Hot Melt Extrusion

Hot Melt Extrusion
Product Description

To successfully develop and manufacture your polymer-based delivery systems, like implants and intra-vaginal rings, we have advanced extrusion capabilities in Malmö (Sweden) and Putnam (US Connecticut). The US site is also a center of expertise for Hot Melt Extrusion (HME).

HME improves the bioavailability of poorly water-soluble drugs (BCS II and IV). During HME, crystalline API is dissolved in a suitable polymer using heat and shear generated in a twin-screw extruder. The US facility has various twin-screw extruders and an extensive library of over 100 screw designs to support technical and GMP development.

We have the capabilities and knowledge base to support your development process from start to finish, including manufacturing supplies for all clinical phases of development and a seamless transition to commercial manufacturing. Moreover, our equipment is fully contained, warranting the safe handling of the highest potency APIs.

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Sever Pharma Solutions

  • SE
  • 2023
    On CPHI since
  • 250 - 499
    Employees
Company types
CMO/CDMO
View company profile
Categories
more categories Show less

Sever Pharma Solutions

  • SE
  • 2023
    On CPHI since
  • 250 - 499
    Employees
Company types
CMO/CDMO
View company profile

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Sever Pharma Solutions resources (3)

  • Design of intra-vaginal drug-releasing rings

    Whitepaper Design of intra-vaginal drug-releasing rings

    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.
  • A COMPARISON OF SATURATED SOLUBILITY ENHANCEMENT VIA SPRAY DRYING AND HOT MELT EXTRUSION PROCESSING

    Whitepaper A COMPARISON OF SATURATED SOLUBILITY ENHANCEMENT VIA SPRAY DRYING AND HOT MELT EXTRUSION PROCESSING

    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.

  • ANALYTICAL TOOLS & TECHNIQUES IN HOT MELT EXTRUSION - CASE STUDY ON PROCESS SCALE UP

    Whitepaper ANALYTICAL TOOLS & TECHNIQUES IN HOT MELT EXTRUSION - CASE STUDY ON PROCESS SCALE UP

    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.