Pharm Res. 2012 Oct;29(10):2635-8. doi: 10.1007/s11095-012-0867-5. Epub 2012 Aug 31.
Complete characterization and mechanistic understanding of physicochemical interactions in solid dosage forms are not only important for consistent manufacturability, stability, and bioavailability of the drug product, but are also expected under the quality-by-design paradigm of drug development. Lack of this understanding can impact successful and timely development, scale-up, and commercial manufacture of dosage forms. This article highlights the stability and bioavailability implications of physicochemical interactions in dosage forms citing a couple of examples where such interactions necessitated the recall of commercial drug products.
全面了解固体制剂中物理化学相互作用的特性和机制，不仅对药物产品的一致性可制造性、稳定性和生物利用度很重要，而且也是药物开发质量源于设计范例的预期要求。缺乏这种理解可能会影响剂型的成功和及时开发、放大和商业制造。本文引用了一些案例，强调了物理化学相互作用对药物稳定性和生物利用度的影响，在这些案例中，这些相互作用需要召回商业药物产品。
