Microprojection array having a beneficial agent containing coating

• US 7,963,935 B2
• Filed: 04/20/2002
• Issued: 06/21/2011
• Est. Priority Date: 04/20/2001
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Daddona, Peter E., Young, Wendy A., Johnson, Juanita A., Cormier, Michel J. N.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Campbell; Victoria P
• Application Number:
  US10/127,108
• Publication Number:
  US 20020177839A1
• Time in Patent Office: 3,349 Days
• Field of Search: 604/46, 604/116, 604/171, 424422-424, 427/2.1
• US Class Current: 604/46
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 5/10 of the posterior pituitary hormones, e.g. oxytocin, ADH

Abstract

The device including a plurality of stratum corneum-piercing microprojections, and a solid coating disposed upon the microprojections, wherein the solid coating includes at least one beneficial agent and a biocompatible carrier is provided. The device is applied to the skin of a living animal (e.g., a human), causing the microprojections to pierce the stratum corneum and deliver an effective dose of the agent to the animal.

Claims

1. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed as a homogenous, amorphous glassy form upon at least a portion of said microprojections,

wherein the coating is substantially dried and includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said agent is dissolved or suspended in said carrier,

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum, and wherein said at least one water soluble biocompatible carrier comprises human albumin.

2. The device of claim 1, wherein said human albumin is bio-engineered human albumin.

3. The device of claim 1, wherein the at least one beneficial agent is suspended in the at least one water soluble biocompatible carrier.

4. The device of claim 1, wherein the at least one beneficial agent is selected from the group consisting of vaccines and desensitizing agents.

5. The device of claim 1, wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.2:

1 to about 5;

1 weight/weight.

6. The device of claim 1, wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.5:

1 to about 2;

1 weight/weight.

7. The device of claim 1, wherein the coating includes a plurality of beneficial agents.

8. The device of claim 1, wherein each of the at least one beneficial agents are included on coatings which are on separate portions of the plurality of microprojections.

9. The device of claim 1, wherein the at least one biocompatible carrier further includes at least one carrier selected from the group consisting of sucrose, trehalose, melezitose, raffinose, and stachyose.

10. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed as a homogeneous, amorphous glassy form upon at least a portion of said microprojections;

wherein the coating is substantially dried and includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said agent is dissolved or suspended in said carrier,

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum, and

wherein the at least one water soluble biocompatible carrier is selected from the group consisting of dextran sulfate, pentosan polysulfate, polyglutamic acid, polyaspartic acid, polyhistidine, and non-reducing sugars.

11. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed as a homogeneous, amorphous glassy form upon at least a portion of said microprojections;

wherein the coating is substantially dried and includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said agent is dissolved or suspended in said carrier,

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum, and

wherein the at least one water soluble biocompatible carrier is a polyamino acid.