy tests, and ensuring the integrity of packaging. It also provides recommendations for aseptic manufacturing processes and maintaining sterility over a product's shelf life. The guidance is intended to help applicants submit sufficient information for FDA review and approval of sterilization validation.
This document discusses aseptic processing and the manufacturing environment for sterile products. It describes the classification system for clean areas from Grades A to D based on particulate and microbial limits. Grade A is required for high risk aseptic operations like filling. Environmental monitoring includes particulate levels, air pressures between rooms, air changes and velocity. Personnel requirements aim to minimize introduction of contaminants through hygiene, clothing and training standards.
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Makalah ini membahas tentang pemeriksaan feses sebagai alat bantu diagnosis penyakit. Terdapat beberapa poin penting yang dijelaskan yaitu: (1) definisi dan manfaat pemeriksaan feses, (2) indikasi penyakit yang dapat didiagnosis melalui feses, dan (3) prosedur pemeriksaan feses secara makroskopis dan mikroskopis beserta interpretasi hasilnya.
This document presents a formulation and evaluation of flurbiprofen loaded emulgel. It begins with an introduction to transdermal drug delivery systems and their advantages over other routes of administration. It then discusses skin anatomy and physiology, the mechanisms of percutaneous absorption, and factors affecting topical absorption. The document provides background on rheumatoid arthritis and defines emulgel. It discusses the ideal properties of emulgel and provides advantages and disadvantages. The objectives and plan of work are then outlined which include literature review, preformulation studies, formulation development, evaluation studies, and stability testing. Finally, the document presents a literature review of several other emulgel formulations.
Formulation and Evaluation of W/O/W Multiple Emulsions with Diclofenac SodiumSagar Savale
Multiple emulsion is novel approach of drug delivery system
for enhancement of bioavailability and pharmacological
activity. It is important to prevent the problem of oral drug
delivery system and they are stabilized by using of combination
of hydrophilic and lipophilic surfactant. The specific ratio of
surfactant concentration is responsible for maintaining the
stability of multiple emulsions, the importance of this study was
to prepare multiple emulsion of Diclofenac sodium by using
two step emulsification process, by using the non-ionic
surfactant units. In multiple emulsion, the stability of multiple
emulsion was evaluated, percent entrapment efficiency as well
as in vitro studies are conducted. The process of primary and
secondary emulsification was optimized to get the stable
multiple emulsion with the high entrapment efficiency. Multiple
emulsion to improve bioavailability with the hypothesis that
improvement of drug release profile will reflect the
enhancement of bioavailability of the drug.
The document summarizes the formulation and evaluation of diclofenac sodium and thiocolchicoside as a topical gel. It describes preparing 6 formulations of gel using different polymers and permeation enhancers. The formulations were characterized for physical properties, pH, drug content, viscosity, spreadability, extrudability and stability. In vitro drug permeation and skin irritation studies were also performed to select the best formulation. Preformulation studies including solubility, melting point, UV, FTIR and DSC were done on the drugs and excipients to ensure compatibility. The results of various evaluation tests are presented and the best gel formulation is selected based on desired properties.
Development and Pharmaceutical Evaluation of Clotrimazole Loaded Topical Hydr...Madiha Mushtaque
SUMMARY. The present study addresses the solubility issue of a hydrophobic antifungal drug and its incorporation
into a hydrogel matrix. The prime objective of the study was to develop a preformed hydrogel
of 1% w/w clotrimazole with the introduction of water miscible co-solvents such as glycerin and polyethylene
glycol. Carbomer was used as gelling agent in different concentrations. The stability of the formulations,
their spreadability, pH, drug content, viscosity and in vitro drug release has been assessed while the
optimization has been carried out through Design Expert® ver. 7.0. A spectrophotometric method has
been developed for the analysis of clotrimazole from the developed formulations and it was found to be
within the USP limits. The best drug release was found from F2 formulation that contains 0.5 g carbomer
hence it was considered as optimized formulation. It is conclu
Formulation and evaluation of antifungal ketoconazole emulgelShwetaKate3
Formulation and evaluation of ketoconazole Emulgel:Controlled drug delivery ,
Presentation by Gajanan S. Lahade
M.pharm second year,
PDEA'S Seth govind raghunath Sable college of pharmacy, saswad ,pune,India
Formulation and evaluation of sustained release microspheres ofReshma Fathima .K
This document describes the formulation and evaluation of fenofibrate microspheres for sustained drug release. Fenofibrate microspheres were prepared using the emulsion-coacervation method with gelatin as the polymer. The microspheres were evaluated for particle size, drug entrapment efficiency, in vitro drug release, and stability. The results showed the microspheres had spherical morphology and successfully entrapped fenofibrate, providing sustained release over 12 hours. Thus, the fenofibrate microspheres developed in this study could be a promising approach for controlled delivery of this drug.
