Formulation and Evaluation of Pulsatile-Release Multiple-Unit Pellets of Meloxicam
Abstract
The present research aimed to design, formulate, and evaluate pulsatile-release multiple-unit pellets of Meloxicam. In the pellet coating and evaluation, five formulations (F1 to F5) were prepared with varying ratios of Eudragit L100 and Ethyl Cellulose. All batches exhibited excellent flow properties with Carr’s index values below 15% and Hausner’s ratio close to 1.12–1.14. The angle of repose for all batches was <30°, suggesting free-flowing properties essential for uniform capsule filling. Friability remained well below 1% across all formulations, indicating strong mechanical stability of the coated pellets. Drug content ranged from 97.1% to 99.4%, with formulation F4 showing the highest drug content (99.4 ± 1.2%), All formulations showed negligible release for the first 2 hours in acidic medium, confirming the integrity of the enteric coating. Formulation F1, containing only Eudragit L100, exhibited the shortest lag time with burst release starting at 3 hours and complete release by 8 hours. Formulation F4 (1.5 g Eudragit L100 : 3 g EC) demonstrated a well-defined lag time of ~5 hours followed by a sharp and complete drug release (~96.8 ± 2.3% at 8 hours), making it the optimized formulation for pulsatile drug delivery. A stability study of the optimized batch F4 under accelerated conditions (40°C/75% RH) for three months showed minimal changes in drug release (from 96.8% to 95.3%) and drug content (from 99.4% to 98.2%).
Keywords: Meloxicam, Pulsatile, Multiple unit Pellets, Eudragit L100.
Keywords:
Meloxicam, Pulsatile, Multiple unit Pellets, Eudragit L100DOI
https://doi.org/10.22270/jddt.v15i9.7353References
1. Gothoskar AV, Joshi AM, Joshi NH. Pulsatile drug delivery systems: a review. Drug Deliv. 2004;11(2):95-104.
2. Bussemer T, Otto I, Bodmeier R. Pulsatile drug-delivery systems. Crit Rev Ther Drug Carrier Syst. 2001;18(5):433-58. https://doi.org/10.1615/CritRevTherDrugCarrierSyst.v18.i5.10 PMid:11763497
3. Youan BB. Chronopharmaceutical drug delivery systems: past, present and future prospects. Adv Drug Deliv Rev. 2004;56(5):451-73. https://doi.org/10.1016/j.addr.2003.10.021 PMid:15019745
4. Gazzaniga A, Maroni A, Sangalli ME, Zema L. Time-controlled oral delivery systems for colon targeting. Expert Opin Drug Deliv. 2006;3(5):583-97. https://doi.org/10.1517/17425247.3.5.583 PMid:16948555
5. Tekade B. W., Jadhao U. T., Thakare V. M., Chaudhari K. P. Nehete AP., Development and optimization of Metoclopramide Hydrochloride pellets by aqueous coating technique. New Trends in Pharmaceutical Sciences. 2014;(I):10-17
6. Gazzaniga A, Palugan L, Foppoli A, Maroni A. Oral pulsatile delivery systems based on swellable hydrophilic polymers. Eur J Pharm Biopharm. 2008;68(1):11-8. https://doi.org/10.1016/j.ejpb.2007.05.022 PMid:17888641
7. Conte U, Colombo P, La Manna A, Dahlin R. An approach to the preparation of sustained-release dosage forms: pulsatile release from coated tablets. J Control Release. 1993 Oct;26(2):165-72. https://doi.org/10.1016/0168-3659(93)90207-L
8. Ishino M, Kou I, Onozaki Y, Noda K, Kohno H, Sugihara G, et al. Development of a novel pulsatile drug delivery system using swellable and erodible polymers. J Pharm Sci. 2006;95(1):175-84.
