Tacrolimus

Liquisolid technique is a new approach for delivery of drugs through oral cavity. This technique is suitable for poorly or water insoluble drugs and also for immediate or sustained release formulations. The technique is based upon the admixture of drug loaded solutions or liquid drug with appropriate carrier and coating materials to convert into acceptably flowing and compressible powder. The selection of non-toxic hydrophilic solvent, carrier, coating excipients and its ratios are independent of the individual chemical entities. Indirectly its leads to enhancement of bioavailibity. Liquisolid tablet of drug Tacrolimus were prepared by using PG, PEG 200, PEG 400, glycerin, Tween 80 and Span 80, as non volatile liquid vehicle, respectively. Tacrolimus is an immunosuppressive drug, which have poor water solubility and low bioavailability, so it is suitable for liquisolid technique. Also Tacrolimus is having daily dose 5-10 mg once a daily. FTIR and DSC studies reveal that there was no possible interaction between drug and tablet excipients. All the formulation was evaluated for disintegration time, hardness and friability time, in-vitro dissolution study.

This study helps to determine the efficacy of tacrolimus (generic form) in renal transplant patients in India. To assess the efficacy of tacrolimus in renal transplant recipients by using graft survival rate (primary objective) and patient survival rate (secondary objective). This is a retrospective study involving collection of data from medical records of patients who underwent renal transplantation in between JUNE 2010-JUNE 2013 at a tertiary care hospital) in India. Study population involves 65 patients between age group of 10-60 years, Male and Female gender, patients receiving tacrolimus (generic form) in their immunosuppressive regimen. Exclusion criteria involved patients with hyperacute graft dysfunction, patients who did not receive tacrolimus as a part of immuno suppressive regimen. Tacrolimus was given in combination with mycophenolatemofetil, corticosteroids. Tacrolimus was given at a dose of 0.15 mg/kg and titrated based on the graft function, trough levels of tacrolimus and other parameters. Of 65 patients,59 were men and 6 were women.86% of patients received graft from living donor, where as 14 % of patients received from cadaveric donor. Graft survival rates for the 1st, 2nd, 3rd years of transplantation were found to be 93.84%,89.23%,87.68 %.Patient survival rate was 98.46% during the 1st year, and it remained same for the succeeding years with no loss of patient lives. The main limitations of this study are inadequate sample size and retrospective nature of study. Through this study, it was concluded that tacrolimus(generic form) demonstrated efficacy in majority of renal transplant patients in preventing graft rejection and maintained favorable function for a period of 3 years.