Spray drying formulation of amorphous solid dispersions

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• 作者：Abhishek Singh ; Guy Van den Mooter ; ^{guy.vandenmooter@pharm.kuleuven.be" class="auth_mail" title="E-mail the corresponding author}
• 关键词：AGU ; anhydro-d-glucopyranose unit ; API ; active pharmaceutical ingredient ; ASD ; amorphous solid dispersion ; ATR-FTIR ; attenuated total reflectance Fourier transform infrared spectroscopy ; BCS ; Biopharmaceutics Classification System ; CAP ; cellulose acetate phthalate ; CAAdP ; cellulose acetate adipate propionate ; CMC ; carboxymethyl cellulose ; CMCAB ; carboxymethylcellulose acetate butyrate ; Compritol 888 ATO ; glyceryl dibehenate ; CQA ; critical quality attribute ; DCM ; dichloromethane ; DMA- N ; N-dimeth
• 刊名：Advanced Drug Delivery Reviews
• 出版年：2016
• 出版时间：1 May 2016
• 年：2016
• 卷：100
• 期：Complete
• 页码：27-50
• 全文大小：2003 K

文摘

Spray drying is a well-established manufacturing technique which can be used to formulate amorphous solid dispersions (ASDs) which is an effective strategy to deliver poorly water soluble drugs (PWSDs). However, the inherently complex nature of the spray drying process coupled with specific characteristics of ASDs makes it an interesting area to explore. Numerous diverse factors interact in an inter-dependent manner to determine the final product properties. This review discusses the basic background of ASDs, various formulation and process variables influencing the critical quality attributes (CQAs) of the ASDs and aspects of downstream processing. Also various aspects of spray drying such as instrumentation, thermodynamics, drying kinetics, particle formation process and scale-up challenges are included. Recent advances in the spray-based drying techniques are mentioned along with some future avenues where major research thrust is needed.