A n oral-dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/ capsules, and so on. Withania somnifera has been used to promote health and longevity by augmenting defenses against disease, arresting the aging process, revitalizing the body in debilitated conditions, and thus creating a sense of well-being. Commercially, it is available either in powder or liquid dosage forms that do not offer patient compliance. In the present study, an attempt has been made to formulate W. somnifera into thin oral films. An attempt was also made to study factors like the effect of the type of solvent used for casting of the film, effect of drying temperature, and viscosity of the solution on the mouth-dissolving film of W. somnifera Linn. The mouth-dissolving films were prepared by the solvent-casting method. Prepared films were evaluated for film-forming capacity, appearance of film, tack test, thickness, in vitro disintegration time, folding endurance, tensile strength, and percentage elongation. This study illustrated that selected process variables have an influence on the physicomechanical properties of the mouth-dissolving film of W. somnifera Linn. Water was found to be an excellent solvent for casting when hydroxypropylmethylcellulose was used as a film former. When mouth-dissolving film of W. somnifera Linn was dried at lower temperatures, it showed optimum physicomechanical performances. Viscosity of the solution plays an important role in physicomechanical properties of the film; as the viscosity of solution increases, there is an increase in folding endurance, tensile strength, and percentage elongation.

O ral dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/capsules.The primary objective of the present research work was to optimize oral thin film (OTF) formulation of phenylephrine HCl, a water soluble drug with three loading concentrations: High, medium and low and also to evaluate their effect on the final product attributes. The OTF was prepared by solvent casting method. All the formulations were evaluated for film forming properties, appearance, thickness, folding endurance, tensile strength, percent moisture absorption, surface morphology, in vitro and in vivo disintegration. Formulations containing low and medium loading concentration gave acceptable results while formulation with higher loading concentration resulting poor film forming properties. Hence, another objective of the present study was to investigate the effect of anti-tacking agent namely magnesium aluminum silicate (MAS), microcrystalline cellulose and colloidal silicon dioxide (CSD) by applying 2 3 full factorial design on improving the film properties of high concentration phenylephrine HCl. Formulation containing microcystalline cellulose and CSD at low level and MAS at high level was found to be suitable for film formation with desirable physicochemical properties, faster disintegration and optimum in vitro release.

Objective: A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Rizatriptan 10 mg Orally Disintegrating Strips (ODS, test) with that of established Oral Lyophilisate Rizatriptan 10 mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. A single oral dose of 10 mg Rizatriptan was administrated to each volunteer. Methods: Plasma concentrations of Rizatriptan were determined by a validated LC-MS/MS bioanalytical method. The plasma concentrations of Rizatriptan were considered for statistical analysis and for establishing bioequivalence. Pharmacokinetic analysis was done by using the non-compartmental method. Pharmacokinetic parameters Cmax, AUC0→t, AUC 0→∞, t1/2, Tmax, and Ke1 were estimated for each subject and each treatment. Results: Ninety percent confidence intervals (90% CI) calculated for the ratio of AUC0→t, AUC0→∞, and Cmax values for the test and reference formulations were 96.91-110.30%, 96.24-109.07%, and 90.37-113.56%, respectively for Rizatriptan. The 90% CIs of AUC0→t, AUC0→∞, and Cmax values were totally within 80-125%. Conclusion: Based on a statistical analysis of the results, both formulations of Rizatriptan 10 mg, were found to be bioequivalent in terms of rate and extent of absorption under fasting conditions.