Formulation and In vitro Evaluation of Fluconazole Topical Gels

Mekkawy, Aml I

doi:10.9734/bjpr/2013/2775

Cited by 20 publications

(13 citation statements)

References 21 publications

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“…Fluconazole is used as the free base in pharmaceutical dosage formulations. It exists mainly in three polymorphic forms, namely I, II, and III . There is a report indicating superior BA of fluconazole polymorph III in comparison with forms I and I–III (50:50); however, no further information about experimental conditions was published .…”

Section: Physicochemical Propertiesmentioning

confidence: 99%

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

Charoo¹,

Cristofoletti²,

Graham³

et al. 2014

Journal of Pharmaceutical Sciences

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Section: Physicochemical Propertiesmentioning

confidence: 99%

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

Charoo¹,

Cristofoletti²,

Graham³

et al. 2014

Journal of Pharmaceutical Sciences

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“…Fluconazole is slightly lipophilic,[59,60] but exhibits good solubility characteristics across a wide pH range, 1.2–7.4 [61,62]. This is also supported by the complete dissolution of the drug in different pH media [20].…”

Section: Discussionmentioning

confidence: 86%

“…The solubility values reported at 37°C were 8.03, 6.91, 7.82 and 6.90 mg/ml in 0.1 N HCl, acetate buffer of pH 4.5, phosphate buffer of pH 6.8 and pH 7.4, respectively [20,61,62]…”

Section: Discussionmentioning

confidence: 99%

“…The solubility values reported at 37°C were 8.03, 6.91, 7.82 and 6.90 mg/ml in 0.1 N HCl, acetate buffer of pH 4.5, phosphate buffer of pH 6.8 and pH 7.4, respectively. [20,61,62] The solubility of the active pharmaceutical ingredient (API) is one of three essential components of the BCSbased biowaiver. For adults, drugs are classified as 'highly soluble' if highest dose strength dissolves in 250 ml of water.…”

Section: Solubilitymentioning

confidence: 99%

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Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population

Charoo¹,

Cristofoletti

Dressman

2015

Journal of Pharmacy and Pharmacology

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Thus, it can be safely concluded that fluconazole meets highly soluble and highly permeable criteria in the paediatric population and can be allocated to class 1 of the Biopharmaceutics Classification System (BCS) for this population as well as in adults. Additionally, fluconazole has an excellent safety profile in children, similar to that in adults. The BCS-based biowaiver claimed in adults can be safely extended to the paediatric population provided that the requirements in excipient selection and dissolution profile comparison using BCS-based dissolution conditions as stated in the biowaiver monograph for fluconazole immediate release dosage forms in adults are fulfilled.

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“…These results in a good agreement with that of Moffat and Modha (Moffat et al, 2010;Modha et al, 2010). (Mekkawy et al, 2013) reported that Fluconazole have displayed a broad band at 3200 cm −1 due to hydrogen bonding O-H stretching vibrations, aromatic C-H stretching vibrations at 3120 cm −1 , aromatic C N stretching vibrations at 1620 cm −1 and aromatic C-F stretching vibrations at 1210, 1220 cm −1 . The IR spectrum of XG which characterized by a broad O-H stretching absorption band centered around 3425.58 cm −1 , C-H stretching band at 2920.23 cm −1 .…”

Section: Resultsmentioning

confidence: 99%

Design, <I>In Vitro</I> and <I>In Vivo</I> Evaluation of Fluconazole Bioadhesive Vaginal Tablets

Samy¹,

Marzouk²,

Ammar³

et al. 2015

j pharmaceut sci pharmacol

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Fluconazole is a synthetic triazole antifungal drug. It is available as tablets, capsules, oral suspension and injection for treatment of oral, esophageal and vaginal candidiasis. The present work was envisaged to develop a novel and aesthetic bioadhesive vaginal delivery system with improved efficacy. The compatibility between the drug, mucoadhesive polymers and tablet excipients (carbopol, HPMC, Xanthan gum and EC) was studied using Fourier transform infrared (FTIR) spectroscopy and differential scanning calorimeter (DSC). Fluconazole bioadhesive vaginal tablets (FBVTs) were prepared using mixtures of polymers that gave the optimal physico-mechanical properties and also showed the most delayed in-vitro release results. The in-vitro susceptibility profile of Candida albicans to Fluconazole was evaluated using agar cup method. The inhibition zones were calculated and these values were taken as the antifungal effect of the drug. The bioadhesive tablets were clinically evaluated in volunteers suffering from vaginal candidiasis and compared with commercial Fluconazole vaginal tablets (Diflucan ® 150 mg).

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Formulation and In vitro Evaluation of Fluconazole Topical Gels

Cited by 20 publications

References 21 publications

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population

Design, <I>In Vitro</I> and <I>In Vivo</I> Evaluation of Fluconazole Bioadhesive Vaginal Tablets

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