Author(s):
Pratikshya Panda, Gauri, Anju Mishra, Sita Ahirwar
Email(s):
anishc@cecbilaspur.ac.in
DOI:
10.52711/0975-4377.2026.00044 
Address:
Pratikshya Panda, Gauri, Anju Mishra, Sita Ahirwar
Students, School of Pharmacy, Chouksey Engineering College, Bilaspur (CG) India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 4,
Year - 2026
ABSTRACT:
Formulation process of a colon-targeting antibiotic tablet was developed by amoxicillin/clavulanate (AC) in hydrophilic matrix polymer and film coating with pH-sensitive Eudragit L100. The aim of this approach was to reduce drug release in the stomach and small intestine while allowing fast release in colon (pH =7). The tablets were made using a direct compression method by taking guar gum as a matrix polymer and film coating with Eudragit L100. The pre-formulation studies (melting point, UV-IR spectra, calibration curves) identified the drug and determined the ?max to be ~228 nm. The results of coated tablets showed limited release amounts of the drug (<10%) in the simulated gastric (pH 1.2) and intestinal fluids (pH 6.8) and around 80% release of AC after transferring the sample into pH 7.2 fluid. The release mechanism of the coated tablet followed Higuchi diffusion model that represents some combination of swelling/erosion of matrix. The tablets showed qualified parameters from the tablet making point of view (weight uniformity, hardness ~5-6 kg, friability <1% and drug content ~100%). Stability studies were done on the tablets (40°C/75% RH for three months) and did not show significant changes in drug content or in release behavior.
Cite this article:
Pratikshya Panda, Gauri, Anju Mishra, Sita Ahirwar. Formulation and Evaluation of pH-Responsive Eudragit L100-Coated Amoxicillin-Clavulanate Matrix Tablets for Colonic Delivery. Research Journal of Pharmaceutical Dosage Forms and Technology. 2026; 18(4):318-4. doi: 10.52711/0975-4377.2026.00044
Cite(Electronic):
Pratikshya Panda, Gauri, Anju Mishra, Sita Ahirwar. Formulation and Evaluation of pH-Responsive Eudragit L100-Coated Amoxicillin-Clavulanate Matrix Tablets for Colonic Delivery. Research Journal of Pharmaceutical Dosage Forms and Technology. 2026; 18(4):318-4. doi: 10.52711/0975-4377.2026.00044 Available on: https://rjpdft.com/AbstractView.aspx?PID=2026-18-4-6
REFERENCES:
1. Mishra AS, Ghosh B, Malliappan SP, Dutta G, Vasanthan M. Formulation approaches for colon-specific drug delivery: conventional to nanocarrier systems. RSC Adv. 2026; 16: 10022-10059. doi:10.1039/D5RA05194K.
2. Martínez E, Gamboa J, Finkielstein CV, Cañas AI, Osorio MA, Vélez Y, et al. Oral dosage forms for drug delivery to the colon: an existing gap between research and commercial applications. J Mater Sci Mater Med. 2025; 36: 24. doi:10.1007/s10856-025-06868-5.
3. Dedroog S, Ouyang J, Vaes E, Willemse F, Andersen SK, Van den Mooter G. Insight in the role of resistant starch and Eudragit S 100 in a coating for controlled release in the colonic region. Eur J Pharm Biopharm. 2025; 215: 114818. doi:10.1016/ j.ejpb.2025.114818.
4. Vemula SK, Narala S, et al. Quality by Design (QbD) approach to develop colon-specific ketoprofen hot-melt extruded pellets: impact of Eudragit® S 100 coating on the in vitro drug release. Pharmaceutics. 2024; 16(10): 1265. doi:10.3390/ pharmaceutics16101265.
5. Alshammari ND, Almotairy A, Almutairi M, Zhang P, Al Shawakri E, Vemula SK, et al. Colon-targeted 3D-printed mesalamine tablets: core-shell design and in vitro/ex-vivo evaluation. J Drug Deliv Sci Technol. 2024; 95: 105580. doi:10.1016/j.jddst.2024.105580.
6. Moutaharrik S, Maroni A, Neut C, Dubuquoy C, Dubuquoy L, Foppoli A, et al. In vitro and in vivo evaluation of a pH-, microbiota- and time-based oral delivery platform for colonic release. Eur J Pharm Biopharm. 2023; 183: 13-23. doi:10.1016/ j.ejpb.2022.12.013.
7. Vemula SK, Daravath B, Gummadi SB, Repka MA. Formulation and development of flurbiprofen colon-specific Eudragit coated matrix tablets: use of a novel crude banana peel powder as a time-dependent polymer. AAPS PharmSciTech. 2023; 24: 189. doi:10.1208/s12249-023-02646-0.
