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 minimise 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 minimised 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.
All parts are designed and manufactured to allow easy handling as well as quick assembling and disassembling, even with gloves in containment solutions such as a laminar flow box or a glovebox. This containment solution is also supported by the very small footprint of the Pharma mini HME and the separate touch screen control which offers the same look and feel as the larger Thermo Scientific Pharma twin-screw extruders. The IP 54 rating and the fanless design allow the operator to spray-wash the Pharma mini HME to bind powdery excipients and API’s.
The conical screw design offers the advantage of reducing total volume and extra pressure build up at the screw tips to extrude a uniform material with constant output rates. In addition, the conical design offers the best mixing capability on such a small scale and allows the Pharma mini HME to operate without the use of expensive and sensitive feeding devices.
In combination with the integrated feed port cooling and an optional continuous force feeder, the Pharma mini HME can be used as continuous small scale compounder to prepare samples for clinical trials or for micro production of medical devices and implants as drug delivery systems. The shape of the extruded material can be controlled by adding various die sections.