US4182756A — High calorie solutions of low molecular weight gl…

Claim 1

Independent Claim 71 words

A substantially clear, nonpyrogenic, stable and sterile solution for intravenous administration to human patients, said solution comprising at least 20% W/V of a glucose polymer mixture having an average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units.

Claim 2

Dependent Claim 71 words

A substantially clear, nonpyrogenic, stable and sterile solution for intravenous administration to human patients, said solution comprising at least 20% W/V of a glucose polymer mixture having an average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units.

Claim 3

Dependent Claim 20 words

The solution defined in claim 1, wherein said solution comprises from 20 to 50% W/V of said glucose polymer mixture.

Claim 4

Dependent Claim 14 words

The solution defined in claim 2, wherein said solution is isotonic to human blood.

Claim 5

Dependent Claim 21 words

The solution defined in claim 3 wherein said glucose polymer mixture has an average degree of polymerization between 4 and 10.

Claim 6

Dependent Claim 21 words

The solution defined in claim 1, wherein said glucose polymer mixture has an average degree of polymerization between 4 and 10.

Claim 7

Dependent Claim 142 words

The solution defined in claim 1, wherein said solution comprises from 20-30% W/V of a glucose polymer mixture having an average degree of polymerization between 4 and 6, less than 1% of its molecules greater than 25 glucose units, 4 to 10% of its molecules between 11 and 25 glucose units, 1 to 3% of its molecules 10 glucose units, 3 to 5% of its molecules 9 glucose units, 5 to 8% of its molecules 8 glucose units, 14 to 17% of its molecules 7 glucose units, 16 to 18% of its molecules 6 glucose units, 8 to 9% of its molecules 5 glucose units, 10 to 13% of its molecules 4 glucose units, 13 to 17% of its molecules 3 glucose units, 8 to 13% of its molecules 2 glucose units, and 1 to 3% of its molecules 1 glucose unit.

Claim 8

Independent Claim 80 words

A method of providing calories to a human patient comprising infusing into a peripheral vein of said patient a clear, nonpyrogenic, stable and sterile solution including at least 20% W/V of a glucose polymer mixture having an average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units.

Claim 9

Independent Claim 80 words

A method of providing calories to a human patient comprising infusing into a peripheral vein of said patient a clear, nonpyrogenic, stable and sterile solution including at least 20% W/V of a glucose polymer mixture having an average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units.

Claim 10

Dependent Claim 23 words

The method of providing calories defined in claim 7 wherein said solution comprises from 20 to 50% W/V of said glucose polymer mixture.

Claim 11

Dependent Claim 17 words

The method of providing calories defined in claim 8, wherein said solution is isotonic to human blood.

Claim 12

Dependent Claim 24 words

The method of providing calories defined in claim 9, wherein said glucose polymer mixture has an average degree of polymerization between 4 and 10.

Claim 13

Dependent Claim 24 words

The method of providing calories defined in claim 7, wherein said glucose polymer mixture has an average degree of polymerization between 4 and 10.

Claim 14

Dependent Claim 145 words

The method of providing calories defined in claim 7, wherein said solution comprises from 20-30% W/V of a glucose polymer mixture having an average degree of polymerization between 4 and 6, less than 1% of its molecules greater than 25 glucose units, 4 to 10% of its molecules between 11 and 25 glucose units, 1 to 3% of its molecules 10 glucose units, 3 to 5% of its molecules 9 glucose units, 5 to 8% of its molecules 8 glucose units, 14 to 17% of its molecules 7 glucose units, 16 to 18% of its molecules 6 glucose units, 8 to 9% of its molecules 5 glucose units, 10 to 13% of its molecules 4 glucose units, 13 to 17% of its molecules 3 glucose units, 8 to 13% of its molecules 2 glucose units, and 1 to 3% of its molecules 1 glucose unit.

Claim 15

Independent Claim 89 words

A method of providing calories to a diabetic human patient without increasing said patient's blood glucose level comprising infusing into a peripheral vein of said diabetic patient a clear, nonpyrogenic, stable and sterile solution including at least 20% W/V of a glucose polymer mixture having an average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units.

