Osmotic system for delivery of fluid-sensitive somatotropins to bovine animals

• US 5,980,509 A
• Filed: 11/24/1997
• Issued: 11/09/1999
• Est. Priority Date: 12/13/1988
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Ziemann, Lyle E., Robinson, Urano A., Magruder, Judy A., Eckenhoff, James B., Wright, Jeremy C., Peery, John R., Cortese, Richard, Smith, Jonathan P., Pike, James B.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/976,513
• Time in Patent Office: 715 Days
• Field of Search: 604/892.1, 604/891.1, 604/890.1, 604/93, 604/122, 604/152, 424/423, 424/424, 424/453, 424/422
• US Class Current: 604/890.1
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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

Abstract

A delivery system is disclosed for delivering a fluid-sensitive beneficial agent such as a somatotropin, or an analogue or derivative thereof, to an animal such as a bovine. The delivery system comprises a wall that surrounds an internal compartment, said wall comprising a first wall section that limits the passage of fluid into the system and a second wall section that permits the passage of fluid into the system. The wall may further comprise an end cap which may be adapted for ultrasonic welding to the first wall section and may maintain the beneficial agent in contact with an exit. The compartment comprises a beneficial agent and an expandable driving member. The delivery system comprises an exit for delivering the beneficial agent to the animal. The exit may compensate for slight variations in the efflux rate of the beneficial agent and maintain a sufficient velocity or efflux rate of beneficial agent outward from the device while minimizing diffusion of fluids from the external environment back into the device.

Claims

1. An improved delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device comprising:

a) a housing comprising a fluid impermeable portion and a fluid permeable portion, the portions forming an internal compartment;

b) a beneficial agent formulation in the internal compartment;

c) expandable means in the compartment for pushing the beneficial agent formulation from the delivery device; and

e) exit means for delivering the beneficial agent formulation from the internal compartment to the animal over a prolonged period of time, wherein the improvement comprises headspace formed in a part of the portion of the internal compartment which contains the beneficial agent formulation which headspace is located away from the exit means and which head space serves to accumulate an air volume in a part of the portion of the internal compartment which contains the beneficial agent formulation away from the exit means.

2. A delivery device according to claim 1 wherein the housing includes an end cap, the end cap comprising an inwardly extending portion, the inwardly extending portion and defining a space therebetween.

3. A delivery device according to claim 2, further including means for maintaining a seal between the exterior environment and the interior chamber until the osmotic pressure within the device reaches a predetermined pressure of between greater than 5 and 10 psi.

4. A delivery device according to claim 2, wherein the end cap includes mating means for adapting the end cap to ultrasonic welding to the, the mating means positioned where the end cap and the fluid impermeable portion join.

5. A delivery device as set forth in claim 4, wherein end cap further comprises a first side and a second side, and wherein the mating means includes a tenon extending outwards from the second side of the end cap, the fluid impermeable portion defining a mortise therein, the tenon sized and positioned for receipt within the mortise.

6. A delivery device for storing and protecting a beneficial agent formulation and for minimizing the dilution of the beneficial agent formulation during the dispensing of the beneficial agent to an animal, the delivery device comprising:

a) a housing comprising a first wall section and a second wall section assembled together to form an internal compartment, wherein the first wall section is substantially impermeable to the passage of fluid, wherein the second wall section is permeable in at least a portion, to a predetermined rate of fluid from the external environment into the internal compartment comprised by the second wall section;

b) a beneficial agent formulation in a portion of the internal compartment comprised by the first wall section;

c) expandable means in a portion of the compartment comprised by the second wall section for pushing the beneficial agent formulation from the delivery device; and

d) an exit passageway through the first wall section, the exit passageway comprising a seal wherein said seal is discharged, leaches or erodes to become unsealed when the pressure within the compartment reaches a predetermined level and which seal thereafter remains unsealed to allow continuous release of beneficial agent during the entire time of delivery, and the exit passageway having a length and area which maintains sufficient outflow of the beneficial agent formulation to prevent an inward flow of fluid from the external environment.

7. A delivery device according to claim 6, the wherein the beneficial agent is bovine somatotrophin and the predetermined rate of fluid from the external environment is about 10 to about 15 mg/water per day.

8. A delivery device according to claim 7, wherein the predetermined rate of fluid is attained by a selected thickness of the second wall section, a selected surface area of the second wall section, and second wall section comprising a selected material.

9. A device according to claim 6, wherein the exit passageway further includes the first wall section defining a passageway of a predetermined inner diameter sufficient to generate a sufficient outward velocity of the beneficial agent formulation to prevent an inward flow of fluid from the external environment to dilute the beneficial agent in the portion of the compartment comprised by the first wall section.

10. A device according to claim 9 wherein the exit passageway further includes means for compensating for slight variations in the outward flow rate.

11. A device according to claim 10 wherein the means for compensating for slight variations in the outward flow rate includes adjusting the thickness of the first wall section defining the exit passageway therein.