Posted by admin on Jun 1, 2012 in |
Background: Metamizole (Dipyrone) is widely used and has effective analgesic, antipyretic, and antispasmodic properties. After oral or intravenous administration, dipyrone is rapidly hydrolyzed to the active moiety 4-methylaminoantipyrine. Aim: The aim of this study was to assess the bioequivalence of 2 oral formulations of Metamizole 500 mg. Methods: This double blind, randomized, single-dose,2-period crossover study in healthy Indian adult volunteers was conducted at PERD Centre, Ahmedabad. Subjects received Metamizole 500 mg of either test or reference formulation with a washout period of 7 days. After study drug administration, serial blood samples were collected over a period of 24 hours. Plasma concentration of 4-methylaminoantipyrine was measured by pre-validated LC-MS method. Pharmacokinetic (PK) parameters Cmax, Tmax, t1/2, AUC0-t, AUC0-∞, and kel, were determined for test and reference formulations. The formulations were to be considered bioequivalent if the log-transformed ratios of Cmax, AUC0-t, and AUC0-∞ were within the predetermined bioequivalence range of 80% to 125%. Results: A total of 14 subjects were enrolled. No significant differences were found based on analysis of...
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Posted by admin on Jun 1, 2012 in |
High molecular weights water soluble homopolymer type of acrylamide was reported to obtain very high viscosity in low concentration, transparency, film forming properties and useful in formation of transdermal gel. The flurbiprofen gels were prepared by using different concentration of polyacrylamide for topical drug delivery with an aim to gradually increase transparency and spreadability. These preparations were further compared with marketed known flurbiprofen gel. Spreadability and consistency of polyacrylamide gel containing flurbiprofen gel (S9) were 6.5g.cm/sec and 5mm as compared to 5.5g.cm/sec and 10mm respectively of known marketed gel, indicating good spreadability nature and consistency of the prepared gel (S9). The transparency nature of prepared batch (S9) was good as compared to the known marketed gel. The percent drug release was 97.85 and 98.84 from S9 and known marketed gel respectively. No irritation was felt in the skin irritation test. Stability studies conducted under accelerated condition was shown satisfactory results. It can be concluded that polyacrylamide gel containing flurbiprofen gel showed good consistency, spreadability, homogeneity and stability and had...
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Posted by admin on Jun 1, 2012 in |
A simple, accurate and precise spectrophotometric method has been developed for simultaneous estimation of Propranolol hydrochloride and Flunarizine dihydrochloride in combined dosage form. Simultaneous equation method is employed for simultaneous determination of Propranolol hydrochloride and Flunarizine dihydrochloride from combined dosage forms. In this method, the absorbance was measured at 289 nm for Propranolol hydrochloride and 253 nm for Flunarizine dihydrochloride. Linearity was observed in range of 24-64 μg/ml and 6-16 μg/ml for Propranolol hydrochloride and Flunarizine dihydrochloride respectively. Recovery studies confirmed the accuracy of proposed method and results were validated as per ICH guidelines. The method can be used for routine quality control of pharmaceutical formulation containing Propranolol hydrochloride and Flunarizine...
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Posted by admin on Jun 1, 2012 in |
The aim of this study was to investigate the possibility of using inorganic and organic markers to visualize the ability of the transparent polysaccharide (TSP) polymer isolated from the endosperm of the seed kernel of Tamarindus indica, a tree that mainly grows in India and South-East Asia, to bind to human mucosal cells. A layer of human buccal cells was prepared on slides and overlaid by 0.2 ml of 0.6, 0.3, 0.15 and 0.075 % TSP solutions in phosphate buffer and then colloidal carbon black particles were deposited on the slides. The unbound colloidal carbon black particles were cleared by thoroughly washing the slides. The slides were then examined by means of Nomarski interference contrast microscopy in order to visualize the degree of surface retention of the black particles by the buccal cells. The same procedure was followed using Escherichia coli as organic markers. The clearly visible binding of black carbon particles to the cells treated with polymer revealed the presence of a thin layer of TSP covering the...
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Posted by admin on Jun 1, 2012 in |
The standard for stability and quality of drugs for approval of marketing, are assured by testing and systematic evaluation using different analytical techniques. The drugs are tested in pharma analytical lab involving analysts associated spectra, chromatogram etc , and the results are analyzed leading to fixation of expiry dates. Once the drug crosses its expiry period, its potency is lost and it deteriorates, not only decreasing in therapeutic activity but also turning to be toxic. In the present investigation RP-HPLC and UV-Visible spectroscopic methods are employed for estimation of drugs oxcarbazepine and pioglitazone in tablet dosage form before expiry period and 10-12 months after its expiry. Chromatography was carried out on a C-18 column using a mobile phase of 0.05M KH2PO4 and 0.5 ml Triethylamine buffer solution: methanol: acetonitrile (60:20:20 v/v) for oxcarbazepine. The flow rate was 1ml/min with detection at 254nm. For pioglitazone a mobile phase of 0.02 M KH2PO4 buffer: acetonitrile (50:50v/v) was used. The flow rate was 2ml/min with detection at 270nm.The calibration curves obtained using...
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