Abstract
This study aims to improve the dissolution rate of ketoprofen by preparing multicomponent crystals with tromethamine. The multicomponent crystals (equimolar ratio) of ketoprofen and tromethamine were prepared by the solvent co-evaporation method. The solid-state properties of the resulting powder were characterized by powder X-ray diffraction, DSC thermal analysis, FT–IR spectroscopy, solubility, and in vitro dissolution rate. The crystal structure of the multicomponent crystal was determined by single-crystal X-ray diffraction analysis. The results showed that the powder X-ray diffraction pattern of the ketoprofen–tromethamine binary system was different from that of the starting materials. This difference indicates the formation of a new crystalline phase between ketoprofen and tromethamine (equimolar ratio). The DSC thermogram of the ketoprofen–tromethamine binary system exhibited a single and sharp endothermic peak at 128.67 °C, attributed to the melting point of a multicomponent crystal of ketoprofen–tromethamine. A single-crystal X-ray analysis revealed that ketoprofen–tromethamine formed a layered structure, salt-type multicomponent crystal. The solubility and dissolution rate of the multicomponent crystal were notably enhanced compared to the intact ketoprofen. The ketoprofen–tromethamine binary system forms salt-type multicomponent crystals, which can significantly increase the solubility and dissolution rate.
Highlights
Most of the pharmaceutical dosage forms available in the market are solid, such as tablets and capsules
The powder X-ray diffraction was carried out to initially evaluate and confirm the formation of multicomponent crystals composed of ketoprofen and tromethamine
The formation of multicomponent crystals composed of ketoprofen and tromethamine
Summary
Most of the pharmaceutical dosage forms available in the market are solid, such as tablets and capsules. Solid dosage forms have the advantage of being more practical and acceptable for patients [1]. One of the challenges faced by the pharmaceutical industry in developing solid dosage forms is the low solubility of the active pharmaceutical ingredients in the aqueous medium. The absorption process in the gastrointestinal tract of a drug that is poorly soluble in water is limited by the dissolution process. The dissolution process in the gastrointestinal tract fluid is a rate-limiting step [2,3]. In order to overcome this problem, it is important to improve the solubility and dissolution rate of active pharmaceutical compounds
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