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At least 217 records · Page 12Linked to original sources
PubMed2003

Clinical development of an everolimus pediatric formulation: relative bioavailability, food effect, and steady-state pharmacokinetics.

The immunosuppressant everolimus used in organ transplantation is formulated as a conventional tablet for adults and a dispersible tablet that can be administered in water for pediatric use. As part of the pediatric clinical development program, the relative bioavailability and food effect for the dispersible tablet were evaluated in healthy adult subjects as a prelude to characterizing the steady-state pharmacokinetics in pediatric kidney allograft recipients. In a randomized, open-label, three-way crossover study, 24 healthy adults received single 1.5-mg oral doses of everolimus as (1) six 0.25-mg dispersible tablets in water, (2) two 0.75-mg conventional tablets, and (3) six 0.25-mg dispersible tablets in water after a high-fat breakfast. Cmax and AUC were evaluated by standard bioequivalence testing to determine relative bioavailability and to quantify the effect of food. In a multicenter open-label efficacy/safety trial, pediatric renal allograft recipients received 0.8 mg/m2 (maximum 1.5 mg) bid everolimus as dispersible tablets in water. Serial trough concentrations over the first week and a steady-state pharmacokinetic profile on day 7 posttransplant were collected in 19 patients ranging from ages 2 to 16 years old. The bioavailability of everolimus from the dispersible tablet was 10% lower relative to the conventional tablet, with a ratio (90% confidence interval) of 0.90 (0.76-1.07). After a high-fat meal, tmax was delayed by a median 2.5 hours, and Cmax was reduced by 50%. Overall absorption, however, was not affected by food inasmuch as the fed/fasting AUC ratio was 0.99 (0.83-1.17). In pediatric patients, steady state was reached between days 3 and 5. The corresponding steady-state parameters were as follows: Cmin, 4.4 +/- 1.7 ng/ml; Cmax, 13.6 +/- 4.2 ng/ml; and AUC, 87 +/- 27 ng.h/ml. Steady-state concentration-time profiles in pediatric transplant patients receiving the dispersible tablet were comparable to those of adult patients receiving the conventional tablet when both were dosed to yield similar trough concentrations. If a pediatric patient is converted from the everolimus dispersible tablet to the conventional tablet, this should be based on a 1:1 milligram switch with subsequent therapeutic drug monitoring to further individualize the dose as needed. The dispersible tablet formulation should be taken consistently either with or without food to minimize fluctuations in exposure over time.

Adult↗
PubMed1976

High-performance liquid chromatographic determination of L-aspartyl-L-phenylalanine methyl ester in various food products and formulations.

A simple, rapid, and specific high-performance liquid chromatographic (HPLC) procedure is described for the analysis of the chemical sweetener L-aspartyl-L-phenylalanine methyl ester (aspartame). Using a strong cation exchange column and pressures less than 1000 psig, an analysis can be performed in less than 15 min. The technique has been applied to a wide range of food products and formulations. No interferences were found in the samples studied. Recoveries are quantitative, and the coefficients of variation for replicate analyses are less than or equal to 2.5%.

Ammonia-Lyases↗
PubMed2002

Influence of food intake and formulation on the pharmacokinetics and metabolism of bosentan, a dual endothelin receptor antagonist.

The purpose of the study was to investigate the effect of food intake on the pharmacokinetics and metabolism as well as the relative bioavailability of bosentan. Sixteen healthy male subjects were treated in a randomized, four-way, crossover design with single oral doses of 125 mg bosentan, given as one tablet (with or without food), two tablets of 62.5 mg (with food), and a suspension (without food). The pharmacokinetic parameters of bosentan (and also three of its metabolites) were very similar after the four treatments: geometric means for Cmax and AUC0-infinity, ranged from 1.3 to 1.6 microg/ml and from 7.8 to 8.9 microg x h/ml, respectively, and median t(max) from 3.0 to 4.0 hours. The bioavailability of the 125 mg tablet relative to that of the suspension, both given fasted, was 102%. In the presence of food, Cmax and AUC0-max increased by 22% and 10%, respectively, whereas the two 62.5 mg tablets were bioequivalent to the 125mg tablet, both under fed conditions. The pharmacokinetics of the metabolites was independent of the treatment administered. In conclusion, bosentan bioavailability from the newly developed 125 mg tablet formulation is similar to that of the suspension, and food intake does not influence its pharmacokinetics to a clinically relevant extent.

