Solid drug storage apparatus, formulations and methods of use

Patent metadata

Field	Value
Publication number	US-10485765-B2
Application number	US-201816226062-A
Country	US
Kind code	B2
Filing date	Dec 19, 2018
Priority date	Dec 31, 2015
Publication date	Nov 26, 2019
Grant date	Nov 26, 2019

Abstract

Embodiments of the invention provide drug packaging and methods for producing drug packaging which can be sealed at room temperature and/or without the need for elevated temperatures above room temperature. Many embodiments provide drug packaging comprising pierceable tubing having a capsule shape (also referred to herein as a pierceable capsule and/or pierceable drug capsule) containing a solid drug such as a drug pellet and methods for producing pierceable drug capsules which can be sealed at room temperature. Embodiments are particularly useful for the packaging and delivery of drugs used in implantable drug delivery devices as well as packaging of drugs that are easily thermally degraded.

First claim

What is claimed is:

1. A method for fabricating a packaging for medication, the method comprising:
sliding a first larger diameter tube over a first open end of a second smaller diameter tube, the first larger diameter tube having a covered end and an open opposite end, the second smaller diameter tube having an enlarged covered end opposite the first open end, each tube having (i) a lumen, the lumen of either the first larger diameter tube or the second smaller diameter tube including a dose of medication, and (ii) a covering over their respective covered ends comprising a pierceable material, the pierceable material forming a bond with at least one of the covered end or the enlarged covered end during a bonding process, wherein the bonding process utilizes a compliant material in conjunction with a compressive force to create the bond; and
advancing the first larger diameter tube over the enlarged covered end of the second smaller diameter tube to join and create a hermetic seal between the first larger diameter tube and the second smaller diameter tube by an interference fit between the tubes, wherein the hermetic seal is created by the interference fit alone without a need for elevated temperature to form the hermetic seal.

2. The method of claim 1 , wherein the dose of medication is accessible or removable by piercing at least one of the covered end or the enlarged covered end.

3. The method of claim 1 , wherein the dose of medication comprises a therapeutic agent which loses bioactivity when exposed to an elevated temperature.

4. The method of claim 3 , wherein at least 90% of the bioactivity of the therapeutic agent is preserved.

5. The method of claim 1 , wherein the dose of medication comprises a therapeutic agent for treating epilepsy.

6. The method of claim 5 , wherein the therapeutic agent comprises furosemide.

7. The method of claim 1 , wherein the pierceable material comprises a metal foil.

8. The method of claim 7 , wherein the metal foil comprises gold, platinum, titanium, tantalum or stainless steel.

9. The method of claim 1 , wherein the pierceable material comprises a polymeric material.

10. The method of claim 9 , wherein the polymeric material comprises polyimide, polyamides or polyethylene teraphalate.

11. The method of claim 1 , wherein the compliant material comprises a graphite gasket.

12. A hermetically sealed packaging for a medication dose comprising a therapeutic agent, the packaging comprising:
a first larger diameter tube having a covered end and an open opposite end;
a second smaller diameter tube having a first open end and an enlarged covered end opposite the first open end;
wherein each tube includes (i) a lumen, the lumen of either the first larger diameter tube or the second smaller diameter tube including the medication dose, and (ii) a covering over their respective covered ends comprising a pierceable material, the pierceable material forming a compressive bond with at least one of the covered end or the enlarged covered end during a bonding process; and
wherein the first larger diameter tube and the second smaller diameter tube are joined to form a hermetic seal between the first larger diameter tube and the second smaller diameter tube by an interference fit between the tubes, the hermetic seal being created by the interference fit alone without a need for elevated temperature to form the hermetic seal.

13. The packaging of claim 12 , wherein the medication dose is accessible or removable by piercing at least one of the covered end or the enlarged covered end.

14. The packaging of claim 12 , wherein the therapeutic agent loses bioactivity when exposed to an elevated temperature.

15. The packaging of claim 14 , wherein at least 90% of the bioactivity of the therapeutic agent is preserved.

16. The packaging of claim 12 , wherein the medication dose comprises a therapeutic agent for treating epilepsy.

17. The packaging of claim 16 , wherein the therapeutic agent comprises furosemide.

18. The packaging of claim 12 , wherein the pierceable material comprises a metal foil.

19. The packaging of claim 12 , wherein the pierceable material comprises a polymeric material.

20. The packaging of claim 12 , wherein the bonding process utilizes a compliant material in conjunction with a compressive force to create the compressive bond.

21. The packaging of claim 20 , wherein the compliant material comprises a graphite gasket.

Assignees

• Incube Labs Llc

Inventors

• Fischer Elmar
• Spehr Paul

Classifications

• A61K9/48 Primary

  Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} · CPC title

• B65D59/04

  Sleeves, e.g. postal tubes · CPC title

• A61K31/635 Primary

  having a heterocyclic ring, e.g. sulfadiazine · CPC title

• B65B5/04

  Packaging single articles · CPC title

• B65B1/04

  Methods of, or means for, filling the material into the containers or receptacles · CPC title