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AAPS PharmSciTech. 2000 June; 1(2): 8–13.
Published online 2015 February 19. doi:  10.1208/pt010208
PMCID: PMC2784827

Pramlintide injection drug product robustness studies

Abstract

The article examines the effects of temperature excursions and actual dose withdrawal on the quality of pramlintide injection, a multidose liquid parenteral formulation. Studies were designed to demonstrate product robustness under conditions that may occur during patient use. Pramlintide %Purity was determined by two high-performance liquid chromatography (HPLC) methods, a reversed-phase (RP-HPLC) and a strong-cation exchange (SCX-HPLC) method. A second RP-HPLC method was used to determine pramlintide potency and the concentration of them-cresol preservative. Antimicrobial preservative effectiveness testing was per USP and European Pharmacopeia (Ph. Eur.). Short-term stability studies were undertaken to probe the effects of the following conditions: 5°C to 40°C and 5°C to −20°C temperature cycling over 10 days; once daily or four-times daily dose withdrawal over 12 or 42 days; and combined 30°C storage and four-times daily dose withdrawal over 42 days. In all cases, pramlintide %Purity and potency values remained essentially unchanged or unchanged relative to controls. Similarly, product appearance, andm-cresol concentration and preservative effectiveness were not significantly affected by the stress conditions used in the 5 studies. Pramlintide injection drug product is extremely robust to challenging stress conditions that may occur during patient use of this multidose product for chronic administration.

Keywords: Pramlintide, Preserved Drug Product, Container Closure Robustness, Temperature Cycling, Preservative Efficacy

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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