Abstract
BackgroundOropharyngeal candidasis is a common opportunistic infection seen in immunocompromised patients. Fluconazole has a broad spectrum antifungal activity including a wide variety of candida species. Aim of the present investigation was to formulate and find out the relative efficacy of in situ gels of fluconazole.MethodThe in situ gels were prepared using polymers which exhibited sol-to-gel phase transition due to change in specific physico-chemical parameters, such as ion triggered system using gellan gum (0.5% w/v) along with sodium carboxylmethylcellulose (0.35%w/v). The study design was bicenter, 'pseudo-randomised, single blind trial conducted in Mangalore., India, which includes 15 HIV positive patients, 15 patients with partial or completes dentures, and 15 patients who were treated with (active control) fluconazole tablets 100 mg/day for 14 days. Severity of disease was scored clinically before treatment and at clinical evaluations on day 3, 7, 14, 18, 21, 35, and 42. Semiquantitative microbiological cultures of oral swabs were also obtained on same days.ResultsAll patients had mycological documented oropharyngeal candidiasis and were treated with fluconazole (0.5%w/v) in situ gels for 14 days Severity of disease was scored clinically before treatment and at different predetermined time intervals along with semi quantitative culture of oral swabs. The clinical response rate showed 97% cure after 14 days in the treated with in situ gel. In comparison, the control group treated with fluconazole tablets showed 85% improvement in symptoms of oral candidiasis. The patients suffering from HIV infection showed relapse in oral candidiasis at the end of 21 days. The patients having oral candidiasis due to partial or complete dentures showed complete recovery and were free from signs and symptoms of oral candidiasis.ConclusionsThe in situ gel formulation of fluconazole was well tolerated with no severe adverse reaction and offers a better alternative to tablet formulation in the treatment of oropharyngeal candidasis.Trial registrationCurrent Controlled Trails ISRCTN90634047
Highlights
Oropharyngeal candidasis is a common opportunistic infection seen in immunocompromised patients
The control group treated with fluconazole tablets showed 85% improvement in symptoms of oral candidiasis
The in situ gel formulation of fluconazole was well tolerated with no severe adverse reaction and offers a better alternative to tablet formulation in the treatment of oropharyngeal candidasis
Summary
Oropharyngeal candidasis is a common opportunistic infection seen in immunocompromised patients. Aim of the present investigation was to formulate and find out the relative efficacy of in situ gels of fluconazole. Fungal pathogens increasingly cause nosocomial infections, especially among the surgical patients and the high risk critically ill, with an attributable death rate estimated at 38% [1]. Local delivery of drugs to the tissues of the oral cavity has a number of applications including the treatment of toothache, periodontal diseases, dental caries, bacterial and fungal infections. Fluconazole is an orally active bistriazole antifungal agent which is used in the treatment of superficial and systemic candidasis [4]. Recurrence of infection is usually seen in approximately 33% of patients treated with tablet formulation of fluconazole. Rene-jean Bensadown et al, demonstrated the ability to deliver high and prolonged salivary concentration of 50 mg mucoadhesive buccal tablets of miconazole helped in reduction of dose, reduced the risk of systemic exposure, drugdrug interaction and other toxicity [6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
