Parenteral delivery system comprising a vial containing a beneficial agent

• US 4,915,689 A
• Filed: 02/24/1986
• Issued: 04/10/1990
• Est. Priority Date: 06/13/1984
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix
• Primary Examiner(s): Pal, Asok
• Application Number:
  US06/832,194
• Time in Patent Office: 1,506 Days
• Field of Search: 604/51, 604/52, 604/93, 604/82, 604/83, 604/84, 137/571, 137/3, 137/9
• US Class Current: 604/83
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: Y10T 137/0329 Mixing of plural fluids of diverse characteristics or conditions
• CPC Class Codes: Y10T 137/0363 For producing proportionate flow
• CPC Class Codes: Y10T 137/86187 Plural tanks or compartments connected for serial flow

Abstract

A parenteral delivery system for delivering a beneficial agent is disclosed. The delivery system comprises a reservoir containing a medical fluid, a vial containing a beneficial solid agent, and a manifold for establishing fluid communication between the reservoir and the vial.

Claims

1. A method for the administration of a beneficial agent to a warm-blooded animal which method comprises:

(a) admitting into the animal an agent delivery member in fluid communication with the parenteral delivery system, the delivery system comprising;

(1) a reservoir of a pharmaceutically acceptable medical fluid;

(2) a vial containing a pharmaceutically acceptable beneficial solid agent selected from the group consisting of dry, spray-dried and lyophilized beneficial agents that dissolve in the presence of an incoming medical fluid;

(3) a rigid manifold that provides fluid communication between the reservoir and the vial and which is capable of supporting at least one of the reservoir and the vial and comprises an internal conduit for conveying fluid therethrough;

(b) permitting fluid to flow from the reservoir through the manifold into the vial to form in the vial a medical solution containing beneficial agent; and

,

(c) administering the agent to the animal by letting the medical solution comprising the beneficial agent flow from the vial to the delivery member, thereby administering the agent to the animal.

2. A parenteral system for administering a beneficial agent to a recipient, the delivery system comprising:

(a) a reservoir of a pharmaceutically acceptable medical fluid;

(b) a vial containing a pharmaceutically acceptable beneficial solid agent, said agent a member selected from the group consisting of crystalline, particle, granule, powder, tablet and friable pharmaceutically acceptable forms that formulates a parenterally administrable solution with medical fluid that enters the vial; and

,

(c) a rigid manifold comprising (1) means for establishing fluid communication between the manifold and the reservoir;

(2) means for establishing fluid communication between the manifold and the vial; and

, (3) means for establishing fluid communication between the reservoir and the vial, and which manifold is capable of supporting the vial when the parenteral system is in operation administering the beneficial agent to a recipient.

3. The parenteral delivery system for administering the beneficial agent to a recipient according to claim 2, wherein the manifold comprises a filter.

4. The parenteral delivery system for administering the beneficial agent to a recipient according to claim 2, wherein the manifold comprises a valve for regulating the flow of fluid from the reservoir to the vial.

5. The parenteral delivery system for administering the beneficial agent to a recipient according to claim 2, wherein the agent is an intravenously administrable drug.

6. A method for the administration of a beneficial agent to a warm-blooded animal, which method comprises:

(a) admitting into the animal an agent delivery member in fluid communication with a primary path of the delivery system, the delivery system comprising;

(1) a reservoir of a pharmaceutically acceptable medical fluid;

(2) a vial comprising from 10 nanograms to 425 grams of a pharmaceutically acceptable beneficial solid agent selected from the group consisting of microcrystalline, pellet, compressed powder, comprises granule and pharmaceutically acceptable forms that disintegrate in the presence of medical fluid that enters the vial and form an agent formulation solution with said medical fluid;

(3) a primary fluid path; and

,

(4) a supportive manifold that provides internal fluid communication between the reservoir and the vial, and between the vial and the primary fluid path;

(b) permitting fluid to flow from the reservoir through the manifold into the vial to form in situ a medical solution containing beneficial agent; and

,

(c) administering the agent to the animal be letting the medical solution flow from the vial through the primary path to the delivery member, thereby administering the agent to the animal.

7. A parenteral delivery system for administering a beneficial drug to a recipient, the delivery system comprising:

(a) a reservoir of a pharmaceutically acceptable fluid;

(b) a vial comprising a pharmaceutically acceptable beneficial solid drug;

(c) a primary fluid path; and

,

(d) a manifold comprising (1) means for establishing fluid communication between the reservoir and the manifold;

(2) means for establishing fluid communication between the vial and the manifold;

(3) means for establishing fluid communication between the reservoir and the vial, and (4) means for establishing fluid communication between the vial, the manifold and the primary path, and which manifold is capable of supporting at least on of the reservoir and the vial when the parenteral delivery system is in operation formulating a parenterally administrable drug solution and administering the drug solution to a recipient.

