This study aimed to develop and evaluate a floating oral in situ gel with leflunomide (LEF) as a liquid gastro-retentive drug delivery system to increase the residence time of the drug in the stomach and sustain drug delivery. Floating in situ gel system of leflunomide was prepared using sodium alginate as a gelling polymer, calcium carbonate as floating agent and different polymers to extended release. The physicochemical properties of in situ gels of leflunomide were in the acceptable range. An analysis of the release kinetics showed that the drug release followed a zero order, except for the formula containing hydroxypropylmethylcellulose (HPMC), which followed Higuchi’s model. Formula (F2) (0.4% HPMC K100M) was considered the best formulation as it had a minimum FLT (36 sec), optimum viscosity (230.5 cps), optimum drug release (97.34%) after 24 h, and the highest t90 value (205.17 days). Therefore, formula (F2) was chosen for further ex-vivo and bioavailability studies. The pharmacokinetic parameters were compared to those of commercially tablets (Apetoid®), and F2 exhibited a relative bioavailability of 197.73%. The prepared floating in situ gel system is a novel approach which indicate a remarkable increase in the residence time of LEF in the stomach and sustain its delivery.

OBJECTIVE:The aim of this work was to formulate and develop LEV loaded nanospheres in situ nasal gel. SIGNIFICANCE:This is an efficient therapy for epilepsy via brain targeting to increase bioavailability and reduce the dose frequency. METHOD:This study looked at the impact of process factors (polymer amount (mg) (50,7 5, and 100), poloxamer 188 concentration (0.5, 1, and 1.5), and polymer type (Eudragit S100, Eudragit L100, and Eudragit RS 100)) on the responses (particle size (nm), entrapment efficiency (%), and zeta potential (mV) in order to optimize LEV-loaded nanospheres utilizing Box-Behnken design. The design expert software was used to perform the process of optimization categorically. Using the nanoprecipitation process, LEV-loaded nanospheres were effectively formulated, which were then evaluated by FTIR and DSC for drug-polymer interaction, TEM, zeta potential, and particle size. RESULTS:The optimized nanospheres formulation, which had the composition of 100 mg Eudragit S100 and 1.5% poloxamer 188, showed a particle size of 79.07 nm, % entrapment efficiency of 99.74%, and a zeta potential of -40.6 mV. DSC thermogram and FTIR spectrum showed no interaction between drug and polymer used. TEM image indicates spherical shape of the nanosphere formulation, LEV-loaded nanospheres in situ nasal gels were prepared using Na CMC at different concentrations (0.5, 1, and 1.5). NG3 (1.5% NaCMC) showed the best characterization of in situ nasal gel (gelation time of 18 s, gelation temperature of 28.6 °C and % drug release of 73%). In ex-vivo permeation study, the amount of LEV permeated from LVT loaded nanospheres in situ nasal gel (NG3) and the plain LVT in situ nasal gel were 75.5 and 67.8, respectively. NG3 confirmed higher permeability so it was chosen for in vivo pharmacokinetic study. It showed absolute bioavailability five folds greater than the IV route of administration. CONCLUSIONS:LEV-loaded nanospheres in situ nasal gels enhanced its tissue permeability and pass BBB directly which bypass the first pass metabolism in liver. So the bioavailability increases.

Hepatic disorders such as hepatic fibrosis, microbial infections, and hepatocellular cancer remain the leading causes of death. Traditional therapy has limitations due to its side effects and inability to deliver appropriate concentration. Nanotechnology has the potential to produce and enable sooner and more accurate individual diagnosis, improve targeted therapies, reduce side effects, and enhance therapeutic monitoring. The field of nanomedicine has the potential to provide novel therapeutic techniques for liver illnesses. The four major cell types in the liver are crucially involved in the complex sequence of events that occur during the initiation and maintenance of liver inflammation and fibrosis. One major biological component believed to oversee the accumulation of nanoparticles in the liver is the kupffer cell. Recently, Nano therapies treat liver fibrosis and infections (Hepatitis B, murine hepatic schistosomiasis, and Sepsis-related liver injury). Nanotechnology also has several applications in treating liver cancer and liver failure. Nanotechnology has several applications in imaging liver disorders using nanomaterials and superparamagnetic iron oxide nanoparticles, and it has a role in addressing oxidative stress-related liver disorders.