Formulation and evaluation of mucoadhesive tablets of carvedilol using natura...Nausheen Fatima
Present work describes formulation and evaluation mucoadhesive tablets of Carvedilol using natural binders such as Chitosan and Guar Gum to reduce the first pass metabolism and frequency of administration.
Formulation and Evaluation of Liquisolid Compact of Etoricoxib for Solubility...ijpsmjournal
Liquisolid compact technique is a novel concept for delivery of drug through oral route. This
approach of delivering drug is mostly suitable for lipophilic drug and poorly or water insoluble drugs. The
main objective of present study was to increase the solubility of water in soluble BSc class II drug etoricoxib.
Etoricoxib is alipophilic drug that is practically insoluble in water and exhibit an excessively slow dissolution
rate in class II compound in biopharmaceutics classification system. The liquid solid compacts were prepared
using PEG 400 as non volatile solvent, microcrystalline cellulose as carrier, aerosil 200 as coating material
and Sodium starch glycolate was used as super disintegrating agent. Several formulations of liquid solid
compacts having different drug concentration in PEG 400 (non volatile solvent) with varying ratio of career
to coating material were prepared. The liquid solid compacts were evaluated for Bulk characterization, Flow
properties, solubility studies, drug content, FTIR studies, DSC studies and in vitro drug release studies. The
saturated solubility studies and in vitro drug release studies shows that the increase in solubility of drug and
enhanced drug release rate in liquisolid compacts compared to pure drug. The Formulation F5 andF4 is
considered as best formulation as it has shown highest drug release in short time (1 hr). Our studies showed
that the solubility of the drug can be significantly enhanced with increase in the carrier content there is
increase in the solubility resulting and enhanced drug release rate.
The document describes the preparation and evaluation of controlled release matrix tablets of metformin hydrochloride. Ten formulations of matrix tablets were prepared using different amounts of polymers HPMC K100 and Carbapol 934 by direct compression method. The tablets were evaluated for pre-compression and post-compression parameters. In vitro drug release studies showed sustained release of the drug from the matrix tablets over an extended period of time based on the type and concentration of polymer used. The kinetic analysis of drug release indicated that the release followed non-fickian or anomalous transport mechanism.
Formulation and Evaluation of Topical Proniosomal Gel of an Antifungal Drug- ...Nirosha Kishore
1. The document describes the formulation and evaluation of a proniosomal gel containing the antifungal drug itraconazole.
2. Various proniosomal gel formulations were prepared using different ratios of span 20, span 80, cholesterol and lecithin using the coacervation phase separation method.
3. The formulations were evaluated for morphology, vesicle size, entrapment efficiency and in vitro drug release. Optimum formulations with smaller vesicle size and higher entrapment efficiency were selected for further stability studies.
This document discusses emulgel, which is an emulsion that is gelled to form a topical drug delivery system. Emulgels allow both hydrophobic and hydrophilic drugs to be delivered to the skin in a controlled manner, with the internal emulsion phases acting as a drug reservoir. The document outlines the ideal properties of drugs for emulgel delivery, describes the formulation process, and evaluates important characteristics like physical appearance and spreadability. Advantages of emulgels include their ability to incorporate hydrophobic drugs and provide controlled release. Factors that can influence skin absorption are also summarized. The document concludes by discussing emulgel as a promising topical delivery system and prospects for further development.
The objective of this study was to develope an ophthalmic insitu gel of diclofenac potassium and to carry out evaluation tests to identify the most ideal formulation.
Insitu gels for ocular drug delivery
- Liquid upon instillation ( solution/suspension)
-Visco-elastic gel in cul-de-sac
- Increased precorneal residence time
Diclofenac potassium
-Non Steroidal Anti-inflammatory Drug (NSAID)
-Treatment of miosis, post operative inflammation in cataract surgery.
Isolation and Purification of Secoisolariciresinoldiglucoside oligomers (Lign...IOSR Journals
The present study aimed to extract and purify the compound of Secoisolariciresinoldiglucoside
oligomers (lignan) from flax seed (Linumusitatissimum) and its antioxidant activity. The Lignan was extracted
by solvents which gave the best results were ethanol : 1,4 dioxane (1:1, v:v).SDG release after alkaline
hydrolysisby using a methanolicNaOH , 20 mM, pH=8 at 50 ºC.followed by using following chromatographic
techniques: Liquid-liquid, Sephadex LH-20 column chromatography, thin layer chromatographic (TLC), high
performance liquid chromatographic (HPLC) and Fourier Transform Infra-Red(FTIR) . The EC50 values of
Pure lignan extract (9 μg/ml) was shown possess DPPH radical scavenging activity compared to reference
substances BHT and vitamin C (EC50= 3 and 4.2 μg/ml) respectively, and this was higher than partial pure
lignan component (EC50= 25.5 μg/ml).The total phenolic content of the pure lignanwas higher than partial
pure lignan which gave 22.312 and 14.85 g/ml respectively.
