V.V.Rajesham

The present study was an attempt to prepare and evaluate Zolmitriptan 9 different oral disintegrating tablets using superdisintegrants like SSG, Crospovidone and Croscarmellose sodium. Formulations were evaluated for their micromeretic properties and post compression studies and found to be within the limits. Based on the disintegrating time and dissolution studies F9 was found to be best formulation. It was found that the sodium starch glycolate is much more effective than the other super disintegrating agents in the preparation of Zolmitriptan oral disintegrating tablets. DSC and FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation.

An accurate & precise liquid chromatographic method was developed for the simultaneous estimation of Itopride (ITP) and Gliclazide (GCZ) in API matrix. The chromatographic analysis was performed on GRACE C18 [250 x 4.6 mm i.d, 5 µ particle size) with mobile phase consisting of 0.05M Potassium Dihydrogen phosphate and 0.5% Tri Ethyl Amine (TEA) buffer having pH 2.7 and Methanol in the ratio of 60:40 v/v at a flow rate of 0.8 mL/ min and UV detection was carried out at 238 nm. The calibration curves of peak area versus concentration, which was linear from 10 - 100 µg/mL for ITP and 5 – 50 µg/mL for GCZ respectively. The retention times of ITP and GCZ were 2.951 and 7.735 min respectively. The method had the requisite accuracy, precision and robustness for simultaneous determination of ITP & GCZ in API matrix. The percentage assays of ITP & GCZ were found out to be 100.80% and 99.76% respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of ITP & GCZ in bulk drug and in its pharmaceutical dosage forms.

Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The present study aimed at preparing fast dissolving oral films of Naratriptan hydrochloride as a model drug which is used for the migraine treatment. Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties like dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased patient compliance. In the present investigation various trials were carried out using two grades of HPMC (E3 and E6), Propylene glycol, PEG-400 and other polymers by solvent casting method.  The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, %drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The optimized formulation S11 prepared using HPMC E6 showed minimum disintegration time (10 sec), highest dissolution rate i.e. 98.23% of drug within 6 min and satisfactory physicochemical properties. Results of DSC and FTIR data of optimized formulation (S11) revealed that there was no incompatibility observed between the drug and excipients used in the formulation. These findings suggest that the fast dissolving oral film containing Naratriptan hydrochloride is considered to be potentially useful for the treatment of migraine where quick onset of action is desirable when compared with reference standard Naratrax conventional tablet.