This study aimed to develop oral lipidic hybrids of amikacin sulfate (AMK), incorporating thiolated chitosan as a P-glycoprotein (P-gp) inhibitor to enhance intestinal absorptivity and bioavailability. Three formulations were designed: PEGylated Liposomes, Chitosan-functionalized PEGylated (Chito-PEGylated) Lipidic Hybrids, and Thiolated Chito-PEGylated Lipidic Hybrids. The physical characteristics of nanovesicles were assessed. Ex-vivo permeation and confocal laser scanning microscopy (CLSM) studies were conducted to evaluate the formulations’ potential to enhance AMK intestinal permeability. In-vivo pharmacokinetic studies in rats and histological/biochemical investigations assessed the safety profile and oral bioavailability. The AMK-loaded Thiolated Chito-PEGylated Lipidic Hybrids exhibited favorable physical characteristics, higher ex-vivo permeation parameters, and verified P-gp inhibition via CLSM. They demonstrated heightened oral bioavailability (68.62% absolute bioavailability) and a sufficient safety profile. Relative bioavailability was significantly higher (1556.3% and 448.79%) compared to PEGylated Liposomes and Chito-PEGylated Lipidic Hybrids, respectively, indicating remarkable oral AMK delivery with fewer doses, reduced side effects, and enhanced patient compliance.

A common fungal infection of the feet known as tinea pedis, which is also known as athlete's foot, significantly lowers quality of life. Its occurrence is caused by dermatophytes, a form of fungus that grows on the dead skin of the feet. Itching, scaling, redness, and skin breaking are among the symptoms that can be brought on by tinea pedis. In extreme circumstances, it may also result in nail infections and painful blisters. Antifungal medications, either systemic or topical, are widely used to treat tinea pedis. In recent years, there has been a surge in interest in developing novel medication delivery systems/strategies for the treatment of tinea pedis. By improving the drug's penetration into the skin and lowering the chance of systemic side effects, these systems seek to increase the safety and efficacy of antifungal therapy. This review has covered the many effective ways to treat tinea pedis, including traditional and state-of-the-art sophisticated delivery techniques. Furthermore, prospective avenues for treatment optimization and recurrence prevention of these severe fungal infections have been emphasized.

Designing an effective intranasal (IN) delivery mechanism for the water-soluble anti-epileptic drug levetiracetam (LEV) for brain targeting effect was the main objective of this work.By using the nanoprecipitation process and the polymer Eudragit S100, nanospheres were prepared.Different weights of Eudragit S100 and varied concentrations of poloxamer 188 (stabilizer) were employed.The produced levetiracetam nanospheres exhibited sufficient entrapment efficiency range from 79.2% to 93.5%, with zeta potential values from 26.7 mV to 40.6 mV.The developed Nanospheres had spherical shape and nanosize range (10.44 to 79.07 nm).In situ gels prepared from Poloxamer 407 (18%) and different mucoadhesive polymers (sodium carboxymethylcellulose (Na CMC) and chitosan) were evaluated for gelling time, gelling temperature, pH and rheology.The nanosphere in situ gels were further evaluated for in vitro drug release and revealed 73.6% to 84.5% release within 8 hrs.The optimum in situ gel formula, based on rank of rheology and % release after 8 hrs, was evaluated for stability, and evaluated for ex-vivo permeation through nasal mucosa.