FORMULATION AND INVITRO EVALUATION OF COLON SPECIFIC DRUG DELIVERY SYSTEM BY ...alok prakash kar
The document describes the formulation and in vitro evaluation of a colon-specific drug delivery system containing metronidazole. Metronidazole tablets were prepared using different polymers like ethyl cellulose, cellulose acetate butyrate, and Eudragit polymers. The tablets were then coated with various polymer coating suspensions. The coated tablets were evaluated for film thickness, weight gain, hardness, disintegration time, and drug release. The results showed that the coating thickness and weight gain increased with increasing polymer concentration in the coating suspension. The coated tablets had suitable hardness and disintegration times while sustaining drug release in the acidic environment of the stomach.
This document outlines a research plan for developing and evaluating a Glipizide loaded transdermal film. The objectives are to conduct preformulation studies, compatibility studies using FTIR, reduce drug particle size using precipitation, characterize drug particle size using SEM, formulate films using solvent evaporation, and evaluate films for properties like drug content and in-vitro drug release. The need is to improve Glipizide's solubility, dissolution, and bioavailability through the transdermal route to reduce side effects. The plan involves literature review, material selection, preformulation tests, film formulation, evaluation, kinetic modeling, and reporting.
Levetiracetam is an anti-epileptic medicine used to treat seizures in epilepsy. It is used for partial-onset, myoclonic, or tonic–clonic seizures. General route of administration is by Oral and IV. But it is not recommended throughout an epileptic attack due to the risk of nausea or vomiting. The Intranasal (IN) route is a promising therapy option, as it allows medications to reach the brain directly, it is regarded an alternative to parenteral administration, and hence the effective dosage predicted via other administration routes is scheduled to be reduced using the IN route
Formulation Development and Characterization of Topical Gel for PsoriasisBRNSS Publication Hub
The purpose of this research work was to develop and characterize a tacrolimus (TAC) gel using different
polymers for the treatment of psoriasis. The physicochemical compatibility was confirmed between
TAC and other excipients by Fourier transfer infrared. Formulated gels were characterized for drug
content, viscosity, extrudability, skin irritation study, pH, in vitro diffusion study, and stability. Release
of TAC from all formulations using dialysis membrane into a phosphate buffer pH 6.8 at 37°C was
performed. Optimized batch was selected from this characterization study. Based on the data collected,
it was revealed that TAC has proven to be a promising candidate for delivery through gel in the treatment
of psoriasis.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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A 3
1. International Journal of PharmTech Research
CODEN (USA): IJPRIF ISSN : 0974-4304
Vol.4, No.3, pp 1332-1344, July-Sept 2012
Formulation Design & Development of Piroxicam
Emulgel
Dignesh M. Khunt*, Ashish D. Mishra, Dinesh R. Shah.
Department of Pharmaceutics, Maliba Pharmacy College, Bardoli 394601,
Gujarat, India
*Corres.author: digneshkhunt80@gmail.com
Mobile No. :- 91-9724825126
Abstract: The objective of this work is to develop emulgel of piroxicam which will increase skin penetration
of drug in comparison with present marketed preparations of the drug. Based on solubility studies oleic acid as
oil, Tween-80 and Span-80 as emulsifiers and propylene glycol and cetostearyl alcohol as co-surfactant were
selected for preparation of emulgel. The emulgels were prepared using different combinations of oil,
emulsifiers, co-surfactant and carbomer (Carbompol 940 and Carbopol 934). They were optimized using 32 full
factorial designs to study the effect of independent variables, i.e. concentration of emulsifiers (X1) and carbomer
(X2) on dependent variables like % drug release at 2 and 6 hours. The prepared emulgels were evaluated in
terms of appearance, average globule size, drug content and in-vitro drug release. In-vitro release study
demonstrated diffusion controlled release of piroxicam from formulation up to 8 hours. The drug release profile
exhibited zero order kinetics. From the regression analysis, it was observed that all three independent variables
had significant effect on response variables. Formulation was optimized using contour plot and response surface
plot. The optimized formulations were found to be F3 and F12 containing lower concentration of Carbopol (0.5
%) and higher concentration of emulsifiers (6%). The optimized formulae ware evaluated for Zeta Potential,
viscosity, spreadability, skin permeation and stability. Skin permeation (%) of optimized batches (F3 and F12)
in 24 hours was found to be 87.89% and 89.09 % respectively. The formulation batch F12 had better anti-inflammatory
activity than marketed preparation.
Keywords: Piroxicam, Emulgel, Carbopol.
