orabase and Candidiasis--Oral

To advance studies on the effect of a new pharmaceutical formulation for the treatment of oral fungal infections, we evaluated the safety and tolerability of orabase ointment containing cinnamaldehyde for use on the oral mucosa.. A clinical trial (phase I) was carried out on 35 individuals with healthy oral mucosa divided into three groups: ointments at 200 µg/mL, n = 12; 300 µg/mL, n = 11; and 400 µg/mL, n = 12. Product safety was assessed using three parameters: (a) clinical evolution as recorded by trained examiners; (b) evolution of the inflammatory process as registered by an exfoliative cytology exam and analyzed by trained pathologists; (c) mucosal swab to count Candida spp. colony-forming units (CFU). These parameters were analyzed both beforehand and at 15 days of treatment.. The three ointment concentrations evaluated did not trigger inflammatory processes. The mycological analyses revealed a reduction of at least 99% in the number of Candida spp. CFU. In the exfoliative cytology analyses, the cells were found to be healthy. Participants reported a pleasant taste, yet 17% reported a slight burning sensation when applying the product.. The ointment is safe and tolerable for use on healthy oral mucosa.. Registration number: RBR-7zwzs3.. The ointment proved to be safe and tolerable for use on oral mucosa, encouraging studies to evaluate its clinical efficacy in patients with oral candidiasis, and contributing to a new therapeutic proposal for the treatment of fungal infections caused by Candida spp.

Topics: Acrolein; Antifungal Agents; Candida; Candidiasis, Oral; Carboxymethylcellulose Sodium; Humans; Mycoses; Ointments

Denture stomatitis is a common and recurring problem of denture wearers. Ketoconazole tablet is one of the antimycotic drugs that often has been used to treat this condition, but systemic use of this drug has some adverse effects that frequently lead to unfavorable compliance and treatment failure. This study was designed to compare the efficacy of topical ketoconazole 2% in orabase and ketoconazole tablet.. Thirty patients with denture stomatitis (positive culture) were divided into two groups. The first group received ketoconazole tablet (orally used 200 mg per day) for 14 days and the second group received 2% topical ketoconazole in orabase applied twice daily on the mucosal denture surface. Candida cultures were taken from the palatal mucosa before and on days 7 and 14 after commencement of the therapy. The mean of colonies before and 7 and 14 days after medication were calculated. One-way ANOVA and paired t-test were used for data analysis (alpha=0.05).. The mean of colonies number before receiving medication in the tablet and topical application groups were 454 and 441 respectively. The mean of colonies number after receiving medication in tablet and topical application group were 137 and 176 (on the seventh day) and 122 and 96 (on the 14th day), respectively; there was no significant difference between the two groups after medication (p=0.18).. Topical ketoconazole 2% in orabase can be useful in managing denture stomatitis. This topical medication has fewer side effects, whereas systemic administration of ketoconazole tablet is associated with some complications.. The application of topical ketoconazole 2% in orabase ointment can be considered in the treatment of denture stomatitis and has comparable efficacy with the ketoconazole tablet.

Topics: Administration, Buccal; Administration, Oral; Aged; Aged, 80 and over; Antifungal Agents; Candidiasis, Oral; Carboxymethylcellulose Sodium; Colony Count, Microbial; Denture, Complete; Drug Carriers; Follow-Up Studies; Humans; Ketoconazole; Middle Aged; Mouth Mucosa; Ointments; Stomatitis, Denture; Tablets

Oral candidiasis may be manifested in the oral cavity as either mild or severe oral fungal infection. This infection results from the overgrowth of Candida species normally existing in the oral cavity in minute amounts based on many predisposing factors. Several aspects have spurred the search for new strategies in the treatment of oral candidiasis, among which are the limited numbers of new antifungal drugs developed in recent years. Previous studies have shown that thyme and clove oils have antimycotic activities and have suggested their incorporation into pharmaceutical preparations. This study aimed to investigate the possibility of the incorporation and characterization of essential oils or their extracted active ingredients in Orabase formulations.. Orabase loaded with clove oil, thyme oil, eugenol, and thymol were prepared and evaluated for their antifungal activities, pH, viscosity, erosion and water uptake characteristics, mechanical properties, in vitro release behavior, and ex vivo mucoadhesion properties.. All prepared bases showed considerable antifungal activity and acceptable physical characteristics. The release pattern from loaded bases was considerably slow for all oils and active ingredients. All bases showed appreciable adhesion in the in vitro and ex vivo studies.. The incorporation of essential oils in Orabase could help in future drug delivery design, with promising outcomes on patients' well-being.

