Review of industrially recognized polymers and manufacturing processes for amorphous solid dispersion based formulations

Abstract

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.

Graphical Abstract

Keywords:

• Amorphous solid dispersion
• poorly soluble drugs
• hydroxy propyl methyl cellulose acetate succinate
• copovidone
• soluplus
• spray drying
• hot-melt extrusion
• meltdose
• kinetisol
• solution-state & solid-state stability

Ethical approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Disclosure statement

The authors declare that they have no conflict of interest.

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Funding

The author(s) reported there is no funding associated with the work featured in this article.