PDA Technical Report No. 10, (TR 10) Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.
This paper, written by Drs. John Wang and Musetta Hanson, is a review of concerns in formulating injectable products containing peptides and proteins. It covers degradation and experimental methods to study denaturation, and evaluates stabilizers and the use of stabilizing excipients.
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Table of Contents
Table of Contents:
I. Introduction
II. Degradation of
Proteins and Peptides
III. Experimental Methods to Study Denaturation and
Evaluation Stabilizers
IV. Use of Excipients to Stabilize Parenteral
Formulations of Proteins and Peptides
V. Special Considerations
VI.
Recommendations
VII. References