Hot Melt Extrusion: Pharmanufacturing v2.0


By: Sandeep Chandra D R --

24 June, 2013

Hot Melt Extrusion: Pharmanufacturing v2.0

Hot Melt Extrusion (HME) has been well adopted by the food industry over the past 50 years. The process is slowly gaining acceptance in the pharmaceutical circles, owing to its many benefits. The whitepaper seeks to explore potential and the challenges faced in the use of this process, and talks about the potential cost savings by adopting this process. Manufacturing via HME is gaining steam in the pharmaceutical industry. Although Big Pharma has been paying attention to the process over the last 15 years, HME is being adopted over the last 4-5 years, due to various benefits such as cost and time savings in the manufacture of formulations. However, HME has an inherent downside ï¾Âƒ?? there are only a few excipients which can currently be used for the process. Also, due to high cost of setup and technical knowhow emerging markets have not made their mark in this mode of manufacture yet and most companies using this technology are based out of the US and Germany. The whitepaper seeks to weighs the pros and cons of the process. Adaptation of Hot Melt Extrusion based manufacturing is both economical and fast, in addition to being PAT compliant. Although not all excipients are HME compatible, pharmaceutical companies are encouraged to engage with CMOs offering HME to realize the cost and quality advantage in the short run ï¾Âƒ?? manufacturing using HME reduces the operating costs typically by about 20%, while offering to solve the age old issue of solubility, which has gained more significance in the light of the growing biologics industry.


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