INSULINS COMBINATIONS
First Claim
1. A pharmaceutical combination comprising (a) a therapeutic effective amount of an insulin compound selected from the group consisting of insulin, insulin analogues and mixtures thereof, and (b) a therapeutic effective amount of a pharmaceutically acceptable betaine of general formula (CH3)3N+—
- (CH2)n—
COO−
, with n being an integer from 1 to 5, in which the insulin and the betaine form at least partly a structure selected from the group consisting of chemical entity, chemical complex, insulin/betaine micelles, insulin/betaine microstructures, insulin/betaine nanostructures, and combinations thereof, and in which the weight ratio therapeutic effective amount of the insulin compound/therapeutic effective amount of betaine is comprised between 1;
400 and 1;
5.
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Accused Products
Abstract
A pharmaceutical association or combination comprising a therapeutic effective amount of insulin or insulin analogue, and a therapeutic effective amount of a pharmaceutically acceptable betaine, in which the insulin and the betaine possibly form a chemical entity or complex, and in which the amount of betaine is adapted for controlling the degradation and/or for increasing the duration of action and/or for enhancing the therapeutically effect of the insulin or insulin analogue.
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Citations
24 Claims
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1. A pharmaceutical combination comprising (a) a therapeutic effective amount of an insulin compound selected from the group consisting of insulin, insulin analogues and mixtures thereof, and (b) a therapeutic effective amount of a pharmaceutically acceptable betaine of general formula (CH3)3N+—
- (CH2)n—
COO−
, with n being an integer from 1 to 5, in which the insulin and the betaine form at least partly a structure selected from the group consisting of chemical entity, chemical complex, insulin/betaine micelles, insulin/betaine microstructures, insulin/betaine nanostructures, and combinations thereof, and in which the weight ratio therapeutic effective amount of the insulin compound/therapeutic effective amount of betaine is comprised between 1;
400 and 1;
5. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- (CH2)n—
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13. A pharmaceutical composition combining:
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a form A comprising a pharmaceutically acceptable short acting insulin compound selected from the group consisting of short acting insulins and their analogues, said form being free of betaine of general formula (CH3)3N+—
(CH2)n—
COO−
, anda form B comprising a mixture of; a. a pharmaceutically acceptable insulin compound selected from the group consisting of short acting insulins, intermediate acting insulins, long acting insulins, analogues thereof and their mixtures, and b. a pharmaceutically acceptable betaine of general formula (CH3)3N+—
(CH2)n-COO−
, with n being an integer from 1 to 5. - View Dependent Claims (14, 15, 16, 17, 18)
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19. An isotonic aqueous composition comprising (a) a therapeutic effective amount of an insulin compound selected from the group consisting of insulin, insulin analogues and mixtures thereof, and (b) a therapeutic effective amount of a pharmaceutically acceptable betaine of general formula (CH3)3N+—
- (CH2)n-COO−
, with n being an integer from 1 to 5, in which the insulin and the betaine form at least partly a structure selected from the group consisting of chemical entity, chemical complex, insulin/betaine micelles, insulin/betaine microstructures, insulin/betaine nanostructures, and combinations thereof, and in which the weight ratio therapeutic effective amount of the insulin compound/therapeutic effective amount of betaine is comprised between 1;
100 and 1;
5.
- (CH2)n-COO−
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20. Process for the preparation of pharmaceutically acceptable co-crystal of one insulin compound selected from the group consisting of short acting insulins, medium acting insulins, long acting insulins, analogues thereof and mixtures thereof, and a pharmaceutically acceptable betaine of general formula (CH3)3N+—
- (CH2)n-COO−
, with n being an integer from 1 to 5, in which a liquid solution of said insulin compound and said betaine is prepared, in which the liquid solution is conditioned so as to cause a co-precipitation of insulin compound and betaine and formation of co-crystal of insulin compound and betaine, and in which the co-crystal is extracted from the solution. - View Dependent Claims (21, 22)
- (CH2)n-COO−
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23. A method selected from the group consisting of method for treating a mammal in need suffering at least one diabetic trouble, method for treating a mammal in need at risk of at least one diabetic trouble, and combination thereof, said method comprising the step of administering a pharmaceutical combination comprising
(a) a therapeutic effective amount of an insulin compound selected from the group consisting of insulin, insulin analogues and mixtures thereof, and (b) a therapeutic effective amount of a pharmaceutically acceptable betaine of general formula (CH3)3N+— - (CH2)n-COO−
, with n being an integer from 1 to 5, in which the insulin and the betaine form at least partly a structure selected from the group consisting of chemical entity, chemical complex, insulin/betaine micelles, and combinations thereof, and in which the weight ratio therapeutic effective amount of the insulin compound/therapeutic effective amount of betaine is comprised between 1;
400 and 1;
5. - View Dependent Claims (24)
- (CH2)n-COO−
Specification