ISP Pharmaceuticals has embarked upon a drug solubility initiative in support of pharmaceutical companies working with APIs that exhibit poor solubility. The initiative will include r&d, the development of ingredients for use in solubilisation, as well as formulation services to enhance solubility using different processing methods.
"More than 60% of drugs in the pharmaceutical developmental pipeline present solubility issues," said Philip Strenger, senior vice president, EMEA & Global Pharma for ISP.
"We are addressing the solubility issue on a number of fronts, using our expertise in material science and our broad portfolio of ingredients as the foundation for activities ranging from traditional formulation technologies to work with emerging formulation technologies."
Dr Tim Bee, senior director of pharmaceuticals at ISP added: "If we are able to make drugs more soluble, we can reduce development timelines and costs. We can improve safety and efficacy of the drugs we make and enhance convenience and compliance at the patient level. From a business standpoint, we can imagine creating new methods to reformulate failed or discontinued drugs and we can develop new delivery technologies that can extend the patent protection of existing drugs."
As part of the initiative, ISP will expand its r&d facilities in Hyderabad, India to create a Solubility Centre of Excellence and add 50% more staff dedicated to solubilisation. The Centre will focus on the use of polymers, disintegrants and cyclodextrin chemistry to improve drug solubility and bioavailability in oral and parenteral pharmaceuticals. It will also work to advance solid dispersion technology for drug formulation - including spray drying and hot melt extrusion (HME) applications.
The company has formed an alliance with Coperion of Stuttgart, Germany to advance HME technology for the pharmaceutical market. ISP brings expertise in ingredient technology, formulating and material science to the alliance. Coperion brings its expertise in extrusion and will provide equipment for testing.
The alliance will develop information on ingredient selection and processing techniques that will allow robust, scalable approaches for HME in creating solid dispersion dosage forms.
"One of the major issues in developing this technology is scalability," said John Fitzpatrick, ISP's new business development manager, EMEA. "In our alliance with Coperion, we will focus on understanding how we can develop scalable processes that are suitable for commercial production."
HME puts combinations of drugs, polymers, and plasticisers into various final forms to achieve designated drug-release profiles. Individual components are mixed and then processed in a controlled environment of temperature and shear within the extruder to create the final material. HME is used to prepare granules, sustained release tablets, and transdermal and transmucosal drug delivery systems.
ISP says benefits include fewer processing steps, no requirements on the compressibility of the drug actives, more uniform dispersion of the drug particles and improved bioavailability of poorly soluble drug actives.