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Volume 7
Pharmaceutical Regulatory Affairs: Open Access
ISSN: 2167-7689
Pharma Europe 2018
May 07-09, 2018
May 07-09, 2018 | Frankfurt, Germany
15
th
Annual European Pharma Congress
Hot-melt extrusion (HME) and its application for bioavailability improvement of poorly water soluble drugs
Devendra Ridhurkar
Egis Pharmaceuticals PLC, Hungary
Statement of the Problem:
For orally administered drugs, water solubility and permeability are the rate-limiting factors to
achieve their desired concentration in systemic circulation for the pharmacological response. Poor water solubility of new
chemical entities belonging to biopharmaceutical classification system (BCS) class II and IV accounts for 40 to 70% incidence
of delay or failure during the drug product development process. Therefore, turning poorly water soluble drugs into viable
therapeutics is the recurring and most challenging aspect facing by formulation scientist for drug product development. Hence,
the poor bioavailability of the drugs has intensified demand for technologies and methods in the pharmaceutical industries to
overcome their traits and meet the aforesaid challenges.
Solution for the Problem:
Development of the formulations of BCS class II and IV drugs by converting the poorly water-
soluble crystalline form into a more soluble amorphous form within the polymeric blends that will enhance the solubility
which in turn leads to the improved bioavailability. These formulations can be developed by adopting various solid dispersion
technological approaches like hot-melt extrusion (HME), kneading technique, co-precipitation, co-grinding, spray-drying,
lyophilization, melt agglomeration process and supercritical fluid process. Among all these approaches, solid dispersion
prepared by HME has gained popularity in the pharmaceutical industry as a means of improving the bioavailability of drugs
due to its wide applications, simple process and low cost.
Conclusion & Significance:
HME is an efficient technology for producing solid molecular dispersions with considerable
advantages including the absence of solvents, few processing steps, and continuous operation over solvent-based processes
such as spray drying and co-precipitation. Also, HME is one of the recommended processes by FDA to encourage move from
batch-to-continuous manufacturing. Moreover, it is a value addition to intangible property of organization and can be used as
noninfringing strategies for product development.
devendraridhurkar@gmail.comPharmaceut Reg Affairs 2018, Volume 7
DOI: 10.4172/2167-7689-C1-031