This study was to compare the bioavailability and pharmacokinetic properties of test product of Metformin hydrochloride extended release formulation of 1000 mg tablet with reference product of Metformin Hydrochloride (Glucophage®) extended release formulation of 1000 mg in Indian healthy male volunteers. Study design is an open-label, randomized, 2-treatment, single-dose, crossover, bioavailability study to compare test product with reference product in 24 healthy human male volunteers under fed condition. A single oral dose of 1000?mg Metformin (XR) extended release test product, with reference product Metformin Hydrochloride (Glycophage®) extended release was administered as per computer generated randomization schedule during 2 period of the study having 7 days of washout period. A liquid Chromatography mass spectroscopy method was developed and validated as per FDA guideline requirements using Atenolol as an internal standard for the determination of Metformin in human plasma. A non-compartmental pharmacokinetic method was employed to determine the pharmacokinetic parameters (Cmax, Tmax, AUC0-t , AUC0-8 and t½) of Metformin using Kinetica (version 4.4.1) software. Cmax, AUC0-t and AUC0-8 were used to test for bioequivalence after log transformation of Metformin plasma concentration data. The required Bioequivalence acceptance criteria as per regulatory is 90% CI for bioequivalence study and the range is 0.80 to 1.25. The 90% confidence intervals for log transformed data for Cmax, AUC0-t and AUC0-8 for test A vs. reference were 83.18-.95.64, 88.06-104.99 and 94.76-121.59 respectively.

The objective of this study was optimization of Solid State Fermentation conditions for the production of Pectinases by using fungus Aspergillus niger. The effect of basic fermentation parameters (pH, Temperature, Moisture Contents, Moistening agent, Carbon Sources and Nitrogen Sources) on enzyme production was studied. Maximum pectinases production was in PME (5.58 mg/ml) using Banana peel as substrate. The optimum conditions for pectinases production for Banana peel were found to be: initial Moisture Content - 70%, initial medium pH - 6 and 7, temperature - 35ºC, concentration of carbon sources - 2% glucose, concentration of nitrogen sources – 3% Urea. The optimal incubation time for production was six days. Results indicate the scope for further optimization of the production conditions to obtain higher Pectinases using the strain under SSF.

A simple, rapid, accurate and economical UV-spectrophotometric method has been developed for estimation of Dextromethorphan hydrobromide from bulk and pharmaceutical formulation. Method applied was area under curve (AUC) in which area under curve was integrated in the wavelength range of 258.4 – 290.8 nm. The ?max of Dextromethorphan hydrobromide in 0.1N HCL was found to be 281 nm. The drug follows linearity in the concentration range 30 - 80µg/ml with correlation coefficient value 0.999. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 101.42 % was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 %. The % recovery was found to be in the range 99.2%– 101.76%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. The above method was a rapid and cost-effective quality-control tool for routine analysis of Dextromethorphan hydrobromide in bulk and in pharmaceutical dosage form