EP1231907A2 - Preparation de fluides a base de dextrose et d'insuline destinee a une infusion intraveineuse - Google Patents

Preparation de fluides a base de dextrose et d'insuline destinee a une infusion intraveineuse

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Publication number
EP1231907A2
EP1231907A2 EP00990877A EP00990877A EP1231907A2 EP 1231907 A2 EP1231907 A2 EP 1231907A2 EP 00990877 A EP00990877 A EP 00990877A EP 00990877 A EP00990877 A EP 00990877A EP 1231907 A2 EP1231907 A2 EP 1231907A2
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EP
European Patent Office
Prior art keywords
dextrose
insulin
vitamins
fluids
solutions
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP00990877A
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German (de)
English (en)
Inventor
Hanamaraddi T. Gangal
Parag H. Gangal
Madhumati H. Gangal
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1231907A2 publication Critical patent/EP1231907A2/fr
Withdrawn legal-status Critical Current

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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
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    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
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    • A61K31/33—Heterocyclic compounds
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    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727—Heparin; Heparan
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    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
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    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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    • A61K33/42—Phosphorus; Compounds thereof
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05—Dipeptides
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Definitions

  • Ringers lactate solutions etc. All these have been used, as basic fluids when patient needed administration of therapeutic fluids and other ingredients. In certain special circumstances, fluids like
  • the body is unable to utilise, the energy substrate and electrolytes available, in view of high levels of catacholamines, along with qualitative and quantitative deficiency of insulin, and disturbed hormonal levels.
  • the fluids needed are broadly categorised for use to suit the various situations. They are to be in packing of 500 ml for calculations .
  • the following abbreviations are used to denote the fluid and their possible place of use.
  • G - Gangal N - Non diabetic, D - Diabetic, E - Electrolytes, H - Heparin, V - Vitamins, I - Insulin, where supplemental Potassium is added they are marked as K.
  • Dext - Dextrose Dextrose.
  • A.E Actual electrolytes to replace the Extra cellular electrolytes
  • A.M Actual electrolytes needed in Maintenance solutions as are presently available, to be taken as 500 ml packing for values of their contents.
  • the fluids needed to treat patients who are said to be non-diabetic, as are known to day, are called GN 1 containing the ingredients as stated in the abbreviated text form in the columns
  • the GD 9 solutions are supplemented with Electrolytes and Vitamins to gain GD 14 - EV solutions.
  • the GD 9 group of fluids is supplemented with Heparin and Vitamins. They provide GD 15 - H V group of solutions.
  • the GD 9 combination fluids are supplemented with Electrolytes, Heparin and Vitamins. These fluids form the GD 16 - EHV. Group of solutions
  • the tables below provide information about A.E, the Actual electrolytes in Extra cellular replacement and A.M, Actual electrolytes in Maintenance solutions as are available.
  • the values expressed in the table against each item is the actual content of the ingredients in 100 ml of each fluids as are in use today.
  • Oil Soluble Vitamins A, D, E, are made water soluble to be used here.
  • the formulations consist of the following and other ingredients mentioned in the above clarifications and in the text.
  • Water is the main and the essential natural component of the body, and is also the main vehicle / media through which the body's circulation is maintained. This makes it possible the essentials of life and function are made available from the body to the cell level and receives back the wastes from the cell level to the organ to be eliminated out of the body. It helps to mentain physiological state in and around the body, congenial to sustain normal life.
  • the volume of the water needed by the body varies with the functional level, the problems faced and the environment. Accordingly the volume of fluid needed to be infused, to balance the need and the output and also to maintain an effective circulation, are required into consideration to asses.
  • Dextrose A major source of energy out of all other essential energy substrates. A must for living and sustaining life.
  • Dextrose in the form of 5% as an isotonic solution has been the main stay of intravenous infusion in all forms of conditions where infusion forms the treatment as well as a resuscitative measure. In states of stress, shock, and critical conditions, this isotonic solution is now understood to have hypotonic solution effect.
  • This type of fluids are likely to cause enormous harmful effects.
  • the fluids we use in hypertonic form enable us to provide needed higher calories along with insulin, and also avoid effects of hypotonic solutions.
  • it forms the main source of energy to be supplemented by amino acids, and emulsified fat solutions. This helps to meet the needs of essential amino acids, and also fats; along with it enables to prevent the bad and rebound effects of prolonged use of carbohydrates alone.
  • Na Sodium chloride forms a major and a main electrolyte. It is also called the second pump to maintain the circulation.