9. Amidon GL, Leesman GD. Pulsatile Drug Delivery System. US Patent No. 5,229,131; 1993
10. Rashid, R.; Zaman, M.;Ahmad, M.; Khan, M.A.; Butt, M.H.;Salawi, A.; Almoshari, Y.; Alshamrani, M.; Sarfraz, R.M.Press-Coated Aceclofenac Tablets for Pulsatile Drug Delivery: Formulationand In Vitro Evaluations. Pharmaceuticals 2022;15:326. https://doi.org/10.3390/ph15030326 PMid:35337124 PMCid:PMC8955762
11. Dash SK, Khan AS, Padhan A and Karna N. Formulation and evaluation of pulsatile drug delivery system of atenolol by using natural gum. IJPSR, 2020;11(7):3229-3242.
12. Bharat W. Tekade, Umesh T. Jadhao, Vinod M. Thakare. Design and Evaluation of a Chronomodulated Drug Delivery for the Treatment of Nocturnal Asthma., American journal of biological and Pharmaceutical Research 2015;2(2):62-69.
13. Yan, J., Xin, P., Mengrui, L., Baomei, Z., Lingbing, L., and Guangxi, Z., "Recent progresses in bioadhesive microspheres via transmucosal administration," Coll. & Surf. Bioint., 2016;140:361-372. https://doi.org/10.1016/j.colsurfb.2015.12.049 PMid:26774569
14. Komal G. Daydar., S.T.Thoke., D.A.Rathod., U.T.Jadhao., G.N.Dhembre., V.R.Kauthekar.,"RP-HPLC Method Development and Validation for the Determination of Meloxicam in Bulk and Its Pharmaceutical Formulation" International Journal of Pharmacy and Pharmaceutical Research (IJPPR) 2024;30(9).
15. Sheng-Feng Hung, Chien-Ming Hsieh, Ying-Chen Chen, Cheng-Mao Lin, Hsiu-O Ho, Ming-Thau Sheu, Formulation and process optimization of multiparticulate pulsatile system delivered by osmotic pressure-activated rupturable membrane, International Journal of Pharmaceutics, 2015;480(1-2):15-26, https://doi.org/10.1016/j.ijpharm.2015.01.006 PMid:25575473
16. Ziwei Z., Xiaole, Q., Xiangbo, L., Jiayu, X., Xuehua, Z., and Zhenghong, W., "A novel pulsatile drug delivery system based on the physiochemical reaction between acrylic copolymer and organic acid: In vitro and in vivo evaluation," Int. J. Pharma., 2014;462(1-2):66-73 https://doi.org/10.1016/j.ijpharm.2013.12.026 PMid:24368107
17. Ziwei Zhang, Xiaole Qi, Xiangbo Li, Jiayu Xing, Xuehua Zhu, Zhenghong Wu, A novel pulsatile drug delivery system based on the physiochemical reaction between acrylic copolymer and organic acid: In vitro and in vivo evaluation, International Journal of Pharmaceutics, 2014;462(1-2):66-73, https://doi.org/10.1016/j.ijpharm.2013.12.026 PMid:24368107
18. Dhiraj S. Bhusewad, Sandip A. Wathore, Gunesh N. Dhembre, Umesh T. Jadhao , Dharamraj A. Rathod, Vyankatesh. R. Kauthekar., "Development and evaluation of pulsatile drug delivery system of Telmisartan". World Journal of Biology Pharmacy and Health Sciences, 2024;20(02):403-412. https://doi.org/10.30574/wjbphs.2024.20.2.0883
19. Qureshi MJ., Ali J., Baboota S., Ahuja A., Mallikarjun C. Pharmacokinetic Study of a Capsule-based Chronomodulated Drug Delivery System of Salbutamol Sulphate in Rabbits Tropical Journal of Pharmaceutical Research January 2014;13(1):17-22. https://doi.org/10.4314/tjpr.v13i1.3
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Copyright (c) 2025 Sneha D. Lahane, Sandip T. Thoke , Umesh T. Jadhao, Gunesh N. Dhembre, Dharmraj A. Rathod, Sandeep A. Wathore

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