Background: Bacterial vaginosis (BV) is one of the most common infections in childbearing age. Aim: To compare the efficacy of metronidazole (once-daily 0.8% MTZ in situ gel) versus twice-daily conventional MTZ vaginal gel in the treatment of bacterial vaginosis (BV). Material and methods: All patients who presented to Assiut Women Health Hospital- Egypt with symptoms suggestive of BV were counseled to participate in the study. One hundred-four eligible participants were randomly assigned to either MTZ in situ gel or a conventional vaginal gel. All participants were followed-up twice after one and 4 weeks of the beginning of treatment to ensure cure of infection and any side-effects. Results: Demographic criteria of the participants were matched in both groups. The cure rate after one week from the treatment was 74.5% in the in situ gel group and 63.8% in the conventional vaginal gel group (P=0.252), while after 4 weeks, the cure rate showed significant difference in the in situ gel group as compared to the conventional vaginal gel group (66.7%) and (40.4%), respectively (P=0.009). Conclusion: Once daily in situ MTZ gel (0.8%) is more effective than twice-daily conventional gel after four weeks of treatment with nearly same side effects. These findings confirm the use of this novel and efficient modality of long-term treatment of BV.

We aimed to investigate the effect of adding sildenafil vaginal gel to clomiphene citrate (CC) in infertile women with prior CC failure. METHODS: This is a self- controlled clinical trial. Women with CC failure (in prior 5 cycles) and thin endometrium were recruited (N = 42). In their 6th (CC only) cycle, women continued on CC 100 mg/ day for 5 days, and had measurement of endometrial thickness and Doppler assessment of uterine arteries on day of HCG administration. In the 7th cycle, women (N = 36) were given usual dose of CC supplemented with sildenafil vaginal gel (5 gm, containing 50 mg sildenafil) twice daily from cycle day 8 to day of HCG administration. Endometrial thickness and uterine artery Doppler were measured on the day of HCG injection. RESULTS: In the 7th (CC + sildenafil vaginal gel) cycle, endometrial thickness was significantly higher than in the 6th (CC only) cycle (9.3 mm +/- 3.1mm versus 6.6 mm +/- 1.4 mm, respectively, P = 0.001). Uterine artery pulsatility index dropped from 2.4 +/- 0.8 in 6th cycle to 1.6 +/- 1.3 in 7th cycle (P = 0.002). Clinical pregnancy rate increased but numbers were too small (only 3 pregnancies). CONCLUSION: Sildenafil vaginal gel significantly increased endometrial thickness and uterine blood flow, and may improve pregnancy rate in patients with CC failure due to thin endometrium. Mucoadhesive vaginal gel formulation allowed shorter duration of sildenafil application, and less frequent daily dosing.

We aimed to investigate the effect of adding sildenafil vaginal gel to clomiphene citrate (CC) in infertile women with prior CC failure. METHODS: This is a self- controlled clinical trial. Women with CC failure (in prior 5 cycles) and thin endometrium were recruited (N = 42). In their 6th (CC only) cycle, women continued on CC 100 mg/ day for 5 days, and had measurement of endometrial thickness and Doppler assessment of uterine arteries on day of HCG administration. In the 7th cycle, women (N = 36) were given usual dose of CC supplemented with sildenafil vaginal gel (5 gm, containing 50 mg sildenafil) twice daily from cycle day 8 to day of HCG administration. Endometrial thickness and uterine artery Doppler were measured on the day of HCG injection. RESULTS: In the 7th (CC + sildenafil vaginal gel) cycle, endometrial thickness was significantly higher than in the 6th (CC only) cycle (9.3 mm +/- 3.1mm versus 6.6 mm +/- 1.4 mm, respectively, P = 0.001). Uterine artery pulsatility index dropped from 2.4 +/- 0.8 in 6th cycle to 1.6 +/- 1.3 in 7th cycle (P = 0.002). Clinical pregnancy rate increased but numbers were too small (only 3 pregnancies). CONCLUSION: Sildenafil vaginal gel significantly increased endometrial thickness and uterine blood flow, and may improve pregnancy rate in patients with CC failure due to thin endometrium. Mucoadhesive vaginal gel formulation allowed shorter duration of sildenafil application, and less frequent daily dosing.

