1*Adarsh Vijendra Institute of Pharmaceutical Sciences, Shobhit University, Gangoh, U.P. India. Email: anil6670anu@gmail.com
2Khyati College of Pharmacy, Ahmedabad, Gujarat, India. Email: tiwarin1707@gmail.com
3Adarsh Vijendra Institute of Pharmaceutical Sciences, Shobhit University, Gangoh, U.P. India. Email: ranjitsps@gmail.com
Colon-targeted drug delivery systems offer a promising strategy for improving therapeutic outcomes in irritable bowel syndrome (IBS) by enhancing site-specific drug release while minimizing systemic adverse effects. In the present study, dual functional-coated bilayer tablets containing amitriptyline (AMT) and pantoprazole (PANTO) were developed and pharmacokinetically evaluated in rats. The core formulation was optimized using factorial screening to achieve robust flow, compressibility, and mechanical integrity. Sequential application of a time-controlled inner membrane (FC1; ethyl cellulose–PVP–PEG) and a pH-responsive outer enteric layer (FC2; Eudragit L 30D-55–TEC–PEG) enabled modulation of lag time and release kinetics.
A sensitive and rapid LC–MS/MS method was developed for simultaneous quantification of AMT and PANTO in rat plasma, achieving a total run time of 2.2 min and low lower limit of quantification. The method demonstrated acceptable linearity, precision, accuracy, and extraction recovery. In vivo pharmacokinetic studies revealed distinct disposition profiles for AMT and PANTO without evidence of pharmacokinetic interference. Statistical analysis indicated that formulation differences primarily influenced absorption rate parameters while maintaining comparable systemic exposure.
In vivo X-ray imaging of BaSO₄-loaded tablets confirmed gastric resistance, intact small intestinal transit, and successful localization in the colonic region without premature disintegration. The combined dissolution, pharmacokinetic, and imaging findings demonstrate that the dual functional-coated bilayer platform provides effective and validated colon-targeted delivery of the AMT–PANTO combination.
Keywords: NA
How to cite this article: ANIL C, NEHA T, RANJIT S. In Vivo Pharmacokinetic And Imaging Evaluation Of Dual Functional-Coated Bilayer Tablets Of Amitriptyline And Pantoprazole For Colon-Targeted Delivery. Int J Drug Deliv Technol. 2026;16(15s): 181-189. DOI: 10.25258/ijddt.16.15s.21
Source of support: Nil.
Conflict of interest: None