[Safety evaluation of the new food-film formulation GLES].
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Animals↗
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Formulation and food effects on the oral absorption of a poorly water soluble, highly permeable antiretroviral agent.
DPC 961 is a low-solubility, high-permeability, second-generation non-nucleoside reverse transcriptase inhibitor. The purpose of these studies was to evaluate the effects of drug substance and formulation variables on DPC 961 oral absorption, and to compare fed and fasted state oral absorption. To accomplish this, groups of four to six dogs were dosed with various formulations of DPC 961 under fasted or fed conditions, and DPC 961 pharmacokinetics were examined. Absolute oral bioavailability, based on i.v. AUC in the same dogs, was 24% after a suspension dose in fasted dogs and was 51% in fed dogs. Bioavailability with an unoptimized tablet formulation was 30% in fasted dogs and 86% in fed dogs. DPC 961 oral absorption was shown to be dependent on drug substance particle size in fasted dogs, after dosing with a tablet formulation where only the drug substance particle size was varied, but there was no difference in fed dogs. AUC and C(max) increased in proportion with increases in tablet strength from 100 to 400 mg, using tablets manufactured from a common granulation. Tablets made with 50 and 66% drug loadings showed similar relative oral bioavailabilities. Tablets prepared with two different polymorphic forms of DPC 961 were also compared, and these were found to be equivalent. These studies provided a useful component of the formulation development process, to help identify and control the variables affecting oral absorption of this potential new therapeutic agent.
Administration, Oral↗
Effects of food on drug absorption.
This chapter provides an update on drug-food interactions reported in the literature during the past five years. The number of studies examining this phenomenon has increased dramatically, and many of the results of these studies have been unpredictable and spectacular. Drug-food interactions should really be considered as formulation-food interactions because of increasing evidence that a drug may be affected differently by food when it is administered in different formulations. Drug-food interactions may be classified into five categories: those causing reduced, delayed, increased, and accelerated absorption, and those in which food has no effect. While it continues to be necessary to examine drug-food interactions for specific drugs and drug formulations, additional avenues need to be explored to seek mechanistic patterns that may lead to better prediction of the nature and extent of changes in circulating drug levels due to the presense of food, and their possible clinical impact.
Absorption↗
Analysis of annatto (Bixa orellana) food coloring formulations. 2. Determination of aromatic hydrocarbon thermal degradation products by gas chromatography.
Twenty samples of commercial annatto formulations have been analyzed for m-xylene and toluene using ambient alkaline hydrolysis, followed by solvent extraction and capillary gas chromatography. Fifteen of the samples contained <5 mg/kg toluene, four samples contained between 5 and 10 mg/kg toluene, and one sample contained 12 mg/kg toluene. The amounts found of m-xylene were 200 mg/kg (one sample), 160 mg/kg (one sample), between 30 and 88 mg/kg (four samples), between 7 and 25 mg/kg (seven samples), and <5 mg/kg (seven samples). Bixin-in-oil formulations contained the highest m-xylene concentrations and also gave the largest increase in headspace m-xylene concentration when heated in closed systems. The results are evidence for the thermal degradation of annatto during source extraction and processing, resulting in contamination by internal generation of both bixin and norbixin types with aromatic hydrocarbons. Two samples of norbixin of known production history (i. e., thermal versus nonthermal processes) were analyzed specifically to identify possible differences in their degradation component profiles. They were found to differ significantly in m-xylene content, which is consistent with their respective production histories.
Bixaceae↗
Intestinal drug efflux: formulation and food effects.
The intestine, primarily regarded as an absorptive organ, is also prepared for the elimination of certain organic acids, bases and neutral compounds depending on their affinity to intestinal carrier systems. Several of the transport systems known to mediate efflux in the major clearing organs--liver and kidney--are also expressed in the intestine. Examples of secretory transporters in the intestine are P-glycoprotein, members of the multidrug resistance associated protein family, breast cancer resistance protein, organic cation transporters and members of the organic anion polypeptide family. In this communication, the P-glycoprotein mediated intestinal secretion of talinolol, a model compound showing metabolic stability, has been investigated in the jejunum, ileum and colon of rat intestine by single-pass perfusion. A model has been developed which demonstrates an increase in carrier-mediated secretion in the order jejunum<ileum<colon. Furthermore, the potency of common excipients in peroral drug products towards inhibition of P-gp mediated secretion has been investigated using a radioligand-binding assay and transport studies in Caco-2 cell monolayers. Finally, evidence is provided which demonstrates that constituents of grapefruit juice not only may influence intestinal drug metabolism, but can also interfere with secretory transport systems, leading to a new and yet undescribed mechanism in drug-food interactions.
