✍ Scribed by E. F. “Gene” Fiese
No coin nor oath required. For personal study only.
General Pharmaceutics is proposed as the broad study of the biopharmaceutical and physical chemical properties of each potential drug substance. When the first quality bulk lot is delivered, usually the first GMP bulk lot, an extensive profiling of the potential drug substance should commence. This profile should include solid-state characterization as well as thorough analyses of solubility, stability, and absorption properties of the drug substance that could affect the development of a viable medicine. As a result of these studies, a number of initial specifications could be developed: the preferred polymorphic or crystalline form identified, the preferred particle size to optimize absorption/development, and an initial biopharmaceutics classification with a dose limit to identify those cases in which the formulation can be expected to improve absorption and exposure. The broad topic of General Pharmaceutics is discussed in this Minireview including many advances in technology in this field as well as the rationale behind the proposed initial specifications.
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Go\vl:intl Hopkiiis), cliriiriiitiii of tlic C4cneriil Uoiird, Lord Riiyleigli, cliiiir1iiiiii of the ISsccutivc C'omlnittcc,
Among the 24 General Principles to be Followed in the Ninth Revision in the Abstracts of the Proceedings of the Ninth Decennial Convention, 1910, published in U. S. 1'. IX, I find on p. xxxii the following: 7. General Forntulce.-It is recommended that general formula be introduced, \*Read before se