MIXTURE DESIGN-BASED OPTIMIZATION OF DOLUTEGRAVIR SMEDDS USING JMP® SOFTWARE: BRIDGING PREFORMULATION TO PRODUCT DEVELOPMENT
DOI:
https://doi.org/10.22159/ijap.2026v18i3.57559Keywords:
Dolutegravir sodium, SMEDDS, JMP® software, OptimizationAbstract
Objective: To address this challenge, the current research undertaken optimize the formulation of Self-microemulsifying drug delivery systems (SMEDDS)by applying structured Quality by Design (QbD) methodology.
Methods: Initial formulation development was guided by preformulation studies and pseudo-ternary phase diagram construction, as detailed in Part 1.An Extreme vertices mixture design in JMP® software was employed for systematic optimization. Ten SMEDDS formulations were prepared and assessed for key quality attributes: drug content, emulsification time, droplet size, and transmittance.
Results: The Optimized formulation included Capmul mcm c8 (0.183), Kolliphor EL (0.603), and Propylene Glycol (0.214). It showed rapid emulsification (45.66 seconds), high drug content (101.76%), fine droplet size (40.72 nm), and excellent clarity (99.22% transmittance). It also exhibited good thermodynamic stability, efficient self-emulsification (Grade A), and strong dilution tolerance. Liquid SMEDDS was made into a solid dosage form by adsorption onto Aerosil 200. The obtained S-SMEDDS exhibit acceptable flow properties, reflected by an angle of repose of 34.18°, Carr’s index of 17.87%, and a Haunser’s ratio of 1.21. It demonstrated high drug content uniformity (99.53%) and only a minimal increase in droplet size (46.2 nm), along with a zeta potential of –9.35 mV, confirming its physical stability.
Conclusion: Drug release studies showed enhanced drug release of (~100% within 60 minutes) from both liquid and S-SMEDDS indicating improved dissolution and potential bioavailability. The study supports S-SMEDDS as an effective delivery platform for poorly soluble drugs like DTG.
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Copyright (c) 2026 MOHAMMED MUKHTAR ALGHADEER, JAYADEV HIREMATH, NIMBAGAL RAGHAVENDRA NAVEEN, NAGARAJA SREEHARSHA, SANTOSH FATTEPUR, PRAKASH GOUDANAVAR, GIRISH MERAVANIGE
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