Stability studies of a somatostatin analogue in biodegradable implants

In recent years, peptides and proteins have received much attention as drug candidates. For many polypeptides, particularly hormones, it is desirable to release the drug continuously at a controlled rate over a period of weeks or even months, and thus a controlled release system is needed. Polylacti...

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Bibliographic Details
Published in:International journal of pharmaceutics 1999-02, Vol.178 (2), p.213-221
Main Authors: Rothen-Weinhold, A., Besseghir, K., Vuaridel, E., Sublet, E., Oudry, N., Gurny, R.
Format: Article
Language:English
Subjects:
Absorbable Implants
Antineoplastic Agents - chemical synthesis
Antineoplastic Agents - chemistry
Antineoplastic Agents - isolation & purification
Biological and medical sciences
Controlled release
Delayed-Action Preparations
Dose-Response Relationship, Drug
Drug Contamination
Drug Delivery Systems
Gamma Rays
General pharmacology
Implant
Medical sciences
Peptides - chemistry
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Polylactic acid
Polymers - chemistry
Somatostatin - analogs & derivatives
Somatostatin - chemical synthesis
Somatostatin - chemistry
Somatostatin - isolation & purification
Stability
Temperature
Time Factors
Vapreotide
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Summary:In recent years, peptides and proteins have received much attention as drug candidates. For many polypeptides, particularly hormones, it is desirable to release the drug continuously at a controlled rate over a period of weeks or even months, and thus a controlled release system is needed. Polylactic acid (PLA) is a biocompatible and biodegradable material with wide utility for many applications, including the design of controlled release systems for pharmaceutical agents. Pharmaceutical development of these delivery systems presents new problems in the area of stability assessment, especially for peptide drugs. In this study, we aimed to investigate the influence of different steps, during the manufacturing of an implant, on peptide stability in the polymeric matrix. Polylactic acid implants containing vapreotide, a somatostatin analogue, were prepared by extrusion. The effects of time, extrusion and temperature on the peptide stability were studied. The influence of various gamma sterilization doses, as well as the conditions under which the implants were irradiated, were also investigated. Peptide stability in the polymeric matrix was evaluated at various temperatures and at various time intervals up to 9 months.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(98)00376-7