Osmotically driven fluid dispenser

• US 4,320,758 A
• Filed: 12/08/1980
• Issued: 03/23/1982
• Est. Priority Date: 05/07/1979
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Landrau, Felix A., Eckenhoff, James B., Geerke, Johan H.
• Primary Examiner(s): ROSENBAUM, C FRED
• Application Number:
  US06/214,182
• Time in Patent Office: 470 Days
• Field of Search: 128/213, 128/260
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• 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 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: B01D 61/002 Forward osmosis or direct osmosis
• CPC Class Codes: B01D 63/00 Apparatus in general for separation processes using semi-permeable membranes
• CPC Class Codes: B01D 71/26 Polyalkenes
• CPC Class Codes: B01D 71/261 Polyethylene

Abstract

An improved version of an osmotically driven mini-osmotic pump that is used to administer drug solutions. The basic components of the improved pump are: an inner flexible bag that holds the drug solution; a plug having a recessed inner end that seals the bag opening; a solution filling/discharge port through the plug; a cup-shaped, thermo-formed sleeve that fits partly about the bag and is made from a dispersion of an osmotically effective solute in a water soluble, theroplastic polymer vehicle; a shape-retaining, semipermeable membrane that encapulates the bag-sleeve subassembly; and a flow moderator that is received through the filling/discharge port in the plug.

Claims

1. In an osmotically driven fluid dispenser comprising an inner flexible bag adapted to contain the fluid, an intermediate layer of an osmotically effective solute composition at least partly encapsulating the bag, an outer, shape-retaining membrane encapsulating the layer of osmotically effective solute composition, said membrane being at least in part permeable to water, and a port that extends from the interior of the bag to the exterior of the dispenser through which the fluid may be charged into the bag and dispensed from the bag, the improvement wherein the layer of the osmotically effective solute composition is in the form of a thermoformed sleeve consisting essentially of a dispersion of about 50% to about 90% by weight osmotically effective solute, in about 10% to about 50% by weight water soluble thermoplastic polymer vehicle.

2. The improvement of claim 1 wherein the osmotically effective solute constitutes about 60% to about 70% by weight of the dispersion and the polymer vehicle constitutes about 30% to about 40% by weight of the dispersion.

3. The improvement of claim 1 wherein the polymer vehicle consists essentially of about 40% to about 70% by weight poly(ethylene oxide) having a molecular weight in the range of about 100,000 to about 4,000,000 and about 30% to about 60% by weight poly(ethylene glycol) having a molecular weight in the range of about 1,000 to about 30,000.

4. The improvement of claim 1 wherein the osmotically effective solute is sodium chloride and the vehicle consists of a mixture of poly(etyhlene oxide) of about 600,000 molecular weight, poly(ethylene glycol) of about 20,000 molecular weight, and colloidal silicon dioxide.

5. In an osmotically driven fluid dispenser comprising an inner flexible bag adapted to contain the fluid, an intermediate layer of an osmotically effective solute composition at least partly encapsulating the bag, an outer, shape-retaining membrane encapsulating the layer of osmostically effective solute composition, said membrane being at least in part permeable to water, and a port that extends form the interior of the bag to the exterior of the dispenser through which the fluid may be charged into the bag and dispensed from the bag, the improvement wherein the layer of the osmotically effective solute composition is in the form of a thermoformed sleeve consisting of a mixture of 64.5% by weight sodium chloride, 20% by weight poly(ethylene oxide) having a molecular weight of about 600,000, 15% by weight poly(ethylene glycol) having a molecular weight of about 20,000 and 0.5% by weight colloidal silicon dioxide.