Solid drug formulation and device for storage and controlled delivery thereof

• US 20100119604A1
• Filed: 11/05/2009
• Published: 05/13/2010
• Est. Priority Date: 04/25/2003
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Uhland, Scott A., Prescott, James H., Staples, Mark A., Santini, John T. JR.
• Application Number:
  US12/612,828
• Publication Number:
  US 20100119604A1
• Time in Patent Office: Days
• US Class Current: 424/484
• CPC Class Codes: A61K 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02

Abstract

Devices and methods are provided for the storage and controlled release of a solid form of a drug. The device comprises a body portion; one or more reservoirs located in and defined by the body portion; a solid matrix which comprises a drug and which is contained in each of the one or more reservoirs; and one or more excipient materials dispersed throughout pores or interstices within the solid matrix and substantially filling any space not otherwise occupied by the solid matrix within each of the one or more reservoirs, wherein the excipient material enhances stability of the drug while stored in the one or more reservoirs or enhances release of the drug from each reservoir. In an alternative embodiment, the device provides for the storage and controlled exposure of a chemical sensor material.

Claims

1. A device for the storage and controlled release of a solid form of a drug comprising:

a body portion;

one or more reservoirs located in and defined by the body portion;

a solid matrix which comprises a drug and which is contained in each of the one or more reservoirs; and

one or more excipient materials dispersed throughout pores or interstices within the solid matrix and substantially filling the space not otherwise occupied by the solid matrix within each of the one or more reservoirs, wherein the excipient material enhances stability of the drug while stored in the one or more reservoirs or enhances release of the drug from each reservoir.

2. The device of claim 1, wherein at least one of the one or more excipient materials is solid at ambient conditions.

3. The device of claim 1, wherein at least one of the one or more excipient materials is liquid at ambient conditions.

4. The device of claim 1, wherein at least one of the one or more excipient materials is a semi-solid or gel at ambient conditions.

5. The device of claim 1, wherein the one or more excipient materials are non-aqueous. 25

6. The device of claim 1, wherein at least one of the one or more excipient materials comprises a polymer.

7. The device of claim 6, wherein the polymer comprises polyethylene glycol.

8. The device of claim 7, wherein the polyethylene glycol has a molecular weight between about 100 and 10,000 Da.

9. The device of claim 1, wherein at least one of the one or more excipient materials comprises a perhalohydrocarbon or unsubstituted saturated hydrocarbon.

10. A method for making a device for the storage and controlled release of a solid form of a drug comprising:

providing a drug in dry, porous matrix form; and

combining with the drug matrix at least one excipient material which substantially fills the pores and interstices within the matrix to form a drug/excipient composite,

wherein the drug/excipient composite, alone or in combination with another excipient material, substantially fills each of one or more reservoirs located in a body portion of a device for the storage and controlled release of the drug.

11. The method of claim 10, wherein the dry, porous matrix form of the drug is first provided in the one or more reservoirs and then fluidized excipient material is added to the one or more reservoirs.

12. The method of claim 10, wherein the dry, porous matrix form of the drug is formed by a method comprising:

dissolving or dispersing a drug in a volatile liquid medium to form a first fluid;

depositing a quantity of the first fluid into each of one or more reservoirs; and

drying the quantity by volatilizing the volatile liquid medium to produce the dry, porous matrix of the drug in the one or more reservoirs.

13. The method of claim 10, wherein the at least one excipient material is in a molten state when combined with the drug matrix.

14. The method of claim 10, wherein the dry porous matrix form of the drug and the at least one excipient material first are combined together outside of the one or more reservoirs to form a drug/excipient composite and then the drug/excipient composite is loaded into the one or more reservoirs.

15. The method of claim 14, wherein the drug/excipient composite is solidified into a pre-form before being loaded into the one or more reservoirs, each pre-form being shaped to fit into and substantially fill one of the one or more reservoirs.

16. The method of claim 14, wherein the drug/excipient composite is melt-extruded into the reservoirs.

17. The method of claim 11, further comprising solidifying the fluidized excipient material.

18. The method of claim 10, wherein the excipient material comprises a saturated solution of the drug.

19. A pharmaceutical composition comprising:

a solid matrix which comprises a drug; and

one or more excipient materials dispersed throughout pores or interstices within the solid matrix, wherein the excipient material enhances stability of the drug while stored and subsequent dissolution upon administration.

20. The composition of claim 19, wherein the composition is in the form of a plurality of discrete pellets.