Labo Smeets has developed in collaboration with Ghent University a technique to produce watersoluble granules containing poorly water soluble drugs of Class II (poorly soluble, highly permeable) or Class IV (poorly soluble, poorly permeable) of the Bio Classification System (BCS).
Improving Water Solubility and Bioavailability
The granulation technique – in combination with suitable excipiens as polyethyleneglycols and maltodextrins – improves the extent but mainly the rate of dissolution of the poorly water soluble drug. The faster release of the API results often in an improved bioavailability and consequently a decreased intake of API to obtain the same clinical effect.
The technique can be applied for the production of human and veterinary medicines. Nowadays, the technique is used for the production of granules administered via drinking water to treat large groups of animals (poultry, pigs, …). The produced granules can also be filled in capsules or can be used as intermediates for the production of tablets.
The main advantages of the technique are the continuous process, no grinding necessary after extrusion, low temperature process (50 °C), limited problems of upscaling and the absence of solvents by which no drying step is necessary. Supersaturation is possible based upon formulation.
The Twin Screw Granulator (Pharma TSG 24) is supplied by Thermo Scientific, an important player in the production of twin screw granulators and extruders. The equipment is operational since January 2011.