Enalapril (EN) is an antihypertensive drug that is sparingly soluble in water with limited oral bioavailability. Successfully prepared self-nanoemulsifying systems (SNES) loaded with EN were developed. The solubility of EN in different oils, surfactants, and cosurfactants was tested. Pseudoternary phase diagrams were developed, and various SNES formulations were prepared and evaluated regarding content uniformity, emulsification time, droplet size (DS), and zeta potential (ZP). The selected system was examined using transmission electron microscopy. Solid Self-Nanoemulsifying Systems (SSNES) were formulated using Avicel((R)) PH101 carrier and Aerosil((R)) 200 adsorbent to form a free-flowing powder. The powder was formulated as an oral disintegrating tablet (ODT) using superdisintegrants and tested for physicochemical properties and stability. Finally, an in vivo pharmacokinetic study in healthy human volunteers was carried out. The composition of the selected SNES was 10% Labrafil((R)), 60% Tween 80, and 30% Transcutol((R)) HP. It developed with an emulsification time of 21 sec, DP range of 60.16 nm, ZP of 1.17 mV, and spherical-shaped globules. The accelerated stability testing proved that there was no significant difference in physical properties after storage for 3 months. The percentage of relative bioavailability for formula F2 was 112.04%. The results of this study proved that the prepared EN-SSNES ODT represents a novel formulation alternative to the currently marketed tablet.

Juvenile idiopathic arthritis (JIA) is a chronic autoimmune —inflammatory disease. It affects up to 1to 4 per 1,000 children worldwide. Leflunomide (LEF) is a disease modifying anti-rheumatic drug (DMARD) which effectively reduces the signs and symptoms of active JIA in children and rheumatoid arthritis (RA) in adults. The objective of the present study was to develop and evaluate an oral floating in situ gel of LEF as liquid gastro-retentive drug delivery system to improve patient compliance, reduce dosing frequency, increase residence time of drug in the stomach and sustain drug delivery of LEF using different release retardant polymers. The prepared gels were characterized for viscosity, drug content, pH, density, gelling strength, invitro gelling and floating studies and in-vitro release study. Concentration of used polymers significantly affected the formulation viscosity, floating behavior and in-vitro drug release. Analysis of the release kinetic data showed that the drug release from in situ gel followed zero order except formulae containing HPMC which exhibited Higuchi's diffusion model. Considering the in-vitro release, viscosity, floating lag time (FLT) and stability studies, formula F2 (containing 0.4%HPMC K100M) was considered the best formula since it showed minimum floating lag time (36 sec), optimum viscosity (230.5 cps) , optimum drug release (97.34%) after 24 hand has the highest t90 value (205.17 days). Therefore, it was chosen for further ex-vivo study in rats to detect gel formation in the stomach. It showed good gel formation. Hence, floating in situ gelling system is considered a novel approach to sustain drug delivery of LEF.

The objective of the present study was to develop niosomal gels loaded with Timolol Maleate (TM), Non-selective beta-adrenergic receptor antagonist, for prolonged duration and improved bioavailability for glaucoma treatment. TM niosomes were prepared by film hydration method with various mixtures of different non-ionic surfactants including Span 20, 40, 60 and Tween 20, 40, along with cholesterol. The prepared vesicles were evaluated for entrapment efficiency, in vitro drug release, particle size, zeta potential and morphology by optical and transmission electron microscopy (TEM). The selected formulations were incorporated into Sodium carboxymethyl cellulose (CMC Na) and Carbopol 934 gels. Gel formulations were characterized for in vitro drug permeation and ex vivo drug permeation through bovine cornea. In addition, stability study, isotonicity test and in-vivo evaluation of the selected formulations were done. The results showed that, the niosomes formed were white and spherical in shape with uniform particle size. Formulations containing span 60 and that containing mixture of span 60 and tween 40 gave the highest entrapment efficiency (94.6% and 98.8%, respectively) and a sustained release of timolol maleate from the niosomes within 24 h (96% and 97.10%, respectively). The in vitro and ex vivo drug release studies showed that there was a slow and prolonged release of drug from niosomal gel formulations. Considering the in-vitro release, niosomal gel formulae GN5 and GN6 (containing CMC Na 3% w/w) were the best among the studied formulations. Draize test was carried out and the intra-ocular pressure lowering activity of prepared formulations were detected and compared with marketed Timogel. Formula containing 3% CMC Na showed relative bioavailability 1.6 times more than bioavailability of marketed Timogel.

