The aim of this study was to control the dissolution rate and permeability of cilostazol. To enhance the dissolution rate of the active pharmaceutical ingredient (API), hot-melt extrusion (HME) technology was applied to prepare a solid dispersion (SD). To control permeability in the gastrointestinal tract regardless of food intake, the HME process was optimized based on physiologically based pharmacokinetic (PBPK) simulation. The extrudates were produced using a laboratory-scale twin-screw hot-melt extruder with co-rotatory screws and a constant feeding rate.
When you’re jostling for market-share in a high-growth, highly Wavelength Pharmaceuticals has recently completed a full risk assessment for potential nitrosamine impurities in its Cilostazol according to ICH Q9 guideline and confirmed no presence of nitrosamines…
Pfizer Vitals, which claimed to stand for quality generics, has suffered a two-fold loss, failing to meet market performance expectations, and getting its carcinogen containing hypertension drug suspended.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces a strategic and long-term manufacturing agreement with Yiling Wanzhou International Pharmaceutical Co., Ltd. for the manufacturing of entecavir and cilostazol. Yiling Wanzhou International Pharmaceutical Co., Ltd. is a subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd. The contracted manufacturing facilities have been inspected by both the U.S. Food and Drug Administration (FDA) and China FDA (CFDA) and operate to strict International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Manufacturing Practice (GMP) standards, which will enable CASI to eventually sell both entecavir and cilostazol in the U.S., China and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that CASI acquired from Sandoz in January 2018.
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.
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