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Pharmaceutical solution formulations for pressurised metered dose inhalers

a technology of pressurised metered dose and formulation, which is applied in the directions of drug composition, dispersed delivery, aerosol delivery, etc., can solve the problems of patient still being under treatment, and achieve the effect of improving the co-deposition of said drugs

Inactive Publication Date: 2009-05-21
CHIESI FARM SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides new medications and methods for preventing and treating severe broncho-pulmonary diseases such as asthma and COPD. This is achieved by providing pressurized solution formulations of two or more drug substances that, when actuated, deliver the active drug substances in a predetermined ratio and with substantially the same particle size distribution. This results in a clinical response of lung function that is greater than the sum of the individual drug substances administered. The invention also provides improved co-deposition of the drug substances in the lung tract of a patient, leading to their synergistic interaction. The active drug substances include a bronchodilating and / or anti-inflammatory compound, more preferably a long acting beta2-agonist and an inhaled corticosteroid.

Problems solved by technology

However, despite modern maintenance treatments, some patients are still under treated particularly when the broncho-pulmonary disease is in a severe form.

Method used

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  • Pharmaceutical solution formulations for pressurised metered dose inhalers
  • Pharmaceutical solution formulations for pressurised metered dose inhalers
  • Pharmaceutical solution formulations for pressurised metered dose inhalers

Examples

Experimental program
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Effect test

example 1

Particle Size Distribution for Formoterol Fumarate and Beclometasone Dipropionate within an Ethanol Based Solution HFA pMDI by Andersen Cascade Impactor (ACI)

[0070]The solution formulation contained beclometasone dipropionate (“BDP”) (100 μg / dose) and formoterol fumarate (“FF”) (6 μg / dose) in 50 μl in HFA 134a propellant vehicle with 12% w / w ethanol as cosolvent and 0.024% w / w hydrochloric acid (1M) as stabilizer. The formulation was packed in cans fitted with 50 μl valves and fired using a 0.30 mm actuator. Aerodynamic particle size assessments were conducted using an Andersen Cascade Impactor fitted with a USP induction port at the beginning and end of can-use life from each of two batches. Each determination was obtained by sampling 15 consecutive doses at a sampling flow rate of 28.3 l / minute. For each can tested the delivered dose was determined using DUSA methodology (Dose Unit Spray Apparatus) at the beginning, middle, and end of can-use life. Quantification of BDP and FF wit...

example 2

Solution Combination Containing Carmoterol Hydrochloride (TA 2005) as LABA and Budesonide (BUD) as ICS

[0073]The LABA TA 2005 is present in the combination at a strength of 1 μg / dose per actuation while budesonide is present at 100 μg / dose per actuation within an acidified ethanol solution pressurized with HFA 134a. Aerodynamic assessment of fine particles was performed by sampling 10 consecutive doses from each pMDI into an ACI. The impactor was fitted with a USP induction port and operated at a sampling flow rate of 28.3 l / minute. Three pMDIs were tested (from the beginning, middle, and end of batch) and were tested at the beginning and end of life. Drug deposition within the impactor was quantified using an HPLC assay. The fine particle dose (FPD) was determined by summation of the drug collected on the ACI stages between S3 and filter.

[0074]Table 3 summarizes the deposition of TA 2005 and budesonide on the individual stages of the ACI, while Table 4 summarizes the aerosol perform...

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Abstract

The invention relates to the prevention and / or treatment of a severe broncho-pulmonary disease by administering a solution formulation from a pressurized metered dose inhaler capable of providing therapeutical doses of two or more active drug substances to the lung, wherein all the active drug substances are fully dissolved in the formulation as well as the two or more active drug substances are delivered with substantially the same particle size distribution.

Description

CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application is a continuation of International Patent Application No. PCT / EP2007 / 003420, filed on Apr. 19, 2007, and claims priority to U.S. patent application Ser. No. 11 / 408,026, filed on Apr. 21, 2006, both of which are incorporated herein by reference in their entireties.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to methods for the prevention or treatment of a severe broncho-pulmonary disease by administering a solution formulation from pressurized metered dose inhalers (pMDIs) which is cable of providing therapeutic doses of two or more active drug substances to the lungs, in which substantially all of the liquid particles emitted on actuation of the inhaler contain the two or more active drug substances in a ratio which is substantially the same as a predetermined ratio of the two or more active drug substances in the medicament and the two or more active drug substances are d...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/12A61P11/06
CPCA61K31/4745A61K31/138A61K31/573A61K31/58A61K45/06A61K47/10A61K31/57A61K9/008A61K2300/00A61K9/08A61K31/167A61K47/06A61P11/00A61P11/06A61P43/00A61K9/124A61K31/4704
Inventor LEWIS, DAVID ANDREWMEAKIN, BRIAN JOHNBRAMBILLA, GAETANO
Owner CHIESI FARM SPA
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