STATISTICAL OPTIMIZATION AND EVALUATION OF ETHOSOMAL MICONAZOLE NITRATE SUSPENSION

Objective: The objectives of the present study were to optimize and evaluate the ethosomal suspension of miconazole nitrate for the treatment of local and systemic fungal infections. Methods: Miconazole topical formulation is prepared for better patient compliance and to reduce the dose of a drug. Miconazole nitrate ethosomes were prepared by the cold method using factorial designing with Ethanol(X1), IPA(Isopropyl alcohol)(X2), and Lecithin(X3) as Independent variables and % EE(Entrapment efficiency)(Y1) and % DR(drug release at 8th h)(Y2) was selected as responses. Results: The results obtained in the design showed that there was no significant interaction among factors. The lecithin concentration had a positive response on % EE, while ethanol concentration and IPA had a positive effect. For % DR, Ethanol, and IPA showed a positive effect and Lecithin had a negative response. The formulation EM22 (3 ml X1,3 ml X2 and 300 mg of X3) characterized by high % EE(77.3 %) and optimum % DR(94.2%) and formulation EM6 (2 ml X1,2 ml X2 and 100 mg of X3) characterized by high % DR(97.32 %) and optimum % EE (74.8 %). EM22 was incorporated in the gel as it is showing more entrapment efficiency and compared with the marketed product for drug release. Conclusion: From the result, it was concluded that formulated ethosomal suspension and optimized gel have more drug release than marketed formulation so that formulated suspension can be used for the preparation of antifungal gels, creams, ointments for sustained release.

Comparative Evaluation of Effectiveness of Denture Adhesive after Incorporating Antifungal Agent – An In-vitro Study

Aims: The aim of current study is to evaluate adhesive force and qualitative mycological culture analysis of Denture adhesive (DA) after incorporating antifungal agent in various concentrations. Study Design: Experimental study. Place and Duration of Study: The current study was conducted at the Department of Prosthodontics, Mansarovar Dental College and Hospital, Bhopal (M. P.) from September 2017 to October 2018. Methodology: A total of 80 specimens were prepared with heat cured acrylic resin, out of which 40 were used for qualitative anti-microbiological test, and 40 were used for Adhesive force measurement test. Both test had four groups: Group A (Control group DA without MN); Group B (DA+MN 10%); Group C (DA+MN 20%); and Group D (DA+MN 30%). Results: The mean zone of inhibition was 8.85 ± 0.28 mm for 10% w/w Miconazole Nitrate (MN), 12.95±0.30 mm for 20% w/w MN, and 22.25 ± 0.38 mm for 30% w/w MN. There was a statistically highly significant (P< .001) difference between the groups, with an F value of 1077.8. Conclusion: Within the limitation of the study qualitative anti-microbial property for favorable laboratory performance can be achieved only after the addition of 20% w/w Miconazole Nitrate to denture adhesive paste.

Antifungal Topical Nanoemulgel Containing Miconazole Nitrate

Nanomulgel have emerged as one of the most interesting topical drug delivery system as it has dual release control system i.e. nanoemulsion and gel. Also the stability of nanoemulsion is increased when it is incorporated in gel. Miconazole nitrate is an antifungal medication topically administered to treat skin infections such as athlete’s foot, jock itch and ringworm. The aim of the present research work was to investigate the potential of nanoemulgel in enhancing the topical delivery of hydrophobic drug. MCZ nanoemulsions were prepared using span 80, tween 80, propylene glycol and different conc. of sunflower oil by High pressure homogenization technique. The prepared nanoemulsions were evaluated for pH, drug content, centrifugation, globule size and zeta potential.F2 showed highest drug content 91.26%.The globule size are found to be satisfactory range of nanoemulsion. The drug release kinetics is in the order of F2>F3>F4>F5>F1.And Nanoemulgel is prepared by using Carbopol 934 as gelling agent The release kinetics of nanoemulgel was found to obey zero order kinetics. The nanoemulgel was found to be stable with respect to physical appearance, pH, rheological properties spreadability and drug content at all temperature and conditions for two month. Hence, in the present study it can be concluded that Miconazole Nitrate nanoemulgel formulation is a promising system for the topical drug delivery and also an alternative method to deliver the hydrophobic drugs in water soluble gel bases. Key words: Hydrophobic drugs, Nanoemulgel, Miconazole nitrate, Topical drug delivery.

