Methods and apparatus for the delivery of solid drug compositions

• US 6,306,420 B1
• Filed: 05/19/2000
• Issued: 10/23/2001
• Est. Priority Date: 09/02/1994
• Status: Expired due to Fees

• Current Assignee: Societe de Conseils de Recherches et d'Applications Scientifiques
• Original Assignee: Societe de Conseils de Recherches et d'Applications Scientifiques
• Inventors: Cheikh, Roland Cherif
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): WARE, TODD
• Application Number:
  US09/574,419
• Time in Patent Office: 522 Days
• Field of Search: 424/422, 424/423, 604/891.1
• US Class Current: 424/422
• 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 method of automatically administering a drug to a patient according to a predetermined delivery profile, the method comprising:

obtaining a device comprising

a housing;

a reservoir operatively connected to the housing and loaded with a solid composition comprising the drug;

a transit assembly attached to said housing and configured to allow the solid composition to pass out of the housing;

an actuator arranged within the housing to move the solid composition from the reservoir to a transit assembly, wherein the solid composition exits the housing at the transit assembly, and

a controller that acts on the actuator to adjust movement of the solid composition out of the housing according to the predetermined delivery profile;

programming the controller of the device to cause the actuator to move the solid composition to the transit area according to the predetermined delivery profile;

bringing the transit area into contact with the body fluids of the patient, and

providing energy to the controller and the actuator to move the composition from the reservoir to the transit area to deliver the drug to body fluids of the patient according to the predetermined delivery profile.

2. A method of claim 1, wherein said delivery profile changes over time.

3. A method of claim 1, wherein said transit area is brought into contact with the body fluids of the patient by implanting said device into the patient.

4. A method of claim 1, wherein said drug is administered to the patient continuously for over 3 months according to said delivery profile.

5. A method of making a solid drug filament, said method comprising;

preparing a non-solid form of said drug,

extruding said non-solid drug into an elongate filament having a cross-section of less than 0.5 mm and a surface area to drug ratio of at least 10 square millimeters per milligram of said drug, and

solidifying said filament to form the solid drug filament.

6. A method of claim 5, wherein said non-solid form of said drug is prepared by mixing a carrier with a sufficient amount of a solvent to form a gel and mixing said gel with said drug to form a homogeneous, non-solid form, and further wherein said filament is solidified by removing said solvent.

7. A method of claim 5, wherein said non-solid form of said drug is prepared by mixing a carrier with said drug to form a mixture and heating said mixture to a temperature above a melting point of said carrier to generate said non-solid form, and further wherein said filament is solidified by cooling to a temperature below said melting point of said carrier.