The notable unbiased of this research work was to evaluate the well-being and effectiveness of metaxalone by administering the newly developed test and reference drug. A two-period, two-categorization, crossover bioavailability study in fed conditions. Eleven participants were dosed and completed the trial successfully. The drugs were administered by way of a schedule. Samples collected in both periods for pharmacokinetic evaluation. Plasma samples analyzed using a validated method. Pharmacokinetic parameters for investigational and reference products were calculated using the metaxalone drug concentration and safety of the participants monitored by measurement of vital sign. Relative estimation factors calculated for Cmax, Tmax, area under the curve (AUC) t, AUC inf, K el, half-life, and 90% confidence intervals applied for to check for whether reference and test products are equivalent. The experimental part of the study was completed with no major adversarial event. No losses or stern adverse events transpired throughout the course of the experiment. The assessment product is analogous to reference product in relation to degree and extent of absorption. The outcome of this study indicates the newly developed drug is equivalent to the innovator drug and medication was well tolerated by all participants.
This study describes the development and validation of dissolution tests for sustained release Dextromethorphan hydrobromide tablets using an HPLC method. Chromatographic separation was achieved on a C18 column utilizing 0.5% triethylamine (pH 7.5) and acetonitrile in the ratio of 50:50. The detection wavelength was 280 nm. The method was validated and response was found to be linear in the drug concentration range of 10-80 microg mL(-1). The suitable conditions were clearly decided after testing sink conditions, dissolution medium and agitation intensity. The most excellent dissolution conditions tested, for the Dextromethorphan hydrobromide was applied to appraise the dissolution profiles. The method was validated and response was found to be linear in the drug concentration range of 10-80 microg mL(-1). The method was established to have sufficient intermediate precision as similar separation was achieved on another instrument handled by different operators. Mean Recovery was 101.82%. Intra precisions for three different concentrations were 1.23, 1.10 0.72 and 1.57, 1.69, 0.95 and inter run precisions were % RSD 0.83, 1.36 and 1.57%, respectively. The method was successfully applied for dissolution study of the developed Dextromethorphan hydrobromide tablets.
Objective was to compare pharmacokinetic characteristics of Sustained-Release (SR) and Immediate-Release (IR) formulations of dextromethorphan hydrobromide following a single oral administration of test and reference formulations in fasting healthy male volunteers. A randomized, 3-way, crossover, bioequivalence study was conducted in 6 healthy male volunteers to compare dextromethorphan hydrobromide Sustained Release (SR) tablet as test and the Immediate Release (IR) as reference product. Blood samples were collected and plasma samples were determined by using validated HPLC method involving a solid phase extraction method. Pharmacokinetic parameters were calculated by non-compartmental analysis. C max of the sustained-release formulation was significantly lower than that of the marketed immediate-release. The T max of sustained-release formulation was significantly long-lasting than that of immediate release. These results are in line with the profile of a sustained-release drug. This was also evident by the lower elimination rate and higher t½ values. However, the bioavailability of sustained-release tablets remained the identical as that of immediate release tablets.
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