US 10,207,008 B2 · Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid

Abstract

An inhalable formulation containing SAE-CD and corticosteroid is provided. The formulation is adapted for administration to a subject by nebulization with any known nebulizer. The formulation can be included in a kit. The formulation is administered as an aqueous solution, however, it can be stored as a dry powder, ready-to-use solution, or concentrated composition. The formulation is employed in an improved nebulization system for administering corticosteroid by inhalation. SAE-CD present in the formulation significantly enhances the chemical stability of budesonide. A method of administering the formulation by inhalation is provided. The formulation can also be administered by conventional nasal delivery apparatus.

Claims21

Dependent claims

An aqueous liquid solution formulation comprising a therapeutically effective amount of corticosteroid dissolved therein, a sulfoalkyl ether cyclodextrin (SAE-CD), and an aqueous liquid carrier, wherein

i. the corticosteroid is budesonide;
ii. the sulfoalkyl ether cyclodextrin has the structure:
wherein:
each R is —H or —(CH2)4SO3Na;
wherein the average degree of substitution of —(CH2)4SO3Na is 6.0 to 7.1 per cyclodextrin molecule;
and
iii. the formulation provides an enhanced pharmacokinetic profile over a suspension based formulation administered under similar conditions;
wherein the molar ratio of SAE-CD to corticosteroid is greater than 10:1, and wherein more than 50% by weight of the corticosteroid is complexed with the SAE-CD;
and wherein the aqueous liquid solution formulation is adapted for pulmonary inhalation.

6 more elements

Dependencies are inferred from the claim text.

Facts

Application

15/817,056Filed 17 Nov 2017 · continuation

Priority

31 Dec 2003

Published

US 2018/0154015 A17 Jun 2018

Granted

19 Feb 2019

Term ends

Not estimatedThe source records don’t support an estimate.

Classification25 codes

A61K 47/6851
The modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site: the antibody targeting a determinant of a…
A61K 9/0078
Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy: for inhalation via a nebulizer…
A61K 31/573
Substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone: substituted in position 21, e.g. cortisone,…
A61K 31/58
Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids: containing heterocyclic rings, e.g. danazol,…

Family

Application60/533,628Us provisional application · filed 31 Dec 2003

PCT/US2005/000082Parent of this continuation-in-part · filed 31 Dec 2004

Application11/479,979Parent of this continuation-in-part · filed 30 Jun 2006

Application11/613,187Parent of this continuation · filed 19 Dec 2006

Application13/015,959Parent of this continuation · filed 28 Jan 2011

Application13/586,380Parent of this continuation · filed 15 Aug 2012

US 2018/0154015 A1Pre-grant publication · published 7 Jun 2018

US 9,827,324 B2Parent of this continuation

Application11/613,187Parent of this continuation-in-part

US 2007/0020299 A1Published application

US 2007/0202054 A1Published application

US 2011/0251157 A1Published application

US 2013/0059826 A1Published application

US 10,207,008 B2This patent

From the US filing history. Foreign family members aren’t listed.

Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid

Life of this patent

Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid

Life of this patent

Abstract

Claims21