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PubMed2002

Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers.

A new modified release (MR) formulation containing 30 mg of gliclazide was developed to obtain a better predictable release of the active principle and to allow once-daily dosing regimen. An absolute bioavailability study was carried out to characterise the performance of the new formulation and the food-effect was also investigated in a separate study. Both studies were single dose, randomised, open label, two way cross over studies with a wash out period between doses. For the bioavailability study, each volunteer received 30 mg of gliclazide given either as a 1 h intravenous infusion or as a 30 mg MR tablet. For the food-effect study, the treatment was given either fasted or 10 min after the start of a standardised Melander breakfast. Blood samples were collected up to 72 h after administrations and plasma samples assayed for gliclazide concentrations using a reverse-phase HPLC method with UV detection. Mean absolute bioavailability of gliclazide was 97% and ranged between 79 and 110% showing complete absorption. A similar moderate to low variability was observed after IV and oral administration showing the MR formulation did not add to the overall variability which is solely due to the disposition parameters, in particular metabolism of gliclazide. No significant difference was observed in t(max), t(1/2z), C(max) and AUC of gliclazide after administration of the 30 mg MR tablet under fasted and fed conditions. In conclusion, after single oral administration of a 30 mg MR tablet, gliclazide was completely absorbed both under fasted and fed conditions. A consistent and optimal release of gliclazide from this formulation leads to a low to moderate overall variability of its pharmacokinetic parameters. Diamicron 30 mg MR can be given without regards to meals i.e. before, during or after breakfast.

Administration, Oral↗

PubMedDate not supplied

Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study.

OBJECTIVE: Proof-of-concept study of evaluation of metabolic effect of novel oral spray insulin (Oralin) formulation at breakfast time in subjects with type 2 diabetes on multiple daily injections. RESEARCH DESIGN AND METHODS: This was an open-label, crossover, randomized study in (n = 23) subjects with type 2 diabetes on multiple daily injections. Subjects received each treatment, in random order, 3 to 7 days apart-a daily dose of SC injection (0.1 u/kg) on one occasion and Oralin spray (100 u) at time 0 min on another occasion. Subjects were given a standard breakfast containing 360 cal (Sustacal liquid meal) 10 min after the dose. Blood samples were taken at regular intervals to measure glucose, insulin, and C-peptide. RESULTS: The 30- and 60-min postprandial glucose levels were significantly lowered with Oralin versus that with the injection treatment (146 +/- 5 mg/dL Oralin vs 184 +/- 7 mg/dL injection at 30 min and 192 +/- 6 mg/dL Oralin vs 236 +/- 9 mg/dL injection, p < 0.003 at 60 min). The rise in serum insulin levels was significantly higher (Cmax = 98 +/- 6 uU/mL for Oralin at 30 min vs 65 +/- 3 uU/ml injection, p < 0.001). The reduction in C-peptide was greater in Oralin during the first 60 min (1.38 +/- 0.21 ng/mL Oralin vs 1.75 +/- 0.38 ng/mL injection, p < 0.001). CONCLUSIONS: This proof-of-concept study results demonstrated that Oralin could be used as meal insulin in place of mealtime-insulin injections in subjects with type 2 diabetes to regulate the postprandial glucose levels.

Administration, Oral↗

PubMedDate not supplied

Effect of meals on the kinetics of etretinate.

Eight healthy men received 100 mg oral doses of etretinate separated by two-week washout periods in an open, randomized, crossover study. Etretinate was administered during a complete fast, with a standard high fat breakfast, a standard high carbohydrate breakfast, and 16 ounces of whole milk. Plasma samples were obtained at specific times over a 48-hour period. Plasma concentrations of etretinate as well as two of its major metabolites were determined by a specific, reverse-phase, high-performance liquid chromatography method. Plasma concentrations of etretinate were greater when administered with a high fat meal and whole milk compared to ingestion with a high carbohydrate meal or during a complete fast. In contrast, there was no increase in the plasma concentrations of the active metabolites following any of the meals. These data indicate that chronic dosing of etretinate with milk or a high fat meal compared with fasting conditions will result in higher concentrations of etretinate, which may ultimately lead to higher metabolite concentrations.

