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        Development and evaluation of film coated aceclofenac and chlorzoxazone tablet with enhanced dissolution rate

        Shaila Jain,Aakankchha Jain,Ashay Jain,Sandeep Shrivastava,Amit Kumar Jain 한국약제학회 2016 Journal of Pharmaceutical Investigation Vol.46 No.5

        Out of many complications two major problems facing in formulation industry are poor solubility and short half-life of drugs which results into poor bioavailability after oral administration. Solid dosage forms are coated for a number of reasons, the most important of which is controlling the release profiles and bioavailability of the active ingredient. Thus the development of a significant dissolution procedure for drug products with limited water solubility has been a challenge to the pharmaceutical industry. Aceclofenac (Biopharmaceutical classification Class II drug) is a novel non-steroidal antiinflammatory drugs (NSAIDs) having anti-inflammatory and analgesic properties, and is widely used in the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. The investigation revealed that there is no official dissolution medium available in the literature. The objective of present study is to formulate film coated tablet of Aceclofenac and Chlorzoxazone having short half-life by coating with hydroxyl propyl methyl cellulose (E5 LV). Then the formulated tablets were evaluated for its physicochemical properties and in vitro release studies. The incorporation of drugs into polymer matrices is considered a valid tool in order to optimize insufficient features of the drug molecule, like solubility, stability or toxic effects. In the present work, the incorporation of aceclofenac was performed in inert HPMC and there was no chemical interaction between the drug and polymers as concluded from the FTIR studies. In the present study, parameters such as solubility, medium pH, surfactant type, dissolution behavior of formulations, stability, and discriminatory effect of dissolution testing in different dissolution mediums were studied for the selection of a proper dissolution medium. The drug showed an enhanced release rate in the dissolution media containing pH 6.8 phosphate buffer, 900 ml with 0.5 % sodium lauryl sulphate at 75 rpm for 60 min and thus was chosen as the discriminating dissolution method for film coated aceclofenac formulation. It was found that greater than 80 % of the label amount is released over 60 min.

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        RP-HPLC method development using analytical QbD approach for estimation of cyanidin-3-O-glucoside in natural biopolymer based microcapsules and tablet dosage form

        Deepika Thakur,Ashay Jain,Gargi Ghoshal,U. S. Shivhare,O. P. Katare 한국약제학회 2017 Journal of Pharmaceutical Investigation Vol.47 No.5

        Anthocyanin has been proven to impart several health benefits and biological functions. Though, various analytical methods have been reported for single/multicomponent analysis of anthocyanins, found to be tedious, time consuming and difficult to reproduce. Analytical studies on specific anthocyanins for estimation using an approach of Analytical Quality by Design are scarce. USP method is only reliable for cyanidin-3-O-glucoside (CY-3- O-Glu) estimation, but exploring many disadvantage of having high buffer concentration in mobile phase system and gradient elution, hence column blockage. So there is need to develop a novel HPLC method to overcome this problem with the use organic solvents with lesser volume of buffer in isocratic mode of elution. The aim is to develop a robust and precise method for estimation of CY-3-O-Glu in biopolymer based microcapsules and tablets. The optimized method consisted of mobile phase containing solvent A and B, flow rate 0.8 mL/min with 20 min of analysis time. The method was further validated in accordance with current ICH guidelines Q2 (R1) and found to be highly selective for component in the presence of degradation products confirmed by Mass spectra. Therefore, the proposed method was found to be suitable for routine analysis of CY-3-O-Glu in food and pharmaceutical based formulations.

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