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-11660304-B2
Publication Date
2023-05-30
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 concerns methods for treating pulmonary arterial hypertension by administering treprostinil as a dry powder inhalation composition using a dry powder inhaler. The dry powder composition comprises treprostinil or a pharmaceutically acceptable salt and is delivered to a patient over one to four breaths to treat pulmonary arterial hypertension.
The dry powder compositions are configured as particles for inhalation, where each particle comprises treprostinil, a non-reducing sugar, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent, and a buffer. The composition also includes molded dry particles and, in some embodiments, specified excipient components in particulate dry powder formulations.
Another claimed dosing regime administers higher daily treprostinil amounts as uniform particles over four to sixteen breaths. The patent text also frames dry powder inhalation as an alternative to nebulized treprostinil and includes comparative safety and side-effect assertions versus a nebulized dose of 54 micrograms of treprostinil.
Claims Coverage
The independent claims cover multiple dry-powder inhalation treatment methods for pulmonary arterial hypertension, with inventive features spanning treprostinil dosing ranges and breath-delivery regimens, dry powder particle configuration with specific excipient classes, capsule-and-inhaler administration using one to two breaths per capsule, and uniform-particle dosing over four to sixteen breaths.
Treprostinil dry powder inhalation over one to four breaths
Administration of a dry powder composition comprising from about 100 micrograms to about 300 micrograms treprostinil or a pharmaceutically acceptable salt by inhalation using a dry powder inhaler over one to four breaths to treat pulmonary arterial hypertension.
Treprostinil dry powder dosing with particle excipient components
A dry powder dose of treprostinil from about 100 micrograms to about 300 micrograms delivered over one to four breaths, where each particle comprises treprostinil, a non-reducing sugar, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent, and a buffer.
Treprostinil dry powder capsule and dry powder inhaler inhale one to two breaths
Providing a patient a dry powder inhaler and at least one capsule containing a dry powder composition comprising at least 100 micrograms of treprostinil plus a non-reducing sugar, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent, and a buffer; instructing the patient to inhale the dry powder composition from each capsule in one to two breaths.
Uniform-particle treprostinil dry powder over four to sixteen breaths per day
Administering a dry powder composition comprising between about 400 micrograms treprostinil and about 1200 micrograms treprostinil to a patient over a day through four to sixteen breaths to treat pulmonary arterial hypertension, wherein the dry powder composition is configured as uniform particles.
Across the independent claims, the coverage focuses on treating pulmonary arterial hypertension with treprostinil delivered as a dry powder inhalation composition, specifying treprostinil dose ranges and breath-delivery schemes, configuring the dry powder as particles containing defined excipient components, and defining capsule-based inhalation using one to two breaths per capsule.
Stated Advantages
Comparative safety and side-effect assertions versus a nebulized dose of 54 micrograms of treprostinil.
The patent text reports nonclinical tolerability for inhaled PRINT-Tre in rats, with coagulation, clinical chemistry, and urinalysis showing no item-related differences.
The human Phase 1 single-ascending dose pharmacokinetic and safety study in healthy volunteers shows dose-proportional increases in Cmax and AUCinf across cohorts.
Documented Applications
Treating pulmonary arterial hypertension.
Dry powder inhalation as an alternative to nebulized treprostinil.
Human Phase 1 single-ascending dose pharmacokinetic and safety study in healthy volunteers using a dry powder inhaler for treprostinil.
Nonclinical assessment of inhaled PRINT-Tre in rats.
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