Formulation and Evaluation of Ketorolac Tromethamine using 32 Factorial Design
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In the present dissertation work, the aim was to prepare nasal in-situ gel of ketorolac tromethamine, a potent non-narcotic analgesic with moderate anti-inflammatory activity to improve its retention time by making sustain release dosage form and also avoid first pass metabolism of drug.
The prepared gel was the concentrate of drug, Carbopol polymer (cross linking gelling agent), HPMC as thickening agent or viscosity enhancing agent and buffering agent. The formulation was evaluated for various tests such as solubility, pH determination, rheological studies using Brookfield viscometer, gelling capacity, drug content, Mucoadhesive strength, gel strength, in-vitro release study and kinetic treatment of release data.
The optimized formulation F6 showed pH (6.4±0.10), drug release at 360min (79.86±0.64), drug content (109.965±0.044), viscosity at 20 rpm at pH 4 and pH 6.4 (293±1.00) (3115±1.00) respectively, Mucoadhesive strength (3763±1.37), gelling capacity (51±0.39). In vitro drug release of the F6 was highly significant (p<0.05) as compare to the other formulation.
Ketorolac tromethamine was successfully formulated in pH triggered in-situ gelling system using Carbopol 934 in combination with HPMC K4M. It was seen that HPMC K4M is important for in-situ gel behaviour along with Carbopol 934 on the basis of main effect of concentration of HPMC K4M and Carbopol 934. In-vitro results indicated that the in-situ gel system is a viable alternative to conventional nasal drops by virtue of its ability to sustain drug release.
Ketorolac tromethamine, in-situ gel, Carbopol, HPMC, sustained release, nasal delivery.