Insights of Pharmaceutical Co crystals

Preshita P Desai*

Received: March 13, 2018;   Published: March 29, 2018

DOI: 10.26717/BJSTR.2018.03.000899

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Abstract

Active pharmaceutical ingredients (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 oral bioavailability [1]. The conventional approaches of formulating API salts and amorphous APIs are also limiting because in most of these cases APIs either lack ionizable functionalities 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 gastro intestinal 5track 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.

Abbreviations: API: Active pharmaceutical ingredients, BCS: Biopharmaceutical Classification System; USFDA: United States Food and Drug Administration; EMA: European Medical Agency

Introduction| Feasibility and Approaches| Regulatory Environment| Scope and Future Prospects| References|