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• W2783233694 abstract "AIM AND OBJECTIVE: The Present study were to develop and evaluate a push-pull based osmotic delivery system for anti-diabeticdrug (Glipizide). To develop push-pull based osmotic delivery system of anti-diabetic drug,belonging to BCS class II and optimize a generic formulation to the innovator. CONCLUSION:The aim of the present study was to formulate and evaluate a generic osmotic controlleddelivery system for an innovator’s anti-diabetic drug. Osmotic devices are most promisingstrategy based systems for controlled drug delivery. They are among the most reliable controlleddrug delivery systems and could be employed as oral drug delivery systems or implantabledevices. Extended release formulation of an anti-diabetic drug based on push pull osmotictechnology was developed and evaluated. The effect of different formulation variable namely,amount of PEO in push and pull layers, effect of various grades of PEO in push and pull layers,amount of sodium chloride in push layer, semi permeable membrane weight gain, were studied.Bi-layer push-pull osmotic tablets were prepared using polyethylene oxide as anexpanding agent. Tablets were coated with semi permeable membrane using Opadry CA andmechanically drilled; in vitro drug release was performed in US food and drug administrationrecommended official dissolution media pH 7.4 phosphate buffer to study the drug releaseprofile.From formulations F1 to F3, poly ethylene oxide of molecular weight 6 lakhs and polyethylene oxide of molecular weight 50 lakhs were used in pull and push layers respectively withvarying concentrations, the drug release profile showed very slow release. To enhance the drugrelease, formulations F4 to F6 were formulated using poly ethylene oxide of 3 lakhs molecularweight, which is of low molecular weight when compared to previous formulation. When polyethylene oxide of 50 lakhs was used in push layer, the release profile showed good zero-orderrelease but the drug release was slow compared with that of innovator.To enhance the drug release further, formulations F6 to F9 were done using PEO ofhigher molecular weight, 70 lakhs in push layer, and PEO of 3 lakhs molecular weight in pulllayer. It showed good release profile similar to innovator, but initial drug release was slow.Formulations F10 and F11 were performed to overcome the initial slow release of drug, byvarying concentration of sodium chloride in push layer. By increasing the concentration ofSodium chloride the drug release was increased and the release profile was similar to innovator. All the above formulations were performed by coating with Opadry CA (a readyformulated semi permeable membrane coating system comprising CA and PEG3350) as semipermeable membrane to get a 14% weight gain, based on information available from patent andliterature. To check the effect of weight gain, formulations F12, F13, F14 were formulated bycoating with Opadry CA to obtain, 8%, 10%, 12% weight gain respectively. Formulation F12and F13 with 8% and 10% showed fast release, whereas, the formulation F14 with 12 % showedsimilar release when compared with innovator. The comparative release profile of formulationswith 12% and 14% showed similar release profile when compared with innovator. So, coating ofsemi-permeable membrane of 13±1% can be recommended to get the desired release profile.But, to avoid extra weight gain when compared to other formulations, 12% was selected asoptimized weight gain, concluding F14 as optimized formulation and continuing further studiesto scale-up formulations.Stability studies were conducted at 40oC/75% RH for 3 months. Physical appearance,assay and dissolution profile of optimized formulation F14 complies with Innovator product andwas found to be stable." @default.
• W2783233694 created "2018-01-26" @default.
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• W2783233694 date "2016-10-01" @default.
• W2783233694 modified "2023-09-27" @default.
• W2783233694 title "Development and Evaluation of Osmotically Controlled Glipizide Extended Release Tablet" @default.
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