Posted by admin on Jun 1, 2012 in |
Controlled porosity osmotic tablet of metoprolol succinate prepared and evaluated in this study. Metoprolol succinate is very high soluble drug, so complete drug release obtained very fast. It is difficult to formulate osmotic tablet of Metoprolol succinate which gives drug release up to 24 hr at zero order. To get desired dissolution profile various formulation parameters like osmogen concentration, level of weight gain and level of pore former concentration were studied. Hypromellose was added as release retardant to reduce its dissolution rate and get drug release up to 24 hr at zero order. As concentration of release retardant increases, dissolution rate decreases. Final optimized formulation with hypromellose was studied for effect of pH of dissolution media, agitation intensity and osmotic pressure of dissolution media. There is no effect of above variables on dissolution confirms that prepared metoprolol succinate tablet gives drug release with osmotic mechanism. Final optimized formulation complies with the USP criteria for the dissolution of metoprolol succinate extended release...
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Posted by admin on Jun 1, 2012 in |
A novel, simple, accurate, sensitive, reproducible, economical spectroscopic method was developed and validated for the determination of Azithromycin dihydrate and Cefixime trihydrate in combined dosage form. Second order derivative spectroscopy method is adopted to eliminate spectral interference. The method obeys Beer’s Law in concentration ranges of 10-40 ppm for Cefixime trihydrate and 25-100 ppm of Azithromycin dihydrate. The method was validated for linearity, accuracy and precision as per ICH guidelines. The zero crossing point for Azithromycin dihydrate and Cefixime trihydrate was 326.4 nm and 226.8 nm, respectively in water. The LOD and LOQ value were found to be 0.54 and 1.64 ppm for Cefixime trihydrate and 0.77 and 2.34 ppm for Azithromycin dihydrate respectively. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form (ZIMNIC...
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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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