Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis

Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.     

Microbial contamination of donor eyes

A total number of 1,516 donor eyes received from various sources during the years 1973-1985 were subjected to the isolation of bacterial contamination. The bacterial cultures taken from the pretreatment eyeball showed culture growth in 366 (24.1%) eyes. Of the 366 positive cultures, 331 (21.8%) were bacterial and 35 (2.3%) were fungal. Amongst the bacterial the major contamination was by staphylococcus aureus and albus and pseudomonas aeruginosa. Gentamicin was found to be the most sensitive antibiotic against a wider group of organisms, the next being chloramphenicol. Thus, treatment of a cadaver eye with a solution of normal saline containing 0.1-0.5 mg/ml of gentamicin is recommended before and after the donor eye is enucleated.     

Evaluation of Depression and Quality of Life in Patients With Psoriasis

Objective::To measure the prevalence of depression in patients with psoriasis and to evaluate the relationship between the severity of psoriasis and depression ...     

β-galactoside prodrugs of doxorubicin for application in antibody directed enzyme prodrug therapy/prodrug monotherapy

Anthracycline antibiotics, particularly doxorubicin and daunorubicin, have been used exten sively in the treatment of human malignancies. However cardiotoxicity and multidrug resistance are significant problems that limit the clinical efficacy of such agents. Rational design to avoid these side effects includes strategies such as drug targeting and prodrug synthesis. Described here are the synthesis and preliminary biological evaluation of the enzymatically activated two new prodrugs (6 & 11) of doxorubicin. These prodrugs were designed as potential candidates for selective chemotherapy in ADEPT or PMT strategies. They are constituted of a galactose moiety, a spacer and the cytotoxic drug and they differ by the type of spacer. The prodrugs were stable in a buffer, and the in vitro studies showed good detoxification and hydrolysis kinetics. As prodrug 11 was readily hydrolyzed, this could be a valuable candidate for further development.     

Development and in vitro cytotoxic evaluation of parenteral docetaxel lipid nanoemulsions for application in cancer treatment

The aim of the present study was to develop stable lipid nanoemulsions (LNEs) for delivery of docetaxel for treatment of cancer. The LNEs of docetaxel were prepared by using olive oil and egg lecithin by hot homogenization followed by ultrasonication. The influence of formulation variables such as change in proportion of charge inducers, that is, oleic acid (negative) and stearyl amine (positive), was studied. Stable LNEs of docetaxel having the mean size range of 190-230 nm and zeta potential of -19.2 to -31 mV in the case of oleic acid emulsions and 49.5 to 50.5 mV in the case of stearyl amine emulsions were developed. There was considerable increase in zeta potential value on increasing concentration of oleic acid, whereas no such effect was observed on increasing stearyl amine concentration. During in vitro studies the cumulative amount of docetaxel released from LNE (control emulsion), LNE-O1, LNE-O2, LNE-O3, LNE-S1, LNE-S2, and LNE-S3 was determined. The results indicated that there was no significant effect in varying the concentration of charge inducers on size and in vitro cumulative release of prepared LNEs at 12 h. The optimized formulations were identified as LNE-O3 and LNE-S3 based on relative stabilities during centrifugal stress, dilution stress, and in storage at room temperature. The total drug content and entrapment efficiency of LNE-O3 were found to be 0.96 ± 0.02 mg/mL and 96.35 ± 1.21%, respectively, whereas for LNE-S3 the total drug content and entrapment efficiency were 0.97 ± 0.01 mg/mL and 97.07 ± 0.82%, respectively. During in vitro studies on cancer cell lines both of the optimized formulations, LNE-O3 and LNE-S3, showed similar values of IC50 (half maximal inhibitory concentration) in comparison to docetaxel solution. Based on this, it was concluded that the optimized LNEs were efficacious for the delivery of docetaxel and could act as alternative delivery systems to overcome the poor solubility, hydrolytic instability, and drug-induced and vehicle-related side effects of docetaxel.