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

• US 5,728,088 A
• Filed: 07/01/1994
• Issued: 03/17/1998
• Est. Priority Date: 12/13/1988
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Robinson, Urano A., Magruder, Judy A., Eckenhoff, James B., Wright, Jeremy C., Peery, John R., Cortese, Richard, Ziemann, Lyle E., Smith, Jonathan P., Pike, James B.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Nguyen, At
• Application Number:
  US08/269,596
• Time in Patent Office: 1,355 Days
• Field of Search: 604/892.1, 604/890.1, 604/891.1, 604/122, 424/473, 424/484, 424/486, 424/422-424, 424/438, 424/472
• US Class Current: 604/892.1
• 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 include means for adapting the end cap for ultrasonic welding to the first wall section and means for maintaining the beneficial agent in contact with exit means. The compartment comprises a beneficial agent and an expandable means. The delivery system comprises exit means for delivering the beneficial agent to the animal. The exit means may include means for compensating for slight variations in the efflux rate of the beneficial agent and means for maintaining for 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. In a delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device having

a housing comprising a fluid impermeable portion and a fluid permeable portion forming an internal compartment;

a beneficial agent formulation in the internal compartment;

an expandable driver in the compartment for pushing the beneficial agent formulation from the delivery device;

a partition substantially impermeable to fluid, the partition disposed between the beneficial agent formulation and the expandable driver;

and exit passageway in the housing for delivering the beneficial agent formulation from the internal compartment to the animal over a prolonged period of time improvement comprising;

the partition including a body portion and a biased skirt for slidably engaging the housing portions, the biased skirt being biased radially outward from the body portion to slidably engage the housing, wherein the partition includes a conical skirt extending obliquely outward from the body portion to be biased radially outward from the body portion while slidably engaging with the housing.

2. A delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device having:

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

a beneficial agent formulation in the internal compartment;

an expandable driver in the compartment for pushing the beneficial agent formulation from the delivery device;

a partition layer substantially impermeable to fluid between the beneficial agent formulation and the expandable driver, wherein the partition layer includes a body portion and biasing means for slidably engaging the first wall section, the body portion adapted to be slidably received within the first wall section and the biasing means having a portion separated from and overlapping the body portion to slidably engage the first wall section, wherein the biasing means includes a conical skirt extending obliquely outward from the body portion to be biased radially outward from the body portion while slidably engaging with the housing; and

an exit passageway for delivering the beneficial agent formulation from the internal compartment to the animal over a prolonged period of time, the improvement comprising headspace spaced away from the exit passageway for accumulating an air volume within the portion of the internal compartment containing the beneficial agent formulation at a location away from the exit passageway.

3. A delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device having:

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

a beneficial agent formulation in the internal compartment;

an expandable driver in the compartment for pushing the beneficial agent formulation from the delivery device; and

an exit passageway for delivering the beneficial agent formulation from the internal compartment to the animal over a prolonged period of time, the improvement comprising headspace for accumulating an air volume within the internal compartment, and further comprising a partition layer substantially impermeable to fluid between the beneficial agent formulation and the expandable means, wherein the partition layer includes a body portion and biasing means for slidably engaging the first wall section, the body portion adapted to be slidably received within the first wall section and the biasing means having a portion separated from and overlapping the body portion to slidably engage the first wall section, wherein the biasing means includes a conical skirt extending obliquely outward from the body portion to be biased radially outward from the body portion while slidably engaging with the housing, wherein the conical skirt separates from and overlaps the body portion while slidably engaging with the fluid impermeable portion.

4. A delivery device according to claim 3 wherein the fluid impermeable portion includes a first wall section and an end cap, the end cap comprising an inwardly extending portion, the inwardly extending portion and the first wall section defining the headspace, the headspace comprising an annular air receiving cavity therebetween.

5. A delivery device according to claim 4, further including means for maintaining a seal between the exterior environment and the interior compartment until the osmotic pressure within the device reaches a predetermined pressure of between greater than 5 and 10 psi.

