Journal
JOURNAL OF MICROENCAPSULATION
Volume 32, Issue 2, Pages 107-122Publisher
TAYLOR & FRANCIS LTD
DOI: 10.3109/02652048.2014.995730
Keywords
Microencapsulation; phase separation coacervation; regulatory perspective
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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.
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