Abstract

Aanchal P. Singhania, Yashvi S. Agarwal, Srushti M. Tambe, Divya D. Jain and Purnima D. Amin

ABSTRACT

Natural polymers or biopolymers have gained immense popularity in biomedical applications, distinctly in the pharmaceutical industry owing to their advantages over synthetic polymers. Over the years, hot-melt extrusion (HME) has also emerged as a promising technology for producing a myriad of pharmaceutical dosage forms. An essential requirement of materials used in HME is their ability to exhibit thermoplastic characteristics, drug-polymer miscibility as well as thermal stability in an allowable extrusion temperature range. Since natural polymers like starch, celluloses are rigid, high molecular weight polymers that do not soften or melt below their decomposition temperatures, exhibit difficultly in extrusion via HME. The fundamental objective of this review is to bridge the current manufacturing gap in the pharmaceutical sphere that exists owing to the poor extrudability of natural polymers via HME. The critical polymer parameters including melt viscosity, Tg, Tm, solubilization capacity, mechanical properties, plasticizer effects as well as characterization techniques with regards to natural polymers are discussed. In light of the current paradigm of drug development, this review summarizes various reports on natural polymers-based formulations developed using HME technology. This review discusses technical and scientific specificities of extrusion of natural polymers to encourage systematic screening and selection of natural polymers for the HME process to minimize the number of trials and improve study design to achieve target formulation.