Mahantesh Kunchanur, Vinodh Kumar Mannur, Lokender Raghuwanshi, Vinayak Mastiholimath
Mahantesh Kunchanur1, Vinodh Kumar Mannur1*, Lokender Raghuwanshi2, Vinayak Mastiholimath1
1Department of Quality Assurance, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Belagavi, Karnataka, India - 590010.
2Assistant Manager Cipla Ltd. Pithampur, Dhar, Madhya Pradesh, India - 454001.
Volume - 16,
Issue - 10,
Year - 2023
Background: Solid lipid nanoparticles are a colloidal carrier system for topical, oral, and parenteral administration that are utilized to increase the bioavailability of mostly lipophilic medications. Mesalamine is an anti-inflammatory drug that works in inflammatory bowel disease and is structurally similar to salicylates. In the current study, glycerylmonostearate was used as a lipid, Tween 80 as a surfactant, and cremophor as a solubilizing agent to enhance the formulation, evaluation, and stability studies of mesalamine-loaded solid lipid nanoparticles. Results: Particle size, entrapment efficiency, scanning electron microscopy, and differential scanning calorimetry were used to characterize the formulations. The drug concentration in the MES-SLNs F-7 was found to be 334mg in a 100ml solution of SLNs, and the size of the MES-SLNs F-7 was 82.1±5.37nm. the zeta potential was -13.9mV, the polydispersity index was 0.35 0.15, and the formulated MES-SLNs showed burst release. The physical stability of the formulated MES-SLNs was determined by measuring the size of the MES-SLNs, and colour stored at four different temperatures (-20C, 40C, room temperature, and 400C) for three months. High Performance Liquid Chromatographic analysis was used to determine the MES-SLNs' chemical stability. At -20°C and 40°C, it was discovered that MES-SLNs were stable. Conclusion: The chemical stability of MES-SLNs was determined by HPLC analysis. It was found that MES-SLNs were stable at -20C and 40ºC.
Cite this article:
Mahantesh Kunchanur, Vinodh Kumar Mannur, Lokender Raghuwanshi, Vinayak Mastiholimath. Design Characterization and Stability studies of Mesalamine Loaded Solid Lipid Nanoparticles. Research Journal of Pharmacy and Technology 2023; 16(10):4767-3. doi: 10.52711/0974-360X.2023.00773
Mahantesh Kunchanur, Vinodh Kumar Mannur, Lokender Raghuwanshi, Vinayak Mastiholimath. Design Characterization and Stability studies of Mesalamine Loaded Solid Lipid Nanoparticles. Research Journal of Pharmacy and Technology 2023; 16(10):4767-3. doi: 10.52711/0974-360X.2023.00773 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-10-43
1. Komal S. Lavhate, Rahul S. Solunke, Kore K. J. Rajkumar V. Madhuri S. Deshmukh T. Development and Characterization of Mesalamine Microsphere for Colon Specific Drug Delivery. Research J. Pharm. and Tech. 2020; 13(4): 1747-1751.doi: 0.5958/0974-360X.2020.00315.7.
2. Venugopal D. Karadi A. Arshad M. Raju A. Spectrophotometric Determination of Mesalamine by Diazotization Coupling Reaction in Solid Dosage Forms. Asian J. Research Chem. 2011; 4(6): 968-70. doi: 10.5958/0974-4150.
3. Motwani S. Khar R. Ahman F. Chpra S. Kohli K. Application of a validated stability-indicating densitometric thin-layer chromatographic method to stress degradation studies on moxifloxacin. Analytical Chemist. 2006; 582(1):75-82. doi: 10.1016/j.aca.2006.08.053.
4. Sagar D. Kadam, Shashikant Dhole, Sohan Chitlange. Formulation and Evaluation of Sustained Release Colon Targeted Mesalamine Tablet. Research J. Pharm. and Tech 2020; 13(5):2241-5. doi: 10.5958/0974-360X.2020.00403.5.
5. ICH Stability Testing of New Drug Substances and Products. Q1A (R2). ICH. 2006.
6. Maruthi R, Chandan R.S, Barath M, G Naveen Datta, Merryl D’silva, Kajal Kumari M, Farhan Ahmad, Geetha R. Analytical Method development and Validation of Teneligliptin by RP-UFLC. Research J. Pharm. and Tech. 2020; 13(9):4035-4040. doi: 10.5958/0974-360X.2020.00713.1.
7. Khaledi S. Jafari S. Hamidi S. Molavi O. Devaran S. Preparation and characterization of PLGA-PEG-PLGA polymeric nanoparticles for co-delivery of 5-Fluorouracil and Chrysin. J Biomater Sci Polym. 2020; 31(9): 1107-26. doi: 10.1080/09205063.2020.1743946.
8. Patle L. Formulation and Evaluation of Ondansetron Floating Tablet. Res. J. Pharm. Dosage Form. & Tech. 2017; 9(4): 173-179. doi:10.5958/0975-4377.2017.00028.3.
9. Ravi Kumar P. Padmavathi Y. Niveditha P. Babu N. Development and Validation of Difference Spectrophotometric Method for the Quantitative Estimation of Mesalamine in Bulk Drug and Dosage forms. Asian J. Pharm. Ana. 2017; 7(4): 225-8. doi: 10.5958/2231-5675.2017.00036.9
10. Mitri K, Shegokar R, Gohla S, Anselmi C, Müller RH. Lipid nanocarriers for dermal delivery of lutein: preparation, characterization, stability and performance. Int J Pharm. 2011; 414(1-2): 267-75. doi: 10.1016/j.ijpharm.2011.05.008.
11. Lim SJ, Kim CK. Formulation parameters determining the physicochemical characteristics of solid lipid nanoparticles loaded with all Trans’ retinoic acid. Int. J. Pharm. 2002; 243: 135-46. doi: 10.1016/s0378-5173(02)00269-7.
12. Huang G, Zhang N, Bi X, Dou M. Solid lipid nanoparticles of Temozolomide: Potential reduction ofcardiacl and nephric toxicity. Int J Pharm. 2008; 355: 314–20. https://doi.org/10.1016/j.ijpharm.2007.12.013.
13. Bhalekar MR, Pokharkar V, Madgulkar A, Patil N, Patil N. Preparation and evaluation of miconazole nitrate-loadedsolid lipid nanoparticles for topical delivery. AAPS Pharm Sci Tech.2009; 10: 289–96. doi: 10.1208/s12249-009-9199-0.
14. Mohammad Mojeeb Gulzar Khan, Atul Arun Shirkhedkar. New, Sensitive, Simple and Validated Stability Indicating TLC/ Densitometric Method for the Estimation of Anti-Ulcer Drug Mesalamine in Bulk and Tablet Formulation. Asian J. Research Chem. 2018; 11(6): 871-875. doi: 10.5958/0974-4150.2018.00152.9
15. Gupta M, Bhargava HN. Development and validation of a high-performance liquid chromatographic method for the analysis of budesonide. J Pharm Biomed Anal. 2006 Feb 13; 40(2):423-8. doi: 10.1016/j.jpba.2005.06.038.
16. Barath M, Chandan R. S, Maruthi R, N Paramakrishnan. Analytical Method Development and Validation of Etravirine by RP-UFLC. Research Journal of Pharmacy and Technology. 2021; 14(7): 3537-2. doi:10.52711/0974-360X.2021.00613.