Method and apparatus for the delivery of elongate solid drug compositions

• US 6,142,972 A
• Filed: 07/07/1998
• Issued: 11/07/2000
• Est. Priority Date: 09/02/1994
• Status: Expired due to Term

• Current Assignee: Societe de Conseils de Recherches et d'Applications Scientifiques
• Original Assignee: Delab Co.
• Inventors: Cheikh, Roland Cherif
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): WARE, TODD
• Application Number:
  US09/110,880
• Time in Patent Office: 854 Days
• Field of Search: 604/57, 604/59, 604/60, 604/61, 604/62, 604/63, 604/64, 604/187, 424/422
• US Class Current: 604/57
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61K 38/28 Insulins
• 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 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• 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

Abstract

The invention features an implantable device for the automatic delivery of an active ingredient according to an adjustable delivery profile. The device includes a housing; a reservoir operatively connected to the housing and arranged to store a solid composition including the active ingredient; an actuator arranged within the housing to move the solid composition from the reservoir to a transit area, wherein the solid composition exits the housing at the transit area; a controller that acts on the actuator to adjust movement of the solid composition out of the housing according to the adjustable delivery profile; and a power source arranged to provide energy to the actuator and the controller. The solid composition can be an elongate, solid composition comprising a drug, and up to 90% of a carrier, wherein the composition has a cross-section of less than 0.5 mm, and wherein the drug and the carrier are selected and compounded in a proportion such that the drug is immediately released from the carrier upon contact with a liquid.

Claims

1. A device for the parenteral administration of a solid drug filament to a patient comprising:

a hollow housing;

a reservoir, disposed within said housing to store a solid drug filament;

an actuator arranged within said housing to move the solid filament from said reservoir to a delivery tube attached to one end of said housing, wherein the filament exits said housing through said delivery tube; and

a plunger arranged to slide within said housing and said delivery tube, and to cut the solid filament into individual dosage units and move said units out of said housing through said delivery tube.

2. A device of claim 1, wherein said reservoir contains the solid drug filament, and wherein the filament comprises up to 90 percent, by weight, of a carrier.

3. A device of claim 2, wherein said filament comprises between 10 and 70 percent, by weight, of carrier.

4. A device of claim 2, wherein said carrier is a cellulose derivative, hyaluronic acid, sugar, or gelatin.

5. A device of claim 2, wherein the drug is a polypeptide, protein, or peptide.

6. A device of claim 2, wherein the drug is insulin.

7. A device of claim 2, wherein the drug is a growth-hormone or an analog thereof.

8. A device of claim 1, wherein said reservoir comprises a bobbin to store said solid drug filament.

9. A device of claim 1, wherein said actuator comprises two rotating wheels arranged to contact and move the filament from said reservoir to said delivery tube.

10. A device of claim 1, further comprising an indicator to measure the amount of solid filament moved out of said housing.

11. A method of parenterally administering a drug to a patient, said method comprising:

obtaining a device of claim 1 loaded with a solid drug filament;

attaching a needle to said delivery tube;

causing said actuator to move said filament from said reservoir to said delivery tube;

inserting said needle into the patient; and

moving said plunger to cut an individual dosage unit from said solid filament and move said unit out of said housing through said delivery tube and into the patient through said needle.

12. The method of claim 11, wherein said drug filament comprises up to 90 percent, by weight, of a carrier.

13. The method of claim 11, wherein said drug filament comprises between 10 and 70 percent, by weight, of a carrier.

14. The method of claim 11, wherein said carrier is a cellulose derivative, hyaluronic acid, sugar, or gelatin.

15. The method of claim 11, wherein the drug in the drug filament is a polypeptide, protein, or peptide.

16. The method of claim 11, wherein the drug in the drug filament is insulin.

17. The method of claim 11, wherein the drug in said drug filament is a growth-hormone or an analog thereof.

18. The method of claim 11, wherein said reservoir comprises a bobbin to store said solid drug filament.

19. The method of claim 11, wherein said actuator comprises two rotating wheels arranged to contact and move the filament, and wherein the actuator is caused to move the filament by rotating the two wheels.

20. The method of claim 11, wherein the device further comprises an indicator and the method further comprises monitoring the indicator to determine the amount of solid filament moved out of said housing.