Pharmaceutical compositions including low dosages of desmopressin

• US 7,799,761 B2
• Filed: 11/12/2003
• Issued: 09/21/2010
• Est. Priority Date: 05/07/2002
• Status: Active Grant

• Current Assignee: Acerus Pharmaceuticals USA LLC
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Fein, Seymour H.
• Primary Examiner(s): Kosar; Andrew D
• Application Number:
  US10/706,100
• Publication Number:
  US 20040138098A1
• Time in Patent Office: 2,505 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 pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier in a dosage form which dispenses by intranasal, transdermal, or intradermal administration from 0.5 ng up to 1 μ

g desmopressin.

2. The pharmaceutical composition of claim 1 in a dosage form comprising a patch, gel, cream, ointment, or iontophore adapted for transdermal delivery.

3. The pharmaceutical composition of claim 1 in a dosage form comprising a patch adapted for intradermal administration.

4. The pharmaceutical composition of claim 1 in a dosage form comprising a spray adapted for intranasal delivery.

5. The pharmaceutical composition of claim 1 in a dosage form sufficient to establish in a patient a steady plasma/serum desmopressin concentration of from about 0.1 picograms desmopressin per mL plasma/serum to 10 picograms desmopressin per mL plasma/serum.

6. The pharmaceutical composition of claim 1 in a dosage form sufficient to establish in a patient a steady plasma/serum desmopressin concentration of from about 0.5 picograms desmopressin per mL plasma/serum to about 5.0 picograms desmopressin per mL plasma/serum.

13. The composition of claim 1 which establishes said plasma/serum desmopressin concentration range for a time between four and six hours.

7. A pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier in a dosage form adapted for intranasal administration which dispenses from 0.1 ng up to 1 μ

g desmopressin and which when administered to a patient establishes a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about a maximum of 10.0 picograms desmopressin per mL plasma/serum and decreases urine production.

8. The composition of claim 7 which establishes a steady plasma/serum desmopressin concentration of from about 0.5 picograms desmopressin per mL plasma/serum to about 5.0 picograms desmopressin per mL plasma/serum.

14. The composition of claim 7 which establishes said plasma/serum desmopressin concentration range for a time between four and six hours.

15. The composition of claim 8 which establishes said plasma/serum desmopressin concentration range for a time between four and six hours.

9. A pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier in a dosage form adapted for intradermal or transdermal administration which dispenses from 0.1 ng up to 1 μ

g desmopressin and which when administered to a patient establishes a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about a maximum of 10.0 picograms desmopressin per mL plasma/serum and decreases urine production.

10. The dosage form of claim 9 which establishes a steady plasma/serum desmopressin concentration of from about 0.5 picograms desmopressin per mL plasma/serum to about 5.0 picograms desmopressin per mL plasma/serum.

11. The dosage form of claim 9 adapted for intradermal administration comprising a patch.

12. The dosage form of claim 9 adapted for transdermal delivery and comprising a patch, gel, cream, ointment, or iontophore.

16. The composition of claim 9 which establishes said plasma/serum desmopressin concentration range for a time between four and six hours.

17. The composition of claim 10 which establishes said plasma/serum desmopressin concentration range for a time between four and six hours.