High-potent Dosage Forms

We offer solutions for companies that need CMO capacity concerning the aseptic filling of syringes and assembly and packaging of pre-filled syringes and auto-injectors. We will enhance your product by adding value through manufacturing if you require additional capacity or a complete technology transfer. q...

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 bioa...

Polymer-based dosage forms continuously administer the drug to the patient for an extended period, varying from weeks to years. These controlled-release products are very suitable for specific indications, patient populations, and drugs due to the long duration of action, avoidance of first-pass metabolism...

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.