Introduction
Piroxicam is a non-steroidal anti-inflammatory
compound with analgesic and antipyretic effects,
used for the treatment of rheumatoid arthritis,
osteoarthritis and traumatic contusions. It is well
absorbed following oral administration however its
use has been associated with a number of
undesirable side effects on the stomach and kidneys
in addition to gastric mucosal damage1,2. Dermal
delivery is an alternative route but requires a
formulation which ensures deep skin penetration,
allowing therapeutic effect at localized site3,4.
Although piroxicam is not easily absorbed after
topical application, some studies have been carried
out to predict the percutaneous absorption of
piroxicam using different substances as permeation
enhancers5-10.
Many widely used topical agents like ointments,
creams, lotions have numerous disadvantages. They
are usually very sticky causing uneasiness to the
patient when applied. Moreover they also have less
spreading coefficient and need to apply with
rubbing. They also exhibit the problem of stability.
Due to all these factors, within the major group of
semisolid preparations, the use of transparent gels
2. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1333
has increased both in cosmetics and in
pharmaceutical preparations11,12.
A gel is colloid that is typically 99% by weight
liquid, which is immobilized by surface tension
between it and a macromolecular network of fibers
built from a small amount of a gelating substance
present. In spite of many advantages of gels a major
limitation is their inability to delivery hydrophobic
drugs12.
To overcome this limitation an emulsion based
approach is being used so that a hydrophobic
therapeutic moiety can be successfully incorporated
and delivered through gels. When gels and
emulsions are used in combined form the dosage
forms are referred as emulgels.
Emulgels for dermatological use have several
favorable properties such as being thixotropic,
greaseless, easily spreadable, easily removable,
emollient, non-staining, transparent with long shelf
life & pleasing appearance12.
The aim of this work was to develop an emulgel
formulation of piroxicam using two different grades
of carbomer (Carbopol 934 and Carbopol 940). The
influence of type and concentration of the gelling
agent and the emulsifying agent on the release of the
drug from the prepared emulgels was investigated
using 32 full factorial design.
Materials and Methods
Materials
Piroxicam was received as a gift sample from
Torrent Pharmaceutical Ltd, Ahmadabad (India).
Carbomers were purchsed from Corel Pharma
Chem., Ahmadabad (India). Oleic acid, Span-80,
Tween-80, methyl salicylate and propyl paraben
were purchased from S.D Fine Chemicals Ltd.,
Mumbai (India) All other chemicals and reagents
used were of analytical grade. Deionized distilled
water was used throughout the study.
Methods
Solubility study
An excess amount of piroxicam was added to each
solvent and was stirred magnetically. After stirring
for 24 hours at 37ºC, the equilibrated sample was
centrifuged for 10 min at 5000 rpm (rotations per
minute) to remove excess amount of piroxicam. The
supernatant was filtered and properly diluted with
phosphate buffer pH 7.4. The concentration of
piroxicam was determined by UV
spectrophotometry10.
Preparation of emulgel
The composition of piroxicam emulgel formulations
is shown in table II and III. First cetostearyl alcohol
is melted which was then mixed with oil, surfactant,
co-surfactant and methyl salicylate in required
quantity. Then 0.5% piroxicam gel was dissolved in
this oil phase. Carbopols in required quantity as
given in formulation table IV and V were dispersed
in water phase. Both the oily and aqueous phases
were separately heated to 50° to 60°C: then the oily
phase was added to the aqueous phase with
continuous stirring (up to 2 hours). The pH was
adjusted to 6 to 7 using triethanolamine.
Table I. Selection of independent and dependent variables
Independent variables Variable level
Low (-1) Medium (0) High (1)
Concentration of Emulsifiers (X1) 2 4 6
Concentration of Carbopol (X2) 0.5 0.75 1.0
Dependent variables
1. % Cumulative release at 2 hours (Q2 in %)
2. % Cumulative release at 6 hours (Q6 in %)
3. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1334
Table II. Formulation of ingredients of emulgel using Carbopol 940
Ingredients(%w/w) F1 F2 F3 F4 F5 F6 F7 F8 F9
Drug (%) 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5
Oleic acid (%) 20 20 20 20 20 20 20 20 20
Propylene glycol (%) 5 5 5 5 5 5 5 5 5
Methyl salicylate (%) 10 10 10 10 10 10 10 10 10
Cetostearyl alcohol (%) 4 4 4 4 4 4 4 4 4
Span-80 (%) 0.9 1.9 2.8 0.9 1.9 2.8 0.9 1.9 2.8
Tween-80 (%) 1.1 2.1 3.2 1.1 2.1 3.2 1.1 2.1 3.2
Carbopol 940 (%) 0.5 0.5 0.5 0.75 0.75 0.75 1 1 1
Water (%) 58.9 57.9 56.8 58.9 57.9 56.8 58.9 57.9 56.8