Adult↗
PubMed2005

Method development and HPLC analysis of retail foods and beverages for copper chlorophyll (E141[i]) and chlorophyllin (E141[ii]) food colouring materials.

An analytical method using high performance liquid chromatography with photodiode array and fluorescence detection has been developed and applied to the determination of the food colour additives copper chlorophylls and copper chlorophyllins (E141[i] and [ii]) in foods and beverages. The analytical procedures from previously reported methods have been refined to cover a range of food colour formulations and retail foods. The method was single-laboratory validated. Recoveries of the polar copper chlorophyllins from spiked samples (at 14.5 mg/kg in all but one case) were in the range 79-109%, except for jelly sweets (49%). Recoveries of relatively non-polar copper chlorophylls were in the range 77-107% (except for 'made' jelly at 50%). The %RSD for recoveries was generally below 12%. Quantitative estimates of the total copper chlorophyll/chlorophyllin content of a small range of food commodities are reported, based on the use of trisodium copper chlorophyllin as a surrogate standard. The majority of E141-containing foods and colour formulations analysed exhibited a multiplicity of components due to the various extraction and purification processes that are used to obtain these colour additives. This was confounded by the presence of overwhelming amounts of native chlorophylls in certain samples (e.g. mint sauce). Food commodities containing significant amounts of emulsifiers (i.e. ice cream), gelatine or fats were problematic during extraction hence further development of extraction regimes is desirable for such products. All of the samples analysed with added E141, had estimated total copper chlorophyllin contents of below 15 mg/kg (range 0.7-13.0).

Acids↗
PubMed1979

The effect of food and tablet formulation on plasma prednisolone levels following administration of enteric-coated tablets.

1 Plasma prednisolone levels have been compared following the administration of enteric-coated prednisolone to fasted and non-fasted subjects. The effect on plasma levels of altering the formulation of the enteric-coating has also been studied. 2 The presence of food in the stomach at the time of administration does not affect the absorption of enteric-coated prednisolone tablets. 3 There was considerable inter-subject variation in plasma prednisolone levels after administration of shellac based enteric-coated tablets. However, plasma levels were more consistent when a preparation whose formulation was based upon cellulose acetate phthalate (CAP) was given. 4 It is concluded that the pattern of absorption and plasma prednisolone levels depend on the formulation of the enteric coating. The bioavailability of the CAP based preparation is similar to that of plain prednisolone.

Adult↗
PubMed1976

[Suitability test of various food mixtures for breeding and rearing of beagle dogs. 2nd Communication: Methods and results of feeding experiments of the Mannheim team (author's transl)].

A comparison of 3 commercially available dog foods (Ssniff C, Altromin H, Altromin HW) with 2 newly formulated dog food mixtures was carried out with regard to breeding, rearing and maintenance of Beagle dogs. No significant differences were found between the individual feeding groups with regard to the fertility and breeding ability of the bitches. All the foods supplied the requirements for energy, nutrients and feed additives in the rearing and maintenance of the dogs. The parameters used for the assessment, such as body weight, daily gain, daily food consumption and feed efficiency, were satisfactory for all food groups and were partially reproduceable. If the consumption of food, energy and nutrients per kg body weight are calculated and are related to the rearing results obtained then inconsistencies occur which can only be explained by differences in digestibility of the individual food components, and these underline the need for digestibility tests in dogs. The 2 newly formulated foods compared favourably with the other food stuffs and fulfilled the requirements for better standardised food mixtures. Further experiments will investigate the effects on the morphological, haematological and clinico-chemical characteristics. A comparison of different age groups confirmed the data in the literature which indicates that younger animals have a higher requirement for energy and nutrients per kg body weight than older animals. Results that have not yet been explained are the findings that the consumption of food, and thus of energy and nutrients, per kg body weight in younger male animals is lower than that of the female animals of the same age to a highly significant degree.

Age Factors↗
PubMed1988

Formulation, acceptability, chemical composition and in vitro digestibility of novel snack food and meat ball analogue.

