Methods and apparatus for the delivery of solid drug compositions

• US 5,660,846 A
• Filed: 06/02/1995
• Issued: 08/26/1997
• Est. Priority Date: 09/02/1994
• Status: Expired due to Fees

• Current Assignee: Delab Co.
• Original Assignee: Societe de Conseils de Recherches et d'Applications Scientifiques
• Inventors: Cheikh, Roland Cherif
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US08/459,514
• Time in Patent Office: 816 Days
• Field of Search: 424/422, 424/423, 514/772.3, 514/781
• US Class Current: 424/423
• 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. An elongate, anhydrous, homogeneous, solid drug composition, said composition comprising a drug, and up to 90% of a carrier, wherein said composition comprises a maximum cross-sectional diameter of less than 0.5 mm, and wherein said drug and said carrier are selected and compounded in a proportion such that said drug is dispersed from said solid, homogeneous composition upon contact with bodily fluids and is distributed within the patient'"'"'s blood stream to achieve a blood level concentration of said drug that is within 50 percent of a blood level concentration of said drug when administered in a liquid formulation, as measured over time after any initial peaks in concentration have stabilized.

2. A composition of claim 1, wherein said composition is in the form of a filament.

3. A composition of claim 1, wherein said drug is insulin.

4. A composition of claim 1, wherein said carrier is water-soluble.

5. A composition of claim 4, wherein said carrier is selected from the group consisting of cellulose, hydroxy propyl methylcellulose, carboxy methylcellulose, hydroxy ethylcellulose, hyaluronic acid, dextrose, mannose, glucose, or gelatin.

6. A composition of claim 1, wherein said composition has a surface area to drug ratio of at least 10 square millimeters per milligram of the drug.

7. A composition of claim 1, wherein said composition comprises at least 30 percent, by weight, of said drug and up to 70 percent, by weight, of said carrier.

8. A composition of claim 1, wherein said composition comprises at least 50 percent, by weight, of said drug and up to 50 percent, by weight, of said carrier.

9. A composition of claim 1, wherein said drug is a polypeptide.

10. An elongate, anhydrous, solid drug composition of claim 1, said composition consisting essentially of at least 10 percent, by weight, of said drug and up to 90 percent, by weight, of said carrier.

11. A composition of claim 10, wherein said composition consists essentially of at least 30 percent, by weight, of said drug and up to 70 percent, by weight, of said carrier.

12. A composition of claim 7, wherein said composition consists essentially of at least 50 percent, by weight, of said drug and up to 50 percent, by weight, of said carrier.

13. A composition of claim 7, wherein said drug is a polypeptide.