Evaluation of versatility of thermoplastic granulation technique

Abstract

Thermoplastic granulation is an emerging technique that encompasses the benefits of both dry and wet granulation methods. It embodies an innovative granulation technique capable of mixing and agglomerating the pharmaceutical powders to produce uniform granules suitable for the manufacturing of pharmaceutically elegant solid dosage forms. Thermoplastic granulation offers several advantages like absence of solvent, suitable process for granulation of moisture sensitive drugs, reduced processing time, ability to granulate powders with poor flow, and poor compressibility. Further, Immediate release as well as extended release dosage forms can be manufactured using the same technique. However, limited or no application has been explored to prepare Delayed release dosage form using the melt granulation technique. newlineAim: In this work, the versatility of the melt granulation technique is established by preparing different Delayed release formulations for providing drug release at basic media and for the protection of acid-labile drug. Further, solubility enhancement of a poorly soluble drug and extended release formulation of a highly soluble drug by melt granulation technique are demonstrated. newlineThe demonstrated thermoplastic granulation techniques are versatile to produce IR, MR, and DR dosage forms by selecting suitable ingredients and techniques. These techniques can be proved as good alternatives for formulations of complex products using conventional equipment, which are available in a small and medium scale pharmaceutical industry. Further, these techniques are solventless, less time consuming, and cost-effective.