Farya Zafar

Development of in vitro - in vivo correlations for newly optimized Nimesulide formulations

Use of the human volunteers in bioequivalence studies is being discouraged by the Food and drug administration after the introduction of biowaiver approaches. In-vitro in-vivo correlation (IVIVC) with the level A is accepted for the registration of new molecules. In the present study deconvolution technique with numeric approaches was applied after compressing and in vitro validating the 100mg Nimesulide immediate, intermediate and slow release tablets. Single centered, crossover, randomized study was conducted in four phases with a two-week washout period to obtain the plasma drug concentration data after administrating test and reference products in male healthy volunteers. KineticaTM 4.4.1 (Thermoelectron corp, USA) was used for the calculation of two ways ANOVA with 90% CI from both log transformed and non- transformed data and Phoenix WinNonlin 7 and its IVIVC toolkit version 7.0 was used for the application of numeric approaches of IVIVC. Results revealed that the individual internal percentage prediction error for AUCinf and Cmax were found to be < 15% while their average values were < 10% in all medium. Numeric values of % PE at pH 6.8 and pH 7.4 (50 rpm in USP II and 100 rpm in USP I and II apparatus) were found to be (2.5842, 2.9789 and, 7.1732; 7.0944, 2.4721 and 4.350) for AUCinf and (2.5842, 0.5736 and 4.6928; 5.6214, 3.0551 and -2.4711) values for Cmax respectively. The low values of prediction errors demonstrate that the correlation model is projecting the in vivo response of each formulation. Percentage External error (% PE) was not required because individual values of percentage internal error (%PE) of Cmax and AUClast were not >15. In order to predict point to point correlation between fraction drug dissolved and drug absorbed, their mean r2 value was found to be > 0.9112 which showed a linear correlation in slightly alkaline pH.

INTEGRATION OF COMMUNITY SETUP IN PHARMACEUTICAL CARE: CURRENT CHALLENGES, PERCEPTION, FACTS AND OPPORTUNITIES IN PAKISTAN

Objective: A qualitative, cross-sectional survey-based study was conducted to evaluate the integration of community setup in pharmaceutical care with respect to current challenges, awareness/perception of individuals from various walks of life, related facts and opportunities which are contextual to local settings in Karachi, Pakistan. Methods: This cross-sectional, a qualitative study, was conducted between May–November 2015. A questionnaire was designed using 15 close ended and 5 open-ended questions. And validated using correlation of spearman coefficient and Cronbach’s α value (α = 0.916 and p = 0.941). Local residents, pharmacist, medical practitioners, and pharmacy technicians were selected as study participants. Informed consents of all respondents were obtained prior to the participation. SPSS 20.0 was utilized and results were calculated with respect to percentages of responses and mean scores. Chi-square test was used to analyze the problems associated in effective implementation and integration of community pharmacy practices in Pakistan. Results: Rate of response in the various cohort were in the order of 76%, 94%, 71% and 83% for local residents, pharmacist, physicians and pharmacy technicians respectively. Community pharmacy knowledge and beliefs mean scores were correspondingly found to be 1.971.83, 1.457.44, 2.842.10 and 2.385.54 for doctors, pharmacist, residents and technicians respectively. Conclusion: A significant difference in the level of perception was observed amongst the professionals and local resident’s cohort, which necessitates the effective and better execution of community residents counseling and more stringent implementation of health care facilities at the community level to improve the medication and health outcomes of related inhabitants.