Journal Name:
- The International Journal of Pharmaceutical Research and Bio-Science
Abstract (2. Language):
Aim: To formulate, develop and optimize Controlled Porosity Osmotic Pump (CPOP) tablets of Milnacipran hydrochloride. Methodology: The CPOP tablet contains pore former i.e. water-soluble additive (PEG-8000) in the coating membrane which after coming in contact with water, dissolve, resulting in an in-situ formation of microporous structure. The plasma half-life of Milnacipran hydrochloride ranges from 6 to 8 hours and the dosage regimen is one 50 mg tablet twice a day. Hence, Milnacipran hydrochloride was chosen as a model drug with an aim to develop a controlled release system for 24 hours. The effect of different variables, like, ratio of drug to osmogent, % weight gain and level of pore former in the coating solution on the In Vitro drug release is studied using 23 factorial design. The effect of pH and agitation on drug release was also carried out. Drug-excipients compatibility was studied by Differential Scanning Calorimetry (DSC). Microporous structure of coating membrane of formulation was determined by Scanning Electron Microscope (SEM). Results: In Vitro dissolution studies revealed that drug release rate increased with the amount of osmogent because of increased water uptake, and hence increased driving force for drug release. Drug release was inversely proportional to membrane weight gain: however, directly related to the concentration of pore former in the membrane. Conclusion: Optimized formulation (SP7) was found to deliver 99.68 % of drug at a zero order rate in 24 hours.
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FULL TEXT (PDF):
- 6
239-259