TENOXICAM-TROMETHAMINE MULTICOMPONENT CRYSTAL: PHYSICOCHEMICAL CHARACTERISTICS, SOLUBILITY, AND DISSOLUTION EVALUATION

USWATUL HASANAH; YESICA AZFITRI; LILI FITRIANI; ERIZAL ZAINI

doi:10.22159/ijap.2024.v16s1.04

Authors

USWATUL HASANAH Department of Pharmaceutics, Faculty of Pharmacy, Universitas Andalas, Padang-25163, Indonesia
YESICA AZFITRI Faculty of Pharmacy, Universitas Andalas, Padang-25163, Indonesia
LILI FITRIANI Faculty of Pharmacy, Universitas Andalas, Padang-25163, Indonesia
ERIZAL ZAINI Department of Pharmaceutics, Faculty of Pharmacy, Universitas Andalas, Padang-25163, Indonesia

DOI:

https://doi.org/10.22159/ijap.2024.v16s1.04

Keywords:

Tenoxicam, Tromethamine, Multicomponent crystal, Solvent drop grinding, Solubility, Dissolution

Abstract

Objective: Tenoxicam is classified as a nonsteroidal anti-inflammatory drug employed for managing musculoskeletal conditions. However, its effectiveness is obstructed by its restricted ability to dissolve in water. This investigation aims to create a multicomponent crystal involving tenoxicam and tromethamine to augment tenoxicam's solubility and dissolution rate.

Methods: Using the solvent drop grinding technique, the multicomponent crystal was synthesized by combining tenoxicam and tromethamine in equimolar proportions. The physicochemical properties of multicomponent crystal were assessed through powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), and FT-IR spectroscopy. Solubility test and dissolution rate profile were conducted to evaluate the effectiveness of multicomponent crystal formation in compared to intact tenoxicam. The solubility test occurred in CO₂-free distilled water over 48 h and was quantified using UV spectrophotometry at 368 nm. Dissolution rate profiles were conducted using a USP type II dissolution apparatus in HCl 0.1 N, and CO₂-free distilled water as the dissolution media.

Results: The multicomponent crystal displayed distinctive characteristics in the diffractogram, including altered melting points, and shifts in the FT-IR spectrum peaks. Within the multicomponent crystal system, the solubility of tenoxicam exhibited a notable increase, specifically by a factor of 11.130. Moreover, the dissolution efficiency of tenoxicam in HCl 0.1 N solution and CO₂-free distilled water showed substantial enhancements, with respective increases of 2.600-fold and 8.605-fold observed at the 60-minute mark.

Conclusion: In conclusion, the tenoxicam and tromethamine multicomponent crystal formation using a solvent drop grinding technique resulted in a novel crystalline structure, enhancing the solubility and dissolution of tenoxicam both in CO₂-free distilled water and HCl 0.1 N.

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