A sensitive, rapid, precise, accurate high-performance liquid chromatographic method was developed for the estimation of Sorafenib (SOR) in the tablet dosage form. Chromatographic separation of SOR was carried out utilizing thermo-scientific model C18 column (4.6 mm i.d. X 250 mm; 5µm particle size) (based on 99.99 % ultra-high purity silica) using mobile phase that consisting of acetonitrile: methanol (40:60 v/v) at a flow rate of 1.0 mL/min. The absorption maximum (?max) of SOR in the mobile phase was found to be 265.5 nm. It had a retention time of 3.223 min. The calibration curve was in linear function of the drug in the concentration range of 2-10 µg/mL (r2 = 0.999) for the optimized method. The regression equation for SOR was found to be Y = 68228 x + 8071. The Detection Limit (DL) & Quantitation Limit (QL) results of SOR were found to be 0.526 µg/mL and 1.594 µg/mL respectively. The developed method was validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 - 102 %, and minimum values of % RSD indicate the accuracy of the method. The detailed quantitative results of the study show that this method is precise, accurate, and cost-effective. Thus, the developed RP-HPLC method can be successfully feasible for the routine quality control analysis of SOR in a pharmaceutical dosage form.
Extended release products are designed to release their medication in a controlled manner at a predetermined rate, duration, and location to achieve and maintain optimum therapeutic blood levels of a drug. The objective of the study is to formulate and evaluate Ilaprazole Controlled release tablets comparable to the innovator product. F1-F9 formulations were prepared using varying concentrations of super disintegrates like Crospovidone, Croscarmellose sodium and Sodium starch glycolate in different concentrations. Based on the hardness, friability, weight variation, drug content, F6 formulation was found to be optimised. The selected F6 formulation was sub coated with HPMC P 50 and followed by enteric coating with Acryl-EZE-80 (Eudragit L100-55). 3 formulations (F10-F12) were prepared by using coating. Among the three formulations, F11 formulation was found to be best. FTIR studies were carried out to find out drug and excipient compatibility studies, the studies revealed that there were no interactions. DSC studies also carried out to demonstrate any changes in physical forms of the drug molecule. Keywords: Ilaprazole, Extended release tablets, Crospovidone, Croscarmellose sodium, Sodium starch glycolate, HPMC P 50, Acryl-EZE-80.
Abstract-The purpose of this research was to mask the intensely bitter taste of Ondansetron HCl and to formulate rapid disintegrating films (RDFs) of the taste-masked drug using methocel E15. Taste masking was done by complexing Ondansetron HCl with ion exchange resin (Polacriline Potassium) which also has disintegrating property, in different ratios and by using sucralose as sweetening agent in very low concentrations. Taste was further masked using vanilla flavor in combination with lychee and banana flavor. Drug-polymer complexes (DPCs) were tested for drug content, in vitro taste in simulated salivary fluid (SSF) of pH 6.2, and molecular property. Complex that did not release drug in SSF was considered taste-masked and selected for formulation RDFs. The complex with drug-polymer ratio of 2:1 did not show drug release in SSF; therefore, it was selected. The properties of films such as hydration study, folding endurance and invitro drug disintegration in the oral cavity were investigated. PEO N-10, 7% wt/wt gave the minimum disintegration time and elegance to the final product. Films of batch F4 containing mannitol and sorbital in the ratio 1:1 and 7% wt/wt PEO N-10 showed faster disintegration, within 12.5 seconds. Good correlation between in-vitro disintegration behavior and in the oral cavity was recognized. Taste evaluation of RDF in human volunteers revealed considerable taste masking with the degree of bitterness below threshold value (0.5) ultimately reaching to 0 within 15 minutes, whereas Ondansetron HCl was rated intensely bitter with a score of 3 for 10 minutes. Films of batch F4 also revealed rapid drug release (t90, 60 seconds) in SGF. Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated films in the oral cavity.
Extended release formulations are designed to release their medication in a controlled manner at a predetermined rate, duration and location to achieve and maintain optimum therapeutic blood levels of a drug. The present investigation is aimed to formulate the extended release matrix tablets of Tenatoprazole sodium with various grades of different polymers like Carbopol, HPMC and Eudragit grades. The tablets were prepared by wet granulation technique. The prepared ER Matrix tablets were evaluated for various physico chemical parameters. All the formulations resulted in acceptable Pharmacopoeia limits. In-vitro drug release studies (USP dissolution rate test apparatus II, 75 rpm, 37°C ±0.5°C) using 0.1N hydrochloric acid (1.2 PH) for first 2 hrs and phosphate buffer (PH 6.8) as a dissolution medium (900ml) for the next 12 hrs. Among all the formulation F-5(drug: Carbopol-974P-NF in ratio of 1:1.5) shows better result upto 12 hours of the drug release was found to be 99.47±0.22 so it's an Optimized formulation.
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