Pharmaceutical compositions including low dosages of desmopressin

• US 7,405,203 B2
• Filed: 05/04/2007
• Issued: 07/29/2008
• Est. Priority Date: 05/07/2002
• Status: Expired due to Term

• Current Assignee: Acerus Pharmaceuticals USA LLC
• Original Assignee: Reprise Biopharmaceutics LLC (Serenity Pharmaceuticals Corporation)
• Inventors: Fein, Seymour H.
• Primary Examiner(s): Kosar; Andrew D
• Application Number:
  US11/744,615
• Publication Number:
  US 20070265207A1
• Time in Patent Office: 452 Days
• Field of Search: None
• US Class Current: 514/10.9
• 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

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 of treating nocturia, primary nocturnal enuresis, or incontinence, or for inducing voiding postponement, said method comprising administering to a patient in need thereof a pharmaceutical composition comprising a dose of desmopressin sufficient to achieve a maximum desmopressin plasma/serum concentration no greater than 10 pg/ml and maintaining the concentration within the range of about 0.5 pg/ml and 10 pg/ml for about four to six hours.

2. The method of claim 1, comprising administering said composition by transmucosal, transdermal, or intradermal delivery.

3. The method of claim 1, comprising treating nocturia.

4. The method of claim 1, comprising administering said composition by intravenous delivery.

5. The method of claim 1, comprising administering said composition by subcutaneous delivery.

6. The method of claim 1, comprising administering said composition by transmucosal delivery.

7. The method of claim 1, comprising administering said composition by transdermal delivery.

8. The method of claim 1, comprising administering said composition by intradermal delivery.

9. The method of claim 1, wherein the desmopressin plasma/serum concentration is maintained at a level no greater than about 5 pg/ml.

10. A method for inducing an antidiuretic effect in a patient comprising the step of administering to a patient a pharmaceutical composition comprising desmopressin by transmucosal, transdermal, or intradermal delivery in an amount and for a time sufficient to establish a maximum serum/plasma desmopressin concentration no greater than 10 pg/ml.

11. The method of claim 10, wherein said patient is suffering from incontinence, primary nocturnal enuresis (PNE), or nocturia.

12. The method of claim 10, wherein said desmopressin pharmaceutical composition is administered in an amount and for a time sufficient to establish a serum/plasma desmopressin concentration no greater than about 5 pg/ml.

14. The method of claim 10, wherein the patient is a human or other mammalian subject.

13. A method for treating a patient suffering from nocturia comprising administering to a patient a pharmaceutical composition comprising desmopressin by transmucosal, transdermal, or intradermal delivery in an amount and for a time sufficient to establish a maximum serum/plasma desmopressin concentration greater than 0.1 pg/ml and less than 10 pg/ml.

15. The method of claim 13, wherein said concentration is maintained greater than 0.1 pg/ml for a time greater than 4 hours.