Pharmaceutical compositions including low dosages of desmopressin

• US 8,143,225 B2
• Filed: 07/15/2008
• Issued: 03/27/2012
• Est. Priority Date: 05/07/2002
• Status: Expired due to Term

• Current Assignee: Acerus Pharmaceuticals USA LLC
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Fein, Seymour
• Primary Examiner(s): Tsang, Cecilia J
• Assistant Examiner(s): GUDIBANDE, SATYANARAYAN R
• Application Number:
  US12/173,072
• Publication Number:
  US 20080274951A1
• Time in Patent Office: 1,351 Days
• Field of Search: None
• US Class Current: 514/21.8
• 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 patch adapted for intradermal administration of desmopressin to a patient, the patch comprising desmopressin and a pharmaceutically acceptable carrier in a dosage form that dispenses from 0.5 ng up to 2 μ

g desmopressin intradermally.

2. The patch of claim 1, wherein the patch comprises a depot of desmopressin.

3. The patch of claim 1, wherein the dosage form is formulated to establish a plasma/serum desmopressin concentration within the range from about 0.1 picograms desmopressin per ml plasma/serum to a maximum of 10.0 picograms per ml plasma/serum and to decrease urine production.

4. The patch of claim 3, wherein the dosage form is formulated to establish a plasma/serum desmopressin concentration within the range from about 0.5 picograms desmopressin per ml plasma/serum to a maximum of 5.0 picograms per ml plasma/serum.

5. The patch of claim 3, wherein the dosage form is formulated to establish a plasma/serum desmopressin concentration within the range from about 0.1 picograms desmopressin per ml plasma/serum to a maximum of 10.0 picograms per ml plasma/serum for a time between four and six hours.

6. The patch of claim 1, wherein the dosage form is effective to produce an antidiuretic effect lasting for a maximum of between about 4 and about 6 hours.

7. The patch of claim 1, wherein the dosage form is effective to produce a urine osmolality ranging above about 300 mOsm/kg for less than about 5 hours after administration.