Process for the production of sustained release drug delivery devices

• US 6,991,808 B2
• Filed: 01/23/2002
• Issued: 01/31/2006
• Est. Priority Date: 01/26/2001
• Status: Expired due to Fees

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Krishnamoorthy, Ramesh, Brubaker, Michael J., Papadopoulos, Pavlos
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Maiorino, Roz
• Application Number:
  US10/055,584
• Publication Number:
  US 20020110635A1
• Time in Patent Office: 1,469 Days
• Field of Search: 604/290, 604/890.1, 427/2.1, 424423-473, 514/772.2
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

Disclosed is an improved sustained release drug delivery device and method of producing such device. The device comprises a drug core in an impermeable cup or impermeable coating layer that is adhered to an uncured suture tab and covered with a permeable polymer coating layer that is similar to the makeup of the suture tab. The permeable polymer coating layer that covers the device, covering the impermeable coating layer and at least a portion of the drug core, is cured (after drying) along with the uncured suture tab. The “cocuring” or one step curing process forms a very strong bond between the outer coating layer to the suture tab preventing leaks.

Claims

1. A sustained release drug delivery device comprising:

a) a drug core comprising at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) an impermeable coating layer impermeable to the passage of said agent adjacent to said drug core that surrounds a portion of said drug core;

c) a suture tab adhered to and extending from said drug delivery device that is used during surgery to adhere said device to the body of a mammalian organism; and

d) a permeable polymer coating layer that is made of a similar polymer material as said suture tab, permeable to the passage of said agent that essentially completely covers the impermeable coating layer and the uncoated portion of the drug core that is not coated with said impermeable coating layer, wherein the sustained release delivery device is made by the step of curing both the polymer coating layer and the suture tab at the same time to bond both together.

2. The sustained release drug delivery device according to claim 1, wherein said suture tab is solid but made of an uncured polymer prior to the step of curing.

3. The sustained release drug delivery device according to claim 1, wherein said impermeable coating layer b) is a cup and said drug core a) is a solid that is shaped to be inserted into said cup.

4. The sustained release drug delivery device according to claim 1, wherein said inner core comprises a plurality of agents.

5. The sustained release drug delivery device according to claim 1, wherein said inner core comprises an effective amount of a low solubility agent.

6. The sustained release drug delivery device according to claim 1, wherein said agent is selected from a group consisting of immune response modifiers, neuroprotectants, corticosteroids, angiostatic steriods, anti-parasitic agents, anti-glaucoma agents, anti-biotics, anti-sense compounds, anti-angiogentic compounds, differentiation modulators, anti-viral agents, anti-cancer agents, and nonsteroidal anti-inflammatory agents.

7. The sustained release drug delivery device according to claim 1, wherein said impermeable coating layer is made of a polymer or a metal.

8. The sustained release drug delivery device according to claim 1, wherein said suture tab has a hole through the proximal end through which a suture can be placed to anchor the device to a structure of a mammalian body.