Animals↗
Saengshik, a formulated health food, decreases blood glucose and increases survival rate in streptozotocin-induced diabetic rats.
Saengshik is a Korean "non-cooked food" that is commercially produced and marketed. Ingredients in commercial Saengshik include grains, vegetables, fruits, mushrooms, sea plants, and various functional botanicals. This study investigated the effects of Saengshik on the survival rate of streptozotocin (STZ)-induced diabetic rats. Male Sprague-Dawley rats weighing around 190 g were randomly assigned to one of the three experimental groups: a healthy normal group (NC) and two groups with STZ-induced diabetes and fed either control diet (DC) or Saengshik diet (DS). Rats in all groups were supplied with a diet of equal energy. The animals were maintained on an experimental diet for 168 days in experiment I and for 42 days in experiment II. The body weight in the DS rats decreased less than in the DC rats in both experiments I and II. There was a trend for blood glucose level in the DS group to decrease during the experimental period in both experiments I and II. A survival rate of 50% was reached on day 49 in the DC group and on day 118 in the DS group. All rats in the DC group died by day 140, while 50% of the rats in the DS group were still alive on day 168, when experiment I was terminated. In experiment II, 50% of the DC group and 90% of the DS group survived at day 42. Saengshik did not have any influence on cholesterol levels, thiobarbituric acid-reactive substances, and activities of superoxide dismutase and glutathione peroxidase. These results suggest that blood glucose concentrations and the survival rate are positively affected by Saengshik feeding in diabetic rats.
Agaricales↗
Development of corn starch-gum bread for phenylketonuria patients.
Phenylketonuria (PKU) is an inherited metabolic disease resulting from an enzyme defect that leads to failure to utilize phenylalanine and it is the most common aminoacidopathy in Turkey. There are a considerable number of individuals suffering from PKU and they need special food formulations, but the choice of special foods is limited for these people. Since the bread is the staple food in Turkey, the primary aim of this study was to develop bread formulation and procedure for PKU patients by using materials available in Turkey. To be able to produce low phenylalanine starch-gum bread, five different commercial food grade gums were added to the corn starch at 1, 2, and 3% addition levels. The addition of surfactant brought about remarkable changes in the starch dough. Loaf of the best overall quality was produced with one of the gums (xanthan gum and carrageenans mixture) at the addition level of 2%, water addition level of 105%, the final proof time of 110 min and the temperature of 30 degrees C when compared with the other gum breads. As a result, a basic formula and procedure for preparing a desirable corn starch-gum bread was reported for PKU patients.
Bread↗
Women's dietary fat and sugar intakes: implications for food based guidelines.
OBJECTIVE: To examine how women's dietary data can be used to formulate food based dietary guidelines for fat. DESIGN: Dietary intake data was assessed cross-sectionally using the 7 d diet history method. Subjects were divided into quartiles on the basis of their intakes of total fat and saturated fatty acids (% energy) and the diets of those in the lowest and highest quartiles were compared. SUBJECTS AND SETTING: Subjects studied were socially advantaged and disadvantaged women (n = 83, mean age 35 years) recruited from their workplaces. RESULTS: The inverse relationship between intakes of sugar and total fat (P < 0.0001) found in this study also extended to saturated fatty acids (P = 0.0007). Women in the lowest quartile of total fat, in common with those in the lowest quartile of saturated fatty acids, were found to have higher intakes of fibre (P < 0.005), vitamin C (P < 0.01), folate (P < 0.005) and vitamin B6 (P < 0.05) while their intakes of vitamin A were lower (P = 0.01). Most (76%) of the differences in sugars intake between women of low and high total fat consumption were accounted for by added sugars, particularly non-fat containing confectionery/drink food sources where median daily intake values were 15 g vs 7 g sugars (P = 0.05) respectively. The finding that at best only 62% of the women had total fat and saturated fatty acids intake in similar quartiles, together with the differences that emerged in their food intake patterns, indicate that the goals for these nutrients may be separately achieved. CONCLUSION: Existing dietary data can be useful for the formulation of specific food based dietary guidelines and diets higher in sugar are not necessarily more dilute in micronutrients.
