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第一行主标题 请输入要描述的内容进行内容补充请输入 - Salt and Solid State Screening 第一行主标题 请输入要描述的内容进行内容补充请输入 - Assessment of Drug Efficacy 第一行主标题 请输入要描述的内容进行内容补充请输入 - Evaluation of Eutectic Systems 第一行主标题 请输入要描述的内容进行内容补充请输入 - Breakthrough in Intellectual Property 第一行主标题 请输入要描述的内容进行内容补充请输入 - Development of Co-crystal |
Drugability Evaluation Drugability Evaluation The objective of evaluating "preferred drug polymorphs" extends beyond simple solubility testing, encompassing a systematic evaluation technique covering safety, efficacy (including in vitro dissolution and in vivo bioactivity), stability, manufacturability, and other aspects related to drug polymorphs. The efficacy assessment of polymorphic substances is crucial in determining their pharmaceutical properties. Polymorph studies are primarily aimed at improving the pharmaceutical properties of active pharmaceutical ingredients (APIs). Statistics show that less than 40% of drug candidates with biological development value successfully reach the market, with the physicochemical properties of the drug candidate itself, particularly solubility issues, being the primary obstacle.
Therefore, screening for and identifying pharmacologically advantageous polymorphic forms through polymorph evaluation become pivotal in enhancing the drugability of candidate drugs. In the evaluation of polymorphic drugs, a comprehensive approach integrating physics, pharmacokinetics, biology, and other methods aids in understanding the intrinsic characteristics and functional properties of polymorphic drugs, thereby improving the efficiency of discovering preferred drug polymorphs and providing a basis for further drug development.
Dissolution rate is a critical parameter for evaluating the inherent quality of drug formulations. For poorly soluble drugs, the dissolution process is often the rate-limiting step in their absorption into the body. Apart from formulation, process, and particle size, the polymorphic form of a drug can significantly influence or alter its dissolution behavior. Studying the in vitro dissolution of different polymorphic forms allows us to observe if and how polymorphs affect the dissolution behavior of formulations. This provides theoretical support for pharmacokinetic and bioequivalence evaluations in humans. Drug Polymorph Dissolution Studies: To learn more, please click on “Study and Prediction of Solid-State Stability.” |