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System for dispensing pharmaceutical active compounds

  • US 6,360,743 B1
  • Filed: 05/10/1999
  • Issued: 03/26/2002
  • Est. Priority Date: 12/11/1992
  • Status: Expired due to Fees
First Claim
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1. A method for dispensing a dose of a pharmaceutically active compound of formoterol plus budesonide or salts or hydrates thereof, which method comprises(1) identifying a patient in need of treatment with said compound;

  • (2) providing a breath-actuated, dry powder inhaler device containing a powder comprising said compound, wherein (a) said powder stored within said device consists essentially of agglomerates of primary particles, at least 80% of said primary particles having a diameter of less than about 10 microns, (b) said device comprises a metered dose of said compound sufficient to produce a predetermined clinically effective result in said patient, said metered dose containing an amount of said compound less than or equal to 70% by weight of the amount of said compound which would be required to produce said predetermined equivalent clinically effective result were the compound administered by a standard pressurized metered dose inhaler; and

    (c) said device comprises a means for using air turbulence to obtain substantial deagglomeration of the primary particles prior to their exiting said device, so that of said metered dose, at least 40% exits said device in the form of unagglomerated particles less than about 10 microns in diameter, and (3) administering said metered dose to the patient by causing the patient to inhale through said device, thereby creating sufficient air turbulence in said device to cause said metered dose of agglomerated primary particles to be substantially deagglomerated prior to exiting said device, such that at least 40% of said metered dose exits said device in the form of unagglomerated particles less than about 10 microns in diameter.

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