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FDA perspective on peptide formulation and stability issues
1Office of New Drug Chemistry, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Parklawn Building, Room 14B-45 5600 Fishers Lane, Rockville, Maryland 20857, USA.
Abstract:
Traditionally, peptide drugs are prepared as sterile solutions and administered to patients by daily injection. However, this form of drug delivery causes pain and inconvenience to patients and thus has been poorly accepted. In addition to improving patient compliance, many novel delivery systems have been developed to address the need for prolonged, localized (targeted), or pulsatile drug action. Examples include, but are not limited to oral, nasal, or long-acting controlled release injectable dosage forms; a number of them have been approved by FDA recently. The unique characteristics and the relevant regulatory issues with respect to each type of delivery system are presented.