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Claims for Patent: 4,201,772

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Claims for Patent: 4,201,772

Title: Sterile aqueous solution of a mixture of isomalto-oligosaccharides and its use for parenteral administration to mammals
Abstract:A sterile aqueous solution containing 0.02 to 30 g per 100 ml solution of a mixture of isomalto-oligosaccharides comprising (a) 0-15 percent by weight of isomaltose, (b) 20-65 percent by weight of isomaltotriose, isomaltetraose and isomaltopentaose, each of these oligosaccharides being present in an amount of at least 5 percent by weight and at most 25 percent by weight, (c) 20-65 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose, each of isomaltohexaose and isomaltoheptaose being present in an amount of at least 5 percent by weight and at most 25 percent by weight and the total amount of isomaltooctaose and isomaltononaose being at least 5 percent by weight and at most 25 percent by weight, 0-30 percent by weight of said mixture being isomaltooligosaccharides of 10 to 20 glucose units and 0-10 percent by weight of said mixture being isomaltooligosaccharides of 15 to 20 glucose units, the percentages being calculated on the total weight of the mixture of isomalto-oligosaccharides, and the use of said sterile aqueous solution for parenteral administration to mammals closely prior to or contemporaneously with the parenteral administration of clinical dextran to reduce the risks for adverse effects of the clinical dextran.
Inventor(s): Ingelman; Bjorn G. (Upsala, SE), Richter; Ary W. (Upsala, SE), Granath; Kirsti A. (Upsala, SE)
Assignee: Pharmacia Aktiebolag (Upsala, SE)
Application Number:05/891,106
Patent Claims: 1. In the known method of parenterally administering to mammals, including man, clinical dextran having a weight average molecular weight (M.sub.w) within the range 30,000 to 80,000, the improvement which comprises administering parenterally to the mammal, closely prior to or contemporaneously with the administration of said clinical dextran, an effective amount of a sterile aqueous solution for parenteral administration containing 0.02 to 30 g per 100 ml solution of a mixture of isomalto-oligosaccharides comprising

(a) 0-15 percent by weight of isomaltose,

(b) 20-65 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose, each of these oligosaccharides being present in an amount of at least 5 percent by weight and at most 25 percent by weight,

(c) 20-65 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose, each of isomaltohexaose and isomaltoheptaose being present in an amount of at least 5 percent by weight and at most 25 percent by weight and the total amount of isomaltooctaose and isomaltononaose being at least 5 percent by weight and at most 25 percent by weight,

- 30percent by weight of said mixture being isomalto-oligosaccharides of 10 to 20 glucose units and 0-10 percent by weight of said mixture being isomalto-oligosaccharides of 15 to 20 glucose units,

the percentages being calculated on the total weight of the mixture of isomalto-oligosaccharides.

2. A method as set forth in claim 1 wherein said sterile aqueous solution contains 0.2 to 30 g of said mixture per 100 ml of solution.

3. A method as set forth in claim 1 wherein said mixture is administered contemporaneously with and in the same solution as said dextran.

4. A method as set forth in claim 1 wherein said mixture comprises 2-10 percent by weight of isomaltose.

5. A method as set forth in claim 1 wherein said mixture comprises 25-55 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose.

6. A method as set forth in claim 1, wherein said mixture comprises 25-55 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose.

7. A method as set forth in claim 1, wherein said mixture comprises 5-20 percent by weight of isomalto-oligosaccharides of 10 to 20 glucose units, 0-7 percent by weight of said mixture consisting of isomalto-oligosaccharides of 15 to 20 glucose units.

8. A method of improving clinical dextran having a weight average molecular weight (M.sub.w) within the range 30,000 to 80,000 with respect to side effects on parenteral administration, characterized in that said clinical dextran is admixed with a mixture of isomalto-oligosaccharides comprising

(a) 0-15 percent by weight of isomaltose,

(b) 20-65 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose, each of these oligosaccharides being present in an amount of at least 5 percent by weight and at most 25 percent by weight,

(c) 20-65 percent by weight of isomaltohexaose, isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose, each of isomaltohexaose and isomaltoheptaose being present in an amount of at least 5 percent by weight and at most 25 percent by weight and the total amount of isomaltooctaose and isomaltononaose being at least 5 percent by weight and at most 25 percent by weight,

0-30 percent by weight of said mixture being isomalto-oligosaccharides of 10 to 20 glucose units and 0-10 percent by weight of said mixture being isomalto-oligosaccharides of 15 to 20 glucose units,

the percentages being calculated on the total weight of the mixture of isomalto-oligosaccharides,

the proportions between said mixture of isomalto-oligosaccharides and said clinical dextran being 1 part by weight of said mixture of 0.5 to 500 parts by weight of said clinical dextran.

