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aerosol products, and while the approach could apply to other dosage forms as well, why aerosol products?  Well, it goes back to mid-1997 when the office and the center formed an OINDP Technical Committee, Orally Inhaled and Nasal Drug Products Technical Committee, and then in 1998, a group of us within that technical committee considered batch release for dose content uniformity and whether a test could be improved.  What we were looking at was dose content uniformity in the perspective of orally inhaled and nasal drug products; that is, the entire range of metered-dose inhalers, dry powder inhalers, nasal sprays, and concentrating on that effort.

Why aerosol products?  It's because these products are a combination -- they're not only formulations but they're formulations with a device.  So it's a drug-device combination product, and as such, there can be greater challenges with regard to dose uniformity, both in mean delivery and in variability.  So we concentrated on that effort and felt that there was an opportunity to improve the presently used dose content uniformity test.

As Dr. Hauck will indicate in his

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