Methods of treatment using orodispersible desmopressin pharmaceutical formulations

• US 8,802,624 B2
• Filed: 05/18/2011
• Issued: 08/12/2014
• Est. Priority Date: 05/07/2002
• Status: Active Grant

• Current Assignee: Ferring BV (Ferring Holding SA)
• Original Assignee: Ferring BV (Ferring Holding SA)
• Inventors: Nilsson, Anders, Lindner, Hans, Wittendorff, Jrgen
• Primary Examiner(s): Russel, Jeffrey E
• Application Number:
  US13/110,619
• Publication Number:
  US 20120071538A1
• Time in Patent Office: 1,182 Days
• Field of Search: None
• US Class Current: 514/6.9
• 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

Described herein are methods of treating diseases or conditions such as incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus, by administering desmopressin acetate in an orodispersiblc solid dosage form that disintegrates in the mouth within 10 seconds and includes an amount of desmopressin acetate, measured as the free base, of from 10 to 600 μg.

Claims

1. A method of treating a disease or condition selected from the group consisting of incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus, comprising administering to a subject an effective and generally non-toxic amount of desmopressin acetate in an orodispersible solid dosage form, wherein said dosage form (A) disintegrates in the mouth within 10 seconds and (B) comprises an amount of desmopressin acetate, measured as the free base, of from 10 to 600 μ

g.

2. The method of claim 1, wherein the disease or condition is primary nocturnal enuresis (PNE).

3. The method of claim 1, wherein the disease or condition is nocturia.

4. The method of claim 1, wherein the dosage form comprises an open matrix network carrying the desmopressin acetate, the open matrix network being comprised of a water-soluble or water-dispersable carrier material that is inert towards desmopressin.

5. The method of claim 4, wherein the open matrix network comprises gelatin.

6. The method of claim 5, wherein the gelatin is fish gelatin.

7. The method of claim 6, wherein the fish gelatin is non-gelling.

8. The method of claim 1, wherein the dosage form disintegrates in the mouth within 5 seconds.

9. The method of claim 1, wherein the dosage form disintegrates in the mouth within 2 seconds.

10. The method of claim 1, wherein the dosage form disintegrates in the mouth within 1 second.

11. The method of claim 1, wherein the dosage form is administered once per day.

12. The method of claim 1, wherein the dosage form is administered twice per day.

13. The method of claim 1, wherein the method achieves a maximum plasma concentration of desmopressin in about 0.5-2 hours after administration.

14. The method of claim 1, wherein the method achieves a mean elimination half-life of desmopressin of about 2.8-3 hours after the maximum plasma concentration is reached.

15. The method of claim 1, wherein the method achieves a linear pharmacokinetics of desmopressin.