DOI: 10.36347/sajp

Pages: 10-15

The present work involves Controlled release Methylphenidate Hydrochloride capsules development in order to meet the required bio-availability and its in-vitro release pattern and the preformulation studies, Physical drug excipient compatibility studies, Analytical method development, Manufacturing of capsules filled with drug loaded pellets and Evaluation procedures for pellets and capsules were studied. The size of pellets (841-1190µm) was found to be within the range of standard sieves. Bulk density of all formulations of Methylphenidate Hydrochloride pellets were found to be in the range of 0.61- 0.67 gm/ml. Tap density of all formulations of Methylphenidate pellets were found to be in the range of 0.63-0.74 gm/ml. The moisture content of all the formulations was found to be within the range of 1.52 – 1.94 %. The compressibility of all formulations was found to be within the range of 14.81-20.45. Stability studies were conducted for optimized formulation (F7) at two different storage conditions 25ºc ± 2ºC /60%RH ± 5% , 40ºC ± 2ºC /75%RH ± 5%for a period of 90 days. The formulation was found to be stable with respect to physical appearance, percentage moisture content, percentage drug content and percentage drug release. The optimized formulation has consistent release profile to provide the drug release for longer duration of 10 hours. FTIR studies have shown that there were no considerable interactions between drug and excipients. The short term stability study also indicates no change in the physical characteristic of drug content.