Submission of Rifaximin to Different Techniques: Characterization, Solubility Study, and Microbiological Evaluation

AAPS PharmSciTech
Ana Carolina KogawaHérida Regina Nunes Salgado

Abstract

Rifaximin, an oral antimicrobial drug, is marketed as 200-mg tablets. The daily dose ranges from 600 mg (1 tablet 3 times a day) to 800 mg (2 tablets twice a day). It is used for a wide range of ages, from adults to children, since it is indicated for the treatment of hepatic encephalopathy, travelers' diarrhea, irritable bowel syndrome, Clostridium difficile, ulcerative colitis, and acute diarrhea. The success of pharmacotherapy will depend on correct fulfillment of drug administration; however, it becomes difficult when the tablets are large and the doses are frequent. Rifaximin belongs to class IV according to the Biopharmaceutic Classification System (BCS), meaning that it is both poorly soluble and poorly permeable. Thus, in this study, solubility of rifaximin was improved by its complexation to β-cyclodextrin by (i) phase solubility diagram, (ii) malaxation, and (iii) decreasing particle size by wet milling. Improved solubility provides lower doses and facilitates compliance with pharmacotherapy. The products formed were analyzed by spectrophotometry in the infrared region (FT-IR), differential scanning calorimetry (DSC), and X-ray diffraction (XRD). Also, their solubility and microbiological activity were determined. The...Continue Reading

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Citations

Nov 27, 2020·Journal of AOAC International·Ana Carolina KogawaMarlus Chorilli
Nov 27, 2020·Journal of AOAC International·Patrícia Aleixa Do NascimentoHérida Regina Nunes Salgado
May 22, 2021·Journal of AOAC International·Jessica Freitas RichardiHérida Regina Nunes Salgado

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Methods Mentioned

BETA
pharmacotherapy
dynamic light scattering
differential scanning calorimetry
X-ray
solubility measurement

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