Treprostinil Administration By Inhalation
Patent No. US11357782 (titled "Treprostinil Administration By Inhalation") was filed by United Therapeutics Corp on Sep 27, 2021.
What is this patent about?
’782 is related to the field of pulmonary hypertension treatment, specifically addressing the delivery of treprostinil, a prostacyclin analog, to patients suffering from this condition. Pulmonary hypertension is characterized by elevated pressure in the pulmonary arteries, leading to various complications. Existing treatments often involve intravenous or subcutaneous administration, which can be inconvenient and carry risks. The patent aims to provide a more convenient and patient-friendly method of delivering treprostinil.
The underlying idea behind ’782 is to enable the administration of treprostinil via inhalation using a metered dose inhaler (MDI) or a dry powder inhaler (DPI) . This approach allows for direct delivery of the drug to the lungs, potentially improving efficacy and reducing systemic side effects. The key insight is that a therapeutically effective dose of treprostinil can be delivered in a small number of breaths using a compact inhalation device, providing patients with greater autonomy and ease of use.
The claims of ’782 focus on a method of treating pulmonary hypertension by providing an inhalation device containing a powder formulation of treprostinil or a pharmaceutically acceptable salt thereof and a dry powder inhaler configured to administer a single event dose of the powder formulation comprising treprostinil or a pharmaceutically acceptable salt thereof, wherein the single event dose comprises at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths, wherein the dry powder inhaler is configured to administer the entire single event dose in less than 5 minutes with at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof being inhaled per breath through coordinated actuation of the dry powder inhaler with each breath, and administering to a human suffering from pulmonary hypertension with the dry powder inhaler the single event dose comprising at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in 1 to 3 breaths, wherein the human administers the entire single event dose with the dry powder inhaler in less than 5 minutes by inhaling at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof per breath by coordinating one actuation of the dry powder inhaler for each separate breath, and wherein administration of an additional single event dose in the same manner occurs at least 3 hours later.
In practice, the patient uses a DPI containing a pre-metered dose of treprostinil powder. Upon inhalation, the patient coordinates their breath with the actuation of the inhaler, ensuring that a sufficient amount of the drug is inhaled with each breath. The device is designed to deliver the entire dose within a short period, typically less than 5 minutes, and in a limited number of breaths (1-3). This method aims to provide a rapid and effective delivery of treprostinil to the pulmonary vasculature, leading to vasodilation and improved blood flow.
This inhaled approach differentiates itself from prior art by offering a more convenient and potentially more targeted delivery method compared to intravenous or subcutaneous administration. The use of a DPI allows for a breath-actuated delivery, which can be easier for patients to manage than coordinating with a pressurized MDI. Furthermore, the ability to deliver a high dose of treprostinil in a small number of breaths, facilitated by the high concentration formulations , minimizes the burden on the patient and enhances adherence to the treatment regimen. The sustained pulmonary vasodilation achieved with inhaled treprostinil also provides a therapeutic advantage over shorter-acting inhaled prostacyclin analogs.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2000s when ’782 was filed, pulmonary hypertension treatments were typically administered intravenously or subcutaneously due to limitations in inhalation technologies. At a time when drug delivery systems commonly relied on nebulizers for inhaled medications, achieving precise and consistent dosing with compact devices like metered dose inhalers was non-trivial. When hardware or software constraints made the formulation of stable and effective aerosolized drugs challenging, especially for complex molecules like treprostinil.
Novelty and Inventive Step
The examiner allowed the claims because the specific method of dosing a dry powder formulation of treprostinil, involving a dose range of 15 to 90 micrograms delivered in 1 to 3 breaths with at least 5 micrograms inhaled per breath, followed by an additional dose at least 3 hours later, was deemed non-obvious. The examiner stated that a person having ordinary skill in the art would not have easily predicted this specific combination of dose, breath count, and timing from the prior art. The applicant demonstrated that this method was not simple or predictable.
Claims
This patent contains 11 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a method of treating pulmonary hypertension using an inhalation device with a treprostinil formulation. The dependent claims generally elaborate on and refine the method described in the independent claim, adding details regarding dosage timing, particle size, formulation composition, inhalation time, inhaler configuration, and plasma concentration.
Key Claim Terms New
Definitions of key terms used in the patent claims.
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Date
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US11357782
- Application Number
- US17486721
- Filing Date
- Sep 27, 2021
- Status
- Granted
- Expiry Date
- May 14, 2027
- External Links
- Slate, USPTO, Google Patents