We aimed to investigate the effect of adding sildenafil vaginal gel to clomiphene citrate (CC) in infertile women with prior CC failure. METHODS: This is a self- controlled clinical trial. Women with CC failure (in prior 5 cycles) and thin endometrium were recruited (N = 42). In their 6th (CC only) cycle, women continued on CC 100 mg/ day for 5 days, and had measurement of endometrial thickness and Doppler assessment of uterine arteries on day of HCG administration. In the 7th cycle, women (N = 36) were given usual dose of CC supplemented with sildenafil vaginal gel (5 gm, containing 50 mg sildenafil) twice daily from cycle day 8 to day of HCG administration. Endometrial thickness and uterine artery Doppler were measured on the day of HCG injection. RESULTS: In the 7th (CC + sildenafil vaginal gel) cycle, endometrial thickness was significantly higher than in the 6th (CC only) cycle (9.3 mm +/- 3.1mm versus 6.6 mm +/- 1.4 mm, respectively, P = 0.001). Uterine artery pulsatility index dropped from 2.4 +/- 0.8 in 6th cycle to 1.6 +/- 1.3 in 7th cycle (P = 0.002). Clinical pregnancy rate increased but numbers were too small (only 3 pregnancies). CONCLUSION: Sildenafil vaginal gel significantly increased endometrial thickness and uterine blood flow, and may improve pregnancy rate in patients with CC failure due to thin endometrium. Mucoadhesive vaginal gel formulation allowed shorter duration of sildenafil application, and less frequent daily dosing.

The purpose of the current study is to develop nanostructured lipid carriers (NLCs) for the delivery of the antihyperlipidemic drug simvastatin (SIM) to increase its extremely low oral bioavailability (5%) and prolong its antihyperlipidemic effect. NLCs were prepared via emulsification-solvent evaporation technique followed by ultrasonication, and the effect of composition of the nanocarriers on the particle size, size distribution, surface charge, entrapment efficiency, drug release kinetics and physical stability was extensively studied. NLCs exhibited nanosized (200 nm) spherical morphologies with narrow size distribution and high drug entrapment efficiency (>75%), sustained drug release pattern, and negative surface charge (zeta potential of −35–40 mV) that imparts sufficient electrostatic physical stability. When tested in vivo, SIM-NLCs of the optimal composition demonstrated improved and prolonged reduction in the total cholesterol and non-high density lipoprotein cholesterol levels, as compared to the drug suspension. After oral administration of a single dose of SIM-NLC, 4-fold increase in bioavailability was observed, as compared to the SIM suspension. Hence, NLCs might provide efficient nanodevices for the management of hyperlipidemia and promising drug delivery systems to enhance SIM oral bioavailability.

The purpose of the current study is to develop nanostructured lipid carriers (NLCs) for the delivery of the antihyperlipidemic drug simvastatin (SIM) to increase its extremely low oral bioavailability (5%) and prolong its antihyperlipidemic effect. NLCs were prepared via emulsification-solvent evaporation technique followed by ultrasonication, and the effect of composition of the nanocarriers on the particle size, size distribution, surface charge, entrapment efficiency, drug release kinetics and physical stability was extensively studied. NLCs exhibited nanosized (200 nm) spherical morphologies with narrow size distribution and high drug entrapment efficiency (>75%), sustained drug release pattern, and negative surface charge (zeta potential of −35–40 mV) that imparts sufficient electrostatic physical stability. When tested in vivo, SIM-NLCs of the optimal composition demonstrated improved and prolonged reduction in the total cholesterol and non-high density lipoprotein cholesterol levels, as compared to the drug suspension. After oral administration of a single dose of SIM-NLC, 4-fold increase in bioavailability was observed, as compared to the SIM suspension. Hence, NLCs might provide efficient nanodevices for the management of hyperlipidemia and promising drug delivery systems to enhance SIM oral bioavailability.

The purpose of the current study is to develop nanostructured lipid carriers (NLCs) for the delivery of the antihyperlipidemic drug simvastatin (SIM) to increase its extremely low oral bioavailability (5%) and prolong its antihyperlipidemic effect. NLCs were prepared via emulsification-solvent evaporation technique followed by ultrasonication, and the effect of composition of the nanocarriers on the particle size, size distribution, surface charge, entrapment efficiency, drug release kinetics and physical stability was extensively studied. NLCs exhibited nanosized (200 nm) spherical morphologies with narrow size distribution and high drug entrapment efficiency (>75%), sustained drug release pattern, and negative surface charge (zeta potential of −35–40 mV) that imparts sufficient electrostatic physical stability. When tested in vivo, SIM-NLCs of the optimal composition demonstrated improved and prolonged reduction in the total cholesterol and non-high density lipoprotein cholesterol levels, as compared to the drug suspension. After oral administration of a single dose of SIM-NLC, 4-fold increase in bioavailability was observed, as compared to the SIM suspension. Hence, NLCs might provide efficient nanodevices for the management of hyperlipidemia and promising drug delivery systems to enhance SIM oral bioavailability.

