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US 2010/0300440 A1Published application
Dry powder inhaler system
AssigneeGalephar P.R., Inc., Ltd.
InventorsArthur Deboeck, Francis Vanderbist, Philippe Baudier
Life of this patent
Estimating the term…
Abstract
The present invention relates to a pharmaceutical composition for inhalation, consisting in a combination of (A) a dry powder formulation containing a micronized active ingredient, alone or mixed with an inactive ingredient, said powder being filled in a hydroxypropylmethylcellulose (HPMC) capsule and (B) a single dose dry powder inhaler device especially adapted to said capsule to provide a high respiratory dose of said active ingredient when said drug is inhaled by the mouth through said device. Said device being characterized in that he is equipped with piercing is needles or pins (in order to pierce the capsule) of diameter of not less than 0.8 mm preferably not less than 1 mm.
Claims61
An improved dry powder inhalation system comprising:
- (A) at least one micronized active ingredient contained in an hydroxypropylmethylcellulose container, said container having an outer surface extending between two end portions intended to be pierced, and
- (B) a dry powder inhaler device comprising a mouthpiece, a chamber in which the container is inserted, means equipped with at least two piercing systems adapted to pierce said container at said two end portions, and a return mechanism so as to remove the piercing systems outside of the pierced container, whereby the chamber has a form and a volume greater than the container so as to enable, after removal of the piercing systems outside the container, a rotation of the container during an inhalation, said piercing systems having an equivalent diameter of not less than 0.8 millimeter (mm), whereby the piercing systems are adapted so that the equivalent diameter of the hole or holes pierced by each piercing system after removal of the piercing system from the hole or holes is from 10% to 31% of the equivalent diameter of the cross section of the portion of the outer surface of the container to be pierced located between the two pierced end portions, said cross section being located in a plane perpendicular to an axis extending between the end portions.
An improved dry powder inhalation system comprising:
- (A) at least one micronized active ingredient contained in an hydroxypropylmethylcellulose container, advantageously an elongated capsule, said container having an elongated outer surface with a longitudinal axis of symmetry, said outer surface extending between two curved end portions intended to be pierced, and
- (B) a dry powder inhaler device comprising a mouthpiece, a chamber in which the container is inserted, means equipped with at least two piercing systems adapted to pierce said container at said two end portions, and a return mechanism so as to remove the piercing systems outside of the pierced container, whereby the chamber has a form and a volume greater than the container so as to enable, after removal of the piercing systems outside the container, a rotation of the container during an inhalation, said piercing systems having an equivalent diameter of not less than 0.8 millimeter (mm), whereby the piercing systems are adapted so that the equivalent diameter of the holes pierced by each piercing system after removal of the piercing system from the hole is from 10% to 31% of the average equivalent diameter of the cross section of the portion of the outer surface of the container perpendicular to the longitudinal axis of symmetry.
The use of a hydroxypropylmethylcellulose capsule for the preparation of a dosage form containing a dry powder of at least one therapeutic active agent to be administered by inhalation after having pierced holes of at least 1 mm in said hydroxypropylmethylcellulose capsule.
A method for treating respiratory diseases or preventing respiratory troubles, using a dry powder inhalation system comprising:
- (A) at least one micronized active ingredient contained in an hydroxypropylmethylcellulose container, said container having an outer surface extending between two end portions intended to be pierced, and
- (B) a dry powder inhaler device comprising a mouthpiece, a chamber in which the container is inserted, means equipped with at least two piercing systems adapted to pierce said container at said two end portions, and a return mechanism so as to remove the piercing systems outside of the pierced container, whereby the chamber has a form and a volume greater than the container so as to enable, after removal of the piercing systems outside the container, a rotation of the container during an inhalation, said piercing systems having an equivalent diameter of not less than 0.8 millimeter (mm), whereby the piercing systems are adapted so that the equivalent diameter of the hole or holes pierced by each piercing system after removal of the piercing system from the hole or holes is from 10% to 31% of the equivalent diameter of the cross section of the portion of the outer surface of the container to be pierced located between the two pierced end portions, said cross section being located in a plane perpendicular to an axis extending between the end portions.
A method for administering at least one active ingredient in the lungs using a dry powder inhalation system comprising:
- (A) at least one micronized active ingredient contained in an hydroxypropylmethylcellulose container, said container having an outer surface extending between two end portions intended to be pierced, and
- (B) a dry powder inhaler device comprising a mouthpiece, a chamber in which the container is inserted, means equipped with at least two piercing systems adapted to pierce said container at said two end portions, and a return mechanism so as to remove the piercing systems outside of the pierced container, whereby the chamber has a form and a volume greater than the container so as to enable, after removal of the piercing systems outside the container, a rotation of the container during an inhalation, said piercing systems having an equivalent diameter of not less than 0.8 millimeter (mm), whereby the piercing systems are adapted so that the equivalent diameter of the hole or holes pierced by each piercing system after removal of the piercing system from the hole or holes is from 10% to 31% of the equivalent diameter of the cross section of the portion of the outer surface of the container to be pierced located between the two pierced end portions, said cross section being located in a plane perpendicular to an axis extending between the end portions.
A method for administering at least one active in the systemic circulation using a dry powder inhalation system comprising:
- (A) at least one micronized active ingredient contained in an hydroxypropylmethylcellulose container, said container having an outer surface extending between two end portions intended to be pierced, and
- (B) a dry powder inhaler device comprising a mouthpiece, a chamber in which the container is inserted, means equipped with at least two piercing systems adapted to pierce said container at said two end portions, and a return mechanism so as to remove the piercing systems outside of the pierced container, whereby the chamber has a form and a volume greater than the container so as to enable, after removal of the piercing systems outside the container, a rotation of the container during an inhalation, said piercing systems having an equivalent diameter of not less than 0.8 millimeter (mm), whereby the piercing systems are adapted so that the equivalent diameter of the hole or holes pierced by each piercing system after removal of the piercing system from the hole or holes is from 10% to 31% of the equivalent diameter of the cross section of the portion of the outer surface of the container to be pierced located between the two pierced end portions, said cross section being located in plane perpendicular to an axis extending between the end portions.
Dependencies are inferred from the claim text.