Author(s):
Nilesh S. Kulkarni, Sonam S. Godase, Shashikant N. Dhole, Rahul R. Chanshetti
Email(s):
drnileshkulkarni2015@gmail.com
DOI:
10.52711/0974-360X.2026.00526 
Address:
Nilesh S. Kulkarni1, Sonam S. Godase1, Shashikant N. Dhole1, Rahul R. Chanshetti2
1Department of Pharmaceutics, Progressive Education Society’s, Modern college of Pharmacy, Moshi, Pune, Maharashtra, India.
2Department of Pharmacology, Progressive Education Society’s, Modern college of Pharmacy, Moshi, Pune, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 8,
Year - 2026
ABSTRACT:
The objective of invention was to develop solid lipid oral formulation to improve solubility for poorly soluble drug levosulpiride. Solvent emulsification evaporation method is used for preparation of solid lipid nanoparticles. Levosulpiride nanoparticles was prepared by solvent evaporation technique using ethyl acetate and acetone in 10:5 ratio as organic phase, glyceryl monostearate, Span 80 and PEG 400. The optimized batch containing (F 3) Levosulpiride: GMS: Span 80: PEG 400(250mg: 63mg: 63mg: 250mg) and (F 4) Levosulpiride: GMS:PEG 400(250mg:63mg:250mg) showed improvement in solubility of levosulpiride over plain levosulpiride. The entrapment efficiency of F 3 and F 4 formulation was found to be 90.50%, 89.44% respectively. The optimized formulations showed improvement in solubility and in-vitro dissolution in distilled water and acidic buffer pH 1.2 as that of plain levosulpiride. The DSC thermogram of the pure drug levosulpiride showed a sharp endothermic peak at 189.50°C (?H-1042J/g) corresponding to its melting point range of 183-186?C. The DSC thermogram of the formulation showed endothermic peak at 172.71°C (?H-499j/g), for formulation F4 peak observed at 177.61°C (?H-504j/g) respectively. It suggest the change in physical state of the drug from crystalline to amorphous state. The change in crystallinity and possible hydrogen bond formation is confirmed by XRD and FTIR studies respectively for prepared SLN over plain drug. The study confirms enhancement in solubility and dissolution rate of levosulpiride through development of SLN.
Cite this article:
Nilesh S. Kulkarni, Sonam S. Godase, Shashikant N. Dhole, Rahul R. Chanshetti. Development and Evaluation of Solid Lipid Nanoparticulate Delivery for Levosulpiride for Oral Administration to Improve Effectiveness. Research Journal of Pharmacy and Technology. 2026;19(8):3727-3. doi: 10.52711/0974-360X.2026.00526
Cite(Electronic):
Nilesh S. Kulkarni, Sonam S. Godase, Shashikant N. Dhole, Rahul R. Chanshetti. Development and Evaluation of Solid Lipid Nanoparticulate Delivery for Levosulpiride for Oral Administration to Improve Effectiveness. Research Journal of Pharmacy and Technology. 2026;19(8):3727-3. doi: 10.52711/0974-360X.2026.00526 Available on: https://rjptonline.org/AbstractView.aspx?PID=2026-19-8-43
REFERENCES:
1. U.S. Department of Health and Human Services, Food and Drug Administration; Center for Drug Evaluation and Research (CDER). Waiver of In-Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Center for Drug Evaluation and Research (CDER): Silver Spring, MD, USA, 2017.
2. Bandawane A, Saudagar R. A Review on Novel Drug Delivery System: A Recent Trend. JDDT [Internet]. 15May2019 [cited 4Feb.2022]; 9(3): 517-21.
3. Madgulkar A.R., Bhalekar M.R., Kapse S.B., Paygude B.V., Reddi S.S. Transdermal Permeation Enhancement of Valsartan Using Solid Lipid Nanoparticles. Research J. Pharm. and Tech. 2011; 4(8): 1297-1302.
4. Kumara Swamy S, Ramesh Alli. Preparation, Characterization and Optimization of Irbesartan Loaded Solid Lipid Nanoparticles for Oral Delivery. Asian Journal of Pharmacy and Technology. 2021; 11(2): 97-4.
5. Jameel Ahmed Mulla, Sarasija Suresh, Imtiyaz Ahmed Khazi. Formulation, Characterization and in vitro Evaluation of Methotrexate Solid Lipid Nanoparticles. Research J. Pharm. and Tech. 2009; 2(4): 685-689.
6. Salunkhe SS, Bhatia NM, Kawade VS, et al. Development of lipid based nanoparticulate drug delivery systems and drug carrier complexes for delivery to brain. J Appl Pharm Sci. 2015;5:110-29.
