Abstract

HOT MELT EXTRUSION TECHNIQUE FOR SOLID ORAL DOSAGE FORM - A REVIEW

Gitanjali Shivaji Bhatjire* and Kishor Sahebrao Salunkhe

Abstract

Interest in hot melt extrusion technique for pharmaceutical application is growing rapidly as HME offers several advantages over traditional pharmaceutical techniques. Hot, melt extruded dosage forms are complex mixture of active medicaments, functional excipients, and other processing aids. Melt extrusion or agglomeration is a process in which agglomeration or size enlargement of fine particles which bound together to form agglomerates or granules. Granulation may be defined as a size enlargement process which converts small particles into physically stronger and larger agglomerates. Granulation is performed for improving flow, compression characteristics and content uniformity, eliminating generation of fine particles thereby increasing bulk density and productivity of the product. Hot melt extrusion is advance granulation technique achieved by the addition of meltable binder which is in solid state at room temperature but melts in the temperature range of 50-800 c. Melted binder then acts like a binding liquid, granules are obtained by cooling it to room temperature. This method is an appropriate alternative to wet granulation for water sensitive materials and it is efficiently applied to enhance the stability of moisture sensitive drug and to improve the poor physical properties such as floe properties. Tablets are solid oral dosage forms containing medicinal substances with or without suitable diluents, manufactured by compression or molding. This review majorly focuses on the hot melt extrusion-an innovative granulation technique and its critical process parameters, evaluation methods for granules and tablets, some of the marketed products available which are prepared by HME technique.

Keywords: Hot melt extrusion, meltable binder, critical process parameters, and granulation.