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Bilcare Research brings multiphase stability and shelf-life testing to drug developers as a step to choosing the right blister-card materials
It is common practice to perform stability testing of pharma tablets as part of the drug-approval process, but frequently, a nonscientific choice has been made for the films and foils used to package that tablet going into the testing. Now, Bilcare Research (Delaware City, DE) is offering a comprehensive testing service, called BilcareOptima, to address these concerns. By performing a raft of separate tests, Bilcare can help the manufacturer choose the right materials for both performance and economics. In some cases, the testing can play a role in determining the final formulation of the product. With the steady stream of product recalls and failed packaging afflicting the industry right now, the timing couldn’t be better. (The latest packaging snafu, announced last week, involved Glenmark Generics of Mahwah, NJ, which has initiated a recall of incorrectly sequenced norgestimate and ethinyl estradiol birth-control pills; this is not to be confused with the earlier packaging problems of Pfizer for its birth control products.)
BilcareOptima comprises a minimum of eight separate tests, all of which meet ICH quality standards, and some of which include proprietary Bilcare technology, according to Dr. Ajith Nair, head of global R&D:
• Physical degradation
• Chemical degradation
• Drug release properties
• Hardness and friability
• Gas liberation
• Material-product interaction
When this round of testing is complete, Bilcare can recommend the best choices for packaging materials, either to meet a desired shelf life, or to address potential problems such as humidity or oxidation effects. The technology isn't new; Bilcare has been performing this testing in its facilities in India and Singapore for several years, but has now equipped the Delaware City plant to perform it. "We would hope that a client would then go on to take advantage of Bilcare’s full range of packaging materials and services after the testing is done, but that’s not a requirement," says John Zripko, SVP, pharma, at Bilcare. The company offers common packaging films such as PVC, PVDC, Honeywell's Aclar film, cold forming foils and specialty products. Additionally, Bilcare offers computer-aided design services for blister cavity and card design, and a joint venture with MeadWestVaco, International Labs of St. Petersburg, FL, to perform contract packaging.