Topics: Adhesiveness; Animals; Antifungal Agents; Candida albicans; Candidiasis, Oral; Carboxymethylcellulose Sodium; Chemistry, Pharmaceutical; Clove Oil; Drug Carriers; Eugenol; Hydrogen-Ion Concentration; Kinetics; Microbial Sensitivity Tests; Oils, Volatile; Rabbits; Solubility; Technology, Pharmaceutical; Thymol; Thymus Plant; Viscosity; Water

Fluconazole mucoadhesive buccal films were prepared using film forming polymers namely; hydroxypropyl methyl cellulose (HPMC), hydroxyethyl cellulose (HEC), chitosan, Eudragit and sodium alginate (SALG) either alone or in combination with bioadhesive polymers. The bioadhesive polymers studied were sodium carboxymethyl cellulose (SCMC), Carbopol 974P, and polycarbophil (AA-A). The prepared films were characterized by means of film thickness, surface pH, swelling capacity, in vitro adhesion, in vivo residence time, in vitro drug release and in vivo drug release to determine the amount of drug release from selected film formulae using microbiological assay and HPLC. Optimum release behavior, convenient bioadhesion, acceptable elasticity were exhibited by film containing 2% HPMC and 1% SCMC (fresh or stored for 6 months). Determination of the amount of drug released in saliva after application of the selected fluconazole films confirmed the ability of the film to deliver the drug over a period of approximately 300 minutes and to reduce side effects and possibility of drug interaction encountered during systemic therapy of fluconazole, which would be beneficial in the case of oral candidiasis.

Topics: Acrylic Resins; Adhesiveness; Adult; Alginates; Antifungal Agents; Candidiasis, Oral; Carboxymethylcellulose Sodium; Cheek; Female; Fluconazole; Glucuronic Acid; Hexuronic Acids; Humans; Hypromellose Derivatives; Male; Methylcellulose; Polyvinyls; Solubility

Buccal bioadhesive films, releasing topical drugs in the oral cavity at a slow and predetermined rate, provide distinct advantages over traditional dosage forms. The aim of present study was to prepare and evaluate buccal bioadhesive films of clotrimazole for oral candidiasis. The film was designed to release the drug at a concentration above the minimum inhibitory concentration for a prolonged period of time so as to reduce the frequency of administration of the available conventional dosage forms. The different proportions of sodium carboxymethylcellulose and carbopol 974P (CP 974P) were used for the preparation of films. Carbopol was used to incorporate the desired bioadhesiveness in the films. The films were prepared by solvent casting method and evaluated for bioadhesion, in vitro drug release and effectiveness against Candida albicans. In vitro drug release from the film was determined using a modified Franz diffusion cell while bioadhesiveness was evaluated with a modified two-arm balance using rabbit intestinal mucosa as a model tissue. Films containing 5% CP 974P of the total polymer were found to be the best with moderate swelling along with favorable bioadhesion force, residence time and in vitro drug release. The microbiological studies revealed that drug released from the film could inhibit the growth of C. albicans for 6 h. The drug release mechanism was found to follow non-Fickian diffusion.

Topics: Acrylates; Adhesiveness; Administration, Buccal; Animals; Anti-Infective Agents, Local; Candida albicans; Candidiasis, Oral; Carboxymethylcellulose Sodium; Chemistry, Pharmaceutical; Clotrimazole; Delayed-Action Preparations; Diffusion; Dosage Forms; Drug Carriers; Drug Compounding; Intestinal Mucosa; Kinetics; Microbial Sensitivity Tests; Models, Chemical; Rabbits; Solubility; Technology, Pharmaceutical

Oral lichen planus (OLP) is a chronic inflammatory disease which is recalcitrant to medical treatment. The purpose of this study was to compare the effectiveness of various forms of the topical steroid fluocinolone acetonide applications in patients with OLP.. Data of OLP patients were collected retrospectively from the chart record and the 97 OLP patients were divided into three groups. The first group (n = 28) was treated with a 0.1% solution of fluocinolone acetonide (FAS), the second group (n = 22) with 0.1% fluocinolone acetonide in orabase (FAO), and the third group (n = 47) with both FAS and FAO (FAS/FAO) throughout the study. Each group was clinically evaluated as complete remission (CR), partial remission (PR), or no response (NR), following the treatment. Also, the side-effect of oral candidiasis was recorded in each group.. Two years of treatment resulted in complete remission of 77.3, 21.4, and 17.0% of patients in the FAO, FAS, and FAS/FAO groups, respectively. There was a statistically significant difference in disease remission (P < 0.05), but not in oral candidiasis appearance (P > 0.05) among various forms of topical steroid application.. The study concluded that FAO or FAS can produce improved results in the management of OLP by long-term follow-up.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Candidiasis, Oral; Carboxymethylcellulose Sodium; Drug Combinations; Female; Fluocinolone Acetonide; Glucocorticoids; Humans; Lichen Planus, Oral; Male; Middle Aged; Remission Induction; Retrospective Studies; Sex Ratio