MiniHME

Conical Micro-Compounder for Hot Melt
Extrusion built to GMP standards

When developing new drugs, shortening time-to-market and reducing waste of expensive API’s and overall development costs provide a distinct competitive advantage. Hence, quick and early assessment of new API/excipient formulations is critical. The Thermo Scientific Pharma mini HME allows users to identify the right drug candidates for hot melt extrusion by compounding as little as 3 grams of material.

The challenge
Hot melt extrusion and continuous processing can lead to speedier formulation development and cost efficient production. But in development of new drugs, users are still faced with several challenges. Due to very expensive and hence limited quantities of API, finding the right API/excipient formulation and testing if this formulation is the right candidate for hot melt extrusion can be difficult. In this phase, the health effects of a new API are often not clear.
Therefore it can be necessary to run such trials in a laminar flow or glovebox.
On the other hand, new special implants designed for controlled drug release are produced in such small dimensions that a delivery rate of only a few grams per hour is required to establish a micro production line.

The solution
With the Pharma mini HME, we offer a micro twin-screw compounder which requires as little as 3 grams of total material to identify the right drug candidates for hot melt extrusion. The compounder with conical co- or counter-rotating screws is designed to minimize waste and reduce downtime necessary for cleaning.
The product contact parts can be easily removed and cleaned using a washing machine and an autoclave. But even washing the product contact parts by hand is simple due to rounded edges and minimized screw threads and crevices. To reduce the risk of cross-contamination and cleaning downtime to a minimum, additional sets of product contact parts are available.

Materials:

  • Pharmaceutical ingredients (API’s)
  • Excipients
  • Medical polymers
  • Drug delivery systems
  • Soft gels

Applications:

  • Hot melt extrusion
  • Medical devices
  • Implants
  • Controlled drug release
  • Handling and processing of highly potent API‘s in a glovebox
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