Abstract Silymarin has a short half-life (4-6 hours) which leads to necessity of frequent administration. Besides, it suffers from intestinal degradation. Thus, our study aims to formulate encapsulated floating microspheres using different polymers as HPMC, EC and a blend of them. Emulsion solvent evaporation technique was applied for preparation of microspheres. Parameters considered during preparation are drug: polymer ratio and emulsifier concentration. Selected formulations were characterized by SEM and subjected for assessment by drug entrapment efficiency, buoyancy for 12 hr, in- vitro drug release, kinetics of release and stability. In-vivo bio-equivalence study was performed using albino rabbits. Formula F24 (treatment II) exhibited high % buoyancy (73.4), higher t90 (190.7 day), high Cmax (1021.3 ng/ml) and Tmax (6 h) with a significant difference between it and treatment I (Silymarin plus) after carrying out ANOVA study. Also formula F24 exhibited MRT (hr) equal 9.44 ± 0.03 and high relative bioavailability RB% (227%), which indicates promising microspheres that could be used for effective management of liver disease.

The objective of the present study was to develop and evaluate an oral floating in situ gel of leflunomide (LEF) as liquid gastroretentive drug delivery system for treatment of Juvenile Rheumatoid Arthritis (JRA) to improve patient compliance, prolong its gastric residence time, and reduce the variations of drug concentration in plasma.LEF is a disease modifying anti-rheumatic drug (DMARD) which effectively reduces the signs and symptoms of active JRA in children and rheumatoid arthritis (RA) in adults.Floating in situ gelling formulations were prepared using different concentrations of sodium alginate and calcium carbonate.The prepared gels were characterized for viscosity, drug content, pH, density, in-vitro gelling capacity, floating lag time, floating duration, gelling strength and in-vitro release study.The formula C4 (containing 1.5% w/v sodium alginate and 1% w/v calcium carbonate) was considered the best formula since it showed minimum floating lag time (40 sec), optimum viscosity (295.4 cps), and gel strength (45 sec) and has optimum drug release (98%) for more than 6hr.Therefore, this formula was chosen for further ex-vivo study in rats to detect gel formation in the stomach.Formula C4 showed good gel formation ex vivo study.Hence, floating in situ gelling system of LEF is considered a novel approach to increase patient compliance and increase gastric residence time of drug in the stomach, which in turn will maintain its plasma level.

Objective : The aim of the present study was to obtain an optimized formula of itraconazole (ITC) proniosomes using Box Behnken design. Methods : Itraconazole proniosomes were prepared using span 60 and/or brij 35 as surfactants, cholesterol and lecithin as a penetration enhancer by slurry method. Various trials have been carried out for investigation of proniosomes. Parameters such as entrapment efficiency (EE%), in vitro drug release, zeta potential, vesicle size and Transmission Electron Microscope were assessed for evaluation of proniosomes. Results : Entrapment efficiency (EE%) was found to be between 78.56% and 95.46%. The release profile of itraconazole proniosomes occurred in two distinct phases, an initial phase for about 8 h, followed by a slow phase for 16 h. The release pattern shown by these formulations was Higuchi diffusion controlled mechanism. The zeta potential values for all itraconazole proniosomes were in the range of-21.71 to-34.53 mV which confirms their stability. All itraconazoleproniosomes formula was found to be nano-sized and were appeared to be spherical in shape with sharp boundaries. One way analysis of variance (ANOVA) study showed that HLB (X 1 ) had the main effects on most responses (Y). Conclusion : Box behnken design facilitates optimization of the formulation ingredients on entrapment efficiency, in vitro release of itraconazole proniosomes, zeta potential and vesicle size. Finally, an optimum level of factors was provided by the optimization process.