6. A delivery device according to claim 4, wherein the end cap includes mating means for adapting the end cap to ultrasonic welding to the first wall section, the mating means positioned where the end cap and the first wall section join.

7. A delivery device as set forth in claim 6, wherein the 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 first wall section defining a mortise therein, the tenon sized and positioned for receipt within the mortise.

8. In a delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device having:

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

a beneficial agent formulation in the internal compartment;

an expandable driver in the compartment for pushing the beneficial agent formulation from the delivery device; and

an exit passageway for delivering the beneficial agent formulation from the internal compartment to the animal over a prolonged period of time, the improvement comprising headspace for accumulating an air volume within the internal compartment, wherein the fluid impermeable portion comprises a first wall section, and the fluid permeable portion comprises a second wall section, a portion of the second wall sized to be telescopically received within a portion of the first wall section the wall sections defining an adhesive receiving space containing an adhesive therebetween.

9. A delivery device according to claim 8, wherein the wall sections comprise means for abutting with the first wall section and smoothing the transition from the first wall section to the second wall section.

10. In a delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device having:

a housing comprising a fluid impermeable wall section and a fluid permeable portion forming an internal compartment;

a joint for joining the fluid impermeable portion to the fluid permeable portion;

a beneficial agent formulation in the internal compartment;

expandable driver in the compartment adjacent the fluid permeable portion for pushing the beneficial agent formulation from the delivery device; and

exit means in the fluid impermeable section for delivering the beneficial agent formulation from the delivery device to the animal over a prolonged period of time, the improvement comprising;

the fluid permeable portion and the fluid impermeable portion defining an adhesive receiving space containing an adhesive therebetween; and

a joint for joining the fluid impermeable portion to the fluid permeable portion, the joint providing a smooth transition from the fluid impermeable portion to the fluid permeable portion.

11. A delivery device according to claim 10, wherein the joint includes a buttress formed upon the fluid permeable portion and positioned to abut the fluid impermeable portion.

12. A delivery device according to claim 10 which further comprises a partition layer substantially impermeable to fluid between the beneficial agent formulation and the expandable means, wherein the partition layer includes a body portion and biasing means for slidably engaging the first wall section, the body portion sized to be slidably received within the first wall section and the biasing means having a portion separated from and overlapping the body portion to slidably engage the first wall section.

13. A delivery device according to claim 10 which further comprises a piston separating the beneficial agent from the expandable driving means, wherein the piston includes a conical skid extending distally, obliquely outwardly from a body portion to separate from and overlap the body portion while slidably engage with the first wall section.

14. A 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 first wall section, a second wall section, and an end cap, the first wall section, the second wall section and the end cap assembled together to form an internal compartment, wherein the first wall section and the end cap are substantially impermeable to the passage of fluid and, wherein the second wall section is permeable in at least a portion to the passage of fluid;

b) means for abutting the first wall section with the second wall section;

c) a beneficial agent formulation in a portion of the internal compartment comprised by the first wall section and the end cap;

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

e) a partition layer substantially impermeable to fluid, the partition layer between the beneficial agent formulation and the expandable means, wherein the partition layer includes a body portion and a conical skirt extending obliquely outward from the body portion to be biased radially outward from the body portion while slidably engaging the first wall section; and

f) exit means in the end cap for delivering the beneficial agent formulation from the delivery device to the animal.

15. A delivery device according to claim 14 wherein the end cap further comprises an inwardly extending portion, the inwardly extending portion and the first wall section defining a space therebetween.

16. A delivery device according to claim 14, wherein the end cap further includes mating means for adapting the end cap to ultrasonic welding to the first wall section, the mating means positioned where the end cap and the second wall section join.

17. A delivery device as set forth in claim 16, wherein the mating means includes a tenon extending outwards from the end cap, the second wall section defining a mortise therein, the tenon sized and positioned for receipt within the mortise.

18. A delivery device according to claim 14, wherein the means for abutting with the first wall section includes a buttress formed upon the second wall section and positioned to abut the first wall section.