Pharmaceutical Research
&
Innovations in Pharma Industry

Biography

Biography: Devendra Ridhurkar

Abstract

For orally administered drugs, solubility and permeability is one of the rate-limi ng factors to achieve their desired concentra on in systemic circula on for pharma¬cological response. Poor solubility of BCS class II and IV drugs is a ributable for delay or failure and due to this reason formula on scien st faces a major challenge to develop a formula on with good bioavailability. Enhancement of solubility and bioavailability of poorly soluble drugs can be achieved by amorphous solid dispersions which are prepared by conver ng the poorly water-soluble crystalline form into a more soluble amorphous form within the polymeric blends. Hot Melt Extrusion (HME) has been widely used to prepare amorphous solid dispersions for the improvement of solubility and dissolu on rates of poorly soluble materials. During the melt extrusion process, the dissolu on of APIs into the polymer matrix is accelerated under the infl uence of shear and heat. HME has gained popularity in the pharmaceu cal industry as a means of improv¬ing the bioavailability of drugs due to its wide applica ons, simple pro¬cess and low costs. HME is an effi  cient technology for producing solid molecular dispersions with considerable advantages including the absence of solvents, few processing steps, and con¬ nuous opera on over solvent-based processes such as spray drying and co-precipita on. Also, HME is one of the recommended processes by FDA to encourage move from batch-to-con nuous manufacturing. Moreover, it can be used to earn intellectual property and to make the noninfringing strategies for products development with ANDA para IV fi llings. Marketed formula ons Kaletra and Onmel which are prepared by HME technology, are the classical examples.