Abstract
Activepharmaceuticalingredients (API) and API drug products
developments are facing impending challenges as approximately
60-70% of newly discovered APIs belong to #biopharmaceutical classification system (BCS) Class II (poor solubility, good
#permeability) or BCS Class IV (poor solubility, poor permeability)
which results in low #oralbioavailability [1]. The conventional
approaches of formulating API salts and amorphous APIs are also
limiting because in most of these cases APIs either lack #ionizablefunctionalities or do not have strong ionization to allow salt
formation. Also, solubility enhanced amorphous form of APIs are
#thermodynamically unstable and are prone to transformation in
more stable but less soluble crystalline form upon storage. Further,
pH gradient across #gastrointestinaltrack adds an additional
challenge as some of these APIs possess variable pH dependent
solubility and some are unstable or are prone to degradation. In this
context, alternative approaches are being researched extensively.
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Insights of #PharmaceuticalCocrystals by Fpreshita P Desai in BJSTR
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