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We prospectively evaluated the effects of pulsed magnetic stimulation (PMS) on sexual function of couples with stress urinary incontinence (SUI) partners. Female SUI subjects received 16 or 32 biweekly PMS sessions, depending on treatment response. Prior to, immediately after, and at 6-months posttreatment, couples completed the Golombok Rust Inventory of Sexual Satisfaction (GRISS) questionnaire. Fifty-three (80.3%) of 66 couples completed reassessments. Based on the overall GRISS score, there were significant improvements in sexual function in both female subjects (M diff −5.05, SE 1.34, p = 0.001) and their partners (M diff −3.42, SE 1.24, p = 0.026). Our findings suggest that PMS improved sexual function of SUI patients and their partners. Refereed/Peer-reviewed

Nanotechnology is seeing higher propensity in various industries, including food and bioactives. New nanomaterials are constantly being developed from both natural biodegradable polymers of plant and animal origins such as polysaccharides and derivatives, peptides and proteins, lipids and fats, and biocompatible synthetic biopolyester polymers such as polylactic acid (PLA), polyhydroxyalkonoates (PHA), and polycaprolactone (PCL). Applications in food industries include molecular synthesis of new functional food compounds, innovative food packaging, food safety, and security monitoring. The relevance of bioactives includes targeted delivery systems with improved bioavailability using nanostructure vehicles such as association colloids, lipid based nanoencapsulator, nanoemulsions, biopolymeric nanoparticles, nanolaminates, and nanofibers. The extensive use of nanotechnology has led to the need for parallel safety assessment and regulations to protect public health and adverse effects to the environment. This review covers the use of biopolymers in the production of nanomaterials and the propensity of nanotechnology in food and bioactives. The exposure routes of nanoparticles, safety challenges, and measures undertaken to ensure optimal benefits that outweigh detriments are also discussed.

Lipophilicity was evaluated as a possible mechanism for drug retardation from a glyceryl monostearate matrix system. Lipophilicity of the glyceryl monostearate matrix system was studied using contact angle measurement of water droplets on the surface of compressed disks, extrudate ascension of water, and movement of water through a powder mixture packed in a high-performance liquid chromatographic (HPLC) column. Increase in glyceryl monostearate content resulted in an increase in water droplet contact angle, decrease in the rate of water ascending the extrudate, and increase in the pressure values as a function of flow rate of water moving through the powder mixture. These could be due to the increase in lipophilicity of the matrix, rendering the matrix less wettable. As a result, the rate of water penetration into the matrix decreased, and the drug release could be sustained.

The bioavailability of a generic preparation of pentoxifylline sustained-release (SR) tablet was evaluated in comparison with a proprietary product (Trental 400). For the study, 12 healthy male volunteers participated; the study was conducted according to a randomized, two-way crossover design. The bioavailability was compared using the parameters total area under the plasma level-time curve AUC0-infinity, peak plasma concentration Cmax, and time to reach peak plasma concentration Tmax. No statistically significant difference was observed between the values of the two products in all three parameters. The 90% confidence interval for the ratio of the logarithmic transformed AUC0-infinity values of the generic pentoxifylline over those of Trental 400 was found to lie between 0.83 and 1.00, while that of the parameter Cmax was between 0.91 and 1.29. In addition, elimination half-life t1/2 and apparent volume of distribution Vd were calculated. There was no statistically significant difference between the t1/2 Vd values obtained from the data of the two preparations.

A study was conducted to compare the bioavailability of a generic product of atenolol (Normaten FC) with the innovator product, Tenormin. Twelve healthy adult volunteers participated in the study conducted according to a randomized, two-way crossover design. The preparations were compared using area under the plasma concentration-time curve AUC0-infinity, peak plasma concentration Cmax, and time to reach peak plasma concentration Tmax. No statistically significant difference was obtained between the Tmax values and the logarithmic transformed AUC0-infinity and Cmax values of the two products. Moreover, the 90% confidence interval for the ratio of the logarithmically transformed AUC0-infinity values of Normaten FC over those of Tenormin was found to lie between 0.82 and 0.98, while that of the logarithmically transformed Cmax values was between 0.82 and 1.09, both being within the bioequivalence limit of 0.80-1.25. The values of elimination half-life t1/2 between the two products were also found comparable and not significantly different statistically. The t1/2 values obtained in our study were slightly longer than those reported in the literature for other population groups.

