Drug abuser patients (n=104), age ranging from 19 to 42 years, were randomly recruited to investigate the serum levels of trace elements (Cu, Zn, Fe, and Mg), malondialdehyde (MDA), and immunoglobulin (IgG, IgA, and IgM) before and after clinical intervention. Control group also included 104 healthy individuals. Blood samples were analyzed for determining trace elements, MDA, and immunoglobulin using atomic absorption spectroscopy, Ultraviolet-Visible (UV-VIS) spectroscopy, and turbidimetry method, respectively. For serum level of Zn and Fe, the differences between the groups (before intervention, after intervention, and control) were not significant (p>0.05). However, significant differences were found in serum copper levels between control group, drug abuser patients, and before and after intervention (p<0.05). The concentration of Mg was found to be significantly higher (p=0.007) in drug abuser patients than the controls, and after intervention, the level was restored to control value. A displacement of elemental homeostasis was observed in drug abuser patients compared to control, and it was improved after intervention. An increase in serum concentration of MDA was found in drug abuser patients compared to control subjects (p>0.05) but was not statistically significant. After intervention, the concentration was restored to control value (p>0.05). The serum concentrations of IgA and IgM were found to be significantly higher (p<0.05) in drug abuser patients before intervention than the controls, and the level tended to be restored to control level after clinical intervention. Serum IgG level was found to be lower in drug abuser patients compared to controls and further declined significantly (p<0.05) after intervention. These findings may suggest a possible imbalance in the levels of micronutrients, antioxidants, and immunoglobulin in drug abuser patients, which tend to be restored to control values after detoxification.

No abstract

Omeprazole (CAS 73590-58-6) effectively suppresses the gastric acid secretion in the parietal cells of the stomach and is a widely prescribed proton pump inhibitor in Bangladesh. The increasing number of omeprazole containing products available in the market raises questions of therapeutic equivalence and/or generic substitution which are yet to be conducted with Bangladeshi population. The aim of the study is to assess the bioequivalence and pharmacokinetic properties of two oral formulations of 20 mg omeprazole capsule, the reference product and Omep-20 as test product using serum data. The randomized, two-way crossover study was conducted on 24 healthy male subjects in compliance with the Declaration of Helsinki and ICH guidelines. Subjects were assigned to receive test and reference as a single dose of 20 mg capsule under fasting condition, following a washout period of one week. After oral administration, blood samples were collected at various time intervals and analyzed for omeprazole concentrations using a validated HPLC method. The pharmacokinetic parameters were determined by non-compartmental method. From serum data, the obtained values for test and reference products were 648.07 +/- 216.27 and 632.69 +/- 257.01 ng/ml for Cmax; 2012.24 +/- 634.48 and 1907.86 +/- 761.91 ng x h/ml for AUC0-24; 2105.21 +/- 623.79 and 1979.18 +/- 748.12 ng x h/ml for AUC0-infinity respectively. No statistically significant differences were observed between two formulations by analyzing different pharmacokinetic parameters in terms of period, sequence or formulation. From the paired t-test, no significant differences between two formulation were observed (p > 0.05). The 90% confidence intervals of Cmax, AUC0-24 and AUC0-infinity were found to be 91.59% to 122.60%, 101.86% to 116.78% and 102.77% to 116.68% respectively which are within the FDA accepted limits for bioequivalence (80%-125 %). Finally it can be concluded that both products are bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable.

ABSTRACT:The purpose of the study was to develop a simple, sensitive and rapid RP-HPLC method for the determination of desloratadine in marketed products. Chromatographic determination was performed in a reverse phase C 18 column (250 mm × 3.3 mm I.D. , 5µm particle size) using a mixture of acetonitrile ‫׃‬ n-pentane sulphonic acid sodium salt monohydrate, adjusted to pH 3.0± 0.05 with phosphoric acid ‫׃06(‬ 40 v/v) as mobile phase and delivered at a flow rate of 1 ml/min. The UV detection was set at 254 nm. The calibration range was from 2.0 to 40 µg/ml. The method was validated in term of linearity (r 2 >0.98, RSD= 1.958%), precision (RSD=3.757 %) and accuracy (deviation<2.653%, RSD< 2.203%). The limit of quantification was 2 µg/ml and the limit of detection was 0.1 µg/ml. The linear ranges of desloratadine were 20.23 ± 0.368 µg/ml and 6.545 ± 0.0495 µg/ml in tablet (potency = 99.175 ± 0.718 %) and syrup (potency = 101.15 ± 1.838 %) respectively. The potency of desloratadine in marketed products was determined by this method with acceptable precision and reproducibility.

The objective of this study was to compare different pharmacokinetic parameters of a local (“X”) and reference (Tavanic) formulations of levofloxacin 250 mg tablets after oral administration of a single dose under fasting condition. Thirteen blood samples were collected from each of the eight Bangladeshi healthy male volunteers over 24 hours after oral administration of the drugs. Serum levofloxacin concentrations were determined by HPLC assay using UV detection, and pharmacokinetic parameters were determined by the non-compartmental method. Mean ± SD of Cmax, AUC0-24, AUC0-α, Tmax, t1/2, kel, were 4.33 ± 1.16 and 4.56 ± 1.51 ?g/mL, 45.90 ± 8.74 and 37.77 ± 9.94 hr-?g /mL, 79.94 ± 32.80 and 66.85 ± 35.43 hr-?g/mL, 1.22 ± 0.49 and 1.28 ± 0.41, 19.90 ± 11.49 and 21.00 ± 16.39 hr, 0.04 ± 0.02 and 0.05 ± 0.03 hr -1 for the local (“X”) and reference formulation, respectively. From the paired t-test, the p-values for two formulations were found to be 0.182, 0.412 and 0.725 for AUC0-24, AUC0-α, and Cmax respectively. The 90% confidence intervals of the mean of the difference between log-transformed values for Cmax were almost within the bioequivalence accepted range of 80% to 125%, namely: (78.90%, 118.36%); but for AUC0-24 and AUC0-α the values were are beyond the acceptable range. (100.83%, 146.52%) and (94.34%, 157.89%) respectively. The results indicate that the two formulations are not bioequivalent for both the rate and extent of absorption. Key words: Levofloxacin, pharmacokinetic, bioavailability, bioequivalence Dhaka Univ. J. Pharm. Sci. Vol.5(1-2) 2006 The full text is of this article is available at the Dhaka Univ. J. Pharm. Sci. website