jpans
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Abstract: Peginterferon α-2a (20kDa) derived from Hansenula Polymorpha is a distinct variety of peginterferons (PEG-IFN). A pilot study of this drug was conducted on healthy human subjects to evaluate its safety and pharmacokinetic behavior in local population. With due approval of the IEC operating under ICH-GCP guidelines; ten healthy male subjects were selected randomly from the Pakistani population after thorough screening and signing of the Informed consent for an open label, single dose study.Each subject received a subcutaneous injection of the drug (180µg) in abdominal skin and blood samples were collected at 0 and 1, 2, 3, 6, 12, 24, 36, 60, 84, 108, 132 and 156 hours, andanalyzed by a validated ELISA method for peginterferon α-2a (20kDa), Unipeg®. The Mean ± SEM (standard error of mean) PK parameters were found to be: Cmax: 18.67±2.92 ng/ml (7.05-34.51); AUC0-∞: 1440±113 h.µg/l] (969-2101); Absorption Half-Life: 17.02±2.06 h (10.37-29.26), elimination half life: 41.437±6.21 h (18.51-78.97 h); volume of distribution 8.933±1.72 L (4.81-18.34), clearance: 112.6±8.21 ml/h (71.96–155.96). The safety of the drug was evaluated by observation of adverse effects and evaluating the change in general health parameters, hematological and biochemical test results during and after the study. No Sever Adverse Effect was observed however the most common adverse event (AE) was the fever; observed in all volunteers (n=10), headache (6), Fatigue (5), Vomiting (4) and diarrhea, loss of appetite, body ache was observed in 3 volunteers. Three out of ten volunteers demonstrated decrease in WBC and platelets count. Changes observed in hematology returned to normal values within 16 days. The safety profile of UNIPEG® was found to be very similar to those of reported in literature for unmodified IFNs and other pegylated interferons generally used in therapy. Future clinical trials are recommended to further establish the safety profile and pharmacokinetics. Keywords: PEG-IFN-α-2a, 20-kDa, Unipeg, Peginterferon alfa-2a, pharmacokinetics, clinical trial, safety.Download Full Article |
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Abstract: Diabetes mellitus is a chronic endocrine diseased condition reflected by higher level of blood glucose which is due to less insulin production, insulin action or both. Bittergourd juice consumption is being traditionally practiced for the treatment of diabetes mellitus in developing country such as India, but not supported through clinical data and highly bitter juice is difficult to drink. Therefore bittergourd fermented beverage with improved nutritional strength and taste was developed and supplemented to diabetic subjects and the evaluation was carried out. The evaluation of the bittergourd fermented beverage, in the first stage was carried out by supplementing the beverage to 30 diabetic subjects as an early morning drink in fasting conditionand the control group was asked to drink water. The fasting and post prandial blood sugar levels were studied and diabetic symptoms were noted. The impact of supplementation of bittergourd fermented beverage on diabetic subjects showed that subjects had significant improvement in reducing the symptoms of diabetes, as well reduced the fasting and post prandial glucose levels by 31% and 25% respectively when compared with the control group. Further 16 diabetic subjects who expressed their consent were given the bittergourd fermented beverage for a period of 5 months and the results of the long duration supplementaion indicated that there was a reduction of fasting blood glucose by 43% and post prandial blood glucose by 41% reflecting advantage of continued consumption of the beverage. In order to understand the direct action of the beverage on blood lipid profile–serum cholesterol, triglycerides, low density lipoprotein cholesterol, high density lipoprotein cholesterol as measured before and after supplementation showed the changes by 4-7% which is not considerable. However the glycoslated haemoglobin indicated encouraging results after the supplementation showing good control from fair control. Therefore, the study clearly reflected the positive effect of bittergourd fermented beverage in reducing and controlling blood sugar levels. Keywords: Bittergourd fermented beverage, diabetes, supplementation, biochemical parameters.Download Full Article |