This study was conducted to compare the bioavailability of two controlled-release metformin preparations (Diabetmin Retard and Glucophage Retard) and also to correlate the in vitro and in vivo data obtained with the two preparations. Twelve healthy volunteers participated in the study, conducted according to a completely randomized, two-way crossover design. The preparations were compared using area under the plasma concentration-time curve AUC0-infinity, time to reach peak plasma concentration Tmax, and peak plasma concentration Cmax, while correlation was determined between in vitro release and in vivo absorption. Diabetmin Retard demonstrated a slower rate of in vitro release, but a faster rate of in vivo absorption than Glucophage Retard. However, the in vivo absorption of both products was found to be slower than that of drug released in vitro. A satisfactory relationship could be established between the in vitro and in vivo results, but there was no rank order correlation. No statistically significant difference was observed between the two preparations in the parameters AUC0-infinity and Cmax. However, a slight but statistically significant difference was observed between the Tmax values, but it may not be therapeutically significant. Moreover, the 90% confidence interval for the ratio of the logarithmic transformed AUC0-infinity values, as well as the logarithmic transformed Cmax values, of Diabetmin Retard over those of Glucophage Retard was within the acceptance criteria of 0.80-1.25.

Ethyl acrylate-methyl methacrylate copolymer (Eudragit NE40D) was evaluated as matrix material for preparing controlled-release tablets of diclofenac sodium. Drug release could be modified in a predictable manner by varying the Eudragit NE40D content, but was pH dependent, being markedly reduced at lower pH. This could be attributed to the low solubility of the drug at these pH values. Thermal treatment of the tablets at 60 degrees C was also found to affect the rate of drug release, which was found to decrease with an increase in the treatment duration, but could be stabilized after 96 hr of treatment. This was also associated with a corresponding increase in the tablet tensile strength. However, treatment of the granules for 5 hr prior to compaction into tablets could shorten the stabilizing time of the drug release to 48 hr and that of the tensile strength to 24 hr. The effect of thermal treatment may be ascribed to better coalescence of the Eudragit particles to form a fine network, resulting in matrix of higher tortuosity and lower porosity.

The in vivo bioavailability of a novel multiparticulate matrix sustained-release theophylline preparation was compared under fed and fasted conditions. Twelve healthy volunteers participated in the study conducted according to a randomized, two-way crossover design. The parameters used for the comparison were: total area under the serum concentration-time curve (AUC0), time to reach peak serum concentration (Tmax), and peak serum concentration (Cmax). No statistically signifcant difference was observed bemeen the fed and fasted logarithmic transformed values of AUCG0 and Cmax as well as the fed and fasted values of Tmax In addition, the 90% confidence interval for the ratio of logarithmic transformed AUC0 values of the fed condition over those of the fasted was calculated to lie between 0.90 and 1.04, which is within the bioequivalence limit of 0.80–1.25. These findings indicate that both the rate and extent of absorption of the novel preparation were not significantly affected by food, although a...

A simple high-peqormance liquid chromatography method is described for the simultaneous determination of two marker drugs, namely paracetamol and sulfapyridine, in serum. indirectly indicative of gastric emptying and orocecal transit, respectively. Extraction of the drugs from serum was achieved with chloroform:isopropyl alcohol (7:3). Analysis was peqormed with a mobile phase comprising 1.9% tetrahydrofuran in 0.01 M sodium acetate bufSer adjusted to pH 4.5, through a YMC-Packed C18 column at a flow rate of 1.0 ml/min and ultraviolet detection at 254 nm. The detection limit is approximately 0.2 μg/ml for paracetamol and 0.1 μg/ml for sulfapyridine. This method is applicable to monitoring gastric emptying and orocecal transit following oral administration of paracetamol and sulfasalazine, the latter being hydrolyzed in the large bowel and absorbed as sulfapyridine.

