Current Issue : July-September Volume : 2013 Issue Number : 3 Articles : 4 Articles
The aim of present investigation is to study different process parameters for to development and characterization of metoprolol succinate sustain release tablet prepared by hot melt granulation and compare with marketed tablet. Different process parameters like Effect of Granule Size, Effect of Heating Time, Effect of Melting Temperature, Effect of Hardness. Metoprolol succinate is a beta 1-selective (cardio selective) adrenergic receptor blocking agent also inhibits beta 2-adrenoreceptors, chiefly located in the bronchial and vascular musculature. It is used in the management of hypertension, angina pectoris, cardiac arrhythmias, myocardial infarction, heart failure, and hyperthyroidism and in the prophylactic treatment of migraine. Metoprolol has no sympathomimetic activity. Metoprolol succinate with its incomplete oral bioavailability due to extensive first pass metabolism, short half life 3-4 hrs, and multiple daily dosing, is appropriate for a sustained release formulation. Different formulations of metoprolol are available using polymers and excipients. Hot melt granulation technique is something new technique over previous....
The study was planned to investigate whether the technique of Solid Dispersions would be helpful for enhancing the dissolution of Piroxicam. Solid dispersions of Piroxicam were prepared by solvent evaporation method using carriers such as Sodium Starch Glycolate, Croscarmellose Sodium. Solid dispersions were characterized by differential scanning calorimeter, X-ray diffractometer and evaluated for dissolution profiles of Piroxicam. A marked increase in dissolution rate was observed with all solid dispersions. Among the carriers studied sodium starch glycolate gave the highest improvement in dissolution rate. Selected dispersions were subjected to stability studies....
Mixing has always been overlooked in the production of dry powder inhaler (DPI) formulations. This study radically investigates the effect of mixing energy on the behaviour of drug-carrier interactions in single active DPI formulations as a function of three different carrier particle sizes (63-90 µm, 125-180 µm and 210-250 µm). Binary mixtures containing coarse lactose (CL) and the active drug, Salbutamol Sulphate (SS) were prepared in triplicates and mixed in eight different mixer rotations and each of these batches were tested for blend homogeneity by using the percentage of relative standard deviation (%RSD) of the drug concentration in six samples. When mixing energy was increased, there was an astonishing and surprising non-linear but similar trends in blend homogeneity observed for all three formulations. This can be divided into four distinct stages in which, during the initial mixing process, there was a non-homogeneous stage, followed by a homogeneous stage at around 13000 mixer rotations and a variable region, where there is a sudden decrease in homogeneity before it reaches a constant homogenous stage at very high mixer rotations (~40000 mixer rotations). Hence, a significant mechanism depicting the interparticulate interactions occurring during the mixing process was proposed in this study. The results obtained by this study ratifies that mixing energy does affect DPI formulation performance and the particle size of carrier employed in the formulation was shown to affect the interparticulate interactions occurring between the drug-carrier and mixing can potentially be utilized to evaluate these interactions....
A simple, rapid, and precise method is developed and validated on high performance liquid chromatography for the determination of impurities of Valsartan and Hydrochlorothiadizide in combined pharmaceutical dosage form. The chromatographic separation was performed on Inertsil ODS 3V, 5 µm (250 mm x 4.6 mm) using gradient elution of buffer-pH 2.5 (1 mL of triethylamine in 1000 mL of water. Adjust the pH to 2.5±0.05 with orthophosphoric acid) and Acetonitrile. The flow rate was maintained at 1.0 mL min-1 and UV detection was performed at 273 nm. The total run time was 40 min within which the main compound as well as all the known impurities and degradation impurities were separated. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, limit of detection and limit of quantitation was established for Valsartan as well as for Hydrochlorothiadizide and its known impurities....
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