The present invention discloses an improved single step process without use of any cross-linker for the manufacture of sustained release dosage forms by simple direct compression method using optimized concentration of thiolated Chitosan- thioglycolic acid (TGA) conjugate alongwith other ingredients. The optimized concentrations of the various ingredients are active drug (25% w/w), thiolated Chitosan- thioglycolic acid (TGA) conjugate (20%w/w), Mannitol (10%w/w), Magnesium stearate (1%w/w), Talc (0.5%w/w) and Lactose (43.5%w/w). The process results in easy manufacture of gastro-retentive controlled release dosage forms which adhere to the mucus layer and release active drug in a controlled manner. This is because the dosage forms do not pass into the intestine until all drug is released. The formulation shows a drug release of around 99% over a period of 24 hours and mucoadhesive strength of 29.49 gm over a period of 6 hours.
Sonia Dhiman, Thakur Gurjeet Singh, Sandeep Arora