Claim 16

Independent Claim 89 words

A method of providing calories to a diabetic human patient without increasing said patient's blood glucose level comprising infusing into a peripheral vein of said diabetic patient a clear, nonpyrogenic, stable and sterile solution including at least 20% W/V of a glucose polymer mixture having an average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units.

Claim 17

Dependent Claim 28 words

The method of providing calories to a diabetic patient as defined in claim 13, wherein said solution comprises from 20 to 50% W/V of said glucose polymer mixture.

Claim 18

Dependent Claim 22 words

The method of providing calories to a diabetic patient as defined in claim 14, wherein said solution is isotonic to human blood.

Claim 19

Dependent Claim 29 words

The method of providing calories to a diabetic patient as defined in claim 15, wherein said glucose polymer mixture has an average degree of polymerization between 4 and 10.

Claim 20

Dependent Claim 29 words

The method of providing calories to a diabetic patient as defined in claim 13, wherein said glucose polymer mixture has an average degree of polymerization between 4 and 10.

Claim 21

Dependent Claim 150 words

The method of providing calories to a diabetic patient as defined in claim 13, wherein said solution comprises from 20-30% W/V of a glucose polymer mixture having an average degree of polymerization between 4 and 6, less than 1% of its molecules greater than 25 glucose units, 4 to 10% of its molecules between 11 and 25 glucose units, 1 to 3% of its molecules 10 glucose units, 3 to 5% of its molecules 9 glucose units, 5 to 8% of its molecules 8 glucose units, 14 to 17% of its molecules 7 glucose units, 16 to 18% of its molecules 6 glucose units, 8 to 9% of its molecules 5 glucose units, 10 to 13% of its molecules 4 glucose units, 13 to 17% of its molecules 3 glucose units, 8 to 13% of its molecules 2 glucose units, and 1 to 3% of its molecules 1 glucose unit.

Claim 22

Dependent Claim 75 words

In the method of providing calories to human patients by intravenously feeding the patient an aqueous carbohydrate solution, the improvement which comprises, infusing into a peripheral vein of said patient a clear, nonpyrogenic, stable and sterile solution comprising glucose polymers having molecules substantially all less than 26 glucose units in length at a rate providing said patient not more than 5 milligrams of glucose polymers a minute for each kilogram of said patient's body weight.

Claim 23

Dependent Claim 75 words

In the method of providing calories to human patients by intravenously feeding the patient an aqueous carbohydrate solution, the improvement which comprises, infusing into a peripheral vein of said patient a clear, nonpyrogenic, stable and sterile solution comprising glucose polymers having molecules substantially all less than 26 glucose units in length at a rate providing said patient not more than 5 milligrams of glucose polymers a minute for each kilogram of said patient's body weight.

Claim 24

Dependent Claim 33 words

The method of providing calories defined in claim 19, wherein said rate of infusion provides between 2 and 3 milligrams of glucose polymer a minute for each kilogram of said patient's body weight.

Claim 25

Dependent Claim 21 words

The method of providing calories defined in claim 19, wherein said aqueous solution of glucose polymers is a 10-50% W/V solution.

Claim 26

Dependent Claim 22 words

The method of providing calories defined in claim 21, wherein said aqueous solution of glucose polymers is substantially isotonic with human blood.

Claim 27

Dependent Claim 21 words

The method of providng calories defined in claim 19, wherein said glucose polymers in said aqueous solution consist essentially of maltose.

Claim 28

Dependent Claim 41 words

The method of providing calories defined in claim 19, wherein said glucose polymers have an average degree of polymerization of at least 4 and are further defined in that at least 85% of the polymers are less than 11 glucose units.

Claim 29

Dependent Claim 23 words

The method of providing calories defined in claim 24, wherein said glucose polymers have an average degree of polymerization between 4 and 10.

Claim 30

Dependent Claim 145 words

The method of providing calories defined in claim 19, wherein said solution comprises from 20-30% W/V of a glucose polymer mixture having an average degree of polymerization between 4 and 6, less than 1% of its molecules greater than 25 glucose units, 4 to 10% of its molecules between 11 and 25 glucose units, 1 to 3% of its molecules 10 glucose units, 3 to 5% of its molecules 9 glucose units, 5 to 8% of its molecules 8 glucose units, 14 to 17% of its molecules 7 glucose units, 16 to 18% of its molecules 6 glucose units, 8 to 9% of its molecules 5 glucose units, 10 to 13% of its molecules 4 glucose units, 13 to 17% of its molecules 3 glucose units, 8 to 13% of its molecules 2 glucose units, and 1 to 3% of its molecules 1 glucose unit.