8. The parenteral delivery system for administering the beneficial agent to a recipient according to claim 7, wherein the manifold comprises a valve for regulating the flow of fluid from the reservoir to the vial.

9. A method for the administration of a beneficial agent to a warm-blooded animal, which method comprises:

(a) admitting into the animal an agent delivery member in fluid communication with a common path f the delivery system, the delivery system comprising;

(1) a reservoir of a pharmaceutically acceptable medical fluid;

(2) a vial containing a pharmaceutically acceptable beneficial solid agent;

(3) a primary fluid path;

(4) a secondary fluid path;

(5) a rigid manifold that provides fluid communication between the reservoir and the vial, between the vial and the primary path and between the reservoir and the secondary path and is capable of supporting at least one of the reservoir and the vial during operation of the delivery system;

(6) a common path in the fluid communication with the primary path and the secondary path;

(b) permitting fluid to flow through the manifold from the reservoir into the vial to form in situ a medical solution containing beneficial agent;

(c) administering the agent by letting medical solution flow from the vial into the primary path and into the common path to the delivery member, thereby administering the beneficial agent to the recipient.

10. A parenteral delivery system for administering a beneficial agent to a recipient, the delivery system comprising:

(a) a reservoir of a pharmaceutically acceptable fluid;

(b) a vial containing a pharmaceutically acceptable beneficial solid agent;

(c) a primary fluid path;

(d) a secondary fluid path; and

,

(e) a rigid manifold comprising (1) means for establishing fluid communication between the reservoir and the manifold;

(2) means for establishing fluid communication between the vial and the manifold;

(3) means for establishing fluid communication between the reservoir and the vial;

(4) means for establishing fluid communication between the vial, the manifold, and the primary path; and

(5) means for establishing fluid communication between the reservoir, the manifold and the secondary path and which manifold is capable of supporting the reservoir and the vial during operation of the parenteral delivery system.

11. The parenteral delivery system for administering a beneficial agent to a recipient according to claim 10, wherein the manifold comprises a filter.

12. The parenteral delivery system for administering the beneficial agent to a recipient according to claim 10, wherein the manifold comprises a valve for regulating the flow of fluid from the reservoir to the vial.

13. The parenteral delivery system for administering the beneficial agent to a recipient according to claim 10, wherein the agent is an intravenously administrable drug.

14. A parenteral delivery system for administering a beneficial agent to a recipient, the delivery system comprising:

(a) a reservoir of a pharmaceutically acceptable fluid;

(b) a vial containing a pharmaceutically acceptable beneficial solid agent;

(c) a primary fluid path;

(d) a secondary fluid path;

(e) a rigid manifold comprising (1) means for establishing fluid communication between the reservoir and the manifold;

(2) means for establishing fluid communication between the vial and the manifold;

(3) means for establishing fluid communication between the reservoir and the vial;

(4) means for establishing fluid communication between the vial, the manifold, and the primary path; and

(5) means for establishing fluid communication between the reservoir, the manifold and the secondary path and which is capable of supporting at least one of the reservoir and the vial; and

,

(f) a common path in fluid communication with the primary path and in fluid communication with the secondary path.

15. A parenteral delivery system for forming a beneficial agent solution for administering to a recipient, wherein the delivery system comprises:

(a) a reservoir comprising a pharmaceutically acceptable fluid;

(b) a vial comprising a pharmaceutically acceptable agent;

(c) a rigid manifold for establishing fluid communication between the reservoir and the vial and which is capable of supporting at least one said reservoir and said vial, wherein the manifold comprises;

(1) an internal conduit for conveying fluid therethrough;

(2) means for connecting the reservoir to the manifold;

(3) means for connecting the vial to the manifold; and

,

(4) a valve for regulating fluid flow through the conduit; and

wherein when the delivery system is in operation the pharmaceutically acceptable fluid flows through the conduit into the vial for forming a parenterally administrable agent solution with the pharmaceutically acceptable agent.

16. A parenteral delivery system for administering a beneficial agent to a recipient, the delivery system comprising:

(a) a reservoir of a pharmaceutically acceptable medical fluid;

(b) a vial containing a pharmaceutically acceptable beneficial solid agent that dissolves in the presence of incoming medical fluid and forms a medical solution comprising the beneficial agent; and

,

(c) a rigid manifold comprising (1) means for establishing fluid communication between the manifold and the reservoir;

(2) means for establishing fluid communication between the manifold and the vial;

(3) means for establishing fluid communication between the reservoir and the vial;

(4) a valve for regulating fluidn flow; and

which manifold is capable of supporting the reservoir and the vial when the parenteral system is in operation administering the beneficial agent to a recipient.