Purpose: The present work endeavors to report a systematic approach of developing the lipidic self-nanoemulsifying formulation of olmesartan medoxomil (OMT) on the principles of Quality by Design (QbD). Methods: For preparing the self-nanoemulsifying formulation, a mixture of oil, surfactant and cosurfactant were used as vehicles. The excipients were selected after screening by solubility as well as pseudoternary phase titration studies. Mixture design was adopted for systematic optimization of the composition of nanolipidic formulations, which were evaluated for smaller globule size, stable zeta potential and lower values of polydispersity index. The optimized liquid self-nanoemulsifying formulation was identified using numerical and graphical optimization techniques, followed by validation of the experimental model. Solidification of self-nanoemulsifying formulation was carried out using porous carriers, and then optimized on the basis of oil adsorption potential, powder flow property and drug release performance. Pharmacokinetic study was performed in male Wistar rats for evaluating the drug absorption parameters. All the experimental data obtained were subjected to statistical analysis using oneway ANOVA followed by post hoc analysis using Student’s t test. Results: The optimized liquid self-nanoemulsifying formulation showed globule size <100 nm, emulsification efficiency <5 minutes and in vitro drug release >85% within in 30 minutes. Further, the solid SNEDDS formulation was effectively formulated using Neusilin US2 with maximum oil adsorption capacity and good micromeritic properties. Pharmacokinetic evaluation indicated 4 to 5-folds increase (P<0.05) in the values of Cmax, AUC, and reduction in Tmax from the nanoformulations vis-à-vis the marketed formulation. Conclusion: Overall, the developed nanolipidic formulation of olmesartan indicated superior efficacy in augmenting the drug dissolution and absorption performance.

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In the present study, Glipizide, a drug mainly preferred for type-II diabetes, is formulated in the form of floating mucoadhesive tablets to improve its bioavailability. Hydroxy Propyl Methyl Cellulose K200M, Sodium Carboxy Methyl Cellulose, Carbopol 974P, Karaya gum, Chitosan, and Xanthan gum were used as mucoadhesive polymers in designing of the floating mucoadhesive tablets. Different proportions of glipizide and polymer were used to prepare tablets. Pre-compression evaluation studies evaluated the powder blend of Glipizide mucoadhesive tablets (Pre-compression blend). It concluded that the blend had good flow property and better compressibility by interpreting the data obtained from the test. Hence the floating mucoadhesive tablets were prepared by direct compression technique. The results of floating lag time, and buoyancy studies suggested that formulations had a satisfactory floating ability. The release profile of the active pharmaceutical ingredient (glipizide) from the prepared dosage form indicated a controlled and enhanced drug release for a period of 12hrs. An in-vivo study done for selected formulation. By the interpretation of data obtained from all the evaluation studies (Pre-compression test, floating property, drug release profile, & in-vivo study) concluded that formulation GF8 containing drug: Carbopol 974P (1:2) was optimized. The drug release kinetics of the formulation GF8 followed the Higuchi model with a regression value of 0.993.

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In this present study, floating mucoadhesive tablets of Rosiglitazone were formulated to improve the gastric retention time and overall bioavailability. Different mucoadhesive polymers like HPMC K200 M, Na CMC, Carbopol 974P, Karaya gum, Chitosan and Xanthan gum were selected to formulate the tablets. Various formulations were prepared by using these polymers in different concentration. The pre-compression blend of Rosiglitazone mucoadhesive tablets were characterized with respect to angle of repose, bulk density, tapped density, carr’s index and hausner’s ratio and all the results indicated that the blend was having good flow property and hence better compression properties. The swelling studies were performed for the formulations and the results depicted that all the formulations have a good swelling index. The drug release studies depicted that the formulations release the drug in first order. So based on the results, formulation RF13 was found to be an optimized formulation. Keywords: Mucoadhesive tablets, Rosiglitazone, Bioadhesive polymers.