Background and Objective: Prolonged pharmacokinetic sampling is a challenge for successful conduction of the bioequivalence studies for drugs having long elimination half-lives. The regulatory authorities have recommended an alternative to consider the partial AUC (AUC 0-72) for studying bioequivalence. However, the results obtained from such truncated approach are not consistent and needs further exploration. We have investigated the suitability of truncated AUC in the fi eld of bioequivalence. Methods: The bioequivalence studies conducted with conventional approach for Bicalutamide, Topiramate and Amitriptyline having long elimination half-lives were investigated. The pharmacokinetic data obtained from these studies was truncated at 72hrs and 2 half-lives post dose. The 90% confi dence intervals constructed for the ratios of means of log-transformed partial AUC (at 72hrs and 2 half-lives post dose) were compared individually with those of the total AUC. The intra-subject variability obtained for partial AUC at 72hrs and 2 half-lives post dose was compared individually for percentage change from that of the total AUC. Results: No change in the study outcome irrespective of the point of truncation of AUC was observed. The 90% confi dence intervals constructed for the ratio of means of log-transformed partial AUC (at 72hrs and 2 half-lives post dose) were well within the acceptable bioequivalence criteria of 0.8-1.25. The intra-subject variability for AUC was not infl uenced irrespective of the point of truncation of AUC. Conclusion: Limiting the pharmacokinetic sample collection period to 72 hours in bioequivalence studies for the drugs having long elimination half-lives is equally accurate and sensitive alternative to the conventional approach. reliably estimate the terminal rate constant (which is needed for a reliable estimate of AUC 0-
A simple gas chromatographic method is described for the determination of histapyrrodine HC1 in marketed formulations. Chlorpheniramine maleate is used as the internal standard. The amount of histapyrrodine HC1 found by the proposed method averaged 19.91 mg/tablet, compared with the label claim of 20 mg/tablet. The method was statistically evaluated for accuracy and precision.
Hidradenitis suppurativa, a chronic recurrent disorder, characterized by painful, deep-seated nodules and abscesses commonly affecting the pilosebaceous-apocrine unit of the axillary, inguinal and mammary region in females, while the perianal area and buttocks are the prevalent sites in males. Its onset is after puberty, and may persist thereafter. Its exact aetiology is speculative. Follicular occlusion is the primary event leading to secondary inflammation, infection and destruction of the unit, ultimately affecting the adjoining subcutaneous tissue. Smoking and obesity may trigger or aggravate the condition. Stage of disease determines the mode of treatment. Medical treatment is valid in the early stage, but the results are transient. The early stage may warrant incision, and drainage of abscesses coupled with limited excision for locally recurring draining sinuses. While radical excision and healing with secondary intention, skin grafting, and flaps is recommended in advanced stages, laser therapy including the diode laser may prove a promising and innovative alternative.
A simple colorimetric method is described for the determination of thiamine hydrochloride (vitamin B,) in dosage forms. The method is based on measurement of a yellow complex formed when thiamine HC1 is treated with /7-methylaminophenol sulfate (Metol) under alkaline conditions. Compounds such as vitamins A, B2, B6, B,2, C, D, and E, and niacinamide, citric acid, liquid glucose, calcium pantothenate, biotin, liver extract, and folic acid do not interfere in the reaction. Extracting the complex into chloroform before quantitation enhances the stability of the reaction product and removes interference of watersoluble colored constituents in syrup samples. Statistical validation shows that the method is precise and accurate. Results agree well with those obtained by other methods in the literature
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