Adult↗

PubMed1987

The effect of dietary fiber on the bioavailability of digoxin in capsules.

Sixteen healthy volunteers were regularly given 0.4 mg of digoxin daily as two capsules with breakfast. After ten days during which breakfast was supplemented with 11 g of bran fiber, steady-state predose mean serum digoxin was lower (0.89 +/- 0.19 versus 0.84 +/- 0.18 ng/mL, P less than .05) and mean 24-hour area under curve determination was lower (30.5 +/- 6.1 versus 28.4 +/- 6.0 ng X hr/mL, P less than .05) than during the control period without bran. Height and time of peak serum digoxin, and 24-hour urinary digoxin were not significantly different. The 6 to 7% reduction in digoxin absorption from capsules is less than that reported from tablets and is probably clinically unimportant.

Adult↗

PubMed1992

Drug-food interaction potential of clarithromycin, a new macrolide antimicrobial.

To evaluate the effect of food on bioavailability, clarithromycin and 14-hydroxyclarithromycin (active metabolite) pharmacokinetics were assessed in 26 healthy adult volunteers after ingestion of a single oral 500-mg dose of clarithromycin in a fasting state (2 hours before breakfast after an overnight fast) and a nonfasting state (0.5 hours after the start of breakfast). Clarithromycin and 14-hydroxy metabolite plasma concentrations were measured using a high-performance liquid chromatographic technique. Food intake immediately before dosing increased the extent of absorption from the 500-mg tablet formulation by approximately 25%. The mean increase in metabolite area under the plasma concentration-time curve was approximately 9%. These results suggest that clarithromycin can be taken without regard to timing in relation to meals.

Absorption↗

PubMed1995

Effect of food on the bioavailability of atorvastatin, an HMG-CoA reductase inhibitor.

To determine whether atorvastatin, a new HMG-CoA reductase inhibitor, could be administered with food in Phase II and III clinical trials, a nonblind, randomized, two-way crossover study was conducted to assess the effect of food on rate and extent of atorvastatin absorption. Sixteen healthy volunteers received single 80-mg atorvastatin capsule doses on two occasions one week apart: once after an 8-hour overnight fast and once with a medium-fat breakfast. The single 80-mg atorvastatin capsule doses were well-tolerated. Mean maximum plasma atorvastatin equivalent concentration (Cmax) and area under the concentration-time curve (AUC) values with food were 47.9% and 12.7% lower, respectively, than without food. Mean time of maximum observed concentration (tmax) and elimination half-life (t1/2) values were 5.9 and 32.0 hours, respectively, with food and 2.6 and 35.7 hours, respectively, without food. A medium-fat breakfast decreased the rate of atorvastatin absorption significantly, but had little impact on extent of drug absorption. Changes in rate of atorvastatin absorption are not expected to have a clinically significant effect, as subsequent multiple-dose clinical studies have shown that dose but not plasma atorvastatin concentration profiles correlates with lipid-lowering effects.

Administration, Oral↗

PubMed1995

In vitro and in vivo evaluation of a once-daily controlled-release pseudoephedrine product.

The functionality of a once-daily, osmotic dosage form--gastrointestinal therapeutic system (pseudoephedrine HCl) or GITS (PeHCl)--was studied in vitro and in vivo. The in vitro release profiles were close to identical from pH 1 to 7.5 and between USP apparatus 2 and 7, independent of paddle speeds from 50 to 200 rpm; GITS also released drug at the normal rate in aqueous media after incubation in bile salts or fatty media. Both strengths of GITS (PeHCl)--240 and 120 mg--were then compared with a commercially available pseudoephedrine solution given every 6 hours and a timed-release 12-hour pseudoephedrine capsule given every 12 hours in a randomized 4-way crossover study in 24 healthy men. All four formulations were equivalent in total drug absorbed. Both GITS treatments had AUCinf values equivalent to those of PeHCl solution and capsules, and Cmax values equivalent to PeHCl capsules. Cmax for GITS and capsule treatments were each significantly lower than for solution, but the differences were small (14-17%). A one-to-one correlation was shown between rate of absorption and in vitro release profiles for the GITS products, indicating that drug release from GITS controls absorption. Insensitivity to conditions of in vivo release accounts for the close in vitro/in vivo correlation of release rates. In a second randomized crossover trial (12 men), the effect of a high-fat breakfast on GITS performance was evaluated. Mean pseudoephedrine concentrations in plasma were close to identical with or without the breakfast, and the treatments were bioequivalent.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1996

