AbstractsMedical & Health Science

Objective To investigate and optimize the sustained release tablets of Dalfampridine and Tramadol by using various hydrophilic and hydrophobic polymers as dissolution controlled release agents by using software design 3 level factorial model. Method Initially, preliminary experiments were performed to determine the main factors and the appropriate ranges in which the optima lie. The effects of polymer concentrations as independent variables (Eudragit RSPO, Eudragit RLPO, HPMC for Dalfampridine and HPMC K100M, HPMC K100LVP, HPMC K15M for Tramadol) on the various times of invitro drug release were tested. Through preliminary screening the retardant polymers concentrations were identified as the most significant variables. On the basis of the preliminary trials a 3-factor, 3-level Box-Behnken design [Table 18 & 20] was employed to study the effect of each independent variable on dependent variables (various drug release times like D1, D6, D12, and T50). This design is suitable for exploring quadratic response surfaces and constructing second-order polynomial models. The design consists of replicated centre points and the set of points lying at the midpoint of each edge of the multidimensional cube that defines the region of interest. The independent factors and the dependent variables used in the design are listed in Table 15 &16. The experiments were conducted as for the design of experiments and the responses for the dependent variables were entered in Table 15 &16. The response surfaces of the variables inside the experimental domain were analyzed using Stat-Ease Design Expert® software V9.0.4. Subsequently, three additional confirmation experiments were conducted to verify the validity of the statistical experimental strategies. Before stating the formulations, the raw materials were analyzed by basic preformulation studies like solubility, partition coefficient, melting point and standard calibration curve. The designed each 17 formulations granule was prepared by wet granulation technique. The prepared granules were subjected to Precompression parameters like angle of repose, tap density, bulk density, compressibility index and Hausner’s ratio and post compression evaluations like weight variations, hardness, and friability followed by invitro evaluation studies. The from dissolution parameters one formulation from each drug was selected. The selected formulations were subjected to stability studies as per ICH guideline and these formulations were analyzed by invivo animal studies to assess pharmacokinetics and bioavailability parameters like AUC, AUMC, Cmax, Tmax, t1/2, MRT & clearances were also evaluated by using PK Solver Version 4.0 software