  • Nacl is an isotonic solution, commonly used as such or in combination with Dextrose solutions. It is one of the main electrolyte, the body needs. It is mainly an extra cellular electrolyte with a small intracellular component, having a reciprocal gradient relation with K ion responding to any effective agents. The intake and output needs to be balanced. The body contains a large amount, nearing around 5000 mEq of Na, with an average need of, 80 - 100, mEq / Day. This is mostly lost in the urine. In the normal individual, on one hand there is a large reserve, on the other hand there is an excellent mechanism to conserve it by normal functioning kidney. This can result in bringing urinary loss of Na to near zero, in the absence of intake ofNa. Still large fluctuations do occur with resultant serious problems. Hence it needs to be managed properly to retain homeostasis
  • Ca Calcium similarly forms a major cation component of the body, having role to play in homeostasis, membrane potentials, inter cellular junctions and cell functions.
  • Calcium forms around 2% of the bodyweight. Ninety nine % of it is in the form of bone. Part of it is constantly changing to contribute to the extra-cellular component. This is under the influence of simple ion exchange. Paratharmone, Vit D, Corticosteroids cause disturbances in Calcium content.
  • any variations in the extra-cellular component affect the homeostasis. This in turn results in deranged cellular functions.
  • Average Indian diet may contain as low as 0.2 Gms as against the daily need of 0.5 to 0.6 gm on an average. The needs are higher in later terms of pregnancy and lactation, thus needing up to around 1 gram of Calcium a day.
  • Intracellular Ca regulates cell metabolism, it's function and inter junction permeability.
  • Ca is an important component of the cell membrane and competes with Na. Raised Ca, in blood increases the threshold for contraction and low Ca leads to tetany.
  • Ca also plays role in coagulation of blood, coupling mechanism between excitation and contraction of muscles, and secretary mechanism of Insulin.
  • K Potassium mainly an intracellular electrolyte having a significant role to play in cell membrane potentials and cell functions.
  • Potassium chloride KC1 solution is available for intravenous use, needs to be diluted considerably to use. Normally there is about 3500 mEq of Potassium in the body, of which 98%is intracellular and hardly 2% is in extra-cellular compartment. This small part of the Potassium plays a major role in the functioning of the smooth, skeletal, and cardiac muscles. As a result any variations that occur in its level can certainly cause considerable problems.
  • electrolytes As are included in the A.E, extra cellular electrolyte replacement component and A.M, electrolyte maintenance replacement component solutions are also essential to the body's function and are required to be maintained in balance.
  • Insulin Insulin is an essential hormone required in the process of metabolism of carbohydrates, proteins, and fats. Involving almost all organs in the body. It is now fairly well established, in clinical states needing intravenous infusions, there is qualitative and quantitative deficiency of insulin.
  • Heparin It is a naturally occurring substance, not occurring in blood to a measurable extent, prevents blood coagulation. It plays significant role in cases of trauma induced on any account. Blood coagulation is essentially a series of enzymatic reactions involving a number of plasma proteins. Many of these are present only in traces. Within an intact healthy circulatory system these enzymes, for the most part, are in an inactive form, when the blood is shed on wettable surfaces, a series of auto catalytic enzymatic reaction is initiated, this is a process of more complex and confused in results, interpretations, and opinions.
  • Vitamins Fat and water-soluble vitamins are organic compounds, forming as components or cofactors for enzymes concerned with metabolism of carbohydrates, fats, and proteins.
  • Vitamin A -Daily dose of around 10,000 to 20,000 I.U in the form of made as water soluble could be essential to maintain the integrity of the epithelial cells, synthesis of glucocortcoids, cholesterol, and for somatic growth, upper respiratory tract epithelium.
  • Vitamin Bi It is mainly concerned with Carbohydrate metabolism. IV / IM administration of large doses may cause anaphylactic shock and interfere with action of other B vitamins.
  • B 3 - Nicotinic acid is required in Protein metabolism, necessary in respiration Be - Indirectly affects carbohydrate metabolism, directly the catacholamines, gamma-amino butyric acid, etc., B 7 - is involved in fundamental biological reactions.
  • B ⁇ is necessary in maintenance of function of the nervous system and conduction mechanism.
  • C - Concerned with cellular respiration / oxidation-reduction reactions, and formation of collagen, intercellular matrix development of cartilage, wound healing, carbohydrate metabolism.
  • Vitamin D - Facilitates interdepartmental metabolism between vitamins, and maintains Ca. homeostasis. It is quite important in the acute conditions, like mobilisation of insulin, coupling mechanism of excitation and contraction mechanism of muscles. These have some relevance to diabetes normal organ function and essential hypertension.
  • E - Alpha Tocopheryl Acetate is said to be essential to maintain integrity and stability of biological membranes, normal structure and function of the nervous system and is mostly used on an empirical base. It is known to be antioxidant.
  • Choline Chloride is akin to B group of Vitamins but synthesised in the human body. It plays an important role as a structural component of tissues and in biological methilation reactions. It is a precursor of acetylcholine, and some hormones. Its biogenesis is universal in nature. It helps to spare amino acids in protein synthesis.
  • DL - Methionine is sulphur containing aminoacid and inseparable dietary component. Methionine has lipotropic action, and is considered as useful adjutant of treatment of liver diseases. It enhances synthesis of glutathione, necessary for detoxification of toxic metabolites of paracetamol. Average needs are around 200 to 500 mgm.
  • Inosital - occurs in nearly all plant, and animal cell, suggesting it to be an essential cell constituent. It is found to be a constituent of an amylase enzyme system. To a certain extent it is synthesised by the intestinal flora. It possesses weak lipotropic activity prevents fatty liver. It could be beneficial in diabetic neuropathy.