Potato purée and wheat flour were blended at a ratio of 7:1 w/w with 2 parts per weight of soybean protein concentrate (SPC) and/or faba bean-protein micellar mass (PMM). Two snack foods were formulated and deep fried. Spices, onion, parsley and chicken stock were added to the aforementioned two recipes to formulate meat ball analogues. Data revealed good acceptability of all products. Moreover, they can be considered as a good source for some essential amino acids; protein (approximately 26%); lipids (approximately 20%); carbohydrates (approximately 48%) and minerals. The in vitro digestibility ranged between 61.0% and 66.9%.

Amino Acids↗
PubMed1986

Review of alterations in oral phenytoin bioavailability associated with formulation, antacids, and food.

Since 1938, phenytoin has been widely used for the control of seizure disorders. Phenytoin is available from a variety of manufacturers in a variety of dosage forms. Certain physiochemical properties of phenytoin may lead to bioavailability changes. The physiochemical properties exert themselves not only in the presence of other drugs but also during the manufacturing process. Manufacturing processes that may influence phenytoin bioavailability include salt form, particle size, product excipient, and dosage form. Drug influences upon phenytoin bioavailability largely include antacid anions, which may form insoluble complexes. Anions present within the diet may also influence the rate and extent of phenytoin absorption. This article reviews the various influences on phenytoin bioavailability with regard to the manufacturing process, antacid, and food.

Administration, Oral↗
PubMed1988

Effect of a formulation of supplementary food for pregnant women on birth weight of newborns.

The effect of a supplementary food mix prepared from roasted mungbean, groundnuts, and sugars on maternal nutrition and birth weight of newborns was studied. The results indicated that supplementary food provided to the pregnant women had a significantly positive effect on the birth weight of newborns. In addition, a significantly higher weight gain by the mothers was observed as compared to the control group.

Adult↗
PubMed1997

[Optimization of cosmonauts' nutrition during the period of acute adaptation and at the closing stage of the mission].

During 22 prime expeditions onboard orbital station "Mir" there obtained material allowing one to assess the nutritional status of cosmonauts in a period of acute adaptation and in the closing stage of mission. There formulated the food rations and additional assortments of food for the mentioned stages of mission. It is found that in the formulated food rations and in the additional assortments of the food there contain the optimal amount of indispensable food ingredients the use of which will allow one to realize the measures for normalizing the life activity and maintaining the adequate level of working capacity of the cosmonauts.

Adaptation, Physiological↗
PubMed1986

Formulation and evaluation of supplementary foods for Thai pregnant women.

To improve maternal nutritional status and to ameliorate protein-energy malnutrition in pregnant women and infants, supplementary foods for rural pregnant women were formulated and evaluated. Six formulas with protein and energy contents of 16-22 g and 350-500 kcal/100 g food, respectively, were developed from locally available raw materials. A field evaluation of formulas I and V was conducted at the regional MCH Center at Rajchaburi, about 120 km from Bangkok. Formulas providing 13 g protein and 350 kcal per day were given to two groups of mothers in the first or second pregnancy, starting at 28 +/- 2 wk of gestation. A third group, unsupplemented, served as controls. Maternal weight gain and left mid-arm circumference were measured every 2 wk. Birth weight, length, head and chest circumferences of newborns, and placental weight were significantly higher in both supplemented groups. These findings suggest that among undernourished mothers, supplementation of as little as 13 g protein and 350 kcal daily during the last trimester can significantly improve maternal weight gain and birth weight of newborns.

Adolescent↗
PubMed1994

The Association of American Feed Control Officials Dog and Cat Food Nutrient Profiles: substantiation of nutritional adequacy of complete and balanced pet foods in the United States.

The Association of American Feed Control Official (AAFCO) formed the Canine (1990-1991) and Feline (1991-1992) Nutrition Expert Subcommittees to update the requirements for substantiation of "complete and balanced" claims for pet foods sold in the United States. There are two means by which a company may substantiate nutritional adequacy for a dog or cat food. The first means is by formulating the food so that nutrient levels fall within the ranges as established in the AAFCO Dog and Cat Food Nutrient Profiles. These profiles replace the National Research Council recommendations as the recognized authority in the United States as that term is applied to AAFCO regulations. Levels of nutrients are based on practical formulations of pet foods with adjustments to account for bioavailability of nutrients in commonly used ingredients. Separate profiles for adult maintenance and growth and reproduction are set, and maximum levels of some nutrients are also established. The second means of substantiation is through the conduct of feeding trials following AAFCO protocols.

Animal Feed↗