General pharmaceutics--the new physical pharmacy. 2003

E F Gene Fiese
Pharmaceutical Research and Development, Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA. FieseEF@groton.pfizer.com

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.

UI MeSH Term Description Entries
D010316 Particle Size Relating to the size of solids. Particle Sizes,Size, Particle,Sizes, Particle
D004304 Dosage Forms Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect. Dosage Form,Form, Dosage,Forms, Dosage
D013678 Technology, Pharmaceutical The application of scientific knowledge or technology to pharmacy and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures, and in the treatment of patients. Technology, Pharmacy,Pharmaceutic Technology,Pharmaceutical Technology,Pharmacy Technology,Technology, Pharmaceutic

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