To Study and Evaluate the Various Aspects in Manufacturing Amorphous Spray Dried Dispersion.

Authors

  • Tushar Suryavanshi Pravara Rural College of Pharmacy, Rahata, DIstrict Ahmednagar, Loni Bk., Maharashtra 413736, India

Abstract

Spray-dried dispersions have become ansignificant formulation technology for the pharmaceutical product development of poorly water-soluble compounds. Even though this technology is now widely used in the industry, especially in the early-phase development, the lack of mechanistic understanding still causes difficulty in selecting excipients and predicting stability of SDD-based drug products. In this review, the authors aim to discuss various principles of polymer science pertaining to the development of SDDs, in terms of selecting polymers and solvents, optimizing drug loading, as well as evaluating physical stability on storage and supersaturation maintenance after dissolution. Spray drying of polymer-API solutions, low critical solution temperature was discussed for setting the inlet temperature for drying. The impact of polymers on the supersaturation creation and maintenance of APIs in dissolution media was also discussed. Moreover, the nature of SDDs, with reference to solid solution and the notion of solid solubility, was examined in the context of pharmaceutical application. Finally, the importance of robust analytical techniques to characterize the SDD-based drug products was highlighted, considering their complexity.

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Published

2017-04-30

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Articles