In this present research work, we have designed a pulsincap formulation comprising mini-
tablets, which to the best of our knowledge this combination has not been reported yet. We successfully combined the advantages of mini-
tablets technology to meet the optimized requirements of our pulsincap formulation. Our main aim was to target
lornoxicam to treat
rheumatoid arthritis as per the chronotherapeutic pattern of the disease. Directly compressing method was used to prepare mini-
tablets. The
drug,
polymers and combine mixtures of
drug and
polymers was evaluated for pre-formulation testing. Prepared mini-
tablets were also evaluated for physicochemical, dissolution and stability studies. From FTIR and DSC evaluation, we found no interaction between the
drug and
polymers used. For mini-
tablets, all the physico-chemical parameters were in limit. The mini-
tablets of
lornoxicam were filled into an insoluble body of
capsule, and its opening was sealed by plugging it with a
polymer. The complete
capsule body after sealing with a cap was given enteric coating. Different
polymers in various concentrations were used as a plug, to identify the most suitable which gives a complete lag time of 5 hours when combined with 5% CAP coating. HPMC-K100M in 30% and
sodium alginate in 40% concentrations were identified as the most suitable plugs. Our optimized pulsincap formulations releases
lornoxicam after a lag time of 5 hrs and maximum portion of the
drug will be released in the early morning hours. It was also found to be stable for a period of 6 months as per ICH guidelines.