Volume : 13, Issue : 04, April – 2026
Title:
QUALITY BY DESIGN APPROACH IN THE DEVELOPMENT AND OPTIMIZATION OF ETRAVIRINE HYDROCHLORIDE -LOADED SOLID LIPID NANOPARTICLES
Authors :
Y. Sarah Sujitha *, Pothuri Gireeshma
Abstract :
The purpose of this study was to development and optimization of Etravirine hydrochloride -loaded solid lipid nanoparticles by quality-by-design. Etravirine hydrochloride loaded solid lipid nanoparticles, was prepared by melt emulsification-probe sonication method. Results: Fourier Transform Infra-Red (FTIR) Spectroscopy reveals there is interaction between drug and formulation excipients. % Entrapment efficiency was found to be 96.42. In-vitro drug release studies using Franz diffusion cells revealed a sustained release profile, with approximately 71.40% of EH released over 12 hours, highlighting the formulation’s potential for prolonged therapeutic efficacy and patient convenience. The optimized formulation exhibited a particle size of approximately 46.21 nm with a narrow PDI, indicating uniformity and stability of SLNs. Morphological characterization using scanning electron microscopy and transmission electron microscopy confirmed the spherical morphology and homogeneous distribution of EH
Key words: Solid lipid nanoparticles, melt emulsification-probe sonication method, scanning electron microscopy & transmission electron microscopy.
Cite This Article:
Please cite this article in press Y. Sarah Sujitha et al., Quality By Design Approach In The Development And Optimization Of Etravirine Hydrochloride -Loaded Solid Lipid Nanoparticles., Indo Am. J. P. Sci, 2026; 13(04).
REFERENCES:
1. R.H. Müller, K. Mäder, S. Gohla, Solid lipid nanoparticles (SLN) for controlled drug delivery – a review of the state of the art. European Journal of Pharmaceutics and Biopharmaceutics 2000; 50(1): 161-177.
2. D.D Kumbhar, V.B. Pokharkar. Physicochemical investigations on an engineered lipid–polymer hybrid nanoparticle containing a model hydrophilic active, zidovudine. Colloids and Surfaces A: Physicochem. Eng. Aspects 2013; 436: 714– 725.
3. D.D Kumbhar, V.B. Pokharkar. Physicochemical investigations on an engineered lipid–polymer hybrid nanoparticle containing a model hydrophilic active, zidovudine. Colloids and Surfaces A: Physicochem. Eng. Aspects 2013; 436: 714– 725.
4. V.B Pokharkar, M.R. Jolly, D.D Kumbhar. Engineering of a hybrid polymer–lipid nanocarrier for the nasal delivery of EH disoproxil fumarate: Physicochemical, molecular, microstructural, and stability evaluation. European Journal of Pharmaceutical Sciences 2015; 71:99–111.
5. S.S Patil, D.D Kumbhar, J.V Manwar, R.G Jadhao, R.L Bakal, S. Wakode. Ultrasound- Assisted Facile Synthesis of Nanostructured Hybrid Vesicle for the Nasal Delivery of Indomethacin: Response Surface Optimization, Microstructure, and Stability. AAPS PharmSciTech 2019 (20) 97.
6. Wu, C.Y., Benet, L.Z., 2005. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharmaceutical Research 22, 11–23.
7. Lobenberg, R., Amidon, G.L., 2000. Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards. European Journal of Pharmaceutics and Biopharmaceutics50, 3–12.
8. Horter, D., Dressman, J.B., 2001. Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. Advanced Drug Delivery Reviews 46,75–87.
9. Blagden, N., de Matas, M., Gavan, P.T., York, P., 2007. Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates. Advanced Drug Delivery Reviews 59, 617–630.
10. R. Janknecht, S.De Marie, I.A.J.M. Bakker-Woudenberg, D.J.A.Crommelin, Liposomal and lipid formulations of amphotericin B,Clin. Pharmacokinet. 23(1992)279–291.
11. P. Couvreur, C. Dubernet, F. Puisieux, Controlled drug delivery with nanoparticles: current possibilities and future trends, Eur. J. Pharm. Biopharm. 41 (1995)2–13.
12. R.H. Mu¨ller, K. Peters, Nanosuspensions for the formulation of poorly soluble drugs. I. Preparation by a size-reduction technique, Int .J. Pharm. 160 (1998) 229–237.
13. R. J. Prankerd, V.J.Stella, The use of oil-in-water emulsions as a vehicle for parenteral drug administration, J. Parent .Sci. Technol.44 (1990)139–149.
14. T. Eldem, P. Speiser, A. Hincal, Optimization of spray-dried and congealed lipid micropellet sand characterization of their surface morphology by scanning electron microscopy, Pharm. Res.8 (1991)47–54.
15. P. Speiser, Lipid nanopellet sals Tra¨gersystemfu¨r Arzne imittelzurperoralen An wendung, European Patent EP0167825, 1990.
16. R.H. Mu¨ller, J.S.Lucks, Arzneistofftra¨gerausfesten Lipid- teilchen, Feste Lipid nanospha¨ren (SLN), European Patent No.0605497, 1996.
17. F. Lai. S.A. Wissing, R.H. Muller, A.M. Fudda, Artemisia arborescens L essential oil loaded solid lipid nanoparticles for potential agricultural application: preparation and characterization. AAPS Pharm Sci Tech 2006; 7(1): E1-E9.
18. S.D. Mandawgade, V.B. Patravale. Development of SLNs from natural lipids: application to topical delivery of tretinoin. International Journal of Pharmaceutics 2008; 363(1-2):123-128.
19. Dasgupta S, Ghosh S, Ray S, Mazumder B. Solid Lipid Nanoparticles (SLNs) Gels for Topical Delivery of Aceclofenac in vitro and in vivo Evaluation. Curr Drug Deliv. 2013;10(6):656–66.
20. S. Wissing, R. Muller. The influence of the crystallinity of lipid nanoparticles on their occlusive properties. International Journal of Pharmaceutics 2002; 242 (1- 2):377-399.