9. A method according to claim 8 wherein said mixture comprises 2-10 percent by weight of isomaltose.

10. A method according to claim 8 wherein said mixture comprises 25-55 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose.

11. A method according to claim 8 wherein said mixture comprises 25-55 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose.

12. A method according to claim 8 wherein said mixture comprises 5-20 percent by weight of isomalto-oligosaccharides of 10 to 20 glucose units, 0-7 percent by weight of said mixture consisting of isomalto-oligosaccharides of 15 to 20 glucose units.

13. A sterile aqueous solution for parenteral administration characterized in that it contains 0.02 to 30 g per 100 ml solution of a mixture of isomalto-oligosaccharides, said mixture of oligosaccharides comprising

(a) 0-15 percent by weight of isomaltose,

(b) 20-65 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose, each of these oligosaccharides being present in an amount of at least 5 percent by weight and at most 25 percent by weight,

(c) 20-65 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose, each of isomaltohexaose and isomaltoheptaose being present in an amount of at least 5 percent by weight and at most 25 percent by weight and the total amount of isomaltooctaose and isomaltononaose being at least 5 percent by weight and at most 25 percent by weight,

0-30 percent by weight of said mixture being isomalto-oligosaccharides of 10 to 20 glucose units and 0-10 percent by weight of said mixture being isomalto-oligosaccharides of 15-20 glucose units,

the percentages being calculated on the total weight of the mixture of isomalto-oligosaccharides,

and in that it also contains 2 to 12 g of clinical dextran per 100 ml solution, said clinical dextran having a weight average molecular weight M.sub.w within the limits 30,000 to 80,000.

14. A sterile aqueous solution according to claim 13 wherein the solution contains 0.02 to 10 g of the isomalto-oligosaccharide mixture per 100 ml solution.

15. A sterile aqueous solution according to claim 14 wherein the solution contains 0.2 to 10 g of the isomalto-oligosaccharide mixture per 100 ml solution.

16. A sterile aqueous solution according to claim 13 wherein the solution contains less than 0.4 g of dextran molecules in the molecular weight range of 3,000 to 10,000 per 100 ml solution.

17. A sterile aqueous soltuion according to claim 13 wherein the isomalto-oligosaccharide mixture in the solution comprises 2-10 percent by weight of isomaltose.

18. A sterile aqueous solution according to claim 13 wherein the isomalto-oligosaccharide mixture in the solution comprises 25-55 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose.

19. A sterile aqueous solution according to claim 13 wherein the isomalto-oligosaccharide mixture in the solution comprises 25-55 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose.

20. A sterile aqueous solution according to claim 13 wherein the isomalto-oligosaccharide mixture in the solution comprises 5-20 percent by weight of isomalto-oligosaccharides of 10 to 20 glucose units and 0-7 percent by weight of said mixture consisting of isomalto-oligosaccharides of 15 to 20 glucose units.

21. A sterile aqueous solution for parenteral administration characterized in that it contains 0.02 to 30 g per 100 ml solution of a mixture of isomalto-oligosaccharides, said mixture of oligosaccharides comprising

(a) 0-15 percent by weight of isomaltose,

(b) 20-65 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose, each of these oligosaccharides being present in an amount of at least 5 percent by weight and at most 25 percent by weight,

(c) 20-65 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose, each of isomaltohexaose and isomaltoheptaose being present in an amount of at least 5 percent by weight and at most 25 percent by weight and the total amount of isomaltooctaose and isomaltononaose being at least 5 percent by weight and at most 25 percent by weight,

0-30 percent by weight of said mixture being isomalto-oligosaccharides of 10 to 20 glucose units and 0-10 percent by weight of said mixture being isomalto-oligosaccharides of 15 to 20 glucose units,

the percentages being calculated on the total weight of the mixture of isomalto-oligosaccharides.

22. A sterile aqueous solution according to claim 21 wherein the content of the mixture of isomalto-oligosaccharides is 0.2 to 30 g per 100 ml solution.

23. A sterile aqueous solution according to claim 21 wherein the isomalto-oligosaccharide mixture in the solution comprises 2-10 percent by weight of isomaltose.

24. A sterile aqueous solution according to claim 21 wherein the isomalto-oligosaccharide mixture in the solution comprises 25-55 percent by weight of isomaltotriose, isomaltotetraose and isomaltopentaose.

25. A sterile aqueous solution according to claim 21 wherein the isomalto-oligosaccharide mixture in the solution comprises 25-55 percent by weight of isomaltohexaose, isomaltoheptaose, isomaltooctaose and isomaltononaose.

26. A sterile aqueous solution according to claim 21 wherein the isomalto-oligosaccharide mixture in the solution comprises 5-20 percent by weight of isomalto-oligosaccharides of 10 to 20 glucose units, 0-7 percent by weight of said mixture consisting of isomalto-oligosaccharides of 15 to 20 glucose units.
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