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

• Current Assignee: Ab Astra
• Original Assignee: Ab Astra
• Inventors: Andersson, Jan, Jägfeldt, Hans, Wetterlin, Kjell, Trofast, Eva
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): SRIVASTAVA, VIRENDRA KUMAR
• Application Number:
  US09/309,039
• Time in Patent Office: 1,051 Days
• Field of Search: 128/203.12, 128/203.15, 128/203.23, 128/203.14, 128/203.21
• US Class Current: 128/203.15
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]

Abstract

A system for dispensing a clinically effective dose of an inhalable, pharmaceutically active compound, which system includes a dry powder inhaler device containing a powder containing the pharmaceutically active compound, wherein

(a) of the powder particles dispensed by the inhaler device (the “metered DPI dose”), at least 40% are less than about 10 microns in diameter at the point the particles exit the inhaler,

(b) the metered DPI dose is sufficient to produce a clinically effective result in a patient; and

(c) the amount of the compound in the metered DPI dose is not more than 70% of the minimal amount of the compound which, when dispensed in a pressurized metered dose inhaler, produces an equivalent clinically effective result in the same patient.

Claims

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.

2. The method of claim 1, wherein said inhaler device is a multidose, breath-activated inhaler.

3. The method of claim 1, wherein said powder additionally comprises a carbohydrate.

4. The method of claim 1, wherein said powder additionally comprises an amino acid.