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Abstract: This research aims at investigating the acidity of candies commonly consumed by children and teenagers. Eight flavors of candy produced by the brand Halls Kraft Foods Brazil Ltda.®: cherry, extra strong, watermelon, strawberry, mint, menthol, wild strawberry and chantilly cream strawberry were analyzed. The candies were crushed. Five grams of crushed candy were added to 10 ml of doubly deionized water and stirred until all candy was dissolved. The pH was measured in triplicate using a potentiometer and combined glass electrode (Tec-2 Tecnal). Fifteen grams of crushed candy were added to 30 ml doubly deionized water. The titratable acidity was measured by adding 100 μl of 0.1 M NaOH to the solution under constant stirring until a pH of 5.5 was reached. This procedure was performed for each of the flavors. Mineral water was used as a negative control and citric acid as positive control. The results were statistically analyzed by the Variance Analysis (ANOVA). Comparisons of means were performed by the Scott Knott Test, at a 5% level of significance (p <0.05). The results showed that all candies had pH values below 5.5, ranging from 3.6 to 5.2. These values were significantly different from the positive and negative controls. The flavors Chantilly Cream Strawberry and Wild Strawberry have shown to be the candies with highest erosive potential due to their lower pH values and higher intrinsic buffer capacity. It is concluded that the candies have erosive potential and their frequent use can contribute to the development of dental erosion. Keywords: Candy, dental erosion, erosion potential, hydrogen-ion concentration, acidity.Download Full Article |
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Abstract: Gentamicin (Gen) is widely used against serious infections, but its therapeutic use is limited due to its nephrotoxicity which causes acute renal failure. We aimed to evaluate the potential protective effect of highly selective angiotensin II (Ang II) type 1 (AT1) receptor blocker Telmisartan (Tel) on the renal damage generated by Gentamicin in rats. 36 Male Wistar rats were divided into six groups (6 rats each): Naive, Tel group (10 mg/kg/day orally for 7 days), control (1 ml/day 0.9% NaCl intraperitoneally i.p. for 7 days), Gen group (100 mg/kg/day i.p for 7 days), Gen + Tel 5 mg/kg/day concurrently for 7 days, Gen + Tel 10 mg/kg/day concurrently for 7 days. Concentrations of serum urea, serum creatinine, and renal reduced glutathione (GSH) levels were evaluated after treatment. Gen was observed to cause a severe nephrotoxicity, which was evidenced by an elevation of serum urea and creatinine levels which weren’t altered by simultaneous treatment with Tel. The oxidative stress caused by Gen demonstrated by a decrease in renal GSH level was significantly attenuated by Telmisartan (the higher dose). Conclusion: This study proves the nephrotoxicity caused by Gentamicin, and suggests that concurrent treatment with Telmisartan ameliorate oxidative stress induced by gentamicin without changes to serum urea and creatinine. Keywords: Nephrotoxicity, Gentamicin, Telmisartan, Oxidative Stress, Rat. |
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Abstract: Although cereals and pseudocereals are deficient in some basic components, fermentation process is the most economical and simple way, how to improve nutritional value, functional qualities and sensory properties of the final products. In our study, we focused on the evaluation of amaranth flour for preparation of new probiotic functional foods suitable for celiac patients. That is why the growth dynamics of several Lactobacillus sp. in amaranth mashes were evaluated. All the monitored strains showed sufficient growth in mashes (growth rates of lactobacilli ranged from 0.73 to 1.52 h-1). Based on the rates, only Lb. rhamnosus VT1 was able to grow with the values higher than 1.38 h-1 in both milk and water based mashes. In the second part of our study, we described behaviour of Lb. rhamnosus GG in amaranth water- or milk- based mashes after 8 h of co-cultivation with Fresco DVS 1010 culture (37 ± 1 °C, 5 % CO2). Final counts after the fermentation reached values 108 CFU.ml-1 and no decrease was recorded during 2-week storage period at 6 ± 1 °C. Thus we may conclude that densities of lactobacilli were able to maintain above the limit of >106 CFU.ml-1 essential from the legislation point of view. Keywords: |