Abstract

Les patients reçoivent des fluides intraveineux sous forme de liquides, de milieux, d'éléments nutritifs, de minéraux, de vitamines, d'antibiotiques, ou d'autres médicaments d'importance vitale, compte tenu d'un certain nombre de critères cliniques. Il existe également des moyens fiables et effectifs de conférer à ces ingrédients des effets prévisibles sans inconvénient majeur. Ceux-ci peuvent être, dans beaucoup de cas, les seuls moyens de traitement possibles en tant que méthode de réanimation pouvant rendre à la vie normale des malades gravement atteints. Les fluides actuellement disponibles sont inappropiés à tous points de vue, sauf pour ce qui concerne l'apport en eau aux patients. Ils ont un effet hypotonique même s'ils sont isotoniques quand ils sont utilisés dans des états critiques. Le sentiment de l'inventeur est que, en pareils états, les besoins du patient sont à peine satisfaits par les fluides d'infusion actuels, ce qui place le patient dans une situation défavorable qui ne lui permet pas de faire face et recouvrer la santé. L'évolution de la science est telle que les souhaits et les attentes des patients continuent de s'améliorer et se traduisent en termes de meilleurs résultats, de réduction des coûts, d'efforts, et de moindre déperdition du temps de travail, par comparaison avec les traitements antérieurs. Et la guérison et l'augmentation de la durée de la vie sont devenues réalité là où naguère elles n'étaient pas possibles. Beaucoup de travail a été accompli par la science médicale dans ces domaines. Les infusions intraveineuses, qui sont encore aujourd'hui une composante des traitements, sont essentiellement constituées de solutions aqueuses de dextrose. La même démarche a été utilisée dans la suite en ce qui concerne l'administration d'antibiotiques, de solutions protéiques ou lipidiques, ainsi que de nombreuses autres matières solubles requises dans ces cas particuliers.
EP00990877A 1999-11-15 2000-11-10 Preparation de fluides a base de dextrose et d'insuline destinee a une infusion intraveineuse Withdrawn EP1231907A2 (fr)

Applications Claiming Priority (3)

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IN1106MA1999 1999-11-15
INMA110699 1999-11-15
PCT/IN2000/000110 WO2001035943A2 (fr) 1999-11-15 2000-11-10 Preparation de fluides a base de dextrose et d'insuline destinee a une infusion intraveineuse

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JP (1) JP2003514014A (fr)
CN (1) CN1284522C (fr)
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ZA (1) ZA200204895B (fr)

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GB0212405D0 (en) * 2002-05-29 2002-07-10 Insignion Holdings Ltd Composition and its therapeutic use
WO2007072147A2 (fr) * 2005-12-19 2007-06-28 Ernst, Johanna, Catarina Composition pour diagnostiquer et traiter des maladies du système circulatoire
US9700599B2 (en) 2012-11-13 2017-07-11 Adocia Rapid-acting insulin formulation comprising a substituted anionic compound
RU2546286C2 (ru) * 2013-06-07 2015-04-10 Федеральное государственное бюджетное научное учреждение "Всероссийский научно-исследовательский институт крахмалопродуктов" Фармацевтическая субстанция и способ ее получения
TW201630622A (zh) 2014-12-16 2016-09-01 美國禮來大藥廠 速效胰島素組合物
JO3749B1 (ar) 2015-08-27 2021-01-31 Lilly Co Eli تركيبات إنسولين سريعة المفعول
PE20200017A1 (es) 2017-06-01 2020-01-06 Lilly Co Eli Composiciones de insulina de rapida accion

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WO1982003773A1 (fr) * 1981-04-27 1982-11-11 Baxter Travenol Lab Solution de dialyse contenant du glucose, des acides amines et de l'insuline
SE502414C2 (sv) * 1990-05-28 1995-10-16 Ljungqvist Olle Medical Ab Användning av glukos för framställning av lösning för preoperativ administrering samt infusionslösning därför
US5449522A (en) * 1993-08-24 1995-09-12 Hill; Albert F. Pharmaceutical composition for immunoenhancement therapy

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AU779798C (en) 2005-11-17
RU2300367C2 (ru) 2007-06-10
ZA200204895B (en) 2003-02-12
CN1284522C (zh) 2006-11-15
JP2003514014A (ja) 2003-04-15
CN1390118A (zh) 2003-01-08
AU779798B2 (en) 2005-02-10
WO2001035943A3 (fr) 2002-03-21
WO2001035943A2 (fr) 2001-05-25
AU3048901A (en) 2001-05-30

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