The objective of the present study was to develop rectal mucoadhesive hydrogels loaded with Tolmetin Sodium, a non-steroidal anti-inflammatory drug, for prolonged duration of action and increased bioavailability. Fourteen formulae were prepared with different types and concentrations of polymers as hydroxypropylmethyl cellulose, hydroxylethyl cellulose, carboxymethyl cellulose and sodium alginate. Each formulation contain Tolmetin Sodium equivalent to 5% w/w active drug. The effect of the employed gel bases on pH, gel strength, mucoadhesion, viscosity and the in vitro release profile of drug was examined. In addition, hydrogel formulations were subjected to rheological and stability studies. The physicochemical characterization revealed that all hydrogels had a suitable pH (6.64–7.75) and gel strength (15.5–65.29 s) for rectal application. The in-vitro drug release from the formulations showed a controlled drug release pattern, reaching 72–92.6% after 8 h. The kinetic analysis of the release data revealed that the drug release from all tested hydrogel bases obeyed the diffusion mechanism. The degradation of Tolmetin Sodium from its rectal hydrogel formulations was found to be a zero-order reaction. All formulations except sodium alginate hydrogel were quite stable. Considering the in-vitro release, rheological properties and shelf life, (CMC; 2%w/w) hydrogel formula was the best among the studied formulations. Therefore, further histopathological and bioavailability studies were carried out to detect different pharmacokinetic parameters of the established formulations compared with commercially available capsules. Formula containing 2% CMC showed relative bioavailability 357.93%. Finally, good correlation was observed between in-vitro and in-vivo profile.

Objectives: The objective of the present study was to incorporateItraconazole (ITC)proniosomes in different gel bases in order to develop ITC proniosomal gel for tansdermalapplication and alsoto achieve high drug plasma levels with enhanced bioavailability. Methods: ITCproniosomes optimized formula was prepared by slurry method and the prepared vesicles were evaluated for their entrapment efficiency (EE%),in-vitroITC release, zeta potential and vesicle size. The prepared optimized formula was then incorporated in different gelling agents as xanthan gum, methyl cellulose (MC), hydroxy propyl methyl cellulose (HPMC) and Carbopol 934. The effect of type and concentration of the employed gel bases on homogeneity, spreadability, extrudability, pH, drug content,the permeation study and viscosity measurement, was studied in all prepared gels. Effect of storage was studied forthe best four formulae at three different temperature for six months. Also,the best formula (G3 containing 5% MC) was used to study the antifungal activity, in vivo therapeutic efficacyand also pharmacokinetic parametersin the ratswhich then compared with commercially available formulations (Sporanox ® ) capsule and solution. Results: The results showed that the drug permeation and rheological properties of ITC proniosomal gel was affected by polymers type and concentration. G3 containing 5% MC showed the best permeation through rat skin (92.15 % ±1.58), the lowest viscosity, high zone of inhibition (3.2 cm). No change was observed (in drug content, spreadability value, pH, in vitro permeation and viscosity) at room and refrigerated temperature, while there was a change at elevated temperature. In pharmacokinetics study, at all time intervals, it was observed that ITC plasma concentrations in rats treated with proniosomal gel were significantly higher than those treated with marketed products. Conclusion: All the formulated gels were of acceptable physical properties and drug content. They exhibited pseudoplastic flow with thixotropic behavior. Regarding in-vitro permeation and rheological properties G3 (5% MC) formula was the best. The prepared ITC proniosomal gel showed enhanced bioavailability in rats compared with the marketed capsule and solution as it exhibited higher AUC0-∞ for proniosomal gel.

