Please use this identifier to cite or link to this item: http://10.1.7.192:80/jspui/handle/123456789/8412
Title: Optimization of Residual Solvents of Peptide Containing Microspheres
Authors: Preksha, Vinchhi
Keywords: PDR00550
Pharmaceutics
Dissertation Report
Issue Date: May-2019
Publisher: Institute of Pharmacy, Nirma University, A'bad
Series/Report no.: PDR00550;17MPH110
Abstract: In recent times, proteins are proved to be an imperative class of therapeutically active agents. Owing to limitations in oral route including enzymatic degradation, poor bioavailability, short half lives, and multiple injections are to be given to provide efficacy. Long acting parenteral formulation is beneficial to surmount the limitations of traditional therapy. Polymeric microspheres have received extensive interest in delivery of protein and peptide molecules in recent years. Biodegradable microspheres dwell in a significant position due to various aspects like prevents protein degradation, sustained and desired release profile, improves patient compliance etc. Among various synthetic polymers, poly lactic co glycolic acid (PLGA) loaded microspheres is having a successful market because PLGA is approved by USFDA as biocompatible and biodegradable polymer. Amongst various formulation techniques for microspheres, organic solvents are an innate part of the process involved. Organic solvents when present in unacceptable limit in finished product are highly toxic. Since some of the organic solvents are carcinogenic, teratogenic as well as neurotoxic, residual solvent contect is a safety concern among various regulatory bodies. According to ICH Q3C guideline they are classified in four categories based on their toxicity. The residual solvent content of finished product should comply with the limits according to ICH guideline. In this study the effect of various formulation components, washing and drying techniques on residual solvents is investigated. When microspheres were formulated by multiple emulsion technique high impurity, high residual methylene dichloride and variability in particle size was observed. Phase separation coacervation technique was employed which resulted in a reduced amount of impurity, uniform particle size distribution and reduced residual solvent. Various strategies were applied to reduce the residual solvent. Large amount of washing solvent, increase in washing time, addition rate of coacervationg agent, increase in temperature, changing polymer solvent: coacervating agent ratio were the strategies applied. There was significant impact of polymer solvent: coacervating agent ratio on residual hardening solvent and residual polymer solvent. Various changes in formulation conditions alter the residual solvent and can be beneficial in complying the limits according to guideline.
URI: http://10.1.7.192:80/jspui/handle/123456789/8412
Appears in Collections:M.Pharm. Research Reports, Department of Pharmaceutical Technology and Biopharmaceutics

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