Formulation and Evaluation of Melt-In-Mouth Tablets of Rizatriptan Benzoate

Abstract

A B S T R A C T Over the past three decades, orodispersible tablets have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance. Rizatriptan Benzoate is potent anti migraine drug having agonist activity at the 5hydroxytryptamine (5-HT) 1B and (5-HT)1D receptor. It commonly used for relief of headaches in treatment of migraine. Conventional tablets of Rizatriptan Benzoate are not capable of rapid action, which is required for immediate relief from migraine pain. Marketed freeze dried tablet of Rizatriptan Benzoate is available. Freeze drying is cumbersome and it yields a fragile and hygroscopic product. Thus, the present investigation deals with development of Orodispersible tablets of Rizatriptan Benzoate to produce the intended benefits. Orodispersible tablets of Rizatriptan Benzoate were prepared using superdisintegrants viz; crospovidone, croscarmellose sodium and sodium starch glycolate using the direct compression method. The tablets prepared were evaluated for thickness, uniformity of weight, hardness, friability, wetting time, in vitro disintegration time and in vitro dissolution time. The tablets disintegrated within 21 to 75 s. Almost 95% of drug was released from all formulations within 15 min. The formulation containing 6% of croscarmellose sodium (F6) was found to give the best results. Apart from fulfilling all official and other specifications, the tablets exhibited higher rate of release. The stability studies were performed as per ICH guidelines. The Optimized formulation (F6) showed no significant variations for the tablets parameters and it was stable for the specified time period. It was concluded the Orodispersible tablets for Rizatriptan Benzoate can be formulated for emergency treatment of migraine.