Pharmaceutical formulations comprising tadalafil
AssigneeKYDES Pharmaceuticals LLC
InventorStephen Kwaku Dordunoo
Life of this patent
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Abstract
Provided are stable, concentrated, and palatable solutions suitable for sublingual and/or transurethral administration containing tadalafil, with or without other active ingredients to address comorbidities, in a liquid vehicle or solvent selected from propylene carbonate, 2-pyrrolidone, dimethyl isosorbide, dimethyl acetamide, n-methyl-2-pyrrolidone, ethanol, water, oleic acid, and isopropyl myristate. The solutions have low irritancy for sublingual tissues and a-are compatible with commercial atomizers. The invention is further directed to methods of treating male erectile dysfunction and/or comorbidities by administering an effective amount of the pharmaceutical formulations comprising tadalafil, with or without other active ingredients, to a patient in need of such treatments.
Claims16
A composition, comprising:
- (a) an active agent selected from:
- (1) tadalafil, or a pharmaceutically acceptable salt thereof, or
- (2) a combination of tadalafil, or a pharmaceutically acceptable salt thereof, with a therapeutic agent for treatment of comorbid diseases or conditions associated with erectile dysfunction selected from the group consisting of premature ejaculation, diabetes, cardiovascular disorders, hypertension, hyperlipidemia, obesity, depression, benign prostatic hyperplasia, hyperprolactinemic disorders, chronic obstructive pulmonary disease (COPD), lower urinary tract symptoms (LUTS), and testosterone deficiency;
- and
- (b) a solvent comprising propylene carbonate, n-methyl-2-pyrrolidone, and glacial acetic acid, wherein the composition is in a sublingual, buccal, or transurethral dosage form, and wherein the sublingual dosage form is a liquisolid formulation.
A method for treatment of erectile dysfunction comprising administering to a patient in need of such treatment, an effective amount of a composition comprising:
- an active agent selected from:
- (1) tadalafil, or a pharmaceutically acceptable salt thereof, or
- (2) a combination of tadalafil, or a pharmaceutically acceptable salt thereof, with a therapeutic agent for treatment of comorbid diseases or conditions associated with erectile dysfunction selected from the group consisting of premature ejaculation, diabetes, cardiovascular disorders, hypertension, hyperlipidemia, obesity, depression, benign prostatic hyperplasia, hyperprolactinemic disorders, chronic obstructive pulmonary disease (COPD), lower urinary tract symptoms (LUTS), and testosterone deficiency;
- and
- a solvent comprising propylene carbonate, n-methyl-2-pyrrolidone, and glacial acetic acid, wherein the composition is in a sublingual, buccal, or transurethral dosage form, and wherein the sublingual dosage form is a liquisolid formulation.
Dependencies are inferred from the claim text.