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Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid prepared from a unit dose suspension

A corticosteroid, unit dose technology, applied in the direction of medical preparations containing active ingredients, anti-inflammatory agents, aerosol delivery, etc.

Inactive Publication Date: 2007-02-28
CYDEX INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And the prior art does not suggest that one cyclodextrin-corticosteroid inhalable formulation would be advantageous over another cyclodextrin-corticosteroid inhalable formulation

Method used

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  • Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid prepared from a unit dose suspension
  • Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid prepared from a unit dose suspension
  • Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid prepared from a unit dose suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0248] Exemplary formulations of the invention are prepared according to the following general methods.

[0249] Method A

[0250] The cyclodextrin is dissolved in water (or buffer) to form a solution containing a known concentration of cyclodextrin. This solution is mixed with a solid, suspension, gel, liquid, paste, powder or other form of active substance, optionally with heating, to form an inhalable solution.

[0251] Method B

[0252] A known amount of substantially dry cyclodextrin is mixed with a known amount of substantially dry active. A liquid is added to this mixture with stirring to form a suspension, gel, solution, syrup or paste, optionally while heating and optionally in the presence of one or more other excipients to form a Solution for inhalation.

[0253] Method C

[0254] A known amount of substantially dry cyclodextrin is added to a suspension containing a known amount of active s...

Embodiment 2

[0257] The MMD of nebulized solutions containing SBE7-[beta]-CD and budesonide was determined as follows.

[0258] Three different cyclodextrin placebo solutions were prepared at different concentrations. 2 mL of the solution was added to the cup of a Pari LC Plus nebulizer supplied with air from a Pari Proneb Ultra compressor. The particle size of the ejected droplets was determined using a Malvern Mastersizer S laser light scattering device.

Embodiment 3

[0260] The stability of the liquid formulations containing SAE-CD was determined by HPLC chromatographic analysis of aliquots drawn periodically from the stock solution.

[0261] By mixing various ratios of 0.01M citric acid with 0.02M Na 2 HPO 4 Mix to prepare citrate phosphate (McIlvaines) buffer at pH 4, 5, 6, 7 or 8. These stock solutions contained 5% by weight Captisol. Budesonide was dissolved at approximately 250 μg / mL in each buffer. Aliquots of the solution were stored at 40°C, 50°C and 60°C. Control samples were stored at 5°C but are not reported here. HPLC analysis of samples was performed initially and after 1, 2 and 3 months of storage.

[0262] equipment

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PUM

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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.

Description

[0001] Inventors: Rupert O. Zimmerer, James D. Pipkin, Diane O. Thompson, Gerold L. Mosher technical field [0002] The present invention relates to a method and formulation for administering sulfoalkyl ether cyclodextrins (SAE-CD) and corticosteroids such as budesonide by inhalation. The formulation is prepared by combining SAE-CD with a suspension-based unit dose formulation of a corticosteroid. The present invention also relates to methods of treating pulmonary diseases and conditions. Background technique [0003] Drug delivery by inhalation can result in drug deposition in various parts of the respiratory tract, such as the throat, trachea, bronchi, and alveoli. In general, the smaller the particle size, the longer the particles remain suspended in the air, so the drug can be delivered deeper into the respiratory tract. Corticosteroids are delivered by inhalation using a nebulizer, metered dose inhaler, or dry powder inhaler. The main advantages of nebulizers are tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K9/14A61K31/57A61K31/16A61K9/00A61K9/08A61K31/715A61K47/40A61K47/48C08B37/16
CPCA61K31/16A61K9/08A61K9/0078A61K47/40A61K9/0075B82Y5/00A61K31/57A61K31/715A61K47/48969A61K31/573A61K47/6951A61K31/137A61K31/167A61K31/46A61K31/56A61K31/58A61P11/00A61P11/06A61P29/00A61P43/00A61K2300/00A61K9/00
Inventor 鲁珀特·O.·齐默勒詹姆斯·D.·皮普金戴安娜·O.·汤普森格罗尔德·L.·莫舍
Owner CYDEX INC
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