ABSTRACT Linseed hydrogel (LSH) was evaluated by acute toxicity for its potential application in oral drug delivery design. White albino mice and rabbits were divided in four groups (I-IV) and different doses of LSH (1, 2 and 5 g/kg body weight) were given except to the control group (I) that was left untreated. Rabbits were monitored for eye irritation, acute dermal toxicity and primary dermal irritation, whereas, body weight, food and water consumption, hematology and clinical biochemistry, gross necropsy and histopathology of vital organs were scrutinized in mice. LSH was considered safe after eye irritation test as no adverse signs or symptoms were seen in the eye. In dermal toxicity and irritation study, skin of treated rabbits was found normal in color without any edema or erythema. After oral administration, there was no sign of any abnormalities in treated group animals (II-IV). The hematology and clinical biochemistry of treated group animals was comparable with the control group. Histopathology of vital organs has not shown any lesion or abnormalities. In the light of these outcomes, it can be concluded that LSH is not a hazardous biomaterial and could be incorporated as an excipient in oral and dermal preparations.

This study aimed to formulate, characterize and evaluate the Gliclazide (GLZ) microcapsules prepared with sodium alginate, guar gum and pectin in different ratios by ionotropic-gelation method. The microcapsules were evaluated against different parameters such as particle size and shape, Carr's index, Hausner's ratio, rheological studies and drug release kinetics. Fourier Transform Infra Red (FTIR) and Differential Scanning Calorimetric (DSC) studies demonstrated the absence of any drug - polymers interaction. Promising characteristics were observed in rheological behavior and release kinetics. The size of microcapsules and percentage yield was in the range of 676 to 727 µm and 69 to 77%, respectively. Scanning electron micrographs revealed that microcapsules were discrete, spherical and free flowing. Entrapment efficiency and uniform drug release kinetics were some of the probable characteristics depicting the novel formulation design of Gliclazide microcapsules.

A simple, rapid and convenient high performance liquid chromatographic method has been developed for the determination and bioequivalence of norfloxacin intablets formulations by using ciprofloxacin as an internal standard. The chromatographic separation was achieved on a C18 column having an isocratic mixture of methanol, disodium hydrogen phosphate buffer and acetonitrile (30:30:40) at pH 3 adjusted with o-phosphoric acid. The eluents were detected at 280 nm and quantitation was achieved on the basis of peak height ratio of norflaoxacin and internal standard. Limit of detection of the method developed was 15 ng mL-1> with a linear range of 30 - 200 ng mL-1. After single oral dose (400 mg) of two formulations (Noroxin, MSD and Ecoflaxin, Technovision Pharmaceutical) of norfloxacin administered to healthy volunteers using a randomize 2x2 crossover design, pharmacokinetics parameters (AUC0-t, AUC0-∞, Cmax, t½ ) were derived from the plasma concentrations curves for both formulations. Pharmacokinetic analysis of the data showed that the two formulations were bioequivalent, while no adverse reactions to drug were observed. In addition, the method evolved has been found suitable for the routine quality control tests.