Method of making controlled release devices

• US 5,788,977 A
• Filed: 02/21/1997
• Issued: 08/04/1998
• Est. Priority Date: 02/23/1996
• Status: Expired due to Term

• Current Assignee: Dow Corning Corporation (Dow, Inc.)
• Original Assignee: Dow Corning France S.A.S. (Dow, Inc.)
• Inventors: Barbaroux, Magali, Aguadisch, Louis, Dalle, Frederic
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US08/803,739
• Time in Patent Office: 529 Days
• Field of Search: 424/422, 424/424, 424/425, 424/430, 424/432
• US Class Current: 424/422
• 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 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0039 Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes

Abstract

A process is disclosed for making devices which release active material, e.g. a drug, at a controlled rate, which device comprises a closed container and the active material. The device is made by first making a hollow envelope, e.g. by extrusion or moulding, followed by introducing the active material into the void of the envelope. The device may have a ring or cylindrical form.

Claims

1. A method of making a device which releases an active material suitable for treating the human or animal body at a controlled rate comprising:

forming a closed hollow envelope having an empty space therein from an uncured silicone containing material;

curing said closed hollow envelope, said closed container being permeable to the active material; and

introducing an active material into the empty space of the closed hollow envelope.

2. The method of claim 1 wherein the closed hollow envelope is formed by a molding process.

3. The method of claim 1 wherein the closed hollow envelope is formed with an integral septum.

4. The method of claim 3 wherein the active material is introduced into the closed hollow envelope by inserting a needle through the septum and injecting the active material in liquid form through the needle.

5. The method of claim 1 wherein the active material is introduced into the closed hollow envelope in a solid form.

6. The method of claim 5 wherein a slit is formed in the closed hollow envelope and the active material is introduced through the slit.

7. The method of claim 1 wherein the device contains more than one closed hollow envelope.

8. The method of claim 7 wherein different active materials are introduced to each of the closed hollow envelopes.