Studies of meloxicam's quick disintegrating tablets

The aim of this study was to design and develop an oral dispersible tablets of meloxicam. Meloxicam is a COX-2 inhibitor type of NSAI drug used as solid dosage form with doses of 7.5 mg and 15 mg. 29 oral dispersible tablet formulations were designed and studied to investigate and select the best tablet formulation. Sour taste of meloxicam in the developed tablets formulation were masked with vanilla aroma and sweetened with aspartam.The oral dispersible tablets were manufactured by direct compression method after the investigation of disintegration time, flow rate, compactability, hardness and freability properties of the powders to be compressed. The batch size of each formulation was to be 500 tablets and 300 tablets were compressed for each serie. The total weight of the oral dispersible tablets of meloxicam with 7.5 mg and 15 mg were 150 mg and 300 mg respectively.The hardness of the oral dispersible tablets to be developed was aimed to be more than 35 N. The friability of the formulated tablets were found less than 0.6%.Disintegration tests of tablets were carried out by USP method and a special method for the oral dispersible tablets reported in the literature in in- vitro mouth medium with phosphate buffer at pH 6.4. The selected tablet formulation G1 disintegrated within 17 seconds.Dissolution tests were caried out by USP paddle method in the dissolution media at pH 6.4 and 7.5 to investigate and to compare the dissolution performance of the generic meloxicam tablets in Turkish drug market and developed tablet formulations. Tablet formulation G1 showed highest dissolution rate of all the tablets tested including the generics in the dissolution medium at pH 6.4 significantly.Zeloxim® and Melox® generics showed highest dissolution results in all of the generics significantly in the dissolution medium at pH 6.4. In the case of dissolution medium at pH 7.5 with phosphate buffer the result of dissolution rate study of the tablet G1 and generics Zeloxim® and Melox® did not show any significant difference.Tablets were tested for the stability in stress condition (40 °C, 75% relative humidity) for one mounth, no impurity increase and no loss of API were found.