Pulsatile drug delivery systems have drawn attention in contemporary research for designing chronotherapeutic systems. The current work aims to design pulsatile ketorolac tromethamine tablets using compression coating for delayed delivery with a lag time suitable for the treatment of morning stiffness in arthritis. Rapidly disintegrating core tablets of ketorolac tromethamine were formulated using super-disintegrants, and the optimized formulation was compression using PEO WSR coagulant and Eudragit RLPO for delaying the release. The central composite design and response surface methodology were employed to optimize the formulation and process parameters namely PEO WSR Coagulant (X
1
), Eudragit RLPO (X
2
), and Hardness (X
3
). The dependent variables optimized were lag time and time required for 95% drug release. Analysis using response surface graphs and mathematical modeling of the results allowed identifying and quantifying the formulation variables active on the selected responses. A polynomial equation fitted to the data was used to predict the composition with optimum responses. Compression-coated pulsatile tablets’ optimized composition exhibited a lag time of 9 h and released 95% of the ketorolac tromethamine in 17.42 h. Validation of the mathematical model assured the reliability of QBD in formulation design.
In vivo
X-ray imaging and pharmacokinetic studies established a strong relationship between the coated polymers maintaining the desired lag time for delayed delivery of the active to coincide with the chronobiology for enhanced bioavailability at the right time when needed.
Diabetes is the most prevailing health disorder with high mortality rate and showing increased health costs across the globe. World Health Organization has claimed that lifestyle changes are one of the major causes of diabetes in this modern living. Gliclazide is an oral antidiabetic drug that is taken by majority of patients suffering with type-2 diabetes. With the increased awareness of nutraceuticals in health care management, many patients are consuming them. Hence, in the present investigation it is sought to determine the pharmacokinetic and pharmacodynamic interactions of gliclazide with eugenol in diabetic induced rabbits. Streptozotocin was used for inducing diabetes in healthy rabbits. Four different groups, each with 6 rabbits, are taken in the study. Group A is diabetic control, Group B is treated with gliclazide alone, Group C is treated with eugenol alone and Group D is treated with combination of gliclazide and eugenol. The results clearly indicated that there is an advantage in both pharmacokinetic and pharmacodynamic parameters with combination therapy of gliclazide and eugenol in diabetic rabbits.
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