8. Heikal EJ, Kaoud RM, Gad S, Mokhtar HI, Alattar A, Alshaman R, et al. Development of novel pH-sensitive Eudragit coated beads containing curcumin-mesalamine combination for colon-specific drug delivery. Gels. 2023; 9(4): 264. doi:10.3390/gels9040264.
9. Singh J, Nayak P. pH-responsive polymers for drug delivery: trends and opportunities. J Polym Sci. 2023; 61(22): 2828. doi:10.1002/pol.20230403.
10. Shaikh M, Desai N, Momin M, Bhatt LK. Formulation development and in-vitro/ex-vivo evaluation for a polysaccharide-based colon targeted matrix tablet. Curr Drug Deliv. 2021; 18(10): 1563-1573. doi:10.2174/1567201818666210708121739.
11. Coban O, Aytac Z, Yildiz ZI, Uyar T. Colon targeted delivery of niclosamide from β-cyclodextrin inclusion complex incorporated electrospun Eudragit® L100 nanofibers. Colloids Surf B Biointerfaces. 2021; 197: 111391. doi:10.1016/ j.colsurfb.2020.111391.
12. Joseph SK, Sabitha M, Nair SC. Stimuli-responsive polymeric nanosystem for colon specific drug delivery. Adv Pharm Bull. 2020; 10(1): 1-12. doi:10.15171/apb.2020.001.
13. Lee SH, Bajracharya R, Min JY, et al. Strategic approaches for colon targeted drug delivery: an overview of recent advancements. Pharmaceutics. 2020; 12(1): 68. doi:10.3390/ pharmaceutics12010068.
14. Chourey N, Chouksey K. Formulation and evaluation of enteric coated matrix tablets of mesalamine for inflammatory bowel disease. J Drug Deliv Ther. 2022; 12(1): 45-50. doi:10.22270/ jddt.v12i1.5176.
15. Hema Naga Durga D, Sowjanya TL, Pavani T, Duppala L. Formulation development and in-vitro evaluation of molsidomine matrix tablets for colon specific release. J Drug Deliv Ther. 2020; 10(2): 112-116. doi:10.22270/jddt.v10i2.3900.
16. Krishnaiah YSR, Satyanarayana S, Prasad YVR, Rama Prasad Y. A pH-dependent colon-targeted oral drug delivery system using methacrylic acid copolymers. II. Manipulation of drug release using Eudragit® L100 and Eudragit S100 combinations. Drug Dev Ind Pharm. 2000; 26(5): 507-512. doi:10.1081/DDC-100101266.
17. Krishnaiah YSR, Satyanarayana S, Prasad YVR. A pH-dependent colon-targeted oral drug delivery system using methacrylic acid copolymers. I. Manipulation of drug release using Eudragit® L100-55 and Eudragit® S100 combinations. Int J Pharm. 1999; 184(1): 1-7. doi:10.1016/S0378-5173(99)00097-3.
18. Bansal AK, Garg S. Design and evaluation of matrices of Eudragit with polycarbophil and carbopol for colon-specific delivery. J Drug Target. 2008; 16(10): 748-756. doi:10.1080/ 10611860802473345.
19. Mack I, et al. Insufficient stability of clavulanic acid in widely used child-appropriate formulations. Antibiotics (Basel). 2021; 10(2): 225. doi:10.3390/antibiotics10020225.
20. Wardrop J, Jaber AB, Ayres JW. Multiple-layer compression-coated tablets: formulation and humidity studies of novel chewable amoxicillin/clavulanate tablet formulations. Drug Dev Ind Pharm. 1998; 24(11): 1067-1071. doi:10.3109/03639049809082720.
21. Kukovetz W, et al. A new amoxicillin/clavulanate therapeutic system: preparation, in vitro and pharmacokinetic evaluation. Int J Pharm. 2007; 335(1-2): 106-113. doi:10.1016/ j.ijpharm.2006.11.007.
22. [Authors as indexed] An evaluation of amoxicillin/clavulanate stability in aqueous systems, including its suitability for outpatient parenteral antimicrobial therapy. Drug Des Devel Ther. 2024.
23. Sharma K, Kumar V, Kaith BS, Kumar V, Som S, Pandey A, et al. Evaluation of a conducting interpenetrating network based on gum ghatti-g-poly(acrylic acid-aniline) as a colon-specific delivery system for amoxicillin trihydrate and paracetamol. New J Chem. 2015; 39: 3021-3034. doi:10.1039/C4NJ01982B.