Formulation development of methylprednisolone dispersible tablets using quality by design approach

The objective of this study was to enhance the solubility of Methylprednisolone by choosing micronized form of drug and to enhance patient compliance by formulating it as dispersible tablets using quality by design (QbD) approach. Dispersible tablets of Methylprednisolone were developed by 23 factorial design. In this study independent variables were concentrations of MCC 102, CCS and Magnesium stearate and dependent variables were disintegration time, hardness and dissolution. The resulting data was fitted into Design Expert Software (Trial Version) and analyzed statistically using analysis of variance (ANOVA). The response surface plots were generated to determine the influence of concentration of MCC 102, CCS and magnesium stearate on responses. The tablets were prepared by direct compression method by choosing micronized form of drug and formulations were evaluated for the standard of dispersible tablets. Results showed that no significant drug-polymer interactions in FTIR studies. According to QbD suggestion the formulation O1 (Desirability- 0.73) with MCC-38mg, CCS-3.5mg and magnesium stearate-2.5mg was formulated and evaluated. The disintegration time was found to be 69 seconds, hardness was found to be 64N and in vitro dissolution with in 30minutes. Optimized O1 formulation was within the limits of standards of dispersible tablets with increased water solubility and better patient compliance. Stability study on optimized O1 formulation showed that there is no significant changes during study period. Thus, O1 formulation was found to be stable. The study indicates that formulation of Methylprednisolone dispersible tablets by using QbD approach is a promising formulation development method. Keywords: Dispersible tablets, Methylprednisolone, Direct compression, Quality by Design and ANOVA

FORMULATION AND EVALUATION OF FLOATING ORAL IN SITU GEL OF DILTIAZEM HYDROCHLORIDE

Objective: The objective of the present study was to formulate and evaluate the floating in-situ gelling system of diltiazem hydrochloride.Methods: Sodium alginate based diltiazem hydrochloride floating in situ gelling systems were prepared by dissolving hydroxyl propyl methyl cellulose (HPMC) in 25% of water, to which calcium carbonate and diltiazem hydrochloride were added with stirring to form, a proper and a homogenous dispersion of diltiazem hydrochloride. Meanwhile, 30% of water was heated to 60 ËšC on a hot plate to dissolve sodium alginate and cooled to 40 ËšC. The resulting solution was added to HPMC solution and mixed well. To 5% of water at 60 ËšC, sodium methyl paraben was added and dissolved and cooled to 40 ËšC and was added to the above mixture and mixed well. The volume was adjusted finally to 100% with distilled water. Prepared formulae were evaluated for physicochemical properties, drug content, pH, in vitro gelling capacity, in vitro buoyancy, viscosity, water uptake and in vitro drug release.Results: Formulation variables such as type and concentration of viscosity enhancing polymer (sodium alginate) and HPMC affected the formulation viscosity, gelling properties, floating behavior, and in vitro drug release. Formulation F5 and F6 showed the floating time of 5 min and more than 20 h respectively. A significant decrease in the rate and extent of the drug release was observed with the increase in polymer concentration in in-situ gelling preparation. Formulation F4, F5, F6 were shown to have extended drug release until the end of 7 h.Conclusion: The prepared in situ gelling formulations of diltiazem hydrochloride could float in the gastric conditions and released the drug in a sustained manner. The present formulation was non-irritant, easy to administer along with good retention properties, better patient compliant and with greater efficacy of the drug

Herbal extraction procedures: need of the hour

Extraction is the first most important step for preparing herbal drug formulations. It serves as an alternate method to identify the lead compound by isolating the active compounds from the crude drug using various extraction techniques by adding suitable solvent. Selection of solvent is the most important step as the success rate depends on it. Thus, by identifying the lead compound, extraction plays an important role in the process of drug discovery. In this review, different methods of extraction used for extracting the herbal extracts have been discussed with their advantages and disadvantages and also a brief discussion on solvent selection and actions of few phytochemicals have also been discussed

The witch's brew, the fears within and the regional security: implications for India

This paper is about the fears within India (K.P.S. Gill, Daily News and Analysis, Mumbai, August 23,2007) because of (a) the criminalization of politics, the irrationality and irresponsibility of political responses over extended periods of time, the continuous degeneration of the policing and internal security apparatus, the failure to maintain and create policing capacities in proportion to the country's needs, and the collapse of the entire justice system, and (b) the growing insurgencies within India, particularly because of communal problems, and the left wing extremism (of the Maoists) and their links with countries in the neighborhood (Bangladesh, Thailand, for example). India itself is deeply susceptible to destabilization because of disorder and no governance plaguing large parts of the country. But of course India has had a long and continuous experience in die management of internal security crises, starting in the massive and bloody upheavals of Partition from the early 1950s and a succession of insurgencies and terrorist movements, starting with the Naga rebellion in 1952. It is also the case that the country has, in many instances, been able to successfully tackle, contain or neutralize such movements whenever a determined political leadership and consensus has backed coordinated action by the security forces. There is yet a range of other internal] security challenges, including communal polarization and rioting, organized and trans-national crime, criminal politics and political crime, afflicting different parts of the country from time to time, and they have been countered with mixed success within a broad context of almost continuous decline in the country's administrative, security and justice systems (Nihar Nayak, Faultiness 17, February 15, 2006: 126-151; ). This paper is a quick summary of all these problems, towards an understanding of the regional security and the implications for India. The paper is closely looking at the country's counter insurgency experiences taking select case studies and analyses the deeper reasons and proposes strategies to overcome and / or eliminate the insurgency and security problems in the country and the South Asian Regio

4,8,9,10-Tetra­kis(4-fluoro­phen­yl)-1,3-diaza­tricyclo­[3.3.1.1]decan-6-one

In the title compound, C32H24F4N2O, all four six-membered rings that constitute the diaza­adamantanone cage adopt chair conformations. Two of the four fluoro­phenyl substituents occupy axial positions and the other two occupy equatorial positions relative to their respective C5N rings of the adamantane framework. The crystal structure is stabilized by C—H⋯O inter­actions, generating a C(5) chain along the a axis