Delivery of solid drug compositions

• US 5,582,591 A
• Filed: 09/02/1994
• Issued: 12/10/1996
• Est. Priority Date: 09/02/1994
• Status: Expired due to Term

• Current Assignee: Ipsen Pharma Sas (Ipsen Sa)
• Original Assignee: Delab Co.
• Inventors: Cheikh, Roland C.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/300,713
• Time in Patent Office: 830 Days
• Field of Search: 604/28, 604/27, 604/38, 604/59, 604/60, 604/181, 604/57, 604/51, 604/52, 604/49, 604/288
• US Class Current: 604/500
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61K 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• CPC Class Codes: A61K 38/25 Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 38/31 Somatostatins
• 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 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/31531 Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31595 Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 5/02 : of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/04 : Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Abstract

A method of parenterally administering a drug to a patient for immediate dispersal of the drug once administered by obtaining an anhydrous, solid drug composition consisting essentially of the drug and up to 50%, by weight, of a pharmaceutically acceptable carrier, wherein the drug and the carrier are selected and compounded such that the drug is dispersed from the composition upon contact with parenteral fluids and is distributed within the patient'"'"'s bloodstream according to a blood level profile of the drug that is comparable to a blood level profile of the drug when administered in a liquid formulation, and introducing the solid drug composition into parenteral fluids of the patient.

Claims

1. A method of parenterally administering a drug to a patient for immediate dispersal of the drug once administered, said method comprising

obtaining an anhydrous, solid drug composition consisting essentially of said drug and up to 50%, by weight, of a pharmaceutically acceptable carrier, wherein said drug and said carrier are selected and compounded such that said drug is dispersed from said composition upon contact with parenteral fluids and is distributed within the patient'"'"'s bloodstream according to a blood level profile of said drug that is comparable to a blood level profile of said drug when administered in a liquid formulation, and

introducing said solid drug composition into parenteral fluids of the patient.

2. A method of claim 1, wherein said composition is compounded with a surface area to weight ratio of at least 10 square millimeters per milligram of said drug.

3. A method of claim 2, wherein said solid drug composition is in the form of a cylinder.

4. A method of claim 1, wherein said drug is a peptide, polypeptide, or protein.

5. A method of claim 4, wherein said drug is selected from the group consisting of insulin, luteinizing hormone-releasing hormone (LH-RH), somatostatin, growth hormone releasing factor (GRF), and analogs thereof.

6. A method of claim 1, wherein said drug is selected from the group consisting of cytostatic compounds, analgesic compounds, and hormones.

7. A method of claim 1, wherein said drug is a vaccine.

8. A method of claim 1, wherein said carrier is water-soluble.

9. A method of claim 1, wherein said carrier is a polymer.

10. A method of claim 1, wherein said carrier is a cellulose, hyaluronic acid, polyalcohol, or sugar.

11. A method of claim 1, wherein said composition consists essentially of said drug and no carrier.