Abstract

FORMULATION AND EVALUATION OF TENOXICAM ORALLY DISINTEGRATING TABLET

Pentewar Ram Shankarrao*, Alure Bhalchandra Shivaji, Kale Kailash Gorakhnath, Sugave Ramling Vainath

Abstract

Orally Disintegrating Tablets (ODTs) have become a very popular dosage form as they disintegrate rapidly (< one minute) in the mouth and don’t require water for administration. This is due to the increased patient compliance, pleasant mouth feel, ease of administration & swallowing and rapid disintegration and dissolution. There are three main manufacturing methods used for the production of ODTs, namely, freeze drying, molding and compression method. Also, different technologies are routinely used for manufacturing ODTs as Orasolv®, Durasolv®, WOWTAB®, Flash tab®, Zydis®, Quicksolv® and Lyoc® technologies. Some methods of manufacturing ODTs are complex, require multiple processes and don’t provide all ODTs ideal properties. For example, freeze drying and molding provide very light and porous products which disintegrate very rapidly, but they are expensive and produce fragile products. On the other hand, compression method is the easiest and cost effective method for the production of ODTs. It has several advantages as simple equipment, commonly available excipients, high doses can be used and limited number of manufacturing steps. Orally disintegrating tablets containing 10 mg of Tenoxicam were manufactured using direct compression method. Experiments were evaluated for effects of formulation parameters like type & concentration of diluents, concentration of disintegrating agent and their interactions on Tenoxicam ODTs properties and Dicalcium phosphate were used as diluents of different properties, in addition to croscarmellose sodium (CCS), sodium starch glycolate, crosspovidone and the treated agar which was used as a natural superdisintegrant in combination with the synthetic. The obtained results revealed that disintegration time of the optimized ODTs formula (12.5 sec. ± 40 sec). ODTs composed of crosspovidone in combination with natural superdisintegrants 5% level was chosen as optimized formula, as it showed the lowest disintegration time with the highest drug release up to 93%. Furthermore, hardness of the manufactured tablets was not significantly affected by the use of Crosspoidone and sodium starch glycolate instead of CCS. Finally, it was concluded that Tenoxicam oral disintegrating tablets were developed using crosspovidone and Treated agar. These tablets provided low disintegration time and high hardness that are acceptable for ODTs.

Keywords: Fast dissolving tablet, Superdisintegrants (synthetic, natural), Tenoxicam.