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Microbial sterility testing of oil-formulated bovine somatotropin using Tween 80 dispersion
1Monsanto Company, Chesterfield, MO 63198, USA.
Abstract:
The Food and Drug Administration requires that sterile pharmaceutical products be free of viable microorganisms. Sterility testing of pharmaceutical products provides added assurance that the product is sterile. Sterility testing is typically done by inoculating the drug product into microbial growth media followed by visual inspection for growth during incubation for a specified time period. A lack of visual growth indicates that the drug product samples tested were sterile. Formulated Posilac bovine somatotropin consists of protein particles suspended in an oil-based excipient. The product formulation is immiscible in aqueous media due to the excipient's water insolubility and the insolubility of the protein particles at near neutral pH values. Because the formulation is packaged and sold as a sterile product, it is critical that a sensitive microbial sterility test method be used for this key quality test. A sterility test method was developed for Posilac that utilized Tween 80 (i.e. polysorbate 80) as a dispersant. Dispersion of the product using Tween 80 produced a homogeneous suspension of bovine somatotropin particles and oil droplets in the micron size range. The suspension did not appreciably settle out with time, attesting to the homogeneous nature of the mixture. This method was found to be compatible with survival, recovery, and growth from low numbers of the test organisms required by the U.S. Pharmacopeia XXIII as well as from two additional test cultures.
Insights
A new sterility test method using Tween 80 effectively disperses Posilac, ensuring accurate microbial testing for sterile pharmaceutical products. This method supports the recovery and growth of test organisms, meeting regulatory requirements.
Area of Science:
- Pharmaceutical Science
- Microbiology
- Analytical Chemistry
Background:
- Sterile pharmaceutical products require rigorous sterility testing to ensure patient safety.
- Posilac, a bovine somatotropin formulation, presents unique challenges for sterility testing due to its immiscible oil-based excipient and protein particles.
- Accurate microbial detection is critical for sterile products like Posilac.
Purpose of the Study:
- To develop and validate a sensitive microbial sterility test method for the Posilac formulation.
- To ensure the method is compatible with the recovery and growth of microorganisms from the product.
- To meet the stringent requirements for sterility testing of pharmaceutical products.
Main Methods:
- A sterility test method was developed utilizing Tween 80 (polysorbate 80) as a dispersant for the Posilac formulation.
- Dispersion with Tween 80 created a stable, homogeneous suspension of product particles and oil droplets.
- The method's compatibility with microbial survival, recovery, and growth was assessed using U.S. Pharmacopeia test organisms and additional cultures.
Main Results:
- Tween 80 effectively dispersed the Posilac formulation into a homogeneous, stable suspension.
- The developed method demonstrated compatibility with the survival, recovery, and growth of low numbers of required test organisms.
- The method met the requirements for sterility testing of pharmaceutical products.
Conclusions:
- A validated sterility test method using Tween 80 is suitable for Posilac.
- This method ensures the reliability of sterility testing for challenging pharmaceutical formulations.
- The findings support the quality control and safety assurance of sterile pharmaceutical products.