EHI Retail Institute (Germany)

The presentation describes four different approaches taken at SB for developing controlled release dosage forms. 1. A buffer-based, membrane-coated dosage form was developed for a potent anti-hypertensive agent, which has a poor solubility above pH=4 and undergoing extensive first pass metabolism on oral administration. 2. Buffer crystals were polymer coated, drug layered by a slurry process and then over-coated with a more permeable polymer blend. These capsule formulations provide in vitro release rates of 30-50 mg/hr for 6-8 hrs. 3. Marumerized matrix beads containing a thrombolytic agent were coated with semi-permeable and enteric polymers. Mixtures of uncoated and differently coated beads were filled into capsules, thus providing distinctly different pulsatile release profiles. 3. A novel easy-to-scale up and cost effective CR technology (capsule and bilayer tablets) based on dry granulation and Thermal Infusion Process was developed for drug substances with an aqueous solubility varying from 1 mg/ml to 1-2 g/ml. 4. Multi-tablet dosage forms based on wet granulation and membrane coating, exhibiting pulsatile release profiles are also described.