Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination (original) (raw)
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Life, 2022
Oral candidiasis is the most common opportunistic fungal infection caused by commensal Candida species. Since there are various local and systemic predisposing factors for the disease, the treatment also varies from topical to systemic antifungal agents. Nystatin is a common antifungal agent used topically. The aim of this systematic review was to evaluate and compare the efficacy of different antifungal agents and the safety of nystatin in the treatment of oral candidiasis. Three electronic databases were searched for randomized controlled trials comparing nystatin with other anti-fungal therapies or placebo. Clinical and/or mycological cure was the outcome evaluation. A meta-analysis and descriptive study on the efficacy, treatment protocols, and safety of nystatin was also conducted. The meta-analysis included five studies, which compared the efficacy of nystatin suspensions with photodynamic therapy. A significant difference in the colony-forming units per milliliters (CFU/mL) of Candida species was observed at 60 days intervals for both palatal mucosa and denture surfaces, with both groups favoring nystatin with low heterogeneity at a 95% confidence interval. Nystatin and photodynamic therapy were found to be equally effective for the clinical remission of denture stomatitis as well as a significant reduction of CFU/mL of Candida species from dentures and palatal surfaces of the patients.
Innovative formulation of nystatin particulate systems in toothpaste for candidiasis treatment
Pharmaceutical Development and Technology, 2015
Oral candidiasis is a mycosis on the mucous membranes of the mouth but not limited to the mouth. Nystatin is one of the most frequently employed antifungal agents to treat infections and may be safely given orally as well as applied topically but its absorption through mucocutaneous membranes such as the gut and the skin is minimal. The purpose of this study is to enhance the effectiveness of nystatin using particulate system such as beads, micro-and nanoparticles of alginate incorporated into toothpaste. Those particulate systems of nystatin were prepared by extrusion/external gelation for beads and emulsification/internal gelation for micro-and nanoparticles and characterized. Small, anionic charged and monodispersed particles were successfully produced. The type of particulate system influenced all previous parameters, being microparticles the most suitable particulate system of nystatin showing the slowest release, the highest inhibitory effect of Candida albicans over a period of one year. Those results allowed the conclusion that alginate exhibits properties that enable the in vitro functionality of encapsulated nystatin and thus may provide the basis for new successful approaches for the treatment of oral antifungal infections such as oral candidiasis.
Journal of Pharmaceutical Sciences, 2012
Oral candidosis is a common opportunistic infection in patients suffering from mucositis (after chemotherapy and radiotherapy administration) and must be treated to prevent infecting other tissue. Nystatin (Nys) is one of the most prescribed drugs to treat this pathology, but because of its physicochemical properties, its pharmaceutical-technological requirements make it a challenge. The purpose of this work was the development and characterization of an optimal Nys delivery system for the potential treatment of oral candidosis avoiding undesirable side effects and toxicity of potential systemic absorption. A nanoemulsion was developed, evaluated, and characterized. It has been formulated successfully as a stable nanoemulsion with a droplet size of 138 nm. Release parameters were estimated using different mathematical approaches, and from the results of ex vivo permeation study of Nys through porcine buccal mucosa, it could be hypothesized that no systemic effects would happen. Microbiologic studies performed revealed an enhanced antifungal effect of the Nys-loaded nanoemulsion. Also, the evaluation of the treated buccal mucosa ultrastructure by transmission electron microscopy revealed a harmless effect. Thus, it could be inferred that the developed formulation could be potentially utilized for candidosis infection under mucositis conditions. K, release rate constant (K 0 zero order, K d first order, K h Higuchi's saquare root, K Korsmeyer-Peppas); %R ∞ , total percentage of drug released; n, diffusional release exponent; t d , time in which the 63.2% of the drug is released; $, shape parameter; CV, coefficient of variation; AIC, Akaike's information criterion.
DESIGN AND EVALUATION OF NYSTATIN GEL BASED EMULSION FOR OROMUCOSAL FUNGAL INFECTION
Nystatin is a polyene antifungal that interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol. Its main action is against Candida spp. It is practically insoluble in water, therefore, the objective of this research is a formulation and evaluation of nystatin gel based emulsion to be applied to the oromucosal surface to increase nystatin solubility that leads to improve local bioavailability. The formulation components were carbomer 940 and hydroxypropylmethyl cellulose K4 (HPMC K4) as gelling agent, aloe vera oil as a component of oily phase, tween 80 and span 80 as a surfactants. The aqueous and oleaginous phases of the emulsion were prepared and it was mixed with the prepared gel. Eight of nystatin gels based emulsion formulations (F1-F8) were prepared and subject to different gel based emulsion evaluation. The selected formula (F6) that has a higher release rate was encountered further investigation which is stability study. There is no important change was detected during stability studies. It can be concluded that the optimized formula (F6) was promising formula in protection of oromucosal from fungal infection.
