PKSC 2010 Lecture Notes - Lecture 14: Fiberboard, Tinning, Toothpaste
12 Oct 2017
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Document Summary
Product protection is the level of protection demanded by the chemistry of the drug alone. Its volatility or tendency to diffuse through the package. Drug must also be protected from chemical interaction with the package. Different methods to evaluate the efficacy of the package to protect the drug are employed based on the specific parameter. For example, light transmission measurements on the container and closure are used for light resistant packages. Barrier of the package to gases and to loss of product by diffusion is determined by the total package. Not only by the separate components, but also how they are assembled. **knowledge of the separate component materials is helpful only in the initial screening, final selection must be made on the barrier properties of the total package. In the moisture permeability test method described in the. Usp, a dessicant (calcium chloride) is carefully prepared and dried and placed inside a package.
