PHARMACEUTICAL COMPOSITIONS INCLUDING LOW DOSAGES OF DESMOPRESSIN

• US 20080274951A1
• Filed: 07/15/2008
• Published: 11/06/2008
• Est. Priority Date: 05/07/2002
• Status: Active Grant

• Current Assignee: Acerus Pharmaceuticals USA LLC
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Fein, Seymour H.
• Granted Patent: US 8,143,225 B2
• Time in Patent Office: Days
• US Class Current: 514/11
• CPC Class Codes: A61K 38/08 Peptides having 5 to 11 amino acids A61K38/043 - A61K38/046 take precedence
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 38/12 Cyclic peptides , e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C A61K38/043 - A61K38/046 take precedence
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2063 Proteins, e.g. gelatin
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 7/12 Antidiuretics, e.g. drugs for diabetes insipidus ADH A61P5/10

Abstract

The present invention is directed to a pharmaceutical composition comprising 0.5 ng to 20 μg desmopressin and a pharmaceutically acceptable carrier. The present invention is also directed to a pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is effective to establish a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about 10.0 picogram desmopressin per mL plasma/serum. Articles of manufacture and methods of using the above invention are also disclosed.

Claims

1-18. -18. (canceled)

19. An article of manufacture for inducing voiding postponement comprising a pharmaceutical composition comprising desmopressin in admixture with a pharmaceutical carrier and packaging material, wherein the amount of desmopressin in said composition is sufficient when administered in accordance with instructions on said packaging material to produce in a patient a duration of antidiuresis lasting for between about 4 and about 6 hours.

20. The article of claim 19 wherein the amount of desmopressin ranges from about 50 ng to about 10 μ

g.

21. The article of claim 19 wherein the amount of desmopressin ranges from about 0.1 μ

g to about 2 μ

g.

22. The article of claim 19 wherein the composition is a transmucosal dosage form.

23. The article of claim 19 wherein the composition is a transdermal dosage form.

24. The article of claim 19 wherein the composition is an intradermal dosage.

25. The article of claim 19 wherein the composition is a subcutaneous dosage form.

26. An article of manufacture comprising packaging material and a pharmaceutical composition,

the pharmaceutical composition comprising an amount of desmopressin ranging from about 0.5 ng/kg of body weight to about 285 ng/kg of body weight of a patient sufficient to produce a duration of antidiuresis in the patient lasting for a maximum of about 4 to about 6 hours after administration, and

the packaging material advising the patient that fluid intake should be restricted and that the pharmaceutical composition can be used for inducing voiding postponement or for treating a condition selected from the group consisting of hemophilia, Von Willebrand'"'"'s Disease, incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus.

27. An article of manufacture comprising packaging material and a pharmaceutical composition,

the pharmaceutical composition comprising an amount of desmopressin ranging from about 0.5 ng/kg of body weight to about 285 ng/kg of body weight of a patient sufficient to produce a duration of antidiuresis in the patient lasting for a maximum of about 4 to about 6 hours after administration, and

the packaging material advises that a risk of hyponatremia or a risk of seizures may occur if fluid intake is not restricted and that the pharmaceutical composition can be used for inducing voiding postponement or for treating a condition selected from the group consisting of hemophilia, Von Willebrand'"'"'s Disease, incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus.

28. The article of claim 27 wherein the packaging material indicates fluid intake should be restricted after administration.

29. The article of claim 28 wherein the packaging material indicates fluid intake should be restricted for about 4 to 6 hours after administration.