Development of Ketorolac Tromethamine Mouth Dissolving Tablet Using Natural Disintegrating Agents

Kumar CSP1, Udaykumar Thummala1, Pulagurtha Bhaskararao2, Divya Narla3, Kranthi Kumar K*4

1Department of Pharmaceutics, School of Pharmacy, Aditya University, Surampalem-533437, India
2Department of Pharmaceutical Analysis, School of Pharmacy, Aditya University, Surampalem-533437, India
3Department of Pharmaceutical Analysis, Aditya College of Pharmacy, Surampalem-533437, India
*4Department of Pharmaceutics, College of Pharmaceutical Sciences, Dayananda Sagar University, Bengaluru, Karnataka, India
4*kranthikumarkotta@gmail.com

Received: 10th Sep, 2025; Revised: 24th Oct 2025; Accepted: 6th Nov, 2025; Available Online: 1st December, 2025

ABSTRACT

The present study focuses on the design & development of Ketorolac Tromethamine (KT) mouth dissolving tablets (MDTs) using natural disintegrating agents with dual intent to enhance disintegration and optimize mouthfeel for improved patient compliance. Natural disintegrants such as fennel, cumin, and coriander powders were incorporated at varying concentrations (2%, 4%, and 6%) and compared with the synthetic super disintegrants Croscarmellose sodium (CCS). KT, a potent non-steroidal anti-inflammatory (NSAID) known for rapid analgesic action, was chosen as the test substance for the investigation, and direct compaction is utilized for tablet preparation. Preformulation studies, including FTIR analysis, confirmed drug-excipient comparability. Evaluation of pre and post compression parameters confirmed excellent flowability, uniformity, and mechanical strength of all formulations. The optimized formulations (F3, F6, F9, F12) exhibited rapid disintegration (< 10 min), reduced wetting time (4-5 min), and friability fell within the standard range (< 1%). In vitro dissolution studies revealed notable improved drug release with F9 (6% coriander powder), showing 88.80% drug release in 60 minutes, comparable to the marketed product (F14). Dissolution efficiency (DE60 %) further supported the superior performance of F9 (75.98%) and F12 (77.20%), with F9 offering a natural alternative to synthetic disintegrants. Kinetic modeling indicated a non-Fickian diffusion mechanism for F9, driven by swelling and wicking action of coriander powder. Overall, the study established that natural disintegrants, especially coriander powder, not only enhance disintegration and dissolution but also improve patient-centric parameters like mouthfeel, making them ideal for MDT formulations. F9 was identified as the optimal formulation, offering an effective, stable, and natural alternative for fast-acting pain relief.

Keywords: Mouth Dissolving Tablets, Improved Mouth Feel, Improved Drug Dissolution, Patient Compliance, and Ketorolac Tromethamine.

How to cite this article: Kumar CSP, Thummala U, Bhaskararao P, Narla D, Kumar KK; Development of Ketorolac Tromethamine Mouth Dissolving Tablet Using Natural Disintegrating Agents. Int J Drug Deliv Technol. 2026;16(1): 447-458. DOI: 10.25258/ijddt.16.1.47