DESIGN AND IN-VITRO CHARACTERIZATION OF DELAYED RELEASE MULTI UNIT PARTICULATES USING WURSTER TECHNOLOGY

The aim of the present research was to design and characterize delayed release Multi Unit Particles (MUPS). These were produced primarily for the purpose of oral modified release dosage forms having gastro resistant and delayedrelease properties. During the development of MUPS agglomeration, generations of fines and twins formation are identified as critical issues. The delayed release multiple units were prepared by layering drug suspension using Wurster technology. The prepared multi unit particulates consist of successive layers of drug layer (Esomeprazole), barrier coat and enteric coat (Eudragit L30 D55) on to inert seeds (sugar spheres #50/60). Finally the MUPS are filled into capsules (white to off white hard gelatin). The MUPS were evaluated for drug content, moisture content, particle size distribution, good flow properties and the filled capsules were evaluated for acid resistance (0.1N HCl for 2 hrs) test and In-vitro drug release (pH 6.8 phosphate buffer) and compared with the innovator product. The characterization of pellets was completed and capsules were packed into HDPE bottle (60cc with 33mm closure) and subjected to accelerated stability testing (40°C/75%RH) for six months and results were compared with initial results. Key words: Delayed release, multi unit particulates (MUPS), Wurster technology, Sugar spheres #50/60, Eudragit L30 D55, Q point at 30minutes NLT 75±5 %, 0.1N HCl, pH 6.8 phosphate buffer.