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Mini-Review Article

Hot Melt Extrusion Technique for Developing Pharmaceutical Co-crystals: A Review

Author(s): Ritu Rathi, Sanshita and Inderbir Singh*

Volume 14, Issue 2, 2024

Published on: 15 December, 2023

Page: [97 - 108] Pages: 12

DOI: 10.2174/0122103031269230231213061146

Price: $65

Open Access Journals Promotions 2
Abstract

Background: In the era of pharmaceutical research and development, the most challenging aspect is to enhance the physicochemical properties of drugs. Hot Melt Extrusion (HME) is a solvent-free, one-step, continuous, scalable, and industrially feasible method for developing pharmaceutical co-crystals. Co-crystallization, as a technique, has gained significant attention for its potential to modify various physicochemical properties of drugs like solubility, stability, compressibility, permeability, taste masking, and therapeutic efficacy.

Methods: We determine the characteristic features of HME and explore published literature using the keywords, HME, co-crystals, and PAT, in databases, such as PubMed, Google Scholar, ScienceDirect, and Research Gate.

Results: The present review embarks on a detailed journey through the multifaceted domain of HME and its pivotal role in co-crystal development. The process parameters, such as temperature, extruder type, screw configuration, screw speed, and feed rate, are involved in determining the characteristics of the co-crystals produced. Additionally, the review explores the role of materials, including Active Pharmaceutical Ingredients (APIs), plasticizers, polymers, and other pharmaceutical aids, underlining their impact on co-crystal development. The existing literature on HME and its application for pharmaceutical co-crystal production is comprehensively surveyed.

Conclusion: The review highlights the utility of Process Analytical Technology (PAT) in realtime process control. The role of HME in the future of pharmaceutical co-crystal development is discussed, making this review essential for researchers and industry professionals alike.

Keywords: Hot melt extrusion, co-crystals, PAT, evaluation, application, active pharmaceutical ingredient.

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Graphical Abstract

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