Adult↗
Preferential alcoholic embryopathy: effects of liquid diets.
Our initial report of a preferential expression of experimental alcoholic embryopathy affecting the male offspring contiguous in utero to male siblings of Long-Evans rats was based on gavage administration of alcohol to pregnant rats without regard to isocaloric, pair-fed exposure paradigms. In this study, pregnant Long-Evans rats were given 35% ethanol-derived calories (EDC) in one of two different liquid diets: 1) a liquid alcohol diet based on Sustacal, a flavored liquid food formulated for human nutritional standards; and 2) a high-protein liquid rodent diet devised by Lieber and DeCarli (L&D). The diets were administered from day 6 to 15 of gestation. Pregnant rats were pair-fed liquid diets containing 0% EDC, but isocalorically balanced to 35% EDC with either sucrose (Sustacal) or maltose-dextrin (L&D). A fifth group of pregnant rats was given access ad libitum to standard certified laboratory rodent diet and served as free-fed controls. On day 20 of gestation, all pregnant rats were euthanized and the products of conception examined by standard teratologic techniques. Pregnant animals fed Sustacal-based diets consistently consumed fewer calories per kilogram body weight per day from day 6 to 15 of gestation (i.e., they were significantly calorie-deprived during pregnancy) as compared with the standard laboratory-diet-fed controls or those consuming L&D diets. Body weights of rats consuming Sustacal diets (both 0 and 35% EDC) were significantly lower throughout gestation when compared with all other groups. Higher (> 150 mg/dl) blood alcohol levels were attained by rats consuming 35% EDC in Sustacal diet as compared with L&D (100 mg/dl) diets.(ABSTRACT TRUNCATED AT 250 WORDS)
Animals↗
Impact of the Pick the Tick food information programme on the salt content of food in New Zealand.
The Pick the Tick programme of the National Heart Foundation of New Zealand aims to provide a framework for cooperation with the food industry to improve nutrition labelling and to develop a healthy food supply. Food manufacturers, whose products meet defined nutritional criteria, are able to display the Pick the Tick logo on food labels. The tick is used by 59% of shoppers in assisting them make healthy food choices. Food companies are encouraged to reformulate product composition if they fail to meet criteria and develop new products to specifically meet the Pick the Tick criteria. The objective of this study was to evaluate the impact of the programme on food formulation. The main outcome measure was the amount of salt not added to food products. Changes to sodium levels were multiplied by the volume of sales and then converted to salt in tonnes to provide a tangible measure of the impact of the programme. In a 1-year period, July 1998 to June 1999, Pick the Tick influenced food companies to exclude approximately 33 tonnes of salt through the reformulation and formulation of 23 breads, breakfast cereals and margarine. Breakfast cereals showed the largest reduction in sodium content by an average of 378 mg sodium per 100 g product (61%). Bread was reduced by an average of 123 mg per 100 g product (26%) and margarine by 53 mg per 100 g (11%). Pick the Tick appeals to the food industry as a tool for marketing food products and has provided an incentive to improve the nutritional value of foods. The tick on approved products not only acts as a 'nutrition signpost' for consumers but can also significantly influence the formulation of products without sacrificing taste or quality.
Food Analysis↗
[Hygienic evaluation of food rations in the experiments with long-term isolation].
Hygienic evaluation of formulated food rations has been performed during 2 long-term studies (135 and 90 days) with participation of 6 male volunteers. The food rations provided for the energy and plastic demands of crewmembers, promoted the maintenance of working capacity and allowed to perform successfully the program of studies.