Vaginal Tablets of Metronidazole (750 mg) plus Miconazole Nitrate (200 mg) versus Oral Metronidazole (2 g) for Bacterial Vaginosis: A Randomized Controlled Trial

Objective: To compare the cure rates, side effects, satisfaction, and recurrence rates of bacterial vaginosis (BV) in women having vaginal tablets of metronidazole (750 mg) plus miconazole (200 mg)—the “NPF group”—versus oral metronidazole (2 g)—the “MET group.” Materials and methods: This September 2019–March 2020 trial enrolled symptomatic women aged 18–45 years diagnosed with BV based on Amsel’s criteria. Excluded were women who were immunocompromised; allergic to metronidazole or miconazole; had BV episodes during the preceding 3 months; or had abnormal vaginal bleeding. After randomization with a ratio 1:1, another vaginal swab was done for Nugent scoring. Two weeks later, the evaluation using Amsel’s criteria and Nugent scores was repeated. Also, symptom resolution, side effects and satisfaction were evaluated. Symptomatic resolution referred to 75% improvement in discharge, irritation, itching, odor, and coital pain. At one and three months, subjective symptomatic recurrence was assessed by telephone. Results: Data on 70 participants were analyzed (NPF, N=34; MET, N=36). Their average age was 32.3±7.9 years (NPF, 34.1±8.1; MET, 30.6±7.3). Without statistical significance, NPF had higher symptom resolution (67.7% vs 58.3%; P=0.420), cure rate by Amsel criteria (82.4% vs 77.8%; P=0.632), and cure rate by Nugent scoring (35.3% vs 16.9%; P=0.075). Both groups reported high satisfaction (NPF, 8.5±1.4; MET, 7.9±2.0; P=0.125). Side effects were comparable, including appetite loss, metallic taste, nausea, and dizziness. Conclusion: For BV treatment, both vaginal ovules containing metronidazole (750 mg) plus miconazole nitrate (200 mg) and oral metronidazole (2 g) show comparable efficacy and side effects.

Formulation and Evaluation of Miconazole Nitrate Loaded Novel Nanoparticle Gel for Topical Delivery

The aim of the present research work is to design miconazole-loaded chitosan nanoparticles that could potentially assemble in wrinkle and hair follicles to provide prolong release to the skin tissue. The amount of drugs required for the preparation of nanoparticles was determined by studying the entrapment efficiency of preliminary batches. The emulsification/Solvent evaporation method was used for the preparation of nanoparticles. Different proportions of Miconazole Nitrate and Chitosan were dissolved in DCM. The size of the globules in the emulsion was reduced by a high energy shearing using a probe Sonicator at 50 % amplitude for 10 Minutes, followed by the addition of 10 ml 2% PVA. After overnight evaporation of DCM, for isolation of dried NPs, the NPs dispersion was centrifuged at 15,000 RCF for 30 minutes. The obtained particles were dispersed in de-ionized water and freeze-dried. 32 full factorial design was selected for optimization purposes. Prepared batches were evaluated for various parameters such as entrapment efficiency, production yield, particle size, zeta potential, and SEM. F5 batch was found to be optimized which was then used for the preparation of gel. Three levels of Carbopol934 and propylene glycol were used for the optimization of gel. The prepared gel was also evaluated for pH, drug content, viscosity, and spreadability. From the study, it was concluded that nanoparticle gel can be used for the treatment of various skin infections over the conventional gel.

Formulation and Evaluation of Miconazole Nitrate Loaded Nanoparticles for Topical Delivery

The aim of the present work was to formulate and evaluate Miconazole nitrate (MN) polymeric nanoparticles (NPs) for systemic delivery of the active ingredient after topical administration. The Solvent evaporation approach was used to make nanoparticles for topical delivery of MN. Particle size, entrapment efficiency and SEM were all measured in MN-SLN. A consistent size distribution (PI 0.300) was used to generate aqueous NPs dispersions with a mean particle size less than 250 nm. After 3 months of storage, the produced semi-solid systems had a mean particle size of less than 250 nm and a PI of less than 0.500. The F5 formulation was been chosen as the model formulation from among the nine nanoparticle formulations developed (F1 to F9). The reason for this was that, according to the ICH stability guidelines, formulation F5 was judged to be optimal and stable. The F5 formulations of miconazole nanoparticles shows the highest entrapment efficiency (93.28%) and drug loading (86.64%). In conclusion, there are two major advantages of using miconazole nanoparticle drug delivery systems. i.e., they are topical preparations that assemble in the hair follicles and wrinkles to produce a systemic and local action. It is possible that nanoparticles will be the most effective treatment for fungal skin infections.