Pharmaceutical compositions including low dosages of desmopressin

• US 7,579,321 B2
• Filed: 07/15/2008
• Issued: 08/25/2009
• Est. Priority Date: 05/07/2002
• Status: Expired due to Fees

• Current Assignee: Serenity Pharmaceuticals Corporation
• Original Assignee: Reprise Biopharmaceutics LLC (Serenity Pharmaceuticals Corporation)
• Inventors: Fein, Seymour
• Primary Examiner(s): Kosar; Andrew D
• Application Number:
  US12/173,074
• Publication Number:
  US 20090005432A1
• Time in Patent Office: 406 Days
• Field of Search: None
• US Class Current: 514/1.1
• 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. A method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising delivering to the bloodstream of the patient an amount of desmopressin no more than about 2 ng/kg by intranasal, transdermal, intradermal, transmucosal, or conjunctival administration, said amount being therapeutically effective to produce an antidiuretic effect lasting for no more than between about 4 and about 6 hours.

2. The method of claim 1 comprising delivering to the bloodstream of the patient an amount of desmopressin no more than about 1 ng/kg.

3. The method of claim 1 further comprising advising a patient that fluid intake should be restricted after administration.

4. The method of claim 1 further comprising advising the patient that no water should be taken after administration.

5. The method of claim 1 comprising administering desmopressin to a patient suffering from nocturia, primary nocturnal enuresis (PNE), or incontinence.

6. The method of claim 1 wherein the method produces a plasma/serum desmopressin concentration in the patient of a maximum of no more than about 10 pg/ml.

7. The method of claim 1 wherein the method produces a plasma/serum desmopressin concentration in the patient of a maximum of no more than about 5 pg/ml.

9. The method of claim 1 or 8 comprising administering the desmopressin by intranasal administration.

10. The method of claim 1 or 8 comprising administering the desmopressin by transdermal administration.

11. The method of claim 1 or 8 comprising administering the desmopressin by intradermal administration.

12. The method of claim 1 or 8 comprising administering the desmopressin by transmucosal administration.

13. The method of claim 1 or 8 comprising administering the desmopressin by conjunctival administration.

14. The method of claim 1 or 8 comprising administering to the patient between 100 and 2000 ng (0.1 μ

g to 2 μ

g) desmopressin.

8. A method for inducing voiding postponement comprising administering to a patient an amount of desmopressin sufficient to produce in the patient a urine osmolality ranging above about 300 mOsm/kg for less than about 5 hours after administration.

15. The method of claim 8 wherein the method produces a plasma/serum desmopressin concentration in the patient no more than about 10 pg/ml.

16. The method of claim 8 wherein the method produces a plasma/serum desmopressin concentration in the patient no more than about 5 pg/ml.

17. The method of claim 8 comprising delivering to the bloodstream of the patient no more than about 2 ng/kg desmopressin.

18. The method of claim 8 comprising delivering desmopressin to the bloodstream of a patient suffering from nocturia, PNE, or incontinence.

19. A method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising delivering to the bloodstream of the patient via transdermal, intradermal, transmucosal, or conjunctival administration no more than about 1 ng/kg desmopressin to produce an antidiuretic effect for no more than about four to about six hours.

20. A method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising delivering to the bloodstream of the patient via intranasal administration no more than about 2 ng/kg of desmopressin so as to produce an antidiuretic effect.

21. The method of claim 20 comprising delivering to the bloodstream of the patient no more than about 1 ng/kg desmopressin.