Hot-melt extrusion (HME)and its application for pharmacokinetic improvement of poorly water soluble drugs.

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Abstract
Pharmacology, Toxicology and Biomedical Reports,2016,2,3,47-51.
Published:August 2016
Type:Review Article

Hot-melt extrusion (HME)and its application for pharmacokinetic improvement of poorly water soluble drugs.

Devendra Ridhurkar*1, Attila Vajdai1 and Zsolt Zsigmond1

1Pharmaceutical Development Division, Egis Pharmaceuticals limited, Budapest, Hungary.

Abstract:

For orally administered drugs solubility is one of the rate-limiting parameter to achieve their desired concentration in systemic circulation for pharmacological response. Poor solubility and poor permeability is responsible for 40 to 70% incidence of delay or failure for new chemical entities during the developmental process. Due to this, formulation scientist faces a major challenge to develope a formulation with good bioavailability.By adopting various technological approaches during the pharmaceutical product development which include physical and chemical approaches such as micronization, pH adjustment, solid dispersion, complexation, co-solvent, salt formation, nanotechnology, use of surfactant, hydrotophy and polymorphs that can be overcome. At present due to its wide applications, simple process and low costs, solid dispersion prepared by hot melt extrusion (HME) has gained popularity in the pharmaceutical industry as a means of improving the bioavailability of drugs. Hot-melt extrusion (HME) is an efficient technology for producing solid molecular dispersions with considerable advantages including the absence of solvents, few processing steps, continuous operation over solvent-based processes such as spray drying and co-precipitation and HME is one of the recommonded process by FDA to encourage move from batch-to-continuous manufacturing.