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Review
. 2018 Jan 15;535(1-2):68-85.
doi: 10.1016/j.ijpharm.2017.10.056. Epub 2017 Nov 2.

Melt extrusion with poorly soluble drugs - An integrated review

Michael A Repka  1 , Suresh Bandari  2 , Venkata Raman Kallakunta  2 , Anh Q Vo  2 , Haley McFall  2 , Manjeet B Pimparade  2 , Ajinkya M Bhagurkar  2
Affiliations
Review

Melt extrusion with poorly soluble drugs - An integrated review

Michael A Repka et al. Int J Pharm. .

Abstract

Over the last few decades, hot melt extrusion (HME) has emerged as a successful technology for a broad spectrum of applications in the pharmaceutical industry. As indicated by multiple publications and patents, HME is mainly used for the enhancement of solubility and bioavailability of poorly soluble drugs. This review is focused on the recent reports on the solubility enhancement via HME and provides an update for the manufacturing/scaling up aspects of melt extrusion. In addition, drug characterization methods and dissolution studies are discussed. The application of process analytical technology (PAT) tools and use of HME as a continuous manufacturing process may shorten the drug development process; as a result, the latter is becoming the most widely utilized technique in the pharmaceutical industry. The advantages, disadvantages, and practical applications of various PAT tools such as near and mid-infrared, ultraviolet/visible, fluorescence, and Raman spectroscopies are summarized, and the characteristics of other techniques are briefly discussed. Overall, this review also provides an outline for the currently marketed products and analyzes the strengths, weaknesses, opportunities and threats of HME application in the pharmaceutical industry.

Keywords: Continuous manufacturing; Dissolution; Hot melt extrusion; Polymer; Poorly soluble drug; Process analytical technology tool; SWOT analysis.

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Conflict of interest statement

Declaration of interest

The authors report no potential conflicts of interest.

Figures

Fig. 1
Fig. 1
The various broad-spectrum applications of hot melt extrusion
Fig. 2
Fig. 2
Typical phase diagram of API/polymer binary mixture
Fig. 3
Fig. 3
Schematic representation of various possible dispersions in the HME process
See this image and copyright information in PMC

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