Method Development and Validation of Spectrophotometric Methods for The Estimation of Rizatriptan Benzoate in Pure and Pharmaceutical Dosage Form

Analytical UV derivative spectrophotometric method was developed and validated to quantify Rizatriptan Benzoate in pure drug and tablet dosage form. Based on the spectrophotometric characteristics of Rizatriptan Benzoate, a signal of zero (225nm), first (216nm), second (237nm), third (233nm), fourth (231nm) order derivative spectra were found to be adequate for quantification. The methods obeyed Beer's law in the concentration range of (0.1-360µg/ml) with square correlation coefficient (r2) of 0.999. The mean percentage recovery was found to be 100.01 ± 0.075. As per ICH guidelines the results of the analysis were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and were found to be satisfactory.

Formulation development and evaluation of Orally Disintegrating Tablets Rizatriptan Benzoate

Formulation research is oriented towards safety, efficacy and quick onset of action of existing drug molecule through novel concepts of drug delivery. Orally disintegrating tablets of Rizatriptan benzoate were prepared by direct compression method to provide faster relief from pain to migraine sufferers. About eleven formulations for the present study were carried out. Croscarmellose sodium, Crospovidone and Sodium starch glycolate (SSG) were used as superdisintegrants, while microcrystalline cellulose was used as diluent. The prepared batches of tablets were evaluated for weight variation, hardness, friability, wetting time, invitro dispersion time, drug content and invitro dissolution studies. The formulation containing combination of Croscarmellose sodium and Sodium starch glycolate showed rapid invitro dispersion time as compared to other formulations. The optimized formulation dispersed in 8 seconds. It also showed a higher water absorption ratio and 99.58% of drug is released within 2 minutes.

Formulation development and characterization of in-situ gel of Rizatriptan Benzoate for intranasal delivery

The present investigation was aimed to formulate and characterize ion-activated in-situ gel loaded with Rizatriptan Benzoate (RIZ) for intranasal administration for brain targeting. The gel was further optimized for process and formulation parameters by using 32 factorial design. The optimized batch having the concentrations of gellan gum and HPMC E15 LV 33.83 mg and 9.6 mg respectively. Gel strength and mucoadhesive strength of the optimized formulation were found to be 32.54 sec and 2580.50 dynes/cm2 respectively. Moreover, improved in-vitro and ex-vivo release profile of in-situ gel were observed in comparison to drug solution. In a nutshell, the developed formulation holds a great promise in overcoming the limitation associated with currently marketed RIZ formulations and illustrates the potential use of ion-activated in-situ gel to administer the drug by nasal route for brain targeting. Keywords: In-situ gel, Rizatriptan benzoate, Ion-activated, Gellan gum, HPMC E15 LV, Brain delivery, Migraine

COMPARATIVE STUDY ON EFFECT OF NATURAL AND SYNTHETIC SUPERDISINTEGRANTS IN THE FORMULATION OF RIZATRIPTAN BENZOATE ORAL DISPERSIBLE TABLETS

Objective: In the present study, the effects of a natural superdisintegrant gellan gum, karya synthetic gum superdisintegrants like sodium starch glycolate, crospovidone and combination of natural and synthetic superdisintegrant were compared in the formulations of rizatriptan benzoate oral dispersible tablets. Methods: This oral dispersible tablets were prepared by direct compression method and evaluated for weight variation, hardness, disintegration time, drug content, friability and dissolution. Drug compatibility with excipients was checked by FTIR studies. Stability study of the prepared tablets was done at 40±2°/75%±5% RH for a period of 1 mo. Results: FTIR studies showed that no any chemical interaction between drugs and excipients. The in vitro drug release study revealed that formulation F9 combination of both crospovidone and karya gum was the most successful formulation and disintegrate time within 13 seconds and drug release within 10 min. The drug release from the best formulations followed first-order kinetics, which is concentration-dependent. Short terms stability studies of the tablet for three months showed non-significant drug loss. Conclusion: The formulation containing a combination of natural and synthetic superdisintegrant was found to be the best results. Apart from fulfilling all official and other specifications, the tablets exhibited a higher rate of drug release.