Who we are - introduction to Sever Pharma Solutions

Sever Pharma Solutions, a leading Contract Development and Manufacturing Organization (CDMO) specializing in controlled release systems for high potent drugs, today announced an expanded agreement with Silo Pharma, Inc. (Nasdaq: SILO), a biopharmaceutical company developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments. Under the new agreement, Sever Pharma Solutions will scale up extrusion processes and continue analytical testing for Silo’s investigational SP-26 ketamine-loaded polymer implant targeting chronic pain and fibromyalgia.

Sever Pharma Solutions US site in Putnam, CT, features two fully commissioned and qualified High Potent API handling suites: One for development, one for GMP manufacturing. Designed with twin and single screw extrusion in mind, these suites bring flexibility, safety, and efficiency to your drug product development journey. From early-stage proof-of-concept in our ISO 8 development suite to seamless scale-up in our ISO 7 GMP suite, Putnam is engineered to eliminate unnecessary tech transfers and reduce timelines — without compromising quality or safety. See what makes Putnam a uniquely capable partner for your most challenging formulations.

Sever Pharma Solutions’ facility in Malmö, Sweden, features state-of-the-art suites dedicated to GMP and non-GMP development of polymer based delivery systems. Our Malmö site utilizes advanced polymer extrusion technologies for the production of implants, drug eluting intrauterine devices and intra-vaginal rings. The air circulation in the suites is single pass and state-of-the-art engineering controls are in-place for ensuring adequate containment for operator safety and prevention of cross-contamination. The recent addition of a three-layer co-extruder further enhances our offering, enabling the production of multilayered fibers with customized drug release profiles. Malmö is now uniquely positioned to streamline your drug development journey, delivering flexibility, safety, and efficiency.

Download our free whitepaper on the design of intra-vaginal drug-releasing rings (IVRs) and the importance of avoiding unnecessary design complexity. You will also get the background on IVR development, which includes polymer selection and drug release kinetics, and learn more about simultaneous drug release.

Solid solutions are similar to liquid solutions and consist of a single phase irrespective of the number of components. A solid solution of a poorly water-soluble drug dissolved in a carrier is particularly interesting in improving oral bioavailability. In a solid solution, the drug’s particle size has been reduced to its molecular dimensions resulting in a more rapid dissolution rate. By judicious selection of a carrier, the dissolution rate of the drug can be increased by up to several orders of magnitude. In a solid solution, the drug’s particle size has been reduced to its molecular dimensions resulting in a more rapid dissolution rate.

This whitepaper compares solubility enhancement between spray drying and hot melt extrusion for a poorly soluble, new active pharmaceutical ingredient.

Hot melt extrusion has been widely used as a processing method for many purposes, including forming a solid molecular dispersion to increase the bioavailability of poorly soluble drugs. Analytical tools and techniques can significantly reduce time and improve success rates in developing hot melt extrusion formulations.

In the scale-up phase, analytical characterization techniques ensure similar solubility enhancement occurs on larger extrusion equipment as with the lab scale equipment used for formulation development.

In this whitepaper, you will learn more about the analytical characterization and techniques that are critical in the scale-up of melt-extruded solid dispersions to ensure similar products are produced, specifically in obtaining similar solubility-enhancing effects.