HOT MELT EXTRUSIONS AS A COST EFFECTIVE METHOD OF INCREASING SOLUBILITY OF WATER INSOLUBLE API’S

Presented by Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering at University of Greenwich
Followed by Dr.-Ing Margarethe Richter, Pharma Applications Specialist at Thermo Fisher Scientific
In the last 20 years, Hot Melt Extrusion (HME) has seized the attention of the pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs). The processing of a wide range of materials including inorganic excipients, hydrophilic polymers or cocrystal formers renders HME advantageous compared to conventional formulation technologies. In this review article, we discuss recent trends for increased solubility/dissolution of water insoluble actives by using HME and predictive tools for process optimisation.
• Identifying the appropriate excipients for HME processing of water insoluble drugs
• Using novel excipients to achieve increased dissolution rates (Granulation)
• Extrusion with polymeric carriers for the development of solid dispersions
• Co-crystallisation of water insoluble drugs
Already a well-known process in the polymer industry, HME is now becoming prevalent in pharmaceutical manufacturing for innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the ability to enhance bioavailability of a drug, i.e., to produce solid dispersions of the API in the polymer matrix. Improved bioavailability of API is one of the key goals in drug formulation, along with achieving the appropriate release profile (i.e., immediate versus sustained release).
This webinar presentation introduces HME technology as an alternative to the more traditional spray drying method. It includes several case studies related to HME for solid oral dosage forms. In addition to solid oral dosage forms, HME can be used for novel delivery methods. The presentation also provides an overview of possible drug delivery applications including examples and case studies.