Adv Pharm Bull. 2020;10(3): 379-388.
doi: 10.34172/apb.2020.046
  Abstract View: 59
  PDF Download: 76

Research Article

Integrated Quality by Design Approach for Developing NanolipidicDrug Delivery Systems of Olmesartan Medoxomil with EnhancedAntihypertensive Action

Jagdish Kumar Arun 1 ORCID logo, Rajeshwar Vodeti 1,2 * ORCID logo, Birendra Shrivastava 1, Vasudha Bakshi 2

1 School of Pharmaceutical Sciences, Jaipur National University, Jagatpura, Jaipur, Rajasthan-302 017, India.
2 School of Pharmacy, ANURAG Group of Institutions, Venkatapur (V), Ghatkesar (M) Medchal (Dist.), Hyderabad, Telangana-500 038, India.


Purpose: The present work endeavors to report a systematic approach of developing the lipidicself-nanoemulsifying formulation of olmesartan medoxomil (OMT) on the principles of Qualityby Design (QbD).Methods: For preparing the self-nanoemulsifying formulation, a mixture of oil, surfactant andcosurfactant were used as vehicles. The excipients were selected after screening by solubilityas well as pseudoternary phase titration studies. Mixture design was adopted for systematicoptimization of the composition of nanolipidic formulations, which were evaluated for smallerglobule size, stable zeta potential and lower values of polydispersity index. The optimizedliquid self-nanoemulsifying formulation was identified using numerical and graphicaloptimization techniques, followed by validation of the experimental model. Solidification ofself-nanoemulsifying formulation was carried out using porous carriers, and then optimizedon 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 absorptionparameters. All the experimental data obtained were subjected to statistical analysis using onewayANOVA 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 withmaximum oil adsorption capacity and good micromeritic properties. Pharmacokineticevaluation indicated 4 to 5-folds increase (P < 0.05) in the values of Cmax, AUC, and reduction inTmax from the nanoformulations vis-à-vis the marketed formulation.Conclusion: Overall, the developed nanolipidic formulation of olmesartan indicated superiorefficacy in augmenting the drug dissolution and absorption performance.
Keywords: Bioavailability, Nanoemulsion, Optimization, Experimental design, Pharmacokinetics
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Submitted: 16 Jul 2019
Revision: 14 Nov 2019
Accepted: 02 Dec 2019
ePublished: 11 May 2020
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