Adult↗
Production of DogiK: an improved Ogi (Nigerian fermented weaning food) with potentials for use in diarrhoea control.
As part of a programme to formulate foods to aid the control of diarrhoeal diseases, an improved ogi (the commonest weaning food in Nigeria) named DogiK has been developed. DogiK was produced by using Lactobacillus starter cultures with antimicrobial activity against diarrhoeagenic bacteria and also possessing amylolytic activity. The survival of diarrhoeagenic bacteria was investigated in locally-fermented ogi and in DogiK. The foods were inoculated with cell suspensions of Salmonella, Shigella, Campylobacter, Aeromonas, Pleisiomonas, Enteropathogenic and Enterotoxigenic Escherichia coli, Yersinia enterocolitica, and Vibrio cholerae. None of the diarrhoeagenic bacteria were detected in DogiK after 6 h whereas in the local ogi Salmonella, E. coli, and Shigella survived for 24 h or more, but showed a sharp decrease in numbers, while V. cholerae survived for 12 h. DogiK is active whether cooked or uncooked and exhibited inhibition of pathogens at neutral pH. It gives consistent quality. Preliminary investigation indicates possession of a better shelf life. Thus, DogiK may have a potential use in the prevention and treatment of diarrhoea.
Diarrhea, Infantile↗
On the novel catalytically-independent antimicrobial function of hen egg-white lysozyme: a conformation-dependent activity.
Dependency of the antimicrobial activity on the conformation of lysozme was examined by the means of gradual thermal inactivation at neutral pH and different temperatures. We found that heating of lysozyme at increasing temperatures for 20 min in pH 6.0 results in progressive loss of enzyme activity, while greatly promotes its antimicrobial action to the Gram-negative bacteria without a detrimental effect on the inherent bactericidal activity to Gram-positive ones, suggesting action independent of catalytic function. The most potent bactericidal conformation of lysozyme to either Gram-negative or -positie bacteria was that retaining approximately 50% of the native enzyme activity (HL80/6). HL80/6 showed several fold increase in surface hydrophobicity, with exposed two thiol groups, and 17% deamidation. Spectrophotometric analysis of HL80/6 revealed slight changes in its secondary structures, but considerable global conformational changes as a result of the formation of beta conformation, via cyclic imide, at the three aspartylglycyl sequences of lysozyme molecule. Direct damage to the bacertial membranes by HL80/6, was demonstrated by using ELISA and liposomal membrane model. Furthermore, the antimicrobial activity of HL80/6 was inhibited by the divalent cations Ca2+ and Mg2+ suggesting that HL80/6 interacts at a divalent cation binding site on the bacterial membrane and subsequently permeabilize it. The results introduce an interesting structure-antimicrobial relationship that the antimicrobial action of lysozyme is independent of its catalytic function. In addition, it is worth emphasizing that the naturally-occurring conformational transition of lysozyme at physiological temperatures can be a biologically relevant event to switch its antimicrobial specificity to include the food-borne pathogens and heralding fascinating opportunities for application in formulated food systems.
Animals↗
Preventive strategies against weight gain and obesity.
A well-resourced, comprehensive, population-based set of strategies is needed to attenuate and eventually reverse the current trends of increasing obesity prevalence now apparent in most countries. The Epidemiological Triad (host, vector, environment) has proven to be a robust model for other epidemics and is applied to obesity. Host-based strategies are primarily educational and these tend to be most effective among people with higher incomes and higher educational attainment. The main vectors for a high-energy intake are energy-dense foods and drinks and large portion sizes and, for low energy expenditure, machines that promote physical inactivity. Vector-based strategies that alter food formulation can have a significant impact, particularly through influencing common, high-volume foods. The increasingly 'obesogenic' environments are probably the main driving forces for the obesity epidemic. There are many environmental strategies that can influence the physical, economic, policy or socio-cultural environments, but the evidence base for these potentially powerful interventions is small. Children should be the priority population for interventions, and improving the general socio-economic conditions for disadvantaged, marginalized or poor population sectors is also a central strategy for obesity prevention. The key settings for interventions are schools, homes, neighbourhoods, primary health care services and communities. The key macroenvironments for interventions are the transport and infrastructure sector, the media and the food sector.