The objective of the present study was to develop fast dissolving oral film of the antipsychotic drug, flupentixol dihydrochloride, to enhance its bioavailability, optimize its therapeutic effect when used to treat depression with anxiety, and increase the convenience and compliance by the mentally ill, developmentally disable, elderly, and pediatric patients. Six formulae were prepared with different concentrations of water-soluble polymers vis. hydroxypropyl methylcellulose (HPMC E5) and carboxymethyl cellulose (CMC) by solvent casting technique. The prepared films were subjected to characterization for folding endurance, weight variations, thickness, disintegration time, drug release pattern, and drug content. Physical compatibility between the drug and excipients was guaranteed in the selected formulation (2% HPMC) by means of differential scanning calorimetry analysis and Fourier-transform infrared spectroscopy. This formulation revealed high stability after testing according to the International Conference on Harmonisation guidelines. In vivo studies based on single phase parallel design were carried out for the optimized formulation in healthy human volunteers. The concentration of flupentixol dihydrochloride in plasma samples was analyzed by a developed validated LC-MS/MS assay method and the pharmacokinetic parameters of the established formulation were compared with the commercially available oral tablets. Faster rate of absorption of flupentixol could be obtained from the oral film formulation and the relative bioavailability was found to be 151.06% compared to the marketed product.

Miconazole nitrate is an imidazole derivative antifungal agent, developed by Janssen Pharmaceutica, commonly applied topically to the skin or to mucous membranes to cure fungal infections. Over 90% of miconazole nitrate is reported to be bound to plasma proteins. In this study, miconazole nitrate was formulated into bioadhesive vaginal suppositories using different suppository bases such as fatty base, emulsion base and water soluble bases. Bioadhesive polymers (e.g Hydroxyethyl cellulose, sodium alginate and carbopol 934) are incorporated into the fatty and emulsion bases by the use of surfactant as tween 80. Studies are carried out to detect the effect of polymer addition at different concentration levels on the physicochemical properties and the in vitro release pattern. Analysis of the release data was carried out to determine the release kinetics of miconazole nitrate from all bases under investigation. Clinical evaluation of the efficacy of a single vaginal daily dose of miconazole nitrate formulated in different bioadhesive suppositories was carried out by selecting three formulations. They are evaluated for their clinical efficacy in treatment of vaginitis using 60 patients where they use 200 mg miconazole nitrate suppositories intra1vaginally once daily for 5 consecutive days and compared with conventional suppositories (Gynozol) which contain 200 mg drug, via trying on extra 20 patients. Bioadhesive vaginal suppositories showed 100% of the cured cases with the patient group received formula F 17, 90% of the cured cases with the patient group received formula F 9 and 85% of the cured cases with the patient group received formula F 4. On the other hand, Gynozol suppositories gave the lowest percentage of the cured cases, 70%.

Niosomes are now widely studied as an alternative to liposomes because they alleviate the disadvantages of liposomes, such as chemical instability, variable purity of phospholipids and high cost. The aim of this work is to formulate and evaluate niosomes as carriers for topical delivery of Tenoxicam, as an anti-inflammatory drug, test their stability and improve their anti-inflammatory effect through niosomal encapsulation with objectives of prolonging its action and avoiding its most side effects. Incorporation of Tenoxicam - entrapped niosomes into gelling agents and increasing their concentrations resulted in a marked decrease in amount of drug permeated from the gel through cellulose membrane and rabbit skin. Polymers used as gelling agents are Carbopol 934 and Carboxy Methyl Cellulose sodium (CMC Na). It was found that permeated amount of Tenoxicam decreased with increasing either concentration of Carbopol 934 from 1% to 2% or concentration of CMC Na from 2% to 4%. Amount of Tenoxicam permeated from cellulose membrane are significantly high compared to the amounts permeated across the skin (p<0.01) from the same formulation. On the other hand, there is an increase in the amount of drug permeated from niosomal gels through rabbit skin, compared to that permeated from control drug gels prepared from the same gelling agents (enhancement effect). Stability study was carried out to detect effect of temperature on leakage of drug from the niosomal vesicles and evaluate the percentage of drug retained in the niosomal vesicles and niosomal gel formulations, respectively at different storage temperature (4 ° C, 25 °C and 37 ° C). The data obtained were compared statistically using one-way analysis of variance (ANOVA), using Tukey-Krammer Multiple Comparison Test. A p-value of 0.05 or less was considered to be significant. Degradation reaction of Tenoxicam was studied using accelerated stability testing, where correlation coefficient (r) was determined according to zero, first and second order equations and the decomposition rate constants were determined according to the most suitable correlation coefficient (r) which was zero-order and temperature of 4 ° C was the best temperature of storage for niosomal formulations.

