Dry powder treprostinil for the treatment of pulmonary hypertension
Inventors
Roscigno, Robert Frank • Farrer, Brian T. • Sprague, Jacob J. • Maynor, Benjamin
Assignees
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Publication Number
US-11712442-B2
Publication Date
2023-08-01
Expiration Date
Abstract
A dry powder inhalation treatment for pulmonary arterial hypertension includes a dose of dry particles comprising greater than 25 micrograms of treprostinil enclosed in a capsule. The dry particles can include treprostinil, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent and a buffer. A method of treating a patient having pulmonary arterial hypertension includes providing a patient a dry powder inhaler, providing the patient at least one capsule for use in the dry powder inhaler, the capsule including at least 25 micrograms of treprostinil.
Core Innovation
The invention relates to a dry powder formulation and treatment method for pulmonary hypertension or pulmonary arterial hypertension. A dry powder drug product comprising treprostinil or a pharmaceutically acceptable salt thereof is administered by inhalation using a dry powder inhaler over one to two breaths. The dry powder drug product comprises a fine particle fraction between about 82 percent and about 89 percent of the total dry powder drug product.
The disclosed approach includes a treprostinil-containing dry powder in capsule form together with a dry powder inhaler, and the patient inhales the dry powder drug product of each capsule with the dry powder inhaler over one to two breaths to treat the condition. The capsule drug product comprises a treprostinil dose between about 25 micrograms and about 100 micrograms of treprostinil or a pharmaceutically acceptable salt thereof, and the fine particle fraction is constrained to between about 82 percent and about 89 percent of the total dry powder drug product.
The formulation concept emphasizes maintaining fine particle fraction performance under storage, including fine particle fraction preservation within the stated range after storage under defined temperature and humidity conditions. The disclosed delivery concept is supported by an inhaler and capsule system, along with reported aerodynamic performance and measured fine particle fraction values.
Claims Coverage
Two independent claims are present. Both claims center on treating pulmonary hypertension or pulmonary arterial hypertension using a treprostinil-containing dry powder inhalation regimen with a defined dose format and a fine particle fraction constraint between about 82 percent and about 89 percent, administered over one to two breaths.
Treprostinil-containing dry powder inhalation with fine particle fraction constraint
Administration of a dry powder composition comprising from about 5 milligrams to about 20 milligrams dry powder drug product to a patient by inhalation using a dry powder inhaler over one to two breaths to treat pulmonary hypertension or pulmonary arterial hypertension, wherein the dry powder drug product comprises treprostinil or a pharmaceutically acceptable salt thereof, and wherein the dry powder drug product comprises a fine particle fraction between about 82 percent and about 89 percent of the total dry powder drug product.
Treprostinil capsule dose with inhaler and fine particle fraction constraint
Providing to a patient having a condition of pulmonary hypertension or pulmonary arterial hypertension a dry powder inhaler and a plurality of drug capsules containing a dry powder drug product, each drug capsule comprising a dose between about 25 micrograms and about 100 micrograms of treprostinil or a pharmaceutically acceptable salt thereof; instructing the patient to inhale the dry powder drug product of each drug capsule with the dry powder inhaler over one to two breaths to treat the condition; and wherein the dry powder drug product comprises a fine particle fraction between about 82 percent and about 89 percent of the total dry powder drug product.
Across both independent claims, the core inventive coverage is directed to inhaled treatment of pulmonary hypertension or pulmonary arterial hypertension using treprostinil-containing dry powder delivered over one to two breaths with a fine particle fraction constrained between about 82 percent and about 89 percent, including both total dry powder dose-based administration and capsule dose-based administration with a plurality of drug capsules and a dry powder inhaler.
Stated Advantages
Fine particle fraction performance is preserved under storage within the stated range after storage under defined temperature and humidity conditions.
Reported aerodynamic performance and measured fine particle fraction values support the disclosed delivery concept.
Documented Applications
Treatment of pulmonary hypertension.
Treatment of pulmonary arterial hypertension.
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