Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Discovery & Development Formulation, Small Molecules, Technology and Equipment

Exploring Hot-Melt Extrusion

This article was published in our sister publication, The Small Molecule Manufacturer, which celebrates the field of small molecule drug development and manufacturing with interviews and articles focusing on success stories, equipment, and new processing techniques. Read more about The Small Molecule Manufacturer here https://themedicinemaker.com/manufacture/small-but-never-forgotten

First developed for polymer processing in the plastics industry in the 1930s, hot-melt extrusion (HME) is a well-established and flexible technology in the pharma industry. HME facilitates the formulation of low-solubility, low-permeability drugs into a number of patient-friendly dose forms, including tablets, capsules or free-flowing granules.

HME uses heat and pressure to melt a polymer before it is forced at constant pressure through an orifice (see sidebar: “How HME Works”). The resulting “extrudate” is then further processed into products that display uniform API particle distribution and density. HME has become widely used in drug product development, because of the added flexibility it offers; by selecting suitable polymeric matrix excipients, formulators can create products that achieve higher bioavailability (than traditional formulations) as well as targeted delivery into the upper regions of the intestine, when drugs have poor solubility and/or poor permeability.

Poorly-soluble APIs are a key challenge for the development of solid dosage forms. The more efficiently the active ingredient can be released from a specific delivery system into the bloodstream, the better its bioavailability. It is estimated that up to 90 percent of all newly-synthesized APIs are poorly soluble and almost half of drug development project failures are due to a lack of API solubility and the resulting poor drug bioavailability and/or variable pharmacological behavior (1).

Read the full article now

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE and always will be!

Login

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine
Register

Or Login via Social Media

By clicking on any of the above social media links, you are agreeing to our Privacy Notice.

About the Author

Sampada Upadhye

Global Study Director, Hot Melt Extrusion Technology, at Catalent

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register