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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Preformulation Studies and Pseudo-Ternary Phase Diagram Development for Dolutegravir Sodium: A Foundational Step toward SMEDDS Design

Jayadev Hiremath1★, Nimbagal Raghavendra Naveen1★, Prakash Goudanavar1★, Girish Meravanige3★, Santosh Fattepur4★, Rashed M. Almuqbil5★, Bandar Aldhubiab5★, Sreeharsha Nagaraja5★★ Corresponding author

  1. 1Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
  2. 2Department of Pharmaceutics, BVVS Hanagal Shri Kumareshwar College of Pharmacy Bagalkote, Karnataka, INDIA.
  3. 3Department of Biomedical Sciences, College of Medicine, King Faisal University, Al-Ahsa, Al-Ahsa, SAUDI ARABIA.
  4. 4School of Pharmacy, Management and Science University, Seksyen 13, Shah Alam, Selangor, MALAYSIA.
  5. 5Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, Al-Ahsa, SAUDI ARABIA.

CORRESPONDENCE

Jayadev Hiremath

Dr. Prakash GoudanavarDepartment of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara-571448, Karnataka, INDIA.

pgoudanavar01@gmail.com

Received: 10-01-2025; Revised: 25-04-2025; Accepted: 23-05-2025.

Volume 59, Issue 3S · pp. s874–s880 · PUBLISHED Jul-Sep 2025 · DOI: 10.5530/ijper.20252845

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ABSTRACT

Background: Dolutegravir Sodium (DTG) is a poorly soluble antiretroviral drug that will find it difficult to achieve oral bioavailability. Preformulation and screening of excipients are mandatory as a stepping stone in formulation development. Objectives: To conduct comprehensive preformulation studies and build pseudo-ternary phase diagrams for DTG with a view to informing future development of a stable SMEDDS formulation. Materials and Methods: UV spectrophotometry was used to establish the maxima of absorption and to construct a standard calibration curve for DTG. Solubility studies were performed using various oils and surface-active agents. The efficiency of emulsification was used to screen the surfactants, while compatibility was established through the use of FTIR spectroscopy. Pseudo-ternary diagrams identified microemulsion regions with Capmul MCM C8 oil and Kolliphor EL/propylene glycol Smix. Results: Enhanced solubility of DTG has been observed in Capmul MCM C8. Kolliphor EL and propylene glycol were chosen to be the surfactant and co-surfactant, respectively, for their emulsification capacity and high transmittance (>94%). FTIR established no meaningful incompatibilities between DTG and chosen excipients. Of Smix ratios examined, 3:1 (Kolliphor EL:PG) showed the largest microemulsion area in pseudo-ternary phase diagrams. Conclusion: The study offers a clear preformulation platform for DTG, determining important excipients and a best-fit Smixratio for microemulsion development. Ternary phase diagrams were constructed to confirm the choice of ingredients for a possible SMEDDS. Subsequent research will construct on this basis to develop and assess a DTG-loaded SMEDDS for enhanced oral bioavailability.

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    Hiremath, J., Naveen, N. R., Goudanavar, P., Meravanige, G., Fattepur, S., Almuqbil, R. M., Aldhubiab, B., & Nagaraja, S. (2025). Preformulation Studies and Pseudo-Ternary Phase Diagram Development for Dolutegravir Sodium: A Foundational Step toward SMEDDS Design. Indian Journal of Pharmaceutical Education and Research, 59(3S), s874–s880. https://doi.org/10.5530/ijper.20252845