Propyl paraben 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02
Triethanolamine (%) Adjust pH 6 to 7
Table III. Formulation of ingredients of emulgel using Carbopol 934
Ingredients(%w/w) F10 F11 F12 F13 F14 F15 F16 F17 F18
Drug (%) 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5
Oleic acid (%) 20 20 20 20 20 20 20 20 20
Propylene glycol (%) 5 5 5 5 5 5 5 5 5
Methyl salicylate (%) 10 10 10 10 10 10 10 10 10
Cetostearyl alcohol (%) 4 4 4 4 4 4 4 4 4
Span-80 (%) 0.9 1.9 2.8 0.9 1.9 2.8 0.9 1.9 2.8
Tween-80 (%) 1.1 2.1 3.2 1.1 2.1 3.2 1.1 2.1 3.2
Carbopol 940 (%) 0.5 0.5 0.5 0.75 0.75 0.75 1 1 1
Water (%) 58.9 57.9 56.8 58.9 57.9 56.8 58.9 57.9 56.8
Propyl paraben 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02
Triethanolamine (%) Adjust pH 6 to 7
Table IV. In-vitro drug release study conditions
Apparatus Franz diffusion cell
Diffusion medium (in receptor compartment ) pH 7.4 phosphate buffer
Diffusion medium volume 15 ml
Temperature 37 ± 0.5ºC
Speed 50 rpm
Sampling volume 3 ml
Sampling interval 1 hour
Table V. Experimental design for animal study
No. Group
1 Control group Carrageenan (1%)
2 Standard group Topical application of marketed formulation (Pirox gel, Cipla) on inflamed
area (localized delivery)
3 Standard group Topical application of marketed formulation (Pirox gel, Cipla) on dorsal
area (transdermal delivery)
4 Test group Topical application of F12 batch on inflamed area (localized delivery)
5 Test group Topical application of F12 batch on dorsal area (transdermal delivery)
4. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1335
Experimental design
A 32 level factorial design was conducted to study
the effect of independent variables (i) Concentration
of emulsifiers (X1) and (ii) Concentration of
Carbopol (X2) on dependent variables % cumulative
drug release at 2 hour (Q2) and % cumulative drug
release at 6 hours (Q6). The independent and
dependent variables are listed in table I while all the
batches ware prepared according to the experimental
design (table II).
Two grades of Carbopol were taken. Same
experimental design was applied for both grades.
Eighteen piroxicam emulgel formulations were
prepared in all.
Characterization of emulgel
Appearance
Appearance of gel was evaluated on the bases of
visual inspection.
Drug content
Drug content of emulsion was measured by UV
spectrophotometer. 1 ml of emulsion was diluted to
20ml with methanol and volume was made up to
100ml using phosphate buffer 7.4. A volume of 2ml
of this solution was further diluted to make 10 μg/ml
solution of piroxicam.
Average globule size
Average globule size was measured by light
microscope.
In-vitro drug release study
The in-vitro drug release of piroxicam from prepared
formulations and marketed formulation (Pirox Gel,
Cipla Pharmaceuticals) were studied through
cellophane membrane using Franz diffusion cell.
The cellophane membrane was previously treated
with sodium hydroxide and soaked overnight in the
phosphate buffer 7.4 at refrigeration temparature.
The treated cellophane membrane was sandwiched
between donor and receptor compartments of Franz
diffusion cell. Formulation equivalent to 2 mg of
piroxicam was added on the cellophane membrane.
A magnetic bar was continuously stirred in diffusion
medium to avoid diffusion layer effect. The
withdrawn sample was analyzed by UV
spectrophotometer. Study conditions were as shown
in the table IV.
Kinetic study and mechanism of drug release
The diffusion profile of all the batches was fitted to
Zero order, First order, Higuchi and Krosmeyer-
Peppas models to ascertain the kinetics of the drug
release13,14.
Optimization of formulation
It was done by contour plot and response surface
plot using Design Expert software 8.0.7.1 trial.
Characterization of optimized batch
Optimized batch was evaluated for all parameters
previously described.
Additional evaluation parameters of optimized batch
are given below.
Viscosity
The Viscosity of emulgel was carried out with
Brookfield viscometer (LVDV II + prime model)
using S64 spindle. The viscosity was measured at 12
rpm.
Globule Size and Zeta Potential
Globule Size and Zeta Potential of emulsions were
determined by Zetatrac. Zetatrac determines Zeta
Potential by measuring the response of charged
particles to an electric field.
In a constant electric field particles drift at a constant
velocity. Through the velocity, the charge and Zeta
Potential are determined. Zetatrac utilizes a high
frequency AC electric field to oscillate the charged
particles. The Brownian motion power spectrum is
analyzed with the Nanotrac controlled reference
technique of particle sizing to determine the
Modulated Power Spectrum, a component of the
power spectrum resulting from the oscillating
particles. Zeta Potential is calculated from the MPS
signal. Also determined are the particle mobility
(velocity per electric field), particle charge and
particle size.
