title: Quality control of residual solvent content in polymeric microparticles.
abstract: Organic solvents are the innate part of pharmaceutical industry, playing vital role in the bulk drug substance as well as finished product manufacturing. Even though they are used for various crucial purposes, they still lack therapeutic beneficial effect and can be toxic if present in unacceptable limits in final product. Hence, their concentration must be regulated in the final pharmaceutical formulation. With the major development in the market of polymeric microparticles in past few decades, drug product manufacturers are paying more attention towards the development of new techniques for reducing residual solvent content of microparticles. This article sheds light on the importance of removal of organic volatile impurities from the formulation and its regulatory aspects. It also highlights how residual solvent affects various physicochemical characteristics of polymeric microparticles and suggests certain solutions as per the current state of art for limiting organic solvent content in the final product.
authors.affiliation: C. U. Shah College of Pharmacy, S. N. D. T. Women's University, Sir Vithaldas Vidya Vihar , Mumbai, Maharashtra , India and.
authors.forename: Kalpana
authors.initials: K
authors.lastname: Dixit
authors.forename: Rajani B
authors.initials: RB
authors.lastname: Athawale
authors.forename: Sarabjit
authors.initials: S
authors.lastname: Singh
mesh_terms: D004345:Drug Industry / Q000379:methods / Q000592:standards; D006801:Humans; D011108:Polymers / Q000009:adverse effects / Q000138:chemical synthesis / Q000737:chemistry; D011786:Quality Control; D012997:Solvents / Q000009:adverse effects / Q000737:chemistry*
chemical_list: D011108:Polymers; D012997:Solvents
keywords: Microencapsulation; phase separation coacervation; regulatory perspective