FDA Perspective on Peptide Formulation and Stability Issues

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 ha...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1998-11, Vol.87 (11), p.1331-1334
Main Authors: Niu, Chien-Hua, Chiu, Yuan-Yuan
Format: Article
Language:English
Subjects:
Biological and medical sciences
Drug Approval
Drug Delivery Systems
General pharmacology
Humans
Medical sciences
Peptides - administration & dosage
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
United States
United States Food and Drug Administration
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Summary: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.
ISSN:0022-3549
1520-6017
DOI:10.1021/js9800782