Author(s):
Dhara Soni, Patel Ria Nitinbhai, Umesh Upadhyay
Email(s):
sonidhara147@gmail.com , patelria24295@gmail.com , umesh.ph@sigmauniversity.ac.in
DOI:
10.52711/0974-360X.2026.00389
Address:
Dhara Soni1*, Patel Ria Nitinbhai2, Umesh Upadhyay3
1Principle PG Scholar, M. PHARM (Pharmaceutics), Sigma Institute of Pharmacy, Sigma University, Bakrol, Vadodara – 390019, Gugarat, India.
2Assistant Professor, Sigma Institute of Pharmacy, Sigma University, Bakrol, Vadodara - 390019, India.
3Pro VC, Sigma Institute of Pharmacy, Sigma University, Bakrol, Vadodara – 390019, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 6,
Year - 2026
ABSTRACT:
Etodolac is a non-steroidal anti-inflammatory drug with poor water solubility, which limits its oral bioavailability and efficacy in chronic conditions like rheumatoid arthritis. In this study, a Quality by Design (QbD) approach was used to formulate an etodolac-loaded self-Microemulsifying drug delivery system (SMEDDS) to improve solubility and dissolution. Initial solubility screening identified suitable oils (e.g. Capmul MCM) and surfactant/co-surfactant blends (e.g. Tween 80, PEG 400). A 3² factorial design varied oil concentration (X1) and surfactant/cosurfactant mix (Smix, X2) to evaluate effects on percent transmittance, self-emulsification time, and 1-hour drug release. The optimized SMEDDS (30% oil, 60% surfactant, 15% cosurfactant, oil: Smix ratio 1:4) formed a transparent nano emulsion with a self-emulsification time of ~18 s and achieved ~97% etodolac release in 1 hour. The liquid SMEDDS showed high transparency (97.2% transmittance) and uniform drug content (96.5%). This formulation was adsorbed onto porous carriers to produce a solid SMEDDS, which yielded tablets with good flow properties and rapid dissolution (>96% release in 1 hour) without significant stability issues. Thus, the QbD-optimized SMEDDS.
Cite this article:
Dhara Soni, Patel Ria Nitinbhai, Umesh Upadhyay. Formulation and Development of Etodolac Self-Micro Emulsifying Drug Delivery System using QbD Approach. Research Journal Pharmacy and Technology. 2026;19(6):2723-9. doi: 10.52711/0974-360X.2026.00389
Cite(Electronic):
Dhara Soni, Patel Ria Nitinbhai, Umesh Upadhyay. Formulation and Development of Etodolac Self-Micro Emulsifying Drug Delivery System using QbD Approach. Research Journal Pharmacy and Technology. 2026;19(6):2723-9. doi: 10.52711/0974-360X.2026.00389 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-6-46
REFERENCES:
1. Dixit V, Zala B, Mody R, Saha RN. Bioavailability enhancement techniques for poorly aqueous soluble drugs and therapeutics. Biomedicines. 2022; 10(9): 2055. doi:10.3390/biomedicines10092055
2. Czajkowska-Kośnik A, Szekalska M, Winnicka K. Solid dispersions obtained by ball milling as delivery platform of etodolac, a model poorly soluble drug. Materials (Basel). 2024; 17(16): 3923. doi:10.3390/ma17163923
3. Barakat NS, Elbagory IM, Almurshedi AS. Optimization and in vivo pharmacokinetic evaluation of self-nanoemulsifying drug delivery systems for etodolac. Int J Nanomedicine. 2015; 10: 5249-5263.
4. Bhalekar MR, Pokharkar VB, Madgulkar AR, Kshirsagar SJ. Design and characterization of self-microemulsifying drug delivery system (SMEDDS) for improved oral delivery of poorly soluble drugs. Res J Pharm Technol. 2018; 11(4): 1427-1435.
5. Gowthamarajan K, Satish Kumar MN, Suresh B. Enhanced oral bioavailability of poorly water-soluble drugs: SMEDDS approach. Indian J Pharm Sci. 2012; 74(3): 231-236.
6. Bhattacharyya S, Bera S, Mukherjee A. Role of Neusilin as a carrier in solid SMEDDS tablet formulation for improved solubility of BCS class II drugs. Res J Pharm Technol. 2021; 14(6): 3371-3376.
7. Gupta S, Kesarla R, Chotai N, Misra A, Omri A. Design and development of SMEDDS of valsartan for improved dissolution and oral bioavailability. Asian J Pharm Sci. 2015; 10(5): 353-361.
8. Shahba AA, Mohsin K, Alanazi FK. Novel self-nanoemulsifying drug delivery systems (SNEDDS) for oral delivery of cationic drugs: Design and optimization. Saudi Pharm J. 2020; 28(3): 322-334.
9. Jain AK, Thanki K, Jain S. Co-encapsulation of poorly soluble drugs: a review of solubility enhancement strategies in solid dispersions and lipid-based formulations. Res J Pharm Technol. 2017; 10(8): 2551-2560.
10. Sharma M, Sharma R, Jain DK. Quality by Design (QbD): A comprehensive understanding of implementation and challenges in pharmaceutical development. Asian J Pharm. 2018; 12(2): S553-S560.
11. Madgulkar AR, Bhalekar MR, Pokharkar VB. Formulation and optimization of SMEDDS for cefpodoxime proxetil. Res J Pharm Technol. 2018; 11(4): 1436-1442.
12. Kulkarni PK, Rane BR, Chogale MM, Kanthale SB. Lipid-based drug delivery systems: a review. Res J Pharm Technol. 2021; 14(6): 3391-3397.
13. Dandagi PM, Mastiholimath VS, Gadad AP. Recent advances in self-emulsifying drug delivery system: A review. Res J Pharm Technol. 2017; 10(8): 2541-2547.
14. Yadav NP, Saini V, Jain A, Sharma R, Jain S. Solid self-microemulsifying drug delivery systems: An overview. Res J Pharm Technol. 2018; 11(5): 1927-1934.
15. Parikh R, Vyas N, Shah P. Quality by Design approach in pharmaceutical product development. Res J Pharm Technol. 2020; 13(4): 1936-1942.
16. Al-Gethamy MH, El-Telbany AM, Alshahrani SM, Alhakamy NA, Aldawsari HM, Alwadei MS. Quality-by-design approach for etodolac solid SMEDDS tablets: Optimization, characterization, and in-vitro evaluation. Eur J Pharm Biopharm. 2025; 198: 105420. doi: 10.1016/j.ejpb.2024.105420.
17. Badhei L, Nandi P, Mishra D, Samal HB. Self‑Micro‑Emulsifying Drug Delivery Systems: In‑Depth Review on Enhancing Solubility and Therapeutic Efficacy of BCS Class II Drugs.