Adolescent↗
The importance of glassy biopolymer components in food.
The glassy state is not just important in low moisture and frozen foods, where it influences the physical and chemical stability and the crispness of some foodstuffs: glassy biopolymer components affect the physical properties of most food systems and low moisture biological systems. Glassy foods are not always fragile and crispy in texture. Therefore, the relationship between mechanical behaviour and molecular dynamics in low-moisture biopolymer systems will be considered. Vitrification of a macromolecular system only requires a mutual fixation of a certain proportion of the chain segments. The higher the rigidity of the chains, the lower the number of the chain segments which must be mutually fixed to vitrify the system. Mechanical stress can help the thermal movement to re-activate the motion of mutually fixed segments and involves a long deformation of glassy material. The stress required to effect long deformation presumably increases up to the strength of the material as the temperature decreases from the glass transition to the temperatures of brittleness (crispness). Vitrification of a loaded viscoelastic system results in an accumulation of mechanical energy (memory effect), which can be released (elastic recovery) above the glass transition temperature due to heating and or addition of a plasticizer. The effects of memory and elastic recovery could be of particular importance for producing foodstuffs which change their form, e.g. self-stirring dry foods and drinks on re-hydration in hot water. The importance of glassy biopolymer ingredients from the viewpoint of food formulation and processing is discussed.
Biopolymers↗
Physico-chemical modification of food proteins: food emulsions.
Physico-chemical protein modification involved in food processing is used for "engineering" the structure-property relationship of foods. The three main tools used for protein modification are food formulation, mechanical and thermal (heating/cooling) treatments. They correspond to the main stages of all food technologies. Food structural design is based upon incompatibility and complexing of food biopolymers as well as upon fundamental features of physico-chemical properties of biphasic aqueous systems. Some examples of functional biopolymer modification are considered in systems such as meat extenders, fat replacers, ice cream mixes and wheat flour doughs.
Chemical Phenomena↗
Interpretation of data on dietary intake.
Although this discussion has focused on the interpretation of dietary data, assuming that it is representative of actual and usual intake and that the nutrient analysis based on it involved the use of up-to-date food composition tables, the readers should be sensitive to other potential sources of error or bias in obtaining information on food and/or nutrient intake. These include errors due to irregularity of food consumption, under- or overreporting of intake, errors in reporting either the amount or the description of the food consumed, recording errors on the part of the interviewer or coding errors on the part of the coder, limitations in the tables of food composition due to missing data for certain nutrients in certain foods or to biologic variability in the same foods from different sources or in those marketed under different conditions, imputed values, the unknown composition of formulated foods or foods prepared from home or commercial recipes, differences in bioavailability of nutrients as a function of the diet, or the use of abridged tables of food composition. In spite of the many unresolved issues relating to dietary standards and the interpretation of dietary intake data, we are still able to make a reasonable assessment of dietary adequacy of groups and individuals with our current system, which is viewed as a unique federal resource. It is hoped that the eventual passage of the National Nutrition Monitoring and Related Research Act will provide both the impetus and the resources to permit us to develop a more sophisticated system for assessing both food intake and nutritional status.
Data Interpretation, Statistical↗
Milk proteins: physicochemical and functional properties.
Because of the growing trend toward widespread use of protein ingredients in food formulation and fabrication, an understanding of the relationships between the physical properties of proteins and their behavior in food systems is desirable. A range of milk-derived protein preparations, i.e., dry milk, milk proteins, caseins, whey proteins, and lactalbumin, are used in a range of food products for their specific functional attributes. In this paper some of the apparent relationships between the properties of the protein components and specific functional properties are discussed. Thus, the roles of milk proteins in determining some important physical characteristics (i.e. color, bulk density, sinkability, dispersibility) of milk powders and their involvement in a range of functional properties (water holding, solubility, rheological behavior, gelation, film formation, emulsification, and foaming) are reviewed. Because of the various methods and conditions used in determining functional properties and the variability in composition of preparations it is difficult to compare data and/or reconcile differences in published information. The desirability of developing standard methods is emphasized.
Amino Acid Sequence↗