Treatments and formulations comprising Torsemide
Inventors
Assignees
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Publication Number
US-10463622-B2
Publication Date
2019-11-05
Expiration Date
Abstract
Disclosed herein are treatments for diseases such as hypertension, diabetes, and congestive heart failure using controlled-release (CR, e.g., extended-release (ER) or prolonged-release (PR)) oral dosage formulations comprising an effective amount of Torsemide.
Core Innovation
The invention relates to an extended-release oral dosage composition and extended release dosing using torsemide. The composition is manufactured by wet granulation and comprises torsemide or a pharmaceutically acceptable salt thereof, hydroxypropyl methyl cellulose, high-density microcrystalline cellulose of nominal particle size about 100 micrometer, lactose monohydrate, and an inhibitor of sodium-glucose linked transporter (SGLT) formulated using a hydrophilic matrix. The composition is defined to provide an extended-release oral dosage form.
A further aspect of the invention concerns methods of treating uncontrolled hypertension by administering a therapeutically effective amount of an oral extended release dosage formulation. The formulation comprises torsemide or a pharmaceutically acceptable salt thereof and an aldosterone receptor antagonist in specified amounts, together with hydroxypropyl methyl cellulose, high density microcrystalline cellulose of nominal particle size about 100 micrometer, and lactose monohydrate. The torsemide and the aldosterone receptor antagonist are comprised in an extended release dosage formulation.
The described problem is the need for torsemide therapies with an extended-release profile suitable for clinical conditions including hypertension and congestive heart failure, while addressing effects related to fluid and sodium/potassium loss and associated kidney function. The disclosure positions the extended-release torsemide formulations as alternative to immediate-release loop diuretics, including use in patient selections involving serum potassium and glomerulus filtration rate (GFR). The disclosure further frames pairing torsemide extended release with an SGLT inhibitor or an aldosterone receptor antagonist as intended to support kidney protection and manage hypertension-related clinical risks.
Claims Coverage
The provided claim set includes two independent claims, supported by dependent claims that refine the SGLT inhibitor target(s), and add method-related clinical diagnosis and patient selection thresholds based on serum potassium and/or glomerulus filtration rate (GFR).
Wet-granulated extended-release torsemide with hydrophilic-matrix SGLT inhibitor
An extended-release oral dosage composition manufactured by wet granulation comprising torsemide or a pharmaceutically acceptable salt thereof, hydroxypropyl methyl cellulose, high-density microcrystalline cellulose of nominal particle size about 100 micrometer, lactose monohydrate, and an inhibitor of sodium-glucose linked transporter (SGLT) or a pharmaceutically acceptable salt thereof, wherein the inhibitor of SGLT is formulated using a hydrophilic matrix.
Extended-release torsemide with aldosterone receptor antagonist for uncontrolled hypertension
A method of treating uncontrolled hypertension comprising administration to a patient in need thereof a therapeutically effective amount of the oral dosage formulation comprising torsemide or a pharmaceutically acceptable salt thereof and an aldosterone receptor antagonist, wherein the torsemide and the aldosterone receptor antagonist are comprised in an extended release dosage formulation.
Across the independent claims, the core claim coverage is for wet-granulated extended-release oral dosage containing torsemide with specified excipients and an SGLT inhibitor in a hydrophilic matrix, and for an extended-release torsemide formulation co-administered with an aldosterone receptor antagonist as a method of treating uncontrolled hypertension, with dependent claims further specifying SGLT isoform targets and method limitations via serum potassium and/or GFR thresholds and diagnosis of congestive heart failure.
Stated Advantages
The disclosure frames the extended-release torsemide formulations as suitable for hypertension and congestive heart failure.
The disclosure states that the formulations address effects related to fluid and sodium/potassium loss and associated kidney function.
The disclosure frames pairing torsemide extended release with an SGLT inhibitor or an aldosterone receptor antagonist as intended to support kidney protection and manage hypertension-related clinical risks.
Documented Applications
Treating uncontrolled hypertension.
Hypertension.
Congestive heart failure.
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