Activity of an Intralipid formulation of nystatin in murine systemic candidiasis
International Journal of Antimicrobial Agents, 2011
Since nystatin (NYT) is used only topically owing to its toxicity upon systemic administration, a study was initiated aiming to develop a formulation of NYT that could be used systemically against invasive mycoses. The present research is a continuation of previous in vitro investigation of the antifungal effect of nystatin-Intralipid (NYT-IL) against Candida, exploring its in vivo activity. NYT-IL was tested in murine systemic candidiasis induced in naïve as well as cyclophosphamide-immunosuppressed female ICR mice. The infection was assessed by survival rate (SR), mean survival time (MST) and qualitative and quantitative fungal organ colonisation. Mice were treated by intravenous administration of various doses of NYT-IL for 5 consecutive days starting either 24 h or 48 h after the initiation of infection. The experiments showed that NYT-IL is therapeutically effective in the murine candidiasis model. NYT-IL was found to be less toxic in vivo than NYT and therefore higher doses of NYT-IL could be used. The efficacy of NYT-IL was expressed in treated naïve and immunosuppressed mice by increased SR, prolonged MST and reduced fungal organ colonisation. Early initiation of treatment increased efficacy. In summary, the Intralipid formulation of NYT can be administered parenterally and is effective against systemic experimental Candida infection.
13 14 Aims: the objective of the current study was to formulate nystatin (Nyst) into nanostructured lipid carriers (NLCs) to enhance its antifungal activity. Place and Duration of Study: Department of pharmaceutical technology, national research centre, Egypt, between mars 2011 to april 2013 Methodology: Nyst loaded NLCs (NYST-NLCs) were prepared by the hot homogenization and ultrasonication method followed by evaluation of its topical effect on the cutaneous candidiasis. The prepared Nyst-NLCs were characterized for entrapment efficiency, particle size, zeta potential, morphology (transmission electron microscopy), thermal characterisation (differential scanning calorimetry) and in vitro drug release. The study design involves the investigation of the effect of three independent variables namely liquid lipid type (Miglyol 812 and Squalene), liquid lipid concentration (30 and 50%) and Nyst concentration (0.125 and 0.25%). A stability study for 6 months was performed. A microbiological study was conducted in male rats infected with Candida albicans. Results: NLC dispersions were spherical in shape with particle size ranging from 68.06±6.56 to 141.8±3.33 nm. The entrapment efficiencies ranged from 45.50±2.34 to 92.73±0.33% with zeta potential ranging from-26.2 to-39.2 mV. The stability studies done for 6 months indicated that Nyst-NLCs were stable for more than 6 monthes.the microbiological studies showed a least number of colonies forming units (cfu/ml) were recorded for the selected Nyst-NLCs compared to the drug solution and the Nystatin® cream present in the market. Conclusion: It can be fulfilled from this work that NLCs represent promising carrier for topical delivery of Nyst offering good physical stability, high entrapment efficiency and controlled drug release. Nyst-NLCs are a good candidate for cutaneous treatment of fungal infection Note: Review paper may have different types of subsections. 15
Effects of nystatin oral rinse on oral Candida species and Streptococcus mutans among healthy adults
Objectives To examine the effect of nystatin oral rinse on oral Candida species and Streptococcus mutans carriage. Materials and Methods Twenty healthy adults with oral candidiasis participated in the single-arm clinical trial and received Nystatin oral rinse for 7 days, 4 applications/day, 600,000 International Units/application. Demographic-socioeconomic-oral-medical conditions were obtained. Salivary and plaque Candida species and Streptococcus mutans were assessed at baseline, 1-week and 3-month follow-ups. Twenty-four salivary cytokines were assessed. Candida albicans isolates underwent Nystatin susceptibility test. Results Half of participants (10/20) were free of salivary C. albicans after using Nystatin rinse. Salivary S. mutans was significantly reduced at 3-month follow-up (p < 0.05). Periodontal status reflected by bleeding-on-probing was significantly improved at 1-week and 3-month follow-ups (p < 0.05). Plaque accumulation was significantly reduced at 1-week follo...
Archives of oral biology, 2018
Nystatin and chlorhexidine are extensively used in oral medicine; however, there is some controversy about the possibility of these drugs showing antagonism. To clarify this issue, this study investigated the efficacy and stability of nystatin and chlorhexidine in combination. An in vitro study was conducted to analyze the effect of nystatin and chlorhexidine combined on Candida albicans ATCC 18804, using the drugs mixed as a single formulation and as independent formulations used sequentially with different time intervals between them. The minimum inhibitory concentration (MIC) and effects on C. albicans suspensions and biofilms were evaluated. Also, the stability of nystatin and chlorhexidine in a mixture was tested by high performance liquid chromatography (HPLC). When nystatin and chlorhexidine were mixed in a single formulation, there was no significant difference in MIC compared to that of the drugs used alone (as the only treatment). However, when these drugs were used as ind...