Effects of Cooking Processes on Breath Hydrogen and Colonic Fermentation of Soybean

Background: Soybean is rich in dietary fibers; consequently, soybean ingestion considerably increases the breath level of hydrogen molecules via anaerobic colonic fermentation. However, the influence of cooking methods on this effect, which can affect the overall health benefits of soybean, remains unknown. Objectives: The aim is to examine whether different methods of cooking soybean affect the colonic fermentation process. Methods: Nine healthy adult volunteers participated in the study; they ingested either roasted soybean flour (kinako) or well-boiled soybean (BS). Differences in their breath components were compared. Both test meals were cooked using 80 g of soybeans per individual. After a 12 h fast, the participants ate the test meals, and their breath hydrogen level was analyzed every 1 h for 9 h by using a gas chromatograph with a semiconductor detector. In addition, particle size distribution and soluble/ insoluble fibers in the feces were examined. Results: The oro-cecal transit time did not significantly differ between individuals who ingested kinako and BS. However, the area under the curve between 7 and 9 h after the ingestion of BS was significantly increased compared with that after the ingestion of kinako. The nutritional analysis indicated that the content of both soluble and insoluble fibers in BS was higher than that in kinako. In addition, the levels of unfermented fragments and soluble/insoluble fibers in the feces were increased after the ingestion of kinako compared with those after the ingestion of kinako. Conclusion: Cooking methods alter the composition of non-digestible fibers in soybean, and this can result in the lack of fermentative particles in the feces, thereby causing alterations in the breath level of hydrogen via colonic fermentation.

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Relative bioequivalence of amoxicillin dissolved in breast milk

Archives of Disease in Childhood ◽

10.1136/archdischild-2013-305151 ◽

2013 ◽

Vol 99 (3) ◽

pp. 258-261

Author(s):

Parvaneh Yazdani-Brojeni ◽

Facundo Garcia-Bournissen ◽

Hisaki Fujii ◽

Reo Tanoshima ◽

Shinya Ito

Keyword(s):

Breast Milk ◽

Human Milk ◽

Healthy Adult ◽

Area Under The Curve ◽

Pharmacokinetic Parameters ◽

Fasting State ◽

Oral Antibiotics ◽

Liquid Chromatography Mass Spectrometry ◽

Antibiotics Use ◽

Adult Volunteers

BackgroundOral antibiotics use in infants in developing countries is challenging because liquid formulations are often unavailable. However, dissolving solid formulation of drugs in water poses a risk of gastrointestinal infection. Although mother's milk may be a potential vehicle, no evidence exists to indicate that antibiotics dissolved in human milk are bioequivalent to those dissolved in water. Therefore, we compared pharmacokinetic parameters of an orally administered antibiotic, amoxicillin, dissolved in human milk, to those of water-dissolved amoxicillin.MethodsA pharmacokinetic study was conducted in 16 healthy adult volunteers in a randomised crossover design. Marketed amoxicillin powder for suspension was dissolved in either human milk or water at a final concentration of 50 mg/mL, and 10 mL was given orally in a fasting state. Timed blood samples were obtained and plasma amoxicillin was quantified using liquid chromatography-mass spectrometry.FindingsResults showed that pharmacokinetic parameters, including area-under-the-curve, Cmax and half-life of the water-based and milk-based amoxicillin administration were not significantly different. 90% CIs of the ratios of these parameters in concomitant breast milk administration to those of water were within 89% and 116%, suggesting they are bioequivalent (defined as a range between 80% and 125%).InterpretationWe conclude that oral administration of amoxicillin dissolved in human milk at 50 mg/mL results in pharmacokinetics profiles comparable to amoxicillin dissolved in water. Pharmaceutical interactions between amoxicillin and breast milk are unlikely, suggesting no need to modify dosing schedules.

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Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00400-20 ◽

2020 ◽

Vol 64 (8) ◽

Cited By ~ 1

Author(s):

George R. Thompson ◽

Phoebe Lewis ◽

Stuart Mudge ◽

Thomas F. Patterson ◽

Bruce P. Burnett

Keyword(s):

Steady State ◽

Healthy Adult ◽

Area Under The Curve ◽

Drug Level ◽

Loading Dose ◽

Open Label ◽

Subsequent Dose ◽

State Administration ◽

Dose Study ◽

Adult Volunteers

ABSTRACT Super bioavailability (SUBA) itraconazole (S-ITZ), which releases drug in the duodenum, and conventional itraconazole (C-ITZ), which releases drug in the stomach, were compared in two pharmacokinetic (PK) studies: a 3-day loading dose study and a 15-day steady-state administration study. These were crossover oral bioequivalence studies performed under fed conditions in healthy adult volunteers. In the loading dose study, C-ITZ (two doses of 100 mg each) and S-ITZ (two doses of 65 mg each) were administered three times daily for 3 days and once on day 4 (n = 15). For the steady-state administration study, C-ITZ (two doses of 100 mg each) and S-ITZ (two doses of 65 mg each) were administered twice daily for 14 days and a last dose was administered 30 min after a meal on day 15 (n = 16). Blood samples collected throughout both studies were analyzed for ITZ and hydroxy-ITZ (OH-ITZ) levels. Least-squares geometric means were used to compare the maximum peak concentration of drug after administration at steady state prior to administration of the subsequent dose (Cmax_ss), the minimum drug level after administration prior to the subsequent dose (Ctrough), and the area under the curve over the dosing interval (AUCtau) of each formulation. The ratios of itraconazole (ITZ) and OH-ITZ for S-ITZ to C-ITZ were between 107% and 118% in both studies for Cmax_ss, Ctrough, and AUCtau, which were within the U.S. FDA-required bioequivalence range of 80% to 125%. At the end of the steady-state administration study, 13 of 16 volunteers obtained higher mean ITZ blood Ctrough levels of >1,000 ng/ml when they were administered S-ITZ (81%) than when they were administered C-ITZ (44%). The study drugs were well tolerated in both studies, with similar adverse events (AEs). All treatment-emergent AEs resolved after study completion. One volunteer receiving C-ITZ discontinued due to a treatment-unrelated AE in the steady-state administration study. No serious AEs were reported. Total, trough, and peak ITZ and OH-ITZ exposures were similar between the two formulations. Therefore, SUBA-ITZ, which has 35% less drug than C-ITZ, was bioequivalent to C-ITZ in healthy adult volunteers and exhibited a safety profile similar to that of C-ITZ.

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