Delivery of solid drug compositions

• US 5,616,123 A
• Filed: 06/02/1995
• Issued: 04/01/1997
• 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:
  US08/460,545
• Time in Patent Office: 669 Days
• Field of Search: 604/60, 604/27, 604/28, 604/48, 604/51, 604/52, 604/53, 604/57, 604/64, 604/93, 604/131, 604/154, 604/174, 604/179, 604/246, 604/59, 604/63, 128/DIG. 12, 128/DIG. 1
• US Class Current: 604/60
• 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. An external, wearable device for the automatic, controlled administration of a solid drug composition to a patient comprising:

a housing;

a plunger located within said housing;

a dispensing tube attached to the outside of said housing, said tube being designed and sized to contain a solid drug composition consisting essentially of the drug and up to 50%, by weight, of a pharmaceutically acceptable carrier, wherein the solid drug has a diameter of less than about 0.8 millimeters;

an actuator arranged within said housing to move said plunger from said housing into said dispensing tube;

a controller that acts on said actuator to regulate the movement of said plunger through said housing and into said dispensing tube; and

a power source arranged to provide energy to said actuator and said controller;

wherein said plunger is capable of moving the solid drug composition out of said dispensing tube at a controlled rate.

2. A device of claim 1, wherein said controller comprises an electrical motor, and said power source is a battery.

3. A device of claim 2, wherein said controller further comprises a microcomputer programmed with a predetermined delivery profile to provide said controlled rate of delivery.

4. A device of claim 1, wherein said actuator comprises two rotating wheels arranged to contact and move said plunger into said dispensing tube.

5. A device of claim 1, wherein said housing has a size of less than 3.0 cm and a thickness of less than 0.5 cm.

6. A method of automatically administering a drug to a patient according to a predetermined delivery profile comprising:

(a) obtaining a device of claim 1;

(b) loading a solid drug composition into said dispensing tube;

(c) inserting said dispensing tube into the patient;

(d) programming said controller of said device to cause said actuator to move said plunger through said dispensing tube according to a predetermined delivery profile;

(e) providing energy to said controller and said actuator to move said plunger within said dispensing tube to move the solid drug composition out of said dispensing tube and into the patient to deliver said drug to body fluids of the patient according to a predetermined delivery profile.

7. A method of claim 6, wherein said device is attached to the patient'"'"'s skin with an adhesive.

8. A device of claim 1, wherein said dispensing tube is designed and sized to contain a cylindrical solid drug composition having a diameter of 0.1 to 0.8 millimeters.