An Integrated Approach to Spray Drying – From Scale-up to Manufacturing
Summary: The use of spray drying to manufacture amorphous dispersions is continuing to grow due to the number of drug candidates exhibiting poor solubility. Nearly 40% of the new chemical entities (NCEs) screened by pharmaceutical companies fail to progress to later stages of development due to poor aqueous solubility.1 The application of a phase-appropriate quality-by-design (QbD) framework increases the understanding of the interplay between the process parameters of spray drying and product quality that, when applied during scale-up, increases the chances of a successful outcome of the commercial manufacturing process.
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1Roots Analysis Business Research & Consulting, Pharmaceutical Spray Drying Market, 2nd edition 2018-2028.