Influence of food on the oral bioavailability of loratadine and pseudoephedrine from extended-release tablets in healthy volunteers.

The effect of a high-fat breakfast on the bioavailability of the components of an extended-release tablet containing 10 mg loratadine in the immediate-release coating and 240 mg pseudoephedrine sulfate in the extended-release core was studied in 24 healthy male volunteers in a single-dose, two-way crossover study. The drug was administered after a 10-hour overnight fast or within 5 minutes of consuming a standardized high-fat breakfast. Serial blood samples were collected over a 48-hour period, and plasma was analyzed for loratadine and its active metabolite descarboethoxyloratadine (DCL), and pseudoephedrine. For pseudoephedrine, maximum concentration (Cmax) and area under the concentration-time curve extrapolated to infinity (AUCzero-infinity) were similar after both treatments, indicating no relevant food effect on the bioavailability of pseudoephedrine. Also, the absorption profiles of pseudoephedrine (from Wagner-Nelson analysis) were similar for the fed and fasted treatments, indicating no apparent differences in absorption. Plasma concentration-time profiles and values for Cmax and AUCzero-infinity of DCL were similar for the two treatments, indicating no relevant food effect on the pharmacokinetics of DCL. In contrast, for loratadine, administration with food resulted in a significantly increased mean Cmax (53%) and AUC from time zero to the final quantifiable sample (AUCif) (76%). However, the resultant Cmax and AUC of loratadine under fed conditions were well below those previously obtained at steady-state after multiple-dose administration of loratadine (40 mg/day) that were shown to be safe and well-tolerated in several clinical studies. The effect of food on the bioavailability and pharmacokinetic profiles of the components of a combination loratadine/pseudoephedrine extended-release tablet is not likely to be clinically significant.

Adult↗

PubMed1988

Intragastric behavior and absorption kinetics of a normal and "floating" modified-release capsule of isradipine under fasted and fed conditions.

From measurements of drug levels in both gastric juice and plasma, we investigated whether or not a prolonged gastric residence time (GRT) is responsible for the slow absorption kinetics of a "floating" modified-release (MR) capsule of isradipine [isopropyl methyl (+/-)-4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-3,5- pyridinedicarboxylate], a lipophilic dihydropyridine calcium channel blocker. The effects of a "high-fat" breakfast on the intragastric behavior and absorption kinetics were also assessed. In an open crossover design, five healthy subjects ingested either a normal or MR capsule of isradipine under fasted conditions. Serial samples of gastric juice (obtained via an indwelling nasogastric tube) and plasma were collected up to 24 h after drug intake, and were analyzed for isradipine by GC and RIA methods, respectively. The pH and titratable acid, protein, and pepsin concentrations of the gastric juice samples were also determined. Four additional subjects were similarly studied after ingesting the capsules following a high-fat breakfast. Under fasted conditions, gastric juice drug levels of the normal and MR capsules indicated a median GRT of less than 1.5 h in both cases. Plasma levels indicated a rapid absorption for the normal capsule (less than 2 h), but a remarkably slow absorption for the MR capsule, lasting 24 h or more. Under fed conditions, gastric juice and plasma profiles of the normal capsule were similar to those for the fasted case. In contrast, the MR capsule had an increased GRT (approximately 2.4 to 4.8 h) that was associated with a delayed and more extensive intragastric drug release. The corresponding plasma profiles showed a rapid absorption phase which correlated closely with the intragastric release kinetics. The influence of a high-fat meal on the release kinetics of the MR capsule did not appear related to the intragastric pH, or acid, protein, or pepsin concentrations. From these results we conclude that: (1) a prolonged GRT is not responsible for the slow absorption achieved with a "floating" MR capsule; (2) the presence or absence of food, rather than buoyancy, is the principal determinant of the GRT of the MR capsule; (3) the release and absorption of a lipophilic drug from a "floating" MR capsule may be affected by intragastric interaction with the lipid phase of meal; and (4) the major portion of drug release from the MR capsule takes place in the colon, rather than in the stomach.