The purpose of the current study is to develop nanostructured lipid carriers (NLCs) for the delivery of the antihyperlipidemic drug simvastatin (SIM) to increase its extremely low oral bioavailability (5%) and prolong its antihyperlipidemic effect. NLCs were prepared via emulsification-solvent evaporation technique followed by ultrasonication, and the effect of composition of the nanocarriers on the particle size, size distribution, surface charge, entrapment efficiency, drug release kinetics and physical stability was extensively studied. NLCs exhibited nanosized (200 nm) spherical morphologies with narrow size distribution and high drug entrapment efficiency (>75%), sustained drug release pattern, and negative surface charge (zeta potential of −35–40 mV) that imparts sufficient electrostatic physical stability. When tested in vivo, SIM-NLCs of the optimal composition demonstrated improved and prolonged reduction in the total cholesterol and non-high density lipoprotein cholesterol levels, as compared to the drug suspension. After oral administration of a single dose of SIM-NLC, 4-fold increase in bioavailability was observed, as compared to the SIM suspension. Hence, NLCs might provide efficient nanodevices for the management of hyperlipidemia and promising drug delivery systems to enhance SIM oral bioavailability.

Purpose: To enhance the dissolution of albendazole (ABZ) using spray-drying technique. Method: ABZ binary mixtures with Kollicoat IR® (KL) and polyvinyl pyrrolidone (PVP) in various drug to polymer ratios (1: 1, 1: 2 and 1; 4) were prepared by spray-drying. The spray-dried particles were characterized for particle shape, and dissolution rate as well as by differential scanning calorimetry(DSC) and Fourier transform infrared (FTIR). Results: Scanning electron micrographs showed a homogeneous distribution of ABZ in the polymer matrix for ABZ-PVP spray-dried system in ratios of 1: 2 and 1: 4, while it was observed only upon using a ratio of ABZ: KL 1: 4 in case of ABZ-KL systems. FT-IR spectra of both physical mixtures and spraydried mixtures did not show any change for all ABZ-polymer systems, thus indicating the compatibility of the carriers with ABZ. ABZ exhibited a noticeable enhanced dissolution rate from its spray-dried coacervate with PVP and this was independent of the drug/polymer ratio. Drug release was 78, 81 and 81 % from the spray-dried ABZ-PVP systems of drug: polymer ratio of 1:1, 1:2 and 1: 4, respectively, within 5 min. Drug showed complete dissolution within 15 min. On the other hand, enhancement of dissolution rate varied with ABZ: Kl ratio. Conclusion: Enhancement of ABZ dissolution for both types of spray-dried particles is due to the reduction in drug particle sizes, wetting of the dissolution medium by the hydrophilic carriers and the amorphosization of the drug crystals by the carriers.

Purpose: To enhance the dissolution of albendazole (ABZ) using spray-drying technique. Method: ABZ binary mixtures with Kollicoat IR® (KL) and polyvinyl pyrrolidone (PVP) in various drug to polymer ratios (1: 1, 1: 2 and 1; 4) were prepared by spray-drying. The spray-dried particles were characterized for particle shape, and dissolution rate as well as by differential scanning calorimetry(DSC) and Fourier transform infrared (FTIR). Results: Scanning electron micrographs showed a homogeneous distribution of ABZ in the polymer matrix for ABZ-PVP spray-dried system in ratios of 1: 2 and 1: 4, while it was observed only upon using a ratio of ABZ: KL 1: 4 in case of ABZ-KL systems. FT-IR spectra of both physical mixtures and spraydried mixtures did not show any change for all ABZ-polymer systems, thus indicating the compatibility of the carriers with ABZ. ABZ exhibited a noticeable enhanced dissolution rate from its spray-dried coacervate with PVP and this was independent of the drug/polymer ratio. Drug release was 78, 81 and 81 % from the spray-dried ABZ-PVP systems of drug: polymer ratio of 1:1, 1:2 and 1: 4, respectively, within 5 min. Drug showed complete dissolution within 15 min. On the other hand, enhancement of dissolution rate varied with ABZ: Kl ratio. Conclusion: Enhancement of ABZ dissolution for both types of spray-dried particles is due to the reduction in drug particle sizes, wetting of the dissolution medium by the hydrophilic carriers and the amorphosization of the drug crystals by the carriers.