Regulatory Considerations in Development of Amorphous Solid Dispersions
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abstract
There is a growing interest in the pharmaceutical industry to develop amorphous solid dispersions (ASDs) of poorly aqueous soluble drugs due to their higher supersaturation solubility in the aqueous media compared to the crystalline form. Despite superior solubility, it is a challenge to maintain the amorphous form of the ASD throughout the shelf life, thus reaping the full therapeutic advantage of the system. To ensure safety and efficacy of the marketed ASDs, it is also important to understand the product and process variables that affect the quality of the products. The measurement systems should be capable of detecting the product changes throughout the shelf life of the product. A good product and process understanding can be obtained by the quality by design (QbD) approach for the pharmaceutical development. QbD is a multi-prong approach to understand, control, and maintain the critical quality attributes (CQA) of the product over its shelf life. Regulatory experience of ASD includes reviews and approvals of numerous new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their related supplements and product recall reports. The present chapter represents some knowledge management aspects from these products as well as internal research of these products in the Food and Drug Administration (FDA) laboratories.
