Review of industrially recognized polymers and manufacturing processes for amorphous solid dispersion based formulations
Evolving therapeutic landscape through combinatorial chemistry and high throughput screening have resulted in an increased number of poorly soluble drugs. Drug delivery strategies quickly adapted to convert these drugs into successful therapies. Amorphous solid dispersion (ASD) technology is widely employed as a drug delivery strategy by pharmaceutical industries to overcome the challenges associated with these poorly soluble drugs. The development of ASD formulation requires an understanding of polymers and manufacturing techniques. A review of US FDA-approved ASD-based products revealed that only a limited number of polymers and manufacturing technologies are employed by pharmaceutical industries.
This review provides a comprehensive guide for the selection and overview of polymers and manufacturing technologies adopted by pharmaceutical industries for ASD formulation. The various employed polymers with their underlying mechanisms for solution-state and solid-state stability are discussed. ASD manufacturing techniques, primarily implemented by pharmaceutical industries for commercialization, are presented in Quality by Design (QbD) format. An overview of novel excipients and progress in manufacturing technologies are also discussed. This review provides insights to the researchers on the industrially accepted polymers and manufacturing technology for ASD formulation that has translated these challenging drugs into successful therapies.
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Following excipients are mentioned in the study besides other: Soluplus
Sumit Kumar Saha, Amita Joshi, Romi Singh & Kiran Dubey
Received 19 Apr 2023, Accepted 02 Jul 2023, Accepted author version posted online: 10 Jul 2023, Published online: 14 Jul 2023, Review of industrially recognized polymers and manufacturing processes for amorphous solid dispersion based formulations, Download https://doi.org/10.1080/10837450.2023.2233595
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