Sever Pharma Solutions provides Hot Melt Extrusion (HME) services from proof of concept through clinical and commercial manufacturing. HME is a highly controllable manufacturing technique in which an API and a polymer are continuously combined at elevated temperatures. The unit operations that take place in the HME process include feeding, melting, mixing, pumping, and discharge. When the drug and polymer are in the extruder, the residence time is controllable and typically very short. Drug degradation can be avoided since HME is an anhydrous process. The technique is commonly employed to enhance the performance of drug molecules exhibiting poor water solubility or poor bioavailability. In addition, HME is used for controlled release, taste masking, devolatilization, and continuous melt granulation.
Laboratory techniques are used to screen the API’s thermal stability and solubility performance in polymer systems. Oral dosage forms are developed and manufactured using Hot Melt Extrusion technology. Formulations are tailored to meet your desired profile for drug release using pharmaceutical-grade polymers and excipients designed for oral use. Sever Pharma Solutions uses state-of-the-art twin screw extrusion technology. Processes are custom designed and developed to enhance drug release. Scale-up is performed from lab to commercial scale volumes. The HME process forms granules or pellets that are then milled into powder. Tablets or capsules are formulated from the powder to deliver a stable, effective dosage form with optimal drug release. Products are characterized using in-depth analytics.
Sever Pharma Solutions’ team of pharmaceutical scientists can assist in the formulation development and design of your oral dosage form.
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