ABSTRACT
Cinitapride hydrogen tartarate is relatively a new prokinetic agent that widely prescribed for GERD and epigastric pain. Present study was aimed to develop and optimize cinitapride [1 mg] immediate release [IR] tablet formulation[s] by direct compression using central composite rotatable technique. Overall nine formulations [FC1-FC9] were generated by varying the composition of binder avicel PH 102 [X1] and superdisintegrant crospovidone [X2]. The effect of interaction of excipients on hardness [Y1], friability [Y2], disintegration [Y3] and dissolution at 15 min [Y4] were analyzed by RSM plotting. On the basis of physico-chemical evaluation FC3, FC4 and FC6 were found to be the optimized formulations however; FC3 was selected to be the best trial owing to excellent drug release [100.17%] with least friability [0.14%]. These IR tablets showed the release pattern similar to the Weibull model with r2 value of 0.9780.998. The dissimilarity [f1] and similarity indexes [f2] of FC3, FC4, FC6 with the marketed product were estimated to be 2.57 and 76.51, 4.51 and 64.46, 4.32 and 66.78 respectively. Trial optimized formulations were highly stable with the shelf lives of 58-64 months. So, keeping in view the results of present investigation, it is concluded that the technique of manufacturing and optimization is found to be excellent for developing immediate release cinitapride tablets
ABSTRACT
A swift, precise and simple HPLC bioanalytical technique with UV detection was established and validated for quantitative estimation of valsartan in human plasma. The analyte was separated from plasma by protein precipitation with acetonitrile and chromatographically separated on Zorbax SB-C18 [5 micro m, 4.6mm x 15cm] column. The solvent mixture system consisting of acetonitrile, water and glacial acetic acid [40:59:1 v/v], was pumped using isocratic mode at 1mL/min flow rate. Samples' detection of drug was made spectrophotometrically at a wavelength of 264nm. The analyte response was instituted to be linear from 0.06 to 8 micro g/mL with a regression value of 0.999. The accuracy of the proposed method was ranged between 97.2-100.3% with 5% RSD. The analytical recovery [>95%] was consistently observed and satisfactory sample stability was also found at different environmental conditions. In conclusion the reported bio-analytical method is easy and robust that was successfully utilized in estimation of valsartan in a pharmacokinetic study
ABSTRACT
This study was conducted to assess the effects of various excipients in 10 different Tizanidine hydrochloride tablet dosage forms that were prepared by direct compression method [DC]
Various excipients are available for DC method; we selected those excipients that are used commonly in tablet manufacturing
The excipients used included lactose anhydrous, di-basic calcium phosphate anhydrous, starch, talc, sodium carboxy methyl cellulose, polyvinyl pyrrolidone [PVP], silicon dioxide [Aerosil], stearic acid, magnesium stearate and microcrystalline cellulose [Avicel]
These tablets were then evaluated by performing different pharmacopoeial and non-pharmacopoeial tests [i.e. diameter, hardness, thickness, weight variation, disintegration and assay]
It was observed that Formulations B, D and H of Tizanidine hydrochloride gave best results within USP specified limits for the tests employed among all the formulations whereas Formulations F and G showed poor friability, disintegration and dissolution profiles rendering starch in combination of talc and sodium carboxy- methyl cellulose unsuitable for Tizanidine hydrochloride tablet formulations
With the present approach, more studies can be designed using other active ingredients and excipients to get an optimal and cost effective product