Dry powder compositions
AssigneeQuadrant Holdings Cambridge Limited
InventorPeter Jackson
Life of this patent
Estimating the term…
Abstract
A hydrophilic therapeutic agent is prepared in storage-stable form, suitable for administration to a patient. The agent is formulated with a hydrophobically-derivatized carbohydrate, making use of ion-pair formation to form a solution of the agent and carbohydrate.
Claims21
A method for the preparation of a therapeutic composition, comprising forming a solution, in an organic solvent, of a hydrophobically-derivatized carbohydrate (HDC) and an ion-pair complex of a hydrophilic therapeutic protein or peptide and an ionic substrate;
- and drying the solution wherein said method comprises the steps of:
- (i) mixing the therapeutic protein or peptide in aqueous solution with the ionic substance to form the ion-pair complex;
- (ii) adding a water-immiscible organic solvent to form an organic phase, and allowing the ion-pair complex to pass into the organic phase;
- (iii) separating the organic phase;
- (iv) adding the HDC to the organic phase;
- and
- (v) drying the organic solution.
A method for the preparation of a therapeutic composition, comprising forming a solution, in an organic solvent, of a hydrophobically-derivatized carbohydrate (HDC) and an ion-pair complex of a hydrophilic therapeutic protein or peptide and an ionic substrate;
- and drying the solution wherein said method comprises the steps of:
- (i) mixing the therapeutic protein or peptide with the ionic substance in an aqueous medium, to form a precipitate;
- (ii) dissolving the precipitate and the HDC in an organic solvent;
- and
- (iii) drying the solution.
A composition, comprising, in solid dose form, a hydrophobically-derivatized carbohydrate, and an ion-pair complex formed between a hydrophilic therapeutic protein or peptide and a pharmaceutically acceptable ionic substrate;
- wherein the solid dose form is particles having a size of less than 10 μm.
A device for the pulmonary delivery of a hydrophilic therapeutic protein or peptide, wherein the device includes a composition comprising, in solid dose form, a hydrophobically-derivatized carbohydrate, the hydrophilic therapeutic protein or peptide, and a pharmaceutically acceptable ionic detergent, wherein the solid dose form is particles having a size of less than 10 μm.
Dependencies are inferred from the claim text.