Claim 31

Independent Claim 59 words

A method of preparing a clear, nonpyrogenic, stable and sterile solution for intravenous administration to human patients comprising: (a) dissolving a corn starch hydrolysate having a dextrose equivalent of 10-25 in distilled water to form a corn starch hydrolysate solution, (b) adding alcohol to said solution to obtain an alcohol concentration of 70 to 95%, (c) agitating said solution,

Claim 32

Independent Claim 59 words

A method of preparing a clear, nonpyrogenic, stable and sterile solution for intravenous administration to human patients comprising: (a) dissolving a corn starch hydrolysate having a dextrose equivalent of 10-25 in distilled water to form a corn starch hydrolysate solution, (b) adding alcohol to said solution to obtain an alcohol concentration of 70 to 95%, (c) agitating said solution,

Claim 33

Dependent Claim 140 words

(d) terminating said agitation of said solution and allowing said solution to remain calm until it separates into supernatant and precipitants portions, (e) decanting said supernatant portion from said solution into a collection container, (f) repeating steps c, d and e a plurality of times, (g) removing said alcohol from said plurality of supernatant portions in said collection container by concentrating said plurality of supernatant solutions, (h) dissolving said concentrated supernatant in distilled water to form a concentrated supernatant solution, then, treating with activated carbon and filtering said concentrated supernatant solution, (i) drying said filtered concentrated supernatant solution to produce a dried glucose polymer mixture, (j) dissolving an amount of said dried glucose polymer mixture into an amount of distilled water in a predetermined ratio to form a preferred % W/V solution, and (k) autoclaving said preferred % W/V solution.

Claim 34

Dependent Claim 140 words

(d) terminating said agitation of said solution and allowing said solution to remain calm until it separates into supernatant and precipitants portions, (e) decanting said supernatant portion from said solution into a collection container, (f) repeating steps c, d and e a plurality of times, (g) removing said alcohol from said plurality of supernatant portions in said collection container by concentrating said plurality of supernatant solutions, (h) dissolving said concentrated supernatant in distilled water to form a concentrated supernatant solution, then, treating with activated carbon and filtering said concentrated supernatant solution, (i) drying said filtered concentrated supernatant solution to produce a dried glucose polymer mixture, (j) dissolving an amount of said dried glucose polymer mixture into an amount of distilled water in a predetermined ratio to form a preferred % W/V solution, and (k) autoclaving said preferred % W/V solution.

Claim 35

Dependent Claim 38 words

The method of claim 27, wherein said corn starch hydrolysate has a dextrose equivalent of 10-13 and consists of 1% glucose, 4% maltose, 5% maltotriose, 4% maltotetraose, 4% maltopentaose and 82% molecules of six or more glucose units.

Claim 36

Dependent Claim 38 words

The method of claim 27, wherein said corn starch hydrolyzate has a dextrose equivalent of 16-20 and consists of 1% glucose, 7% maltose, 9% maltotriose, 6% maltotetraose, 6% maltopentaose and 71% molecules of six or more glucose units.

Claim 37

Dependent Claim 36 words

The method of claim 27, wherein said corn starch hydrolysate has a dextrose equivalent of 13-17 and consists of 1% glucose, 3% maltose, 8% maltotriose, 6% matotetraose and 82% molecules of five or more glucose units.

Claim 38

Dependent Claim 36 words

The method of claim 27, wherein said corn starch hydrolysate has a dextrose equivalent of 18-22 and consists of 1% glucose, 6% maltose, 8% maltotriose, 7% maltotetraose, and 78% molecules of five or more glucose units.

Claim 39

Dependent Claim 41 words

The method of claim 27, wherein said distilled water is between 30°-45° C. when said corn starch hydrolysate is dissolved therein and said corn starch hydrolysate solution is maintained between 20°-35° C. during said agitation of said corn starch hydrolysate solution.

