Non Micronized Piroxicam-Liquid-Filled Dispersion (SEDDS) into Hard Gelatine Capsules: An Approach to Improve Dissolution and Stability of Piroxicam Formulation
The formulation of liquid fill dispersion is an effective method of increasing the dissolution rate of poorly soluble drugs, and hence, of improving the bioavailability. The dispersion was used to prepare different dispersion of Piroxicam using triethyl citrate(TEC), acconon and polysorbate-80. The physical characteristics of the binary systems were determined Particle size analysis, Zeta potential and by HPLC. The release rate from the resulting dispersion was determined from dissolution studies by use of USP dissolution apparatus I (basket method). The dissolution rate of Piroxicam is increased in all the dispersion systems compared to that of pure drug. A liquid dispersion system of Piroxicam and triethyl citrate(TEC): acconon : polysorbate-80 blend in different ratios, was also prepared. The capsule formulation was subjected to stability studies at different temperature and humidity conditions as per ICH guidelines. Physical and chemical properties of the dispersion didn’t change during a period of storage at room temperature and at 40°C, 75% RH. It was found that Piroxicam was chemically stable against the effects of temperature and humidity. However, the relative humidity and storage time exerted an effect on the dissolution behaviour of Piroxicam. The changes in dissolution behaviour after storage under conditions of high humidity and temperature might be related to the formation of Piroxicam microcrystal and to water absorption by the carrier during storage. It is predicted that acceptable shelf-lives should result when moisture resistant packaging is used for pharmaceutical formulations of this type.