7. Habib, R.; Azad, A.K.; Akhlaq, M.; Al-Joufi, F.A.; Shahnaz, G.; Mohamed, H.R.H.; Naeem, M.; Almalki, A.S.A.; Asghar, J.; Jalil, A.; et al. Thiolated Chitosan Microneedle Patch of Levosulpiride from Fabrication, Characterization to Bioavailability Enhancement Approach. Polymers. 2022; 14: 415.
8. Kaur, U.; Acharya, K.; Singh, A.; Gambhir, I.S.; Chakrabarti, S.S. Levosulpiride associated neuroleptic malignant syndrome in an elderly patient: A tale of confusing brand names. Acta Neurol. Belg. 2021; 2021: 1–3.
9. Yang S, Zhu J, Lu Y, et al. Body distribution of camptothecin solid lipid nanoparticles after oral administration. Pharmaceutical Research. 1999; 16(5): 751-757.
10. Martins SM, Sarmento B, Nunes C, et al. Brain targeting effect of camptothecin-loaded solid lipid nanoparticles in rat after intravenous administration. European Journal of Pharmaceutics and Biopharmaceutics. 2013; 85(3): 488-502.
11. Patel M, Souto EB, Singh KK. Advances in brain drug targeting and delivery: limitations and challenges of solid lipid nanoparticles. Expert Opinion on Drug Delivery. 2013; 10(7): 889-905.
12. Cao F,Guo J,Ping Q.The physicochemical characteristics of Freeze dried Scutellarin-cyclodextrin tetra component complexes . Drug dev Ind Pharm. 2005; 31: 747-756.
13. Abdelwahed W, Degobert G, Stainmesse S, et al. Freeze drying of nanoparticles: formulation, process and storage considerations. Adv Drug Deliv Rev. 2006; 58: 1688-1713.
14. Nilesh S. Kulkarni, Nisharani S. Ranpise, Shashikant N. Dhole, Govind Mohan. Physico-Chemical Evaluation and In-vitro Release Studies of Irbesartan: β-Cyclodextrin: Soluplus Ternary Inclusion Complex . Research J. Pharm. and Tech. 2014; 7(9): 987-994.
15. Ravi G, Vishal Gupta N, Balamuralidhara V. Rivastigmine Tartrate Solid Lipid Nanoparticles Loaded Transdermal Film: An In vivo study. Research J. Pharm. and Tech. 2018; 11(1): 227-230.
16. Mohd Yasir, Iti Chauhan, Misbahu J. Haji, Abdurazak J. Tura1, Prasoon K. Saxena. Formulation and Evaluation of Glyceryl Behenate based Solid Lipid Nanoparticles for the Delivery of Donepezil to Brain through Nasal Route. Research J. Pharm. and Tech 2018; 11(7): 2836-2844.
17. D. Krishna Veni, N. Vishal Gupta. Quality by Design approach in the development of Solid Lipid Nanoparticles of Linagliptin. Research J. Pharm. and Tech. 2019; 12(9): 4454-4462.
18. Ramanuj Prasad Samal, Pratap Kumar Sahu. Formulation Development and In vitro Characterization of solid lipid Nanoparticles of Felbamate. Research J. Pharm. and Tech. 2020; 13(9): 4185-4189.
19. Krishna Yadav, Deependra Singh, Manju Rawat Singh. Development and Characterization of Corticosteroid loaded Lipid carrier system for Psoriasis. Research J. Pharm. and Tech. 2021; 14(2): 966-970.
20. P.A. Panmand, P. R. Mahaparale, V. P. Thorat. Development and Evaluation of Acitretin Loaded Solid Lipid Nanoparticles for Topical Drug Delivery System. Research Journal of Pharmacy and Technology. 2024; 17(3): 1015-2.
21. S. D. Mankar, Anjali Dama, M. S. Bhosale, Dr. S. S. Sidhheshwar. Design, Development, Characterization of Solid Lipid Nanoparticles for Oral Administration. Research J. Science and Tech. 2020; 12(1): 79-95.
22. Gidwani B,Vyas A.Preparation, Characterization, and optimization of altretamine-loaded solid lipid nanoparticles using Box Behenken design and response surface methodology.Artif Cella Nanomed Biotechnol. 2016; 44(2): 571-580.
23. Gururaja MP, Nidhi P Shetty, Himanshu Joshi. Attenuation of Experimentally Induced Anxiety by Panchagavya Ghrita in Mice. Research Journal of Pharmacy and Technology. 2022; 15(11): 4897-0.
24. Havan G. M., Vasaikar Rupali S., Patil J. K., Hasni Sayyed Hamid, Jain Akash, Vipul H. Jain. Study of CNS Depressant activity of Ethanolic extract of Madhuca longifolia Flower. Res. J. Pharmacology and Pharmacodynamics. 2019; 11(4): 127-131.