Photomicrography
Morphology of emulsion was studied under light
microscope. Optimized batches of the emulgel were
viewed under light microscope to study their shape.
The emulgel was suitably diluted, mounted on glass
slide and viewed by light microscope under
magnification of 40 X.
Skin permeation and skin retention study
Skin permeation study was carried out with rat
dorsal skin using modified Franz diffusion cell by
the same method as described above in the in-vitro
drug release study of emulgel. The skin was
carefully checked through a magnifying glass to
ensure that samples were free from any surface
irregularity such as tiny holes or crevices in the
portion that was used for permeation studies.
5. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1336
The ability of emulgel to help retain the drug within
the skin (i.e. depot-effect) was investigated by
determining the amount of drug retained in the skin
samples employed in permeation studies. For this,
remaining emulgel from the donor compartment was
pipette out and dissolved in phosphate buffer.
Absorbance was measured by UV
spectrophotometer to determine amount of drug
retained and remaining to diffuse.
Spreadability
One of the criteria for an emulgel to meet the ideal
quantities is that it should possess good
spreadability. It is the term expressed to denote the
extent of area to which gel readily spreads on
application to skin or affected part. The therapeutic
efficacy of a formulation also depends upon its
spreadability.
Spreadability of emulgel and marketed gel was
measured in terms of diameter of emulgel circle
produced when emulgel is placed between two glass
plates of definite weight. A weighed quantity (350
mg) of emulgel or gels was taken on one glass plate
and another glass plate was dropped from a distance
of 5 cm. The diameter of the circle of spread
emulgel was measured15,16.
In-vivo Anti- inflammatory activity
All the experimental procedures were carried out in
accordance with committee for purpose of
experiments on animal’s guidelines (CPSCEA). The
study was reviewed and approved by Institutional
Ethics Committee (Protocol number: MPC/16/2012),
Maliba Pharmacy College, India.
Edema was induced on the left hind paw of the rats
by subplantar injection of 1 %( w/v) carrageenan.
They were divided into 5 groups of 5 rat each (table
V). Formulations i.e. F12 and standard (Pirox gel,
Cipla) containing 0.25 mg of piroxicam were
applied after carrageenan administration17, 18.
The area to which gels were applied was kept
constant (1 cm2). The paw thickness was measured
at intervals of 30, 90, 180, 360 and 1440 minute by
measurement of diameter using Vernier callipers.
The % inhibition of paw edema in drug treated
group was compared with carregenan control group
and calculated according to the formula:
% inhibition of drug = Dc-Dt/ Dc x 100
Where, Dc = Rat paw diameter (in mm) of control
group.
Dt = Rat paw Diameter of test group
Stability study
Stability study of selected formulation was done at
room temperature for 1 month and formulation was
finally evaluated for appearance, drug content and
pH.
Result and discussion
Solubility
Solubility in various excipients is shown in table VI.
From data shown in Table VI, highest solubility of
piroxicam was found in oleic acid amongst oils,
Tween 80 amongst surfactants and propylene glycol
amongst co-surfactants. Hence these components are
selected for preparation of emulgel system.
Appearance of emulsions and emulgels
All formulation batches were found to be
homogenous yellowish milky emulsions while
emulgels were found to be yellowish white viscous
creamy preparation.
Drug content
Drug content details of emulgel are shown in table
VII. Amount of drug in the emulgel indicates the
suitability of the system for high entrapment in the
internal phase.
Average globule size
Average globule size measurements are shown in
table VII. The results indicate that globule size of
droplet varies from 11 to 17 μm.
Table VI. Solubility study data
Components Solubility (mg/ml)
Water 0.13
Linseed oil 5
Oleic acid 13.2
Phosphate buffer 7.4 0.20
Propylene glycol 6
Tween 80 16
Span 80 3.2
6. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1337
Table VII. % Drug content and average globules size
Batch
No.
% Drug
Content
(n=3)
Average
globules size
(μm) (n=50)
Batch
No.
% Drug Content
(n=3)
Average globules
size (μm)
(n=50)
F1 98.29 ± 0.5 15.5 ± 0.25 F10 97.38 ± 0.64 13.42 ± 1.04
F2 97.21± 0.9 17 ± 0.75 F11 99.24 ± 1.43 12.75 ± 2.12
F3 101.23± 1.0 15 ± 1.0 F12 97.98 ± 2.29 11 ± 0.47
F4 99.01± 0.7 16.37 ± 0.35 F13 99.41 ± 0.28 11.9 ± 0.4
F5 97.69± 0.8 13.12 ± 1.06 F14 101.77 ± 2.88 12.75 ± 0.32
F6 100.13± 0.99 11.38 ± 0.56 F15 98.95 ± 0.83 12.5 ± 1.25
F7 99.1 ± 0.42 11 ± 0.95 F16 101.45 ± 1.66 12.9 ± 0.18
F8 102.59 ± 1.54 12.5 ± 1.25 F17 100.11 ± 1.75 12.5 ± 0.95
F9 101.7± 0.35 12.9 ± 1.3 F18 102.54 ± 0.59 12.1 ± 2
In-vitro drug release
The results of in-vitro drug release study are shown
in table VIII and comparative drug release is shown
in figure 1.
