Chemotherapeutic Microparticle Compositions
AssigneeeSpraye, Inc.
InventorsAditya Das, John Patton, Daniel Green, Danforth P. Miller
Life of this patent
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Abstract
This disclosure provides for compositions and methods for treating incipient or moderate pulmonary fibrosis and idiopathic pulmonary fibrosis (collectively pulmonary fibrosis or “PF”) in patients in need thereof. Provided is a dry powder composition comprising an effective amount of a) pirfenidone; and b) nintedanib or a pharmaceutically acceptable salt thereof, wherein the composition is suitable for direct pulmonary delivery. Also contemplated are compositions for direct pulmonary delivery comprising 1 to 5 active pharmaceutical ingredients.
Claims39
A dry powder composition comprising an effective amount of a) pirfenidone, and a second medicament selected from b) nintedanib, treprostinil, treprostinil palmitil, or seralutinib, or a pharmaceutically acceptable salt thereof, and which further comprises c) a lecithin component.
A dry powder composition suitable for direct pulmonary administration, which composition comprises:
- a) an effective amount of pirfenidone and nintedanib or a pharmaceutically acceptable salt thereof;
- b) an effective amount of di-stearoylphosphatidyl choline;
- c) an effective amount of calcium chloride;
- and
- d) optionally one or more pharmaceutically acceptable additives,
- wherein said powder composition comprises particles having an average particle size of from about 0.5 to about 15 μm and a bulk density of from about 0.03 g/cc to about 0.30 g/cc, from about 0.04 g/cc to about 0.10 g/cc, from about 0.05 g/cc to about 0.09 g/cc, or from about 0.06 g/cc to about 0.08 g/cc.
A method for treating a patient diagnosed with pulmonary fibrosis (PF), which method comprises:
- a) administering to the patient via inhalation to a patient's lung or lungs a dry powder composition which itself comprises particles comprising:
- i) an effective amount of a pharmaceutical combination of pirfenidone and optionally an effective amount of treprostinil, treprostinil palmitil, or treprostinil sodium;
- and
- ii) nintedanib or a pharmaceutically acceptable salt thereof;
- wherein the particles further comprise a di-fatty acid phosphatidyl choline and calcium chloride in an amount sufficient to impart structural stability;
- and further wherein said particles in said dry powder composition have an average particle size of from about 0.5 to about 15 μm and the dry powder composition has a bulk density of from about 0.03 g/cc to about 0.30 g/cc, and the patient is diagnosed as having an interstitial lung disease, progressive fibrosing interstitial lung disease (PH-ILD), systemic sclerosis-associated interstitial lung disease (SSc-ILD), or idiopathic pulmonary fibrosis and pulmonary fibrosis.
A method of preparing a dry powder composition comprising pirfenidone and nintedanib or a pharmaceutically acceptable salt thereof, the method comprising:
- a) emulsifying a suspension medium comprising pirfenidone, nintedanib or a pharmaceutically acceptable salt thereof, and a di-fatty acid phosphatidyl choline in a volatile solvent to form a stable nanoemulsion;
- b) atomizing the stable nanoemulsion into droplets;
- and
- c) spraying the droplets into a drying chamber, wherein heated drying gas removes the volatile solvent, thereby obtaining the dry powder composition,
- wherein an outlet temperature is controlled at no more than 72° C.
A dry powder composition comprising an effective amount of:
- a) a first medicament which is nintedanib, and
- b) optionally a second medicament selected from treprostinil, treprostinil palmitil, seralutinib, or pirfenidone, or a pharmaceutically acceptable salt thereof, and which further comprises a lecithin component, optionally a di-fatty acid phosphatidyl choline.
Dependencies are inferred from the claim text.