Claim 40

Dependent Claim 13 words

The method of claim 27, wherein said alcohol is ethanol 3A, 190-200 proof.

Claim 41

Dependent Claim 16 words

The method of claim 27, wherein said filtered concentrated supernatant solution is dried by spray drying.

Claim 42

Dependent Claim 25 words

The method of claim 27, wherein diatomaceous earth is added to said corn starch hydrolysate solution during said agitation of said corn starch hydrolysate solution.

Claim 43

Dependent Claim 25 words

The method of claim 27, wherein said supernatant portion of said corn starch hydrolysate solution is filtered before said supernatant portion enters said collection container.

Claim 44

Dependent Claim 23 words

The method of claim 27, wherein said filtered concentrated supernatant solution is passed through an ion exchange resin before it is spray dried.

Claim 45

Independent Claim 93 words

A method of preparing a clear, nonpyrogenic, sterile and stable solution for intravenous administration to human patients comprising: (a) dissolving a corn starch hydrolysate having a dextrose equivalent of 10-25 in distilled water to form a corn starch hydrolysate solution, (b) subjecting said corn starch hydrolysate to fractionation through a semipermeable membrane to obtain a preferred glucose polymer mixture, (c) dissolving an amount of said glucose polymer mixture into an amount of distilled water in a predetermined ratio to form a preferred % W/V solution, and (d) autoclaving said preferred % W/V solution.

Claim 46

Independent Claim 93 words

A method of preparing a clear, nonpyrogenic, sterile and stable solution for intravenous administration to human patients comprising: (a) dissolving a corn starch hydrolysate having a dextrose equivalent of 10-25 in distilled water to form a corn starch hydrolysate solution, (b) subjecting said corn starch hydrolysate to fractionation through a semipermeable membrane to obtain a preferred glucose polymer mixture, (c) dissolving an amount of said glucose polymer mixture into an amount of distilled water in a predetermined ratio to form a preferred % W/V solution, and (d) autoclaving said preferred % W/V solution.

Claim 47

Dependent Claim 38 words

The method of claim 38, wherein said corn starch hydrolysate has a dextrose equivalent of 10-13 and consists of 1% glucose, 4% maltose, 5% maltotriose, 4% maltotetraose, 4% maltopentaose and 82% molecules of six more more glucose units.

Claim 48

Dependent Claim 38 words

The method of claim 38, wherein said corn starch hydrolysate has a dextrose equivalent of 16-20 and consists of 1% glucose, 7% maltose, 9% maltotriose, 6% maltotetraose, 6% maltopentaose and 71% molecules of six or more glucose units.

Claim 49

Dependent Claim 36 words

The method of claim 38, wherein said corn starch hydrolysate has a dextrose equivalent of 13-17 and consists of 1% glucose, 3% maltose, 8% maltotriose, 6% maltotetraose and 82% molecules of five or more glucose units.

Claim 50

Dependent Claim 36 words

The method of claim 38, wherein said corn starch hydrolysate has a dextrose equivalent of 18-22 and consists of 1% glucose, 6% maltose, 8% maltotriose, 7% maltotetraose, and 78% molecules of five or more glucose units.

Claim 51

Dependent Claim 19 words

The method of claim 38 wherein said corn starch hydrolysate is subjected to reverse osmosis through said semipermeable membrane.

Claim 52

Dependent Claim 18 words

The method of claim 38 wherein said corn starch hydrolysate is subjected to ultrafiltration through said semipermeable membrane.

Claim 53

Dependent Claim 34 words

The method of claim 38 wherein said preferred glucose polymer mixture is further refined by treatment with activated carbon before it is dissolved in said distilled water to form said preferred % W/V solution.

Claim 54

Dependent Claim 29 words

The method of claim 38 wherein said preferred glucose polymer mixture is spray dried before it is dissolved in said distilled water to form said preferred % W/V solution.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1983-01-07	1983-07-09	1984-01-08	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1987-01-07	1987-07-09	1988-01-08	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1991-01-07	1991-07-09	1992-01-08	$7700.00	Window Closed / Lapsed

High calorie solutions of low molecular weight glucose polymer mixtures useful for intravenous administration

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