A trial for restriction of drug absorption from suppositories to only the lower part of the rectum, mucoadhesive diclofenac (DC) suppositories were prepared using Witepsol W-25 as a base, carbopol 934 (CP) and white bees wax (Wax) as additives. CP has a mucoadhesive property and wax added to give the suppositories the required stiffness. Double – phased suppositories were prepared as a front layer that contains 10% CP and 20% wax and a terminal layer that contains DC with different ratios of CP. Double – phased and single – phased suppositories containing CP alone nearly exhibit the same in-vitro release profiles, while values of AUC 0-6h and MRT of DC after rectal administration of double-phased suppositories to rats were higher than those for single-phased suppositories with or without CP. Moreover, the initial plasma metabolites concentrations after rectal administration of doublephased suppository were significantly lower and tended to exhibit delayed Tmax compared to single phased suppository. These results proved that the double-phased mucoadhesive suppository could suppress the initial metabolism of DC and may be useful in improving the bioavailability of some drugs as DC.

Miconazole n itrate i s an imidazole der ivative characterized by l onger half-life a nd hi gher efficacy in the treatment o f t he protozoal an d anaerobic bacterial i nfection of t he vagina. O ver 9 0% is reported to be bound to plasma proteins. S ince miconazole is not av ailable as g el f ormulation, m iconazole was formulated into buffered gels (pH 4.75) using different hydrophilic gel bases, including hydroxypropylmethyl cellulose (HPMC), carbopol 934 and sodium alginate. Determination of drug content, pH, viscosity, % adhesion and in vitro release through both art ificial and natural diffusion ba rrier were investigated f or a ll the prepared bi oadhesive gels alone and i ncorporated wi th enhancers n amely tween 80 (T80) and taurocholic acid. The results obtained revealed that a sodium alginate gel was found to have the highest viscosity and t he highest bioadhesive strength by the in vitro evaluation. H PMC gel base showed the highest miconazole release through both cellulose membrane and rabbit skin at pH 4.75, while sodium alginate showed the lowest release rate. The t otal amounts of miconazole rel eased through the cellulose barri er were higher than those r eleased through the rabb it skin ba rrier. The am ount of the d rug released after 8 hours through cellulose barrier w ere 42.90%, 3 9.40% and 21.75% and through rabbit skin were 25. 31%, 14.70% and 11 .33% for H PMC, carbopol 934 and sodium al ginate r espectively. Tested enhancers were shown to increase the amount of miconazole released at an optimum concentration specific for each vehicle, as shown by 1% tween 80 which proved to be superior when incorporated with s odium alginate a nd ca rbopol 934 while 3% taurocholic a cid was found also t o be effective with s odium al ginate. The best linear relations and the highest correlation coefficient was obtained with the non-Fickian diffusion equation fo r all gel bases. Two formulations were selected and evaluated for t heir cl inical efficacy in t he treatment o f Trichomonas v aginalis using the chosen 40 patients w here they use 200 mg miconazole nitrate i ntravaginally once daily at bed time f or 5 consecutive days and com pared wi th c onventional treatment using miconazole ni trate (200mg) vag inal suppositories (Gynozol) tried on extr a 20 patients. Bioadhesive vaginal gels sh owed 95% of the cured cases with the patient group r eceived a gel of 15% sodium alginate and 1% tween 80. O n the other h and, 8 0% of t he patients re ceived the gel f ormula containing 15 % sodium alginate i ncorporated with 3% taurocholic acid were cured. While, Gynozol gave the lowest p ercentage of t he cured cases (7 0%).