Formulation batches F3 and F12 release drug faster
than the other formulation due to the lower
concentration of Carbopol and higher cocentration
of emulsifiers. An increase in concentration of
Carbopol leads to decreased drug release from
formulation due to increase in viscosity of
formulation.
Kinetic study and mechanism of drug release
The correlation coefficient value (R2) of each
formulation for zero order, first order, Higuchi,
Hixon Crowell and value of release exponent from
Korsmeyer Peppas model are shown in table IX.
The release kinetics data indicates that the release of
drug from emulgels follows zero order kinetics
because the correlation coefficient values are higher
in case of zero order equation. The release rate is
independent of the concentration of the drug. The
release exponent value of Korsmeyer Peppas
equation is near to 1, this suggests that the emulgel
follows case II transport mechanism (zero order
release).
Data analysis of 32 full factorial design
Multiple regression analysis of F1-F9 batches are
shown in table X.
The response (Y1 and Y2) obtained at
various levels of the 2 independent variables (X1 and
X2) were subjected to multiple regression to yield a
second-order polynomial equation (full model).
Equation clearly reflects the wide range of values for
response (Y1 and Y2).
2 – 0.525
Y1= 14.52 + 3.66 X1 – 6.282 X2 + 1.01 X1
X2
2 -0.8425 X1X2
The amount of drug released at 2 hr from the F10-
F18 batches of emulgel varied from 14.41% to
22.42%. Correlation coefficient was found be 0.940
suggesting best fit to model. From the P-value, it can
be concluded that X1 and X2 have the prominent
effect (P < 0.05) on the Q2. Postive sign of X1 in
regression equation indicates that the response value
increases as the number of factors increases.
Negative sign of X2 in regression equation indicates
that the response value decreases as the number of
factors increases.
Y2 = 60.327 + 5.183 X1 – 3.377 X2 + 0.91 X1
2 -0.57
X2
2 – 0.405 X1X2
The amount of drug released at 6 hr from the F1-F9
batches of emulgel varied from 52.52% to 69.64%.
Correlation coefficient was found to be 0.9994
suggesting best fit to model. From the P-value, it can
be concluded that X1 and X2 have the prominent
effect (P < 0.05) on the Q6. Postive sign of X1 in
regression equation indicates that the response value
increases as the number of factors increases.
Negative sign of X2 in regression equation indicates
that the response value decreases as the number of
factors increases.
Similar results were found for F10-F18 bathes,
multiple regression analysis of which is given in
table XI.
8. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1339
Table X. Multiple regression analysis for Y1 and Y2 (Full model) (batch F1-F9)
Q2 = Y1 Q6= Y2
Dependent variables P value Coefficients P value Coefficients
Intercept 0.002526 14.52 3.99*10-8 60.327
X1 0.005007 3.66 3.73*10-5 5.183
X2 0.022568 -6.282 1.03*10-5 -3.377
X3 0.743054 1.01 0.032117 0.91
X4 0.538926 -0.525 0.009023 -0.57
X5 0.474354 -0.8425 0.031719 -0.405
Table XI. Multiple regression analysis for Y1 and Y2 (Full model) (batch F10-F18)
Q2 = Y1 Q6= Y2
Dependent variables P value Coefficients P value Coefficients
Intercept 1.21*10-5 19.58778 1.85*10-07 60.36556
X1 0.002699 1.745 0.000185 3.293333
X2 0.001525 -2.12 0.001103 -1.80833
X3 0.914296 0.038333 0.553409 0.166667
X4 0.051985 -1.02667 0.347551 -0.27833
X5 0.812491 0.06 0.805951 -0.0475
Results of Analysis of variance (ANOVA)
ANOVA was done using Microsoft Excel. Results
of ANOVA for Q2 and Q6 are shown in Table XII.
Contour plot and response surface plot
Results of contour plot and response surface plot are
shown in figure 1(a) and figure 1(b). From this F3
and F12 batches were selected as optimized batches
exacting the maximum drug release from the
emulgel formulation.
