Dry Powder Treprostinil For The Treatment Of Pulmonary Hypertension
Patent No. US10898494 (titled "Dry Powder Treprostinil For The Treatment Of Pulmonary Hypertension") was filed by Healthcare Royalty Partners Iv Lp As Successor Subordinated Lender on May 5, 2017.
What is this patent about?
’494 is related to the field of pharmaceutical formulations and drug delivery, specifically addressing the treatment of pulmonary arterial hypertension (PAH) . PAH is a serious condition characterized by high blood pressure in the lungs, leading to right ventricular failure. Current treatments include prostacyclin analogs like treprostinil, which can be administered intravenously, subcutaneously, orally, or via nebulization. Inhaled treprostinil, delivered via nebulizer, targets the pulmonary arteries directly, but existing nebulizers are cumbersome and inconvenient, limiting dosing and patient compliance.
The underlying idea behind ’494 is to provide a more convenient and effective inhaled treprostinil therapy for PAH using a dry powder inhaler (DPI) . This involves formulating treprostinil into stable, uniform dry powder particles suitable for deep lung delivery. The key insight is that by encapsulating a precise dose of treprostinil in a capsule for use with a DPI, patients can achieve higher drug concentrations in the pulmonary arteries with a simpler, more portable device compared to traditional nebulizers. This approach aims to improve patient compliance and potentially expand the treatable patient population.
The claims of ’494 focus on methods of treating pulmonary hypertension by administering a dry powder composition containing treprostinil via inhalation. Specifically, the independent claims cover methods involving delivering a dose of 100 to 300 micrograms of treprostinil using a dry powder inhaler over one to four breaths. The claims also specify the use of a capsule containing the dry powder, which includes treprostinil along with excipients like a non-reducing sugar, wetting agent, hydrophobicity modifier, pH modifier, and buffer.
In practice, the invention involves a patient using a DPI to inhale the treprostinil dry powder from a capsule. The formulation is designed to ensure that the particles have an aerodynamic size suitable for reaching the small pulmonary arteries. The excipients in the formulation contribute to the stability, dispersibility, and solubility of the treprostinil, ensuring efficient delivery and absorption in the lungs. The use of a DPI offers a significant advantage over nebulizers by eliminating the need for bulky equipment, electricity, and reconstitution steps, making it easier for patients to adhere to their treatment regimen.
The invention differentiates itself from prior approaches by providing a stable, convenient, and potentially more effective inhaled treprostinil therapy. Unlike nebulized treprostinil, which requires a cumbersome device and multiple breaths to achieve a therapeutic dose, the dry powder formulation allows for higher doses of treprostinil to be delivered in fewer breaths . The specific excipients and particle characteristics are optimized to ensure efficient lung deposition and rapid dissolution, potentially leading to improved clinical outcomes for PAH patients. The use of PRINT technology to manufacture the particles also ensures batch-to-batch uniformity, which is critical for consistent dosing.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’494 was filed, dry powder inhalers were a common method for delivering medication directly to the lungs. At a time when pulmonary hypertension treatments were available as nebulized solutions, creating a stable and uniform dry powder formulation for inhalation presented technical challenges. Achieving consistent dosing and efficient delivery of the drug to the pulmonary arteries required careful consideration of particle size, shape, and formulation to ensure proper aerosolization and deposition in the lungs.
Novelty and Inventive Step
The examiner approved the patent because the prior art did not teach or suggest a method for treating pulmonary hypertension using inhalation of 100-300 micrograms of dry powder treprostinil. While a prior art reference disclosed inhalation of treprostinil, it taught a lower dose range (15-100 micrograms) and specified that the highest tolerated dose was 90 micrograms. The examiner stated that there was no motivation, teaching, or suggestion for a skilled artisan to modify the prior art to arrive at the claimed invention.
Claims
This patent contains 19 claims, of which claims 1, 10, 12, and 13 are independent. The independent claims focus on methods for treating pulmonary hypertension by administering treprostinil via dry powder inhalation. The dependent claims generally specify details and limitations to the methods described in the independent claims, such as dosage amounts, inhalation parameters, and composition characteristics.
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Description
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US10898494
- Application Number
- US16099135
- Filing Date
- May 5, 2017
- Status
- Granted
- Expiry Date
- May 5, 2037
- External Links
- Slate, USPTO, Google Patents