title: Microbial sterility testing of oil-formulated bovine somatotropin using Tween 80 dispersion.
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.
authors.affiliation: Monsanto Company, Chesterfield, MO 63198, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Workman
authors.forename: R A
authors.initials: RA
authors.lastname: Clayton
mesh_terms: D000818:Animals; D002417:Cattle; D004340:Drug Contamination / Q000517:prevention & control; D013006:Growth Hormone; D008826:Microbial Sensitivity Tests; D009821:Oils; D011136:Polysorbates / Q000494:pharmacology*; D011785:Quality Assurance, Health Care; D013501:Surface-Active Agents / Q000494:pharmacology*
chemical_list: D009821:Oils; D011136:Polysorbates; D013501:Surface-Active Agents; D013006:Growth Hormone