Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-03-29
2004-05-18
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S738000, C536S103000, C536S124000
Reexamination Certificate
active
06737414
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a composition for enteral nutrition comprising fibres.
BACKGROUND OF THE INVENTION
More precisely, the object of the invention is a composition for enteral nutrition comprising branched maltodextrins.
Artificial nutrition makes it possible, in adults as in children, to compensate for a defective intestine, to put an inflammatory intestine to rest, to correct severe undernourishment in a patient unable or unwilling to eat, either because of a serious condition, or because of a cumbersome treatment. Its duration can extend from a few days to four weeks to several months or years. Depending on the cases, the artificial nutrition will be performed by the digestive route (enteral nutrition) or by the venous route (parenteral nutrition). Always introduced in a hospital setting, in medicine, surgery and intensive care, artificial nutrition can now be continued at home in cases requiring a very prolonged treatment. The basic principle of enteral or parenteral artificial nutrition is the supply of all the nutrients necessary for life: sugars, fats, proteins, minerals, trace elements, vitamins, which the subject can no longer take in by the usual oral route.
Enteral nutrition is the most simple and the most physiological route for nutritive assistance. The site of delivery is in general intragastric, with the aid of a tube introduced by the nasal route. An effective and well-tolerated enteral nutrition involves two basic technical principles: the slowness (1 to 3 ml/min) and the continuous nature (from 12 h to 24 h per day) of the food instillation.
In the case of extensive intestinal lesions compromising the functions of absorption, the foods used are predigested (amino acids, monosaccharides).
When the small intestine is still functional, a semi-basic diet composed of less degraded, or even nondegraded, nutrients is used. Minerals, trace elements and vitamins, are added systematically and daily. The nutrients are prepared, mixed and stored under conditions of strict cleanliness, or even asepsis in case of industrial preparation.
Hospitalized patients and in particular patients on antibiotics or suffering from intestinal disorders, resulting either in constipation, or in diarrhoeas and receiving nutritional assistance by the enteral route need a supply of appropriate fibre.
The fibres are recognized for their beneficial effects on human health and should form an integral part of the daily food supplies. Fibres are generally classified into two categories: soluble fibres and insoluble fibres. Soluble fibres, such as pectin, inulin, resistant starches are fermented by the intestinal bacterial flora. This fermentation releases short-chain fatty acids in the colon, which have the effect of reducing the pH thereof and consequently of limiting the development of pathogenic bacteria.
Insoluble fibres, such as cellulose, maize or soya bean fibres have an essentially mechanical role in the gastrointestinal tract. They are only very slightly fermented by the intestinal flora and contribute to reducing the duration of the intestinal transit.
A fibre-enriched composition for enteral nutrition should ideally:
be similar to the fibres conventionally consumed;
generate a production of beneficial volatile fatty acids;
not cause flatulence in the patient;
improve intestinal motility;
not have residues;
be soluble;
have adequate viscosity so as to facilitate its instillation;
be stable during storage and during sterilization;
be gradually assimilated;
promote mineral absorption.
Several compositions for enteral nutrition containing fibres have been proposed. Pectin fibres have been proposed, but have disadvantages such as an excessively high viscosity, and a lack of improvement in mineral absorption.
Patent EP-B1 0,756,828 describes fibre-enriched compositions, containing a mixture of soluble fibres, insoluble fibres and resistant starch. These compositions contain a high proportion of soluble fibres and have a high viscosity which is not suited to instillation by a tube. These compositions also have problems of stability.
The document EP-A1 1,010,374 describes a mixture of fibres for enteral nutrition comprising soluble and insoluble pea fibres, inulin and fructooligosaccharides. These compositions are also too viscous especially because of the presence of pea fibres and inulin which are scarcely soluble; the fructooligosaccharides are not stable during sterilization. This instability results in gradual hydrolysis, which generates a release of glucose and fructose and a colour which are undesirable. These mixtures of fibres only partially promote mineral absorption, and are not gradually assimilated. Moreover, the pea fibres and inulin generate problems of flatulence in the patient. As for the fructooligosaccharides, these molecules remain poorly tolerated by the body, which is expressed by the onset of diarrhoea.
SUMMARY OF THE INVENTION
The aim of the present invention is therefore to remedy the disadvantages of the prior art. The applicant has indeed found that the incorporation of the said branched maltodextrins into a composition for enteral nutrition advantageously makes it possible to reconcile all these objectives which have up until now been reputed irreconcilable by devising and producing, at a cost of numerous research studies, a novel fibre-enriched composition for enteral nutrition which meets all the abovementioned criteria, namely the viscosity, the solubility, a satisfactory stability during storage and during sterilization manifested by the absence of retrogradation, a gradual assimilation, an absence of generation of flatulence, and a considerable improvement in mineral, and in particular calcium and magnesium, absorption.
DETAILED DESCRIPTION OF THE INVENTION
The subject of the invention is therefore a fibre-enriched composition for enteral nutrition, characterized in that it comprises branched malto-dextrins having between 15 and 35% of 1→6 glucoside linkages, a reducing sugar content of less than 20%, a polymolecularity index (ratio of weight-average molecular mass over number-average molecular mass) of less than 5, and a number-average molecular mass Mn at most equal to 4500 g/mol.
The expression branched maltodextrins is understood to mean, for the purposes of the present invention, the maltodextrins described in patent application EP 1,006,128 of which the assignee is proprietor. These branched maltodextrins have an indigestibility character which has the consequence of reducing their calorific value, by preventing their assimilation in the small intestine. They therefore represent a source of indigestible fibres beneficial to the metabolism and the intestinal balance. As a guide, their insoluble fibre level is generally greater than 506 on a dry matter basis. Their high content of 1→6 glucoside linkages confers quite particular prebiotic properties on them: it has indeed appeared that the bacteria of the cæcum and of the colon of humans and of animals, such as butyrogenic, lactic or propionic bacteria, metabolize highly branched compounds. Moreover, these branched maltodextrins promote the development of the bifidogenic bacteria to the detriment of the undesirable bacteria. This results in properties which are quite beneficial to the health of the consumer. Finally, the branched character of the said maltodextrins considerably and advantageously reduces their tendency to undergo retrogradation, which makes it possible to envisage their use in applications where the absence of retrogradation is necessary, in particular during prolonged storage in aqueous solution.
All the branched maltodextrin compositions described in patent application EP 1,006,128 and its US counterpart (U.S. Pat. No. 09/455,009; Assignee Roquette Frères) are appropriate for the preparation of compositions for enteral nutrition according to the invention. The entire content of U.S. Ser. No. 09/455,009 is herein incorporated by reference.
According to a preferred variant, they have a reducing sugar content of between 2 and 5% and a number-average molec
Jones Dwayne C.
Roquette Freres
Sturm & Fix LLP
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