Abstract: A breath actuated metered dose inhaler including a housing, a canister and a trigger mechanism. The trigger mechanism is activated by the inhalation of air which comprises of a diaphragm. The central rigid disk of the diaphragm is provided with the interlocking means to firmly secure and bound the peripheral flexible polymer ring with the central rigid disc. The mechanical interlock between a central rigid disk and a peripheral flexible polymer ring on the diaphragm prevent peripheral flexible polymer ring from being peeled off from the central rigid disc while the vacuum is being retained prior to inhalation.

Abstract: Provided herein are new devices for indicating the status of events, such as the number of relevant events that are remaining and/or that have already occurred up to the present moment and to related devices, systems, and methods. In some aspects, the event-related indicator devices of the invention are used within larger dispensing devices or systems, e.g., to provide the status of administration of a substance contained therein (e.g., a drug). In an exemplary embodiment, the indicator devices find particular utility within medicament dispensers, such as metered dose inhalers, to provide a visual indication of the status of doses having been or remaining to be administered.

Abstract: There is provided a dose counter assembly for use with a medicament dispenser, the dose counter assembly comprising: a) a units dose display means comprising a first count indicia and one or more driver teeth; b) a tens dose display means comprising a second count indicia; and c) a driver, wherein the first count indicia and second count indicia align at a common viewing area to collectively display a count sequence.

Abstract: The invention of the present disclosure relates to a medicament dispenser for dispensing medicament from a plurality of elongate form medicament carriers, the dispenser comprising a dispensing mechanism for dispensing the medicament held within the dispenser, wherein the dispensing mechanism is capable of independently advancing each medicament carrier held within the dispenser, the dispensing mechanism comprising a driver, a carrier engagement for each medicament carrier for individually advancing the medicament dose portions thereof, an advancer for each carrier engagement, a flow director capable of dispensing a medicament dose from a plurality of medicament carriers, and a cover for the medicament access body operating as a component of the dispenser actuation mechanism.

Abstract: The present invention provides a stable pharmaceutical composition to be used with pressurized metered dose inhalers and comprises a ?2 agonist, a propellant, a co-solvent, an organic acid(s) and optionally water. The invention further provides stable pharmaceutical composition comprising ?2 agonist, an inhaled corticosteroid and/or a long acting muscarinic antagonist. The invention also provides pharmaceutical composition for the treatment or prophylaxis of asthma, chronic obstructive pulmonary disease (COPD), rhinitis or as adjunct therapy for cystic fibrosis, non-cystic fibrosis bronchiectasis, lung infections or pulmonary fibrosis.

Abstract: This invention provides a process for preparing an inhalable active pharmaceutical ingredient comprising the steps of heating a suspension of an active pharmaceutical ingredient in a liquefied propellant in a vessel, evaporating the propellant and collecting the resultant powder.

Abstract: This invention provides a process for preparing an inhalable dry powder pharmaceutical formulation comprising the step of heating a sealed wrapper containing a desiccant and an inhaler or a capsule, the inhaler or capsule further containing a dry powder formulation comprising an inhalable active pharmaceutical ingredient and a carrier, wherein the wrapper forms a barrier to the ingress of moisture and wherein heating the sealed wrapper and its contents is performed at a temperature of 30-50° C.

Abstract: This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 ?g; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 pg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.

Abstract: This invention provides a process for preparing an inhalable active pharmaceutical ingredient comprising the steps of heating a suspension of an active pharmaceutical ingredient in a liquefied propellant in a vessel, evaporating the propellant and collecting the resultant powder.

Abstract: This invention provides a process for preparing an inhalable dry powder pharmaceutical formulation comprising the step of heating a sealed wrapper containing a desiccant and an inhaler or a capsule, the inhaler or capsule further containing a dry powder formulation comprising an inhalable active pharmaceutical ingredient and a carrier, wherein the wrapper forms a barrier to the ingress of moisture and wherein heating the sealed wrapper and its contents is performed at a temperature of 30-50° C.

Abstract: The present invention provides a solution formulation for inhalation comprising: a liquid phase; an active ingredient containing a carboxylic ester in which the oxygen atom is covalently bound to a quaternary nitrogen-containing heterocycle, dissolved in the liquid phase; and a magnesium or calcium salt, dissolved in the liquid phase. The formulation is particularly suited to pMDIs and nebulizers.

Abstract: Accordingly, the present invention provides a solution formulation for inhalation comprising: a liquid phase; an active ingredient having a functional group which is susceptible to hydrolysis and/or solvolysis, dissolved in the liquid phase; and a magnesium or calcium salt, dissolved in the liquid phase. The formulation is particularly suited to pMDIs and nebulisers.

Abstract: The present invention provides a solution formulation for inhalation comprising: a liquid phase; an active ingredient containing a carboxylic ester in which the oxygen atom is covalently bound to a quaternary nitrogen-containing heterocycle, dissolved in the liquid phase; and a magnesium or calcium salt, dissolved in the liquid phase. The formulation is particularly suited to pMDIs and nebulisers.

Abstract: This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 ?g; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 ?g; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.

Abstract: This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 ?g; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 ?g; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.