| Title of Invention | AN AQUEOUS INSULIN PREPARATION HAVING SUPERIOR PHYSICAL STABILITY |
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| Abstract | Insulin preparations of superior physical stability, comprising dissolved and/or precipi- tated human insulin or an analogue or derivative thereof, and a water-soluble reduced or non-reducing carbohydrate containing at least 4 carbon atoms in the main carbohy- drat~ structure, or a water-soluble non-reducing ester and/or ether derivative of a ~ carbohydrate or reduced carbohydrate containing at least 4 carbon atoms in the main carbohydrate structure, or mixtures thereof are disclosed. |
| Full Text | Introduction The present invention relates to aqueous insulin preparations comprising human insulin or M analogue or derivative thereof, which preparations have superior physical stability. The invention furthermore relates to parenteral formulations comprising such insulin preparations and to a method for improving the physical stability of insulin preparations. 1. AP- aqueous ridiculing preparahon comprising: dissolved and/or precipitated human insulin or an analogue and/or a derivative thereof, and 100 to 400 mM, preferably 150 to 250 mM, more preferably 180 to 230 mM, of a water-soluble reduced or non*reducing carbohydrate containing at least 4 carbon atoms in the main carbohydrate structure, or a water-soluble non-reducing ester and/or ether derivative of a carbohydrate or reduced carbohydrate containing at least 4 carbon atoms in tlie maieic carbohydrate somatic, or mixture thereof. 2 An unwind preparation according to claim U wherein said carbohydrate or carbohydrate derivative contains from 5 to 18 carbon atoms in the main carbohydrate structure. 3. An insulin preparation according to claim 2, comprising mannitol, sorbitol, xylitol, inositol, trehalose, sucrose or any mixture thereof, preterably mannitol and/or sorbitol, more preferably mannitol. 4. An insulin preparation according to any of the redwing claims, which further comprises a halogenated, preferably a chloride, more preferably sodium chloride. 5. An insulin preparation according to any of the preceding claims, comprising an analogue of human insulin wherein position B28 is Asp, Lys, Leu, Val or Ala and position B29 is Lys or Pro; or des(B28-B30), des(B27) or des(B30) human insulin. 6. An insulin preparation according to claim 5, comprising an analogue of simian insulin wherein position B28 is Asp or Lys, and position B29 is Lys or Pro, preferably Asp®'* human lustily or insulin. 7 8. .An insulin preparation according to claim 7, comprising a derivative of human muslin An aqueous insulin, substantially as herein described, with reference to the accompanying drawings. A parent , substate ia 1 ly as here in descry . With reference to the accompanying drawings, A method for preparing an insulin preparation, , substantially as herein described, with reference to the accompanying.' drawings. |
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1336-mas-1997-claims filed.pdf
1336-mas-1997-claims granted.pdf
1336-mas-1997-correspondnece-others.pdf
1336-mas-1997-correspondnece-po.pdf
1336-mas-1997-description(complete)filed.pdf
1336-mas-1997-description(complete)granted.pdf
| Patent Number | 209528 | ||||||||
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| Indian Patent Application Number | 1336/MAS/1997 | ||||||||
| PG Journal Number | 50/2007 | ||||||||
| Publication Date | 14-Dec-2007 | ||||||||
| Grant Date | 04-Sep-2007 | ||||||||
| Date of Filing | 19-Jun-1997 | ||||||||
| Name of Patentee | M/S. NOVO NORDISK A/S | ||||||||
| Applicant Address | NOVO ALLE, DK-28880, BAGSVAERD | ||||||||
Inventors:
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| PCT International Classification Number | A61 K 0 38/28 | ||||||||
| PCT International Application Number | N/A | ||||||||
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PCT Conventions:
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