A novel multiparticulate matrix sustained-release theophylline preparation was evaluated in comparison with a reference product, Neulin-SR®, in a multiple-dose administration study, conducted according to a randomized, two-way crossover design involving 12 healthy volunteers. Comparison was made using the parameters, area under the serum concentration-time curve from time 0 to 12 hr (AUC0-12), time to reach peak serum concentration (Tmax), peak serum concentration (Cmax), trough serum concentration (Cmin), average drug concentration (Cav), degree of fluctuation (DF), percentage of time serum drug concentrations lie within the therapeutic range (occupancy time) and time for 50% of dose absorbed (T50%). The parameters, Cmax, Cmin, AUC0-12 Cav, and DF were logarithmic transformed prior to statistical analysis. A statistically significant difference was obtained between the values of the two preparations in the Tmax, Cmin, DF, and T50%; but not in the Cmax, AUC0-12, Cav, and occupancy time. These find...

The bioavailability of a generic preparation of metoprolol (Beatrolol®) was evaluated in comparison with a proprietary product (Betaloc®). Twelve healthy volunteers participated in the study conducted according to a two-way crossover desing. The bioavailability was compared using the parameters, total area under the plasma level-time curve (AUC0-00), peak plasma concentration (Cmax), and time to reach peak plasma concentration (Tmax). No statistically significant difference was observed between the values of the two products in all three parameters. Moreover, the 90% confidence interval for the ratio of the logarithmic tranformed AUC0-00 values of Beatrolol over those of Betaloc was found to lie between 0.93 and 1.07, which is within the acceptable equivalence limit of 0.80-1.25. From the data obtained, it also appeared that a relatively high proportion of our volunteers were poor metabolizers of metoprolol. The mean elimination half-life (t1/2), was found to be relatively larger than those report...

A novel multiparticulate matrix controlled release preparation of theophylline was formulated and evaluated in-vitro. The preparation which consisted of spherical drug pellets in a size range of 1.18-1.70 mm diameter was produced using an extrusion-spheronisation technique. The drug was embedded in a mixture of nonsoluble matrix materials forming the pellets to control the drug release. For this purpose, microcrystalline cellulose (MCC) and its mixture with glyceryl monostearate (GMS) were evaluated. When microcrystalline cellulose was used alone, the drug release was not sufficiently sustained and was essentially complete within 6 hours. However, incorporation of glyceryl monostearate significantly retarded the rate of drug release. Moreover, the rate of drug release could be readily modified in a predictable manner by varying the amount of glyceryl monostearate. The rate of the drug release was relatively insensitive to changes in the drug to matrix ratio. Drying of the drug pellets at temperatu...

Hoe Siong Chiong,1 Yoke Keong Yong,1 Zuraini Ahmad,1 Mohd Roslan Sulaiman,1 Zainul Amiruddin Zakaria,1 Kah Hay Yuen,2 Muhammad Nazrul Hakim1,31Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia; 2School of Pharmaceutical Sciences, Universiti Sains Malaysia, Gelugor, Malaysia; 3Sports Academy, Universiti Putra Malaysia, Serdang, MalaysiaBackground: Liposomal drug delivery systems, a promising lipid-based nanoparticle technology, have been known to play significant roles in improving the safety and efficacy of an encapsulated drug.Methods: Liposomes, prepared using an optimized proliposome method, were used in the present work to encapsulate piroxicam, a widely prescribed nonsteroidal anti-inflammatory drug. The cytotoxic effects as well as the in vitro efficacy in regulation of inflammatory responses by free-form piroxicam and liposome-encapsulated piroxicam were evaluated using a lipopolysaccharide-sensitive macrophage cell line, RAW 264.7.Results: Cells treated with liposome-encapsulated piroxicam demonstrated higher cell viabilities than those treated with free-form piroxicam. In addition, the liposomal piroxicam formulation resulted in statistically stronger inhibition of pro-inflammatory mediators (ie, nitric oxide, tumor necrosis factor-α, interleukin-1β, and prostaglandin E2) than piroxicam at an equivalent dose. The liposome-encapsulated piroxicam also caused statistically significant production of interleukin-10, an anti-inflammatory cytokine.Conclusion: This study affirms the potential of a liposomal piroxicam formulation in reducing cytotoxicity and enhancing anti-inflammatory responses in vitro.Keywords: liposomes, nitric oxide, cytokines, prostaglandin E2, interleukin-1β, piroxicam