Adult↗

PubMed2006

Advantages and drawbacks of immunoaffinity columns in analysis of mycotoxins in food.

A number of countries are setting legislations on mycotoxins. In order to reduce dispute between importing and exporting countries, the analytical data should be as comparable as possible, especially when levels are close to the regulatory limits. The present trend in the analysis of mycotoxins is to use immunoaffinity column (IAC) as a clean-up and enrichment technique, and Association of Official Analytical Chemists and European Union have validated methods which address a few food commodities. This study describes our experience using both conventional and IAC approaches in the analysis of three mycotoxins. Aflatoxins (AFs): Aflatoxin G1 has been detected by liquid-liquid partitioning methods with HPLC detection as false-positive in some maize. On IACs, this compound behaves as an AF, lowering the amount of the AFs trapped. The problem was solved using either TLC or HPLC with detection in the Kobra cell. Depending on the additives to food during the processing and cooking, the AFs might appear as an opened ring not recognised by the antibody. Fumonisins (FB): Compounds interfering with the FB's antibodies were also observed while analysing breakfast cereals leading to underestimation of FB. Ochratoxin A (OTA): Depending on the food composition and extraction techniques, OTA is underestimated with IAC in some breakfast cereals and coffee. These data strengthen the necessity to validate methods using IAC for each complex matrix.

Aflatoxin B1↗

PubMed1994

Effect of meal macronutrient and energy content on human performance.

The effects of planned meals, varying in carbohydrate (CHO), fat and caloric content, on psychomotor performance by male subjects with unrestricted access to commercially-available foods was investigated in two residential studies. In the first study, two groups of three subjects (n = 6) completed psychomotor tasks before and after consuming a lunch consisting of 431 or 844 kcal, with caloric differences produced through covert changes in either fat or CHO content. The effects of each of four lunch conditions (low-fat, high-fat, low-CHO, high-CHO) were determined for three consecutive days. In the second study, two groups of three subjects (n = 6) received breakfast, lunch and an afternoon snack and completed psychomotor tasks after breakfast and lunch. Cumulative caloric content of the three eating occasions was approximately 700, 1200 or 1700 kcal (low, medium or high), again with differences resulting from covert changes primarily in either fat or CHO content. The effects of each of six food conditions were determined for two consecutive days. While changes in some aspects of performance were altered after meals, the effects were not related to the CHO, fat or caloric content of the meal. When subjects have unrestricted access to commercially-available foods, neither calories nor the relative fat or CHO content of normal meals influence human psychomotor task performance.

Adult↗

PubMed1996

Micro- and macroanalyses of patterns within a meal in anorexia and bulimia nervosa.

Hospitalized women with anorexia nervosa and/or bulimia nervosa and dietarily restrained and unrestrained, clinically normal women were provided with a multi-item breakfast meal. Eating patterns and hunger and satiety ratings were assessed. Subjects were offered three foods which varied in fat and carbohydrate contents. Anorectic-restrictors differed most from the control subjects: they had a longer meal duration, a slower overall rate of eating, more frequent pauses during the meal, and more short bouts of eating. They also displayed abnormal ratings of hunger and satiety: they were generally less hungry, had less urge to eat, and were more full than controls of bulimics. Both anorectic and bulimic patients showed more variability in total energy intake than did the controls. Patients usually displayed one of two patterns - either severe restriction or overeating. Abnormal hunger and satiety patterns indicating confusion typified the responses of bulimics; additionally, they showed more urge to eat in the post-meal period than did the controls. A higher proportion of fat in the initial part of the breakfast was related to a larger meal size for the bulimics. It is suggested that these techniques may be useful in evaluating the outcome of treatment for eating disorder patients.

