Alimentative infusion liquids for administration through periphe

Details Alimentative infusion liquids for administration through periphe Alimentative infusion liquids for administration through periphe

1997-10-07

1999-11-30

Henley, III, Raymond

Drug, bio-affecting and body treating compositions

Inorganic active ingredient containing

Phosphorus or phosphorus compound

424641, 424677, 424682, 514 23, 514400, 514561, 514565, 514566, A61K 3342, A61K 3332, A61K 3314, A61K 3306, A61K 3170

Patent

active

059938633

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

This invention relates to an alimentative infusion liquid to be administered via a peripheral vein. More particularly, it relates to an infusion liquid to be administered via a peripheral vein which is a hyperalimentative infusion liquid containing sugars, amino acids, electrolytes and a fat emulsion, having an excellent stability and causing no trouble such as angialgia during the administration.


BACKGROUND ART

Intravenous infusion is carried out for the purpose of supplying nutrients to maintain a patient's life when oral or nasal feeding is impossible or insufficient, when the digestion and absorption functions of the patient are in a poor state, even if such a feeding means can be carried out, or when the passage of food through the digestive tract makes the patient's condition or disease more serious. Examples of commercially available infusion preparations include a sugar intravenous infusion liquid which contains reducing sugars and the like, an amino acid intravenous infusion liquid which contains essential amino acids and the like, an electrolyte infusion liquid which contains minerals and the like, a fat emulsion which contains a plant oil emulsion and the like, and a vitamin mixture. These infusion preparations are appropriately selected depending on the condition of the patient and are mixed upon use. However, mixing these preparations at the time of their use requires complex handling and, above all things, raises the problem of microbial contamination. With the aim of overcoming such problems, various infusion preparations, in which some of the aforementioned infusion liquids are mixed in advance, have been proposed. Infusion preparations which contain sugars, amino acids, electrolytes and a fat emulsion, all being essential nutrients to be supplied, are especially useful from a clinical point of view.
However, since these sugar infusion liquids, amino acid infusion liquids, electrolyte infusion liquids and fat emulsion are different from one another in terms of the conditions for their stable existence, various problems arise when they are mixed, and the mixture becomes useless in many cases.
For example, because of its unstable nature, a fat emulsion is apt to form bulky fat particles and to cause phase separation (creaming) when mixed with other infusion liquids. In particular, divalent cations contained in an electrolyte infusion liquid cause aggregation and disintegration of fat emulsion particles.
In the case of an electrolyte infusion liquid, since it contains calcium and phosphoric acid as essential components to maintain the balance of electrolytes, it is apt to form calcium phosphate by the reaction of calcium with phosphoric acid and thereby to generate turbidity and precipitation. In order to prevent the formation of turbidity and precipitation, such an electrolyte infusion liquid is usually adjusted to a low pH value (less than pH 5). When such a electrolyte infusion liquid is mixed with an amino acid infusion liquid, the pH of the mixture increases to the amino acid pH value because of the strong buffer action of amino acids, thus requiring a large quantity of acidic materials (for example, hydrochloric acid, acetic acid and the like) to keep the pH value at a low level. However, acidic materials can be used only in a limited amount because a large quantity of acid spoils the balance of the infusion components. As a consequence, the pH value of the mixture of electrolyte and amino acid infusion liquids cannot be lowered to a satisfactory level, thus resulting in the generation of turbidity and precipitation during heat sterilization of the mixture.
In addition, when a mixture of an amino acid infusion liquid with a sugar infusion liquid is sterilized by heating, it is known that considerable coloring occurs due to the Maillard's reaction.
As described above, it is difficult to prepare a storable infusion preparation which contains a sugar, amino acids, electrolytes and a fat emulsion, in advance, because mixing these different types of infusion liquids or emu

REFERENCES:
patent: 4920098 (1990-04-01), Cotter et al.
Parry et al., "Effect of Various Nutrient Ratios on the Emulsion Stability of Total Nutrient Admixtures" Am. J. of Hospital Pharmacy, 43:3017-3022 (1986).

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