Hot melt extrusion: A single-step continuous manufacturing process for developing amorphous solid dispersions of poorly soluble drug substances
1 Analytical Research & Development, Hikma Pharmaceuticals, Columbus, Ohio 43228, USA.
2 Department of Pharmaceutics, ST. Peter’s Institute of Pharmaceutical Sciences, Telangana, 506001 India.\
Review Article
GSC Advanced Research and Reviews, 2022, 13(02), 126–135.
Article DOI: 10.30574/gscarr.2022.13.2.0311
Publication history:
Received on 03 October 2022; revised on 09 November 2022; accepted on 12 November 2022
Abstract:
In today’s world with increasing patient population, the demand for pharmaceutical medications is increasing enormously. However, poor solubility of drug substances and underdeveloped manufacturing process are affecting the revenue of the pharmaceutical industries. Improving the solubility and establishing a robust manufacturing process is the primary prerequisite of the developmental scientists. Among various approaches amorphous solid dispersion has gained a tremendous response for improving the solubility of the drug substances. In addition, the process of hot melt extrusion has attracted the investigators from regulatory agencies and industries. The process of hot melt extrusion involves application of thermal and mechanical energy on to the processing material. The process requires no solvent and is referred as “green technique.” Various factors need to be taken into consideration for developing amorph amorphous solid dispersions. The miscibility of drug and polymer, solubility of drug in polymer, drug-polymer interactions, glass transition temperature, storage conditions majorly influence the stability of the amorphous solid dispersions systems. Though hot melt extrusion is most widely employed for developing amorphous solid dispersions still a lot of research is warranted for developing strategies to formulate high drug loading medications with improved stability. This review article mainly focuses on the instrumentation, and process for developing amorphous solid dispersions by hot melt extrusion with a small note on the various advantages and limitations.
Keywords:
Poor solubility; Amorphous solid dispersions; Hot melt extrusion; Stability; High drug loads; Miscibility
Full text article in PDF:
Copyright information:
Copyright © 2022 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
