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Volume 4, Issue 2 American Journal of Ethnomedicine
ISSN 2348-9502
Natural Products Congress & World Pharma Congress 2017
October 16-18, 2017
3rd World Congress on
NATURAL PRODUCTS CHEMISTRY AND RESEARCH
&
12th WORLD PHARMA CONGRESS
October 16-18, 2017 Budapest, Hungary
Hot-Melt Extrusion: A cost effective approach leading to enhancement of bioavailability and
acceleration of drug product development process via turning poorly water soluble drugs into viable
therapeutics
Devendra Ridhurkar
Egis Pharmaceuticals PLC, Hungary
For orally administered drugs, water solubility and permeability are the rate-limiting factors to achieve their desired concentration
in systemic circulation for the pharma¬cological 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 of drug product developmental process facing by formulation scientist. 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. 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 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 improv¬ing the bioavailability of drugs due to its wide applications, simple pro¬cess and low
cost. HME is an efficient technology for producing solid molecular dispersions with considerable advantages including the absence
of solvents, few processing steps, and con¬tinuous 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 non-infringing strategies for product developments.
Biography
Devendra Ridhurkar works as a Senior Scientist at Egis Pharmaceu¬ticals PLC, Budapest, Hungary with a focus towards development of platform and other
emerging technologies in innovative and complex generic formulations. Before Egis, he worked at Dr. Reddy’s Laboratories, India. He has served as a Scientist
at IPCA laboratories, Macleods Pharmaceuticals and Alkem laboratories, India. He has 11 years of experience in drug products development, using different
approaches and various technologies which include hot melt extrusion (HME), gastro-retentive drug delivery systems, and nanotechnology and cyclodextrin
complexation. He is an expert in materializing the design of experiments (DOE) and quality by design (QBD). He obtained his MPharm and PhD in Pharmaceutics
from Indian Institute of Technology, Banaras Hindu University, India. He has five patents and published eight peer-reviewed papers in reputed national and
international journals. He has attended and presented his research work at various national and international conferences.
Devendra Ridhurkar, American Journal of Ethnomedicine, 4:2
DOI: 10.21767/2348-9502-C1-002