Pharmacokinetic Comparison of Omeprazole Granule and Suspension Forms in Children: A Randomized, Parallel Pilot Trial.

Although, omeprazole is widely used for treatment of gastric acid-mediated disorders. However, its pharmacokinetic and chemical instability does not allow simple aqueous dosage form formulation synthesis for therapy of, especially child, these patients. The aim of this study was at first preparation of suspension dosage form omeprazole and second to compare the blood levels of 2 oral formulations/dosage forms of suspension & granule by high performance liquid chromatography (HPLC). The omeprazole suspension was prepared; in this regard omeprazole powder was added to 8.4% sodium bicarbonate to make final concentration 2 mg/ml omeprazole. After that a randomized, parallel pilot trial study was performed in 34 pediatric patients with acid peptic disorder who considered usage omeprazole. Selected patients were received suspension and granule, respectively. After oral administration, blood samples were collected and analyzed for omeprazole levels using validated HPLC method. The mean omeprazole blood concentration before usage the next dose, (trough level) were 0.12±0.08 µg/ml and 0.18±0.15 µg/ml for granule and suspension groups, respectively and mean blood level after dosing (C2 peak level) were 0.68±0.61 µg/ml and 0.86±0.76 µg/ml for granule and suspension groups, respectively. No significant changes were observed in comparison 2 dosage forms 2 h before (P=0.52) and after (P=0.56) the last dose. These results demonstrate that omeprazole suspension is a suitable substitute for granule in pediatrics.

Patulin in apple leather in Iran.

Apple leather is made by dehydration of cooked fruit into leathery sheets. Mould growth and patulin production can occur in damaged apples or when fallen fruit is collected for apple leather processing. A survey was conducted to determine levels and dietary intake of patulin from apple leather marketed in Iran. Patulin was detected in all samples at concentrations ranging from <10 to 2559 µg/kg. Mean patulin concentration was 620 µg/kg and 91.4% of the samples had levels higher than 50 µg/kg. Estimated daily intake (EDI) of patulin for adults and children considering the mean concentration of patulin obtained in this study (620 µg/kg) were higher than the provisional maximum tolerable daily intake (PMTDI) of 0.4 µg/kg bw/day for patulin that has been established by the Joint FAO/WHO Expert Committee on Food Additives. This indicated the need for stricter control and improvement in processing techniques to reduce the incidence of patulin in apple leather.

A rapid and sensitive microscale HPLC method for the determination of indomethacin in plasma of premature neonates with patent ductus arteriousus.

Indomethacin (IND) is the drug of choice for the closure of a patent ductus arteriosus (PDA) in neonates. This paper describes a simple, sensitive, accurate and precise microscale HPLC method suitable for the analysis of IND in plasma of premature neonates. Samples were prepared by plasma protein precipitation with acetonitrile containing the methyl ester of IND as the internal standard (IS). Chromatography was performed on a Hypersil C(18) column. The mobile phase of methanol, water and orthophosphoric acid (70:29.5:0.5, v/v, respectively), was delivered at 1.5 mL/min and monitored at 270 nm. IND and the IS were eluted at 2.9 and 4.3 min, respectively. Calibrations were linear (r>0.999) from 25 to 2500 microg/L. The inter- and intra-day assay imprecision was less than 4.3 % at 400-2000 microg/L, and less than 22.1% at 35 microg/L. Inaccuracy ranged from -6.0% to +1.0% from 35 to 2000 microg/L. The absolute recovery of IND over this range was 93.0-113.3%. The IS was stable for at least 36 h when added to plasma at ambient temperature. This method is suitable for pharmacokinetic studies of IND and has potential for monitoring therapy in infants with PDA when a target therapeutic range for IND has been validated.