Comparing two treatment methods of Vitamin E suppository and conjugated estrogen vaginal cream on the quality of life in menopausal women with vaginal atrophy

Menopause is one of the most critical stages in a woman's life. Special attention needs to be paid to the quality of life of menopausal women. Symptoms of genitourinary atrophy can affect women's comfort and quality of life. The aim of this study was to compare two treatment methods of vitamin E suppository and conjugated estrogens vaginal cream on the quality of life of menopausal women with vaginal atrophy. This clinical trial was performed on 52 menopausal women [40-65 years old], referring to the gynecology clinic of Ghaem Hospital, Mashhad, Iran in 2013. Women were randomly assigned to two groups to use either conjugated estrogens vaginal cream or vitamin E suppository for 12 weeks. Women's quality of life was measured in both groups before the study and 4, 8 and 12 weeks after the interventions. Data collection tools included a demographic questionnaire and Menopause-Specific Quality of Life [MENQOL] questionnaire. Fisher's exact test, repeated measures ANOVA, Mann-Whitney and t-test were performed to analyze data, using SPSS version 11.5. The mean scores of quality of life before intervention and after 4, 8 and 12 weeks of therapy were 70.03 +/- 26.34, 53.96 +/- 23.75, 43.03 +/- 20.62 and 33 +/- 18.26 in vitamin E suppository group, respectively. These values in the estrogen cream group were 64 +/- 27.83, 50.76 +/- 21.51, 37.23 +/- 20.96 and 29.53 +/- 18.65, respectively. Comparison of quality of life scores between the two groups did not show a statistically significant difference [P>0.05]. The two groups were not significantly different in terms of the effectiveness of two methods of therapy. Therefore, it seems that vitamin E suppository could be used as an effective method for the improvement of quality of life in patients with vaginal atrophy

PLGA nanospheres loaded with autoclaved leishmania major [ALM] and CPG-ODN: preparation and in vitro characterization

Several antigens, adjuvants and delivery systems have been evaluated for induction of protective immune responses against Leishmaniasis, but most of them have been inefficient. In this study, PLGA nanospheres as antigen delivery system CpG-ODN as an immunoadjuvant for increasing the immune responses against Autoclaved Leishmania major [ALM] were prepared and characterized. PLGA nanospheres prepared by a double-emulsion [W/O/W] technique. The internal aqueous phase contained ALM and CpG-ODN, while the oily phase contained the solution of PLGA in dichloromethan and the external aqueous phase was PVA 7.5% [WIV] solution. Particulate characteristics were studied by scanning electron microscopy and particle size analysis. The encapsulation efficiency was determined by Lowry method for ALM and UV spectroscopy at 260 nm for CpG-ODN. The release profiles of antigen and CpG-ODN from nanospheres evaluated for one week. Nanospheres were spherical in shape, having smooth surfaces. Mean diameters for blank and ALM + CpGODN loaded nanospheres recorded as 302 +/- 129 and 333 +/- 128 nm respectively. Also, the encapsulation efficiencies of ALM and CpG-ODN were 71.6 +/- 8.8 and 49.1 +/- 2.4%, respectively. Evaluation of the release profiles of ALM and CpG-ODN from nanospheres showed that 44.8 +/- 0.8% of ALM and 29.5 +/- 0.2% of CpGODN released from nanospheres in one week. The prepared nanospheres with desirable size, encapsulation efficiency, and slow rate of release, had acceptable features for future in vivo studies

Evaluation of the clearance characteristics of liposomes in the human nose by gamma-scintigraphy

The nasal cavity possesses many advantages as a site for drug delivery, such as, ease of administration, applicability for long term treatments and a large surface area for absorption. One important limiting factor for nasal drug delivery is the limited time available for absorption within the nasal cavity due to mucociliary clearance. Several drug delivery systems including different kinds of microspheres and liposomes have been tried for encapsulation of drugs and increasing the residence time in nasal cavity. In this study the clearance rate of three kinds of liposomes: neutral [phosphatidylcholin [PC] and cholesterol [Chol]], cationic [PC, Chol and stearylamine] and fusogenic [PC, Chol, dioleoyl phosphatidylethanol amine] was determined by gamma scintigraphy with lactose powder being used as negative control. Liposomes were prepared by dehydration-rehydration method. 99mTc labeled liposomes were prepared using technetium pertechnetate in the presence of a potent reducing agent, stannus chloride. The labeling procedure was set in a manner that each 150 ml of liposome suspensions contained 2 MBq of radioactivity. Labeling efficiency was calculated by paper chromatography using acetone as mobile phase. Each delivery system containing 2 MBq of activity was sprayed into right nostril of four healthy volunteers and one-minute static views were repeated each half hour until 4 hours. Clearance rates were compared using two Regions of Interest [ROIs]; the initial site of deposition of particles, and all of nasopharynx region. The clearance rate of each one of liposomes was calculated after applying the physical decay corrections. The mean labeling efficiencies for neutral, cationic and fusogenic liposomes were calculated as 91%, 20% and 69%, respectively. The cleared percent of preparations from nasopharynx region after 4 hours was determined as follows: neutral liposomes 18 +/- 2.9%; fusogenic liposomes 53.5 +/- 1.2%; cationic liposomes 69.7 +/- 4.2%; lactose powder 74.5 +/- 4.9%. Neutral liposomes showed the lowest clearance rate compared to lactose powder [P<0.0001], followed by fusogenic liposomes [P<0.01] and cationic liposomes [P<0.05]. The clearance profiles of formulations from deposition ROI and nasopharynx ROI were identical. This study shows the neutral liposomes have the highest mucoadhesion properties and are suitable nasal delivery systems. Furthermore, this study proves that limiting step for the nasal clearance of nasally administered particulate systems is their dislocation from the initial site of deposition, and their following interactions with mucus layer in the rest of nasal passage does not significantly affect the clearance time

effects of polysorbate surfactants on the structure of mucus glycoproteins

A dynamic oscillatory technique was used to assess the effect of polysorbate non-ionic surfactants on mucus rheology. Adherent mucus gel was scraped from the surface mucosa of pig stomachs and purified by gel exclusion chromatography followed by ultrafiltration and gelation. Rheological measurements of this gel were carried out on a Carri-Med Controlled Stress Rheometer. Appropriate volumes of surfactant solution were added to weighed samples of mucus gel so that a final concentration of 20 mM surfactant was achieved in a gel containing 8% w/w solids content. Polysorbate 20 [PS20], polysorbate 40 [PS40], polysorbate 60 [PS60] and polysorbate 80 [PS80] all decreased both storage [elastic] modulus G' and loss [viscous] modulus G" significantly at 10 Hz [P<0.05, ANOVA]. The extent of rheological changes induced by the four polysorbates could be ranked as: PS80>PS20>PS60>PS40. The mechanisms by which surfactants disturb the mucus structure are not fully understood, nonetheless, they could possibly affect the mucus gel properties by causing depletion of the glycoprotein constituents such as non-mucin proteins and mucin associated lipids. This might lead to the conclusion that polysorbates, by reducing the viscoelasticity of mucus gel could alleviate its barrier properties and facilitate the diffusion of concomitantly administered drugs via mucus gel