Topically active steroids for use in interstitial pulmonary fibrosis
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Publication Number
US-9763963-B2
Publication Date
2017-09-19
Expiration Date
Abstract
The present invention features methods of delivering corticosteroids or metabolites thereof for treating inflammatory conditions otherwise difficult to cure with topical administration.
Core Innovation
The invention relates to treating interstitial lung disease by orally delivering a topical active corticosteroid to expose a potent metabolite, specifically 17-beclomethasone monopropionate (17-BMP), to pulmonary circulation, including pulmonary artery. The corticosteroid is beclomethasone dipropionate (BDP), and the approach increases lung delivery so that the metabolite reaches the pulmonary circulation rather than relying on inhalation exposure of the parent corticosteroid.
A key problem addressed is systemic corticosteroid side effects during treatment of interstitial pulmonary fibrosis and related interstitial lung disease. The oral delivery approach minimizes systemic corticosteroid side effects by exposing the metabolite 17-BMP to pulmonary circulation while detecting no parent BDP in right atrial blood, supporting the concept of metabolite delivery to the lung.
The description further provides pharmacokinetic and clinical-supportive findings, including that 17-BMP is detected in right atrial blood while no parent BDP is detected. Clinical findings in post-allogeneic HCT patients are described as improved preservation of DLCO and fewer early noninfectious pulmonary complications, supporting the use of oral topical active corticosteroid delivery for prevention, amelioration, and/or treatment of damage resulting from interstitial lung disease.
Claims Coverage
The independent claims cover oral delivery of beclomethasone dipropionate to expose 17-beclomethasone monopropionate to pulmonary circulation, and delivery of the corticosteroid or its metabolite to the pulmonary artery for treating interstitial lung disease. Across the independent claims, three main inventive aspects are present: oral/topical active corticosteroid delivery, pulmonary circulation/pulmonary artery delivery of the metabolite, and a dosing relationship versus inhalation.
Oral delivery exposing 17-beclomethasone monopropionate to pulmonary circulation
A method of treating an interstitial lung disease comprising oral delivery of an effective amount of a topical active corticosteroid, wherein the corticosteroid is beclomethasone dipropionate, sufficient to expose a metabolite thereof, wherein the metabolite is 17-beclomethasone monopropionate, to the pulmonary circulation of a subject.
Oral dosage delivering beclomethasone dipropionate or 17-beclomethasone monopropionate to pulmonary artery
A method of delivering a corticosteroid or metabolite thereof to a subject's pulmonary artery for treatment of an interstitial lung disease by administering to the subject an effective amount of an oral dosage of the corticosteroid, wherein the corticosteroid is beclomethasone dipropionate or its metabolite 17-beclomethasone monopropionate.
Pulmonary artery metabolite delivery at least 5-fold greater than inhalation-delivered corticosteroid
A method for preventing, ameliorating and/or treating damage resulting from an interstitial lung disease, the method comprising delivering to a subject's pulmonary artery a metabolite of an orally administered corticosteroid in a dose that is at least 5 fold greater than the corticosteroid delivered via inhalation, wherein the corticosteroid is beclomethasone dipropionate and the metabolite is 17-beclomethasone monopropionate.
Overall, the claim set focuses on oral delivery of the topical active corticosteroid beclomethasone dipropionate to achieve pulmonary delivery of the metabolite 17-beclomethasone monopropionate via pulmonary circulation/pulmonary artery, including a prevention/amelioration/treatment method using a metabolite dose at least 5-fold greater than the corticosteroid delivered via inhalation.
Stated Advantages
Minimizing systemic corticosteroid side effects.
Improved preservation of DLCO.
Fewer early noninfectious pulmonary complications.
Documented Applications
Treatment, prevention, amelioration and/or treatment of damage resulting from interstitial lung disease, including in post-allogeneic HCT patients.
Interventions aimed at preserving pulmonary diffusing capacity (DLCO) and reducing early noninfectious pulmonary complications in the described patient context.
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