Assessing The Rationale Of Fdc Containing Ofloxacin And Azoles: Dissolution, Permeation And Antimicrobial Studies

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dc.contributor.authorPawar, A.en_US
dc.contributor.authorKamble, A.en_US
dc.contributor.authorKorake, S.en_US
dc.contributor.authorDhapte-Pawar, V.en_US
dc.date.accessioned2020-09-24T08:01:48Z
dc.date.available2020-09-24T08:01:48Z
dc.date.issued2020-01
dc.description.abstractObjective: To study fixed-dose combinations (FDC) of antibacterial and antiprotozoal products (ofloxacin and azoles), prescribed for the treatment of diarrhea. Methods: Rationality of these FDC products was verified by assessing parameters such as drug content and release by assay and dissolution tests, respectively mentioned in the Indian Pharmacopoeia (IP). Amount of drug solubilized and permeated as per the Biopharmaceutics Classification System (BCS) was determined. Ex vivo permeation study was performed on the gut of goat using the everted gut sac technique. Antimicrobial efficacy in terms of minimum inhibitory concentration (MIC) was assessed using agar well diffusion method against Shigella boydii, the causative agent for diarrhea. Comparative studies were performed on an individual as well as combination doses of antibacterial and antiprotozoal products for the synergistic effects to assess the rationale of these FDC. Results: The BCS solubility of ciprofloxacin (CPX), norfloxacin (NFX) and tinidazole (TNZ) was high in acidic medium (pH 1-5) and decreased at pH above 5. The assay studies showed that the individual drug contents of FDC were within the IP limits. In vitro dissolution results for both, individual drugs and their combination illustrated 99 % drug release within 30 min in 0.01N HCl. Ex vivo permeation of TNZ was higher than CPX and NFX in individual drugs. No significant change in the permeation rate was observed for individual drugs and their FDC. CPX and NFX exhibited more antimicrobial activity in terms of inhibitory zones than their FDC with antiprotozoal TNZ, above 2.5 µg/ml MIC. The pharmaceutical, biopharmaceutical and antimicrobial evaluation study showed the similarity of FDC with the individual drugs. Conclusion: The study showed no significant data to justify the therapeutic advantage of FDC over individual drugs.en_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune 411038, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Drug Regulatory Affairs, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune 411038, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune 411038, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune 411038, Maharashtra, Indiaen_US
dc.identifier.citationPawar A., Kamble A., Korake S., Dhapte-Pawar V.. Assessing The Rationale Of Fdc Containing Ofloxacin And Azoles: Dissolution, Permeation And Antimicrobial Studies. International Journal of Pharmacy and Pharmaceutical Sciences. 2020 Jan; 12(1): 36-42en_US
dc.identifier.issn0975-1491
dc.identifier.issn2656-0097
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/206097
dc.languageenen_US
dc.publisherInnovare Academic Sciences Pvt. Ltd.en_US
dc.relation.issuenumber1en_US
dc.relation.volume12en_US
dc.source.urihttps://doi.org/10.22159/ijpps.2020v12i1.35440en_US
dc.subjectFixed-dose combinationen_US
dc.subjectCiprofloxacinen_US
dc.subjectNorfloxacinen_US
dc.subjectTinidazoleen_US
dc.subjectDissolutionen_US
dc.subjectPermeationen_US
dc.subjectAntimicrobialen_US
dc.titleAssessing The Rationale Of Fdc Containing Ofloxacin And Azoles: Dissolution, Permeation And Antimicrobial Studiesen_US
dc.typeJournal Articleen_US
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