Therapeutic preparation for inhalation
AssigneeAstraZeneca AB
InventorsKjell Göran Erik Bäckström, Carl Magnus Olof Dahlbäck, Peter Edman, Ann Charlotte Birgit Johansson
Life of this patent
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Abstract
A therapeutic preparation for inhalation which comprises insulin and a substance which enhances the absorption of insulin in the lower respiratory tract, is provided in the form of a powder preparation suitable for inhalation.
Claims75
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a substance that enhances the absorption of insulin in the lower respiratory tract, provided that if the substance is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length;
- removing the solvent to obtain a solid comprising said insulin and said substance;
- processing said solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns;
- and
- incorporating the powder into a dry powder inhaler device adapted for inhalation through the mouth.
A process for the manufacture of a therapeutic composition comprising insulin, comprising dry-mixing insulin together with a substance that enhances the absorption of insulin in the lower respiratory tract, and processing said mixture to obtain a powder of which at least 50% consists of particles which have a diameter of up to 10 microns, provided that if the substance is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a substance that enhances the absorption of insulin in the lower respiratory tract, provided that if the substance is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length;
- removing the solvent to obtain a solid comprising said insulin and said substance;
- processing said solid to obtain a powder, at least 50% of the total mass of which consists of particles that have a diameter of up to 10 microns;
- and
- incorporating the powder into a dry powder inhaler device, wherein the powder is suitable for inhalation into the lower respiratory tract.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a substance that enhances the absorption of insulin in the lower respiratory tract, provided that if the substance is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length;
- removing the solvent by spray drying the solution, to obtain a solid comprising said insulin and said substance;
- and
- processing said solid to obtain a powder at least 50% of the total mass of which consists of particles that have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a substance that enhances the absorption of insulin in the lower respiratory tract, provided that if the substance is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length;
- removing the solvent to obtain a solid comprising the insulin and the substance;
- micronizing the solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract;
- and
- preparing an ordered mixture of the powder with a pharmaceutically acceptable carrier.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and an anionic surfactant that enhances the absorption of insulin in the lower respiratory tract, provided that if the surfactant is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length;
- removing the solvent to obtain a solid comprising the insulin and the anionic surfactant;
- and
- micronizing the solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a salt of a fatty acid that enhances the absorption of insulin in the lower respiratory tract;
- removing the solvent to obtain a solid comprising the insulin and the salt;
- and
- micronizing the solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a bile salt that enhances the absorption of insulin in the lower respiratory tract;
- removing the solvent to obtain a solid comprising the insulin and the bile salt;
- and
- micronizing the solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a substance that enhances the absorption of insulin in the lower respiratory tract, wherein the substance is selected from the group consisting of a single-chain phospholipid, a double-chain phospholipid wherein each chain of the double-chain phospholipid is eight or fewer carbon atoms in length, an alkyl glycoside, a cyclodextrin, and a cyclodextrin derivative;
- removing the solvent to obtain a solid comprising the insulin and the substance;
- and
- micronizing the solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract.
A process for the manufacture of a therapeutic composition comprising insulin, comprising
- forming, in a solvent, a solution of insulin and a substance that enhances the absorption of insulin in the lower respiratory tract, provided that if the substance is a double-chain phospholipid, each chain of the phospholipid is eight or fewer carbon atoms in length;
- removing the solvent to obtain a solid comprising the insulin and the substance;
- micronizing the solid to obtain a powder at least 50% of the total mass of which consists of particles which have a diameter of up to 10 microns, wherein the powder is suitable for inhalation into the lower respiratory tract;
- and
- incorporating the powder into a dry powder inhaler device adapted for inhalation through the mouth.
Dependencies are inferred from the claim text.