Melt extrusion with poorly soluble drugs - An integrated review.

Autor: Repka MA; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA; Pii Center for Pharmaceutical Technology, University of Mississippi, University, MS 38677, USA. Electronic address: marepka@olemiss.edu., Bandari S; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA., Kallakunta VR; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA., Vo AQ; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA., McFall H; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA., Pimparade MB; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA., Bhagurkar AM; Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2018 Jan 15; Vol. 535 (1-2), pp. 68-85. Date of Electronic Publication: 2017 Nov 02.
DOI: 10.1016/j.ijpharm.2017.10.056
Abstrakt: 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.
(Published by Elsevier B.V.)
Databáze: MEDLINE
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