Teva Branded Pharmaceutical Products R&d, Inc.

Mukul Dalvi

Seah Kee Tee

Libo Wu

Jacquelyn McCabe

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.

Inhalable formulation

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&#xb0; C.

Dry powder formulation

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.

Inhalable medicament

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 &#x3bc;g; and wherein the dose provides a baseline-adjusted FEVin 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 &#x3bc;g; and wherein the dose provides a baseline-adjusted FEVin a patient of more than 150 mL within 30 minutes of receiving the dose.

Dry powder inhaler

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 &#x3bc;g; and wherein the dose provides a baseline-adjusted FEVin 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 &#x3bc;g; and wherein the dose provides a baseline-adjusted FEVin a patient of more than 150 mL within 30 minutes of receiving the dose.

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Weston, FL, United States of America

Mukul Dalvi