Anorexia Nervosa↗

PubMed1999

Greater appetite control associated with an increased frequency of eating in lean males.

Eight healthy males of age 22.9+/-4.2 years (mean+/-SD) and body weight 73.26+/-11.50 kg, with BMI of 23.11+/-2.84 kg/m(2)underwent two different eating meal frequency patterns on 2 separate days. On both days they were fed approximately 33.3% of their average daily energy requirements as a breakfast pre-load meal: served either as a single meal (SINGLE) or divided into five equal portions (served hourly) (MULTI). Five and a half hours after the initial meal, an ad libitum meal was served. Venous blood was tested to determine plasma glucose and serum insulin concentrations every hour until the ad libitum lunch, and at 15-, 45- and 75-min after lunch. Visual analogue scales (VAS) were completed every hour until the ad libitum lunch, and at 15-, 45- and 75-min after lunch as a measure to determine hunger, appetite and satiety indices. Although both groups were fed isocaloric and identical macronutrient "breakfast pre-loads" (3450+/-466 kJ), the SINGLE group consumed 26.6% more (p<0.02) energy in the ad libitum lunch (5111+/-1502 kJ vs. 3752+/-893 kJ) than the MULTI group did. The pre-load feeding pattern had no effect on blood glucose responses throughout the trial. Following the larger SINGLE pre-load, serum insulin concentration rose to a higher (p<0.01) level compared to the first of the MULTI pre-load meals (123.04+/-61.51 microIU/ml vs. 37. 30+/-26.65 microIU/ml SINGLE vs. MULTI, respectively). Serum insulin rose to a higher (p<0.01) level following the fifth and final of the MULTI pre-load meals compared to the serum insulin levels in the SINGLE group at the same time into the trial (74. 21+/-51.64 microIU/ml vs. 24.98+/-13.46 microIU/ml MULTI vs. SINGLE, respectively). Despite consuming more energy in the ad libitum lunch, the SINGLE group showed no difference in serum insulin concentration following the ad libitum lunch compared to the insulin response of the MULTI group. These data suggest that when the nutrient load was spread into equal amounts and consumed evenly through the day in lean healthy males, there was an enhanced control of appetite. This greater control of satiety when consuming smaller multiple meals may possibly be linked to an attenuation in insulin response although clearly both other physical (gastric stretch) and physiological (release of gastric hormones) factors may also be affected by the periodicity of eating.

Adult↗

PubMed2001

Cadmium absorption in women fed processed edible sunflower kernels labeled with a stable isotope of cadmium, (113)Cd.

The apparent fractional absorption of cadmium (Cd) from sunflower kernels (SFK) was determined in women volunteers by using kernels labeled with a stable isotope of Cd ((113)Cd) by injecting it into the flowering head. Fourteen women who were between the ages of 30 and 70 years, who did not use tobacco products, who were in good health, and who had been consuming a self-selected diet low in Cd content participated in the study. The volunteers were fed a breakfast composed primarily of cereal, milk, and fruit juice. The breakfast also contained a portion of (113)Cd-labeled SFK processed into a buttery spread. Each volunteer collected individual stool samples for 21 days beginning immediately after they had consumed the labeled kernels. The total amounts of Cd and (113)Cd excreted in each stool were determined by isotope dilution inductively coupled plasma mass spectrometry. Mean fecal Cd excretion was 14.1+/-4.1 microg/day and mean (113)Cd absorption was 10.6+/-4.4%. In agreement with previous studies, no significant (P>0.3) correlation between Cd absorption and serum ferritin concentrations was found in women whose serum ferritin concentrations were >25 ng/mL. These data suggest that the availability of Cd from highly processed sunflower kernels to humans is similar to that reported for other types of food.

Absorption↗

PubMed2002

Sources of dietary fat in middle schools.

