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US 2007/0190159 A1Published application
Polyamino acid-based insulin preparation
AssigneeNovo Nordisk A/S
InventorsKasper Andreasen, Per Balschmidt, Lone Kimer
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Abstract
This invention relates to sustained release preparations of insulin comprising poly-amino acid particles, insulin and one or more preservative agents, and a method of preparing such preparations.
Claims37
A pharmaceutical preparation comprising
- i. Particles comprising polyamino acids, wherein said polyamino acids
- a. are linear with alpha-peptide linkages,
- b. comprise at least two types of recurring amino acids which are identical or different from one another, selected from the group consisting of a hydrophobic neutral amino acid (AAN), and an amino acid having an ionisable side chain (AAI), at least a portion of the AAI amino acid being in ionised form, and
- c. Have a weight average molar mass Mw of not less than 4000 D;
- ii. An active ingredient selected from the group consisting of insulin;
- an insulin derivative;
- an insulin analogue;
- and combinations of any of the foregoing;
- and
- iii. One or more preservative agents.
7 more elements
A method of preparing a pharmaceutical preparation, said method comprising the steps of
- 1. Mixing a polyamino acid particle solution with an insulin solution to form a mixture;
- 2. Adding one or more preservative agents;
- 3. Incubating the mixture;
- and
- 4. Optionally adjusting the pH of the mixture.
2 more elements
Dependencies are inferred from the claim text.