Table XII. ANOVA for dependent variables for F1-F18
Source Sum of
Squares
Degrees of
Freedom Mean Square F Value Significance
F
For Q2 = % drug release at 2 hours (F1-F9)
Regression 322.5603 5 64.51206 15.12272 0.024448
Residual 12.79771 3 4.265903 - -
Total 335.358 8 - - -
For Q6 = % drug release at 6 hours (F1-F9)
Regression 232.575 5 46.51501 1030.867 4.76*10-05
Residual 0.135367 3 0.045122
Total 232.7104 8
For Q2 = % drug release at 2 hours (F10-F18)
Regression 47.36198 5 9.472396 44.0774 0.005220422
Residual 0.644711 3 0.214904 - -
Total 48.00669 8 - - -
For Q6 = % drug release at 6 hours (F10-F18)
Regression 84.9162 5 16.98324 135.3296 0.000992
Residual 0.376486 3 0.125495 - -
Total 85.29269 8 - - -
9. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1340
Figure 1 (a) Counter plot and Response surface plot for F1-F9
Figure 1 (b) Counter plot and Response surface plot for F1-F9
10. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1341
Evaluation of Optimization
Viscosity of optimization batch
Viscosity of the emulgel was measured at 12 rpm.
Viscosity of F3 and F12 was found to be 21445 ±
0.59 cp and 19446 ± 0.74 cp respectively.
Globule Size and Zeta Potential
The results of Globule size and Zeta Potential
measurement of the batch F3 and F12 emulgels are
shown in figure 2 (a, b). Results revealed that both
batches had reasonable globule size and PDI
(Polydispersibility index).
Figure 2 (a) Globule Size and Zeta Potential of F3
Figure 2 (b) Globule Size and Zeta Potential of F12
Photomicrography
The suitably diluted emulsions of optimized batches
(F3 and F12) were observed under light microscope
at 40X (figure 3). From the photomicrograph, nearly
spherical globules of emulsion were observed.
Though this study does not give any exact estimate
of size however it gives a general idea about
formation of emulsion and success of the method
used.
11. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1342
Figure 3 Photomicrographs of F3 and F12
Skin permeation and skin retention study
The skin permeation of Piroxicam from the
optimized emulgel was studied through the rat’s
dorsal skin using a modified Franz diffusion cell.
The diffusion medium used was phosphate buffer
pH 7.4. The result of skin permeation for 24 hours of
emulgel is as shown in figure 4.
Optimized batch F3 and F12 the amount of drug
permeated through skin in 24 hours was 87.89% and
89.09 %. In marketed formulation, skin permeation
was found to be 60.56% where as drug retention in
skin was found to be 28 %. It can be concluded that
drug permeation is enhanced in the emulgels.
Spreadability
Spreadability of the formulations is shown in table
XIII. Spreadability of emulgel is an important
parameter. Results of spreadability indicate that
spreadability of emulgel is better than the marketed
gel.
In-vivo study of the emulgels (Anti-inflammatory
activity)
This study was conducted by applying emulgel F12
topically at site of inflammation and also at a site
away from inflammation (transdermal application)
because emulgels were exhibiting high in-vitro
release in comparison to marketed formulation
whereas skin retention was found to be negligible in
emulgels. The anti-inflammatory action of
formulation F12 was calculated and it was compared
with marketed preparation (Pirox gel, Cipla). The %
inhibition of marketed formulation and F12 are
given in table figure 5.
100
90
80
70
60
50
40
30
20
10
0
0 10 20 30
Cumulative % drug permeated
Time (hours)
F3
F12
Pirox Gel (M)
Figure 5. % Inhibition of inflammation
12. Dignesh M. Khunt et al /Int.J.PharmTech Res.2012,4(3) 1343
Table XIII Spreadability of the formulation
Batch Diameter of circle (mean ± s.d. , n=3)
F3 3.13 ± 0.11
F12 3.77 ± 0.20
Marketed formulation 2.27 ± 0.25
Table XIV Results of stability study (mean ± s.d., n=3)
Before After
Appearance pH Drug content
(%)
Appearance pH Drug content
(%)
yellowish
white viscous
creamy
6.29 ± 0.53 99.45 ± 1.23 yellowish
white viscous
creamy
6.96 ± 0.73 98.00±0.64
Results show that the F12 formulation is more
effective in inhibiting inflammation than marketed
formulation. It is effective topically as well as
transdermally.
Stability study
Stability study was performed on optimized batches
F3 and F12 at ambient conditions. The results
obtained after 1 month time period are shown in
table XIV.
Conclusion
The present investigation deals with the formulation
design and development of emulgel of piroxicam.
Optimization was done using factorial design at 3
levels and 2 factors. From the polynomial equation
and contour plots generated, both independent
factors showed significant effect on dependent
variables. The release of Piroxicam was good fit to
the zero order and Higuchi model. The formulation
batch F12 showed better anti-inflammatory activity
than marketed preparation. Thus emulgel of
Piroxicam is suitable to dermal delivery.
Acknowledgements
We would like to thank Dr. Bhavin Vyas and Mr.
Shrikant Joshi (Faculty of Pharmacology, Maliba
Pharmacy College, India) for their kind help in
conducting animal study.
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