BACKGROUND: The current study uses an ecological approach to describe the food environment at 24 middle schools and multiple food sources' dietary fat contribution. METHODS: Five consecutive days were sampled for collection of school meals, a la carte, and student store data. Bag lunch contents were observed on 3 days. Measurement included grams of saturated and total fat plus sales or participation data. RESULTS: Average total fat grams per meal were 21 g (SD = 2) for bag lunches, 14 g (SD = 5) for Type A breakfast, and 31 g (SD = 8) for Type A lunches. Average fat grams per item were 13 g (SD = 3) for a la carte and 6 g (SD = 2) for student stores. Students purchased or brought to school a mean of 26 g (SD = 3) of total and 8 g (SD = 1) of saturated fat. Contributions to total fat grams were 42% by Type A lunches, 27% by a la carte foods, 25% by bag lunches, 3% by Type A breakfast, and 2% by student stores. Findings for saturated fat were similar. CONCLUSIONS: Middle school students eat excessive amounts of fat at school, and multiple sources of food must be considered to understand the school food environment.

Adolescent↗

PubMed1986

The effect of food on the oral administration of 6-mercaptopurine.

The effect of food on the bioavailability of 6-mercaptopurine (6-MP) has been investigated. Seven patients were studied on two separate occasions. On the first occasion 6-MP was administered p.o. after an overnight fast and on the second, 15 min after a standard breakfast. 6-MP concentrations were determined by high-performance liquid chromatography. Variable plasma drug levels were observed between individual subjects in the fasting state. The peak levels of 6-MP were lower and took longer to be achieved following administration after a standard breakfast than after an overnight fast. In two subjects levels were undetectable (less than 20 ng/ml). In view of these observations it is suggested that 6-MP should be administered before food if maximum blood levels are to be achieved.

Administration, Oral↗

PubMed1988

The adjustment of diet and insulin dose during long-term endurance exercise in type 1 (insulin-dependent) diabetic men.

We examined in 2 consecutive years the effect of a 75-km (greater than 7 h) cross country skiing on dietary and insulin requirements and glycaemic control in 9 Type 1 (insulin-dependent) diabetic patients. In the first year, the patients were hyperglycaemic (20.9 +/- 1.8 mmol/l) before the race due to excessive carbohydrate loading (65 g) and reduction (by 58%) of short-acting insulin for breakfast. In the second year, breakfast included less carbohydrate (40 g) and more protein, and the morning short-acting insulin was reduced by 35%. With this adjustment of therapy the pre-exercise hyperglycaemia was less (p less than 0.05). The morning intermediate-acting insulin was reduced by 28 and 38% in consecutive years. During both races carbohydrate intake approximated 40 g/h, and blood glucose was maintained at near normal levels after 33 km of skiing. Hypoglycaemia did not occur during exercise, but one patient had symptomatic hypoglycaemia after finishing the second race. The day after exercise insulin sensitivity was increased in all four patients studied. Insulin treated patients can perform strenuous long-term exercise and maintain near normoglycaemia with a proper adjustment of therapy. Augmented insulin sensitivity may contribute to post-exercise hypoglycaemia.

Adult↗

PubMed1985

The influence of insulin antibody levels on the plasma profiles and action of subcutaneously injected human and bovine short acting insulins.

The influence of moderate and low insulin antibody levels on insulin absorption and plasma free insulin profiles is uncertain. Two groups of six C-peptide negative diabetic patients, one with low (3.8 +/- 0.8 mu/l) and one with moderate (16.4 +/- 2.0 micrograms/l) serum insulin antibody levels, were studied. Subjects were given 0.3 U/kg neutral human or acid bovine soluble insulin subcutaneously in random order before breakfast on separate days. Moderate antibody levels significantly blunted the rise in plasma free insulin that followed injection of the human and bovine insulins (p less than 0.05). The rise in blood glucose after breakfast was significantly greater in patients with moderate antibody levels (p less than 0.05) and more marked following the bovine than the human insulin (p less than 0.05). Plasma free insulin, blood glucose and 3-hydroxybutyrate profiles suggest that acid bovine soluble insulin has a significantly more protracted action than neutral human insulin.

3-Hydroxybutyric Acid↗