Abstract: A dry powder inhalation apparatus includes a housing, a reservoir for medicament located within the housing, a mouthpiece disposed on the housing for insertion in the mouth of a user for inhalation of a predetermined dose of medicament, a delivery channel between a discharge outlet of the reservoir and the mouthpiece for delivering the predetermined dose of medicament, a device positioned within the housing and normally held adjacent the reservoir for receiving the predetermined dose of medicament from the discharge outlet and transferring it to the delivery channel, and a release mechanism adapted to release the device and permit controlled movement thereof to the delivery channel for the delivery, the release mechanism being located at least partially outside of the housing for manual operation by the user.

Abstract: The present invention provides a method for the sterilization of a labile glucocorticosteroid, which method comprises heat-treating by moist heat the labile glucocorticosteroid in the form of a suspension for a sterilizing-effective time. The methods and compositions according to the invention are useful as therapeutic tools to prevent, reverse, and/or reduce the symptoms of allergic and/or inflammatory conditions in a mammalian patient. The invention also provides methods and compositions, which may be manipulated and fine-tuned to fit the condition(s) to be treated while producing fewer side effects.

Abstract: The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 .mu.m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 .mu.m or less.

Abstract: The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 .mu·m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 .mu·m or less.

Abstract: The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 .mu.m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 .mu.m or less.

Abstract: A dry powder inhalation apparatus operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device normally held adjacent a reservoir for receiving medicament in a cup or receptacle and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device is achieved by a yoke acting on an abutment thereof. Spillage of medicament in the apparatus is avoided.

Abstract: The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 .mu.m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 .mu.m or less.

Abstract: The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 ?m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 ?m or less.

Abstract: A method of treating at least one of COPD and/or asthma in a subject is provided, wherein an inhalable medicament is administered, in particular a new solid-state form of tiotropium bromide. The medicament can be in the form of solid amorphous particles containing an intimate admixture of tiotropium bromide together with a pharmaceutically acceptable co-solid having a glass transition temperature of at least -50° C., such as a sugar and/or sugar alcohol.

Abstract: The present invention provides a method for the sterilization of a labile glucocorticosteroid, which method comprises heat-treating by moist heat the labile glucocorticosteroid in the form of a suspension for a sterilizing-effective time. The methods and compositions according to the invention are useful as therapeutic tools to prevent, reverse, and/or reduce the symptoms of allergic and/or inflammatory conditions in a mammalian patient. The invention also provides methods and compositions, which may be manipulated and fine-tuned to fit the condition(s) to be treated while producing fewer side effects.

Abstract: An inhalable medicament is provided, in particular a new solid-state form of tiotropium bromide. The medicament can be in the form of solid amorphous particles containing an intimate admixture of tiotropium bromide together with a pharmaceutically acceptable co-solid having a glass transition temperature of at least ?50° C., such as a sugar and/or sugar alcohol.

Abstract: A dry powder inhalation apparatus operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device normally held adjacent a reservoir for receiving medicament in a cup or receptacle and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device is achieved by a yoke acting on an abutment thereof. Spillage of medicament in the apparatus is avoided.

Abstract: The invention relates to dry powder inhalation apparatus usually operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device (4) normally held adjacent a reservoir for receiving medicament in a cup or receptacle (15) and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device (4) is achieved by a yoke acting on an abutment (16) thereof. Spillage of medicament in the apparatus is avoided.

Abstract: An airflow adaptor for a breath-actuated dry powder inhaler. The airflow adaptor includes a conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further includes provisions for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor.

Abstract: The invention provides a dry powder inhalation composition comprising medicament particles and a mixture of lactose particles with a VMD of between about 70 and about 120 microns and a diameter of less than 250 microns, the mixture being characterized in that up to 96% by weight of the lactose particles are less than 150 microns in diameter and wherein up to 25% by weight of the lactose particles are less than 5 microns in diameter. The compositions provide for a more accurate, uniform and consistent dispersion when used with, for example, a multidose dry powder inhaler. Also disclosed are methods for use of the compositions of the invention.

Abstract: An inhaler includes an accurate and consistent mechanical dose metering system that dispenses dry powdered medicament in discrete amounts or doses for patient inhalation, a pressure relief system that manages pressure within a medicament reservoir of the inhaler to ensure consistently dispensed doses, and a dose counting system indicating the number of doses dispensed by or remaining in the inhaler.

Abstract: An airflow adaptor for a breath-actuated dry powder inhaler. The airflow adaptor includes a conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further includes provisions for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor.

Abstract: An inhalable medicament is provided, in particular a new solid-state form of tiotropium bromide. The medicament can be in the form of solid amorphous particles containing an intimate admixture of tiotropium bromide together with a pharmaceutically acceptable co-solid having a glass transition temperature of at least ?50° C., such as a sugar and/or sugar alcohol.

Abstract: The present invention relates to a spray device (e.g., an inhaler) comprising an aerosol formulation administered to the respiratory or nasal tract in which the level of formulation remaining in the device can be readily inspected. The device comprises a glass vial (1) coated with a coating of polymeric material having at least one clear or translucent portion (4).

Abstract: An inhalable dry powder medicament is provided. The medicament, which provides improved fine particle fraction, may be prepared by (i) fractionating a particulate active ingredient based on aerodynamic particle size, (ii) recovering at least one fraction of the particulate active ingredient and (iii) combining the recovered fraction with a carrier to provide the inhalable dry powder medicament.