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-11744836-B2
Publication Date
2023-09-05
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 system for treating pulmonary arterial hypertension using a dry powder inhaler and one or more dosage units. The system includes dry powder particles comprising treprostinil or a pharmaceutically acceptable salt thereof and an excipient matrix, where the dry powder particles are formed from a solution comprising a pH modifying agent and a bulking agent.
The dry powder particles are filled into one or more dosage units configured to be inserted into the dry powder inhaler for administration to a patient. The one or more dosage units include a total predetermined amount of treprostinil or the pharmaceutically acceptable salt thereof in the range of 100 µg to 350 µg.
In the described embodiments, the dry powder particles are characterized by a mass median aerodynamic diameter (MMAD) between 1 µm and 5 µm and are dried to less than 5 percent water content. The excipient matrix comprises trehalose, L-leucine, polysorbate 80, sodium citrate, and sodium chloride, and the dosage units are configured for administration using the dry powder inhaler.
Claims Coverage
The patent document includes one independent claim directed to a treating system for pulmonary arterial hypertension, with dependent claims adding inventive features relating to particle aerodynamic size, residual water content, excipient matrix composition, dosage unit administration configuration, and treprostinil amount ranges.
Dry powder inhaler treatment system with treprostinil dry powder particles
A system for treating pulmonary arterial hypertension comprising a dry powder inhaler and a dose of dry powder particles comprising treprostinil or a pharmaceutically acceptable salt thereof, and an excipient matrix, wherein the dry powder particles are formed from a solution comprising a pH modifying agent and a bulking agent.
Dosage units inserted into the dry powder inhaler with predetermined treprostinil amount
The system where the dry powder particles are filled into one or more dosage units configured to be inserted into the dry powder inhaler for administration to a patient, and where the one or more dosage units include a total predetermined amount of treprostinil or the pharmaceutically acceptable salt thereof in the range of 100 µg to 350 µg.
Particle aerodynamic size constraint
The system where the dry powder particles have a mass median aerodynamic diameter (MMAD) between 1 µm and 5 µm.
Low residual water content
The system where the dry powder particles are dried to less than 5 percent water content.
Specified excipient matrix components
The system where the excipient matrix comprises trehalose, L-leucine, polysorbate 80, sodium citrate, and sodium chloride.
Dosage unit administration over one to two breaths
The system where each capsule contains an amount of dry powder particles configured to be administered to the patient over one to two breaths using the dry powder inhaler.
Dosage unit treprostinil amount range (additional range)
The system where each dosage unit contains treprostinil or the pharmaceutically acceptable salt thereof in an amount of 50 µg to 220 µg.
Overall claim coverage centers on a dry powder inhaler system for pulmonary arterial hypertension using treprostinil or a pharmaceutically acceptable salt thereof in an excipient matrix, with particles formed from a solution comprising a pH modifying agent and a bulking agent, and dosage units configured for inhaler insertion and administration with a specified total treprostinil amount range. Dependent features further specify MMAD, low residual water content, excipient matrix components, administration over one to two breaths, and additional treprostinil amount ranges.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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