Systems and methods for increasing stability of dronabinol compositions

Patent metadata

Field	Value
Publication number	US-10624859-B2
Application number	US-201314416202-A
Country	US
Kind code	B2
Filing date	Aug 20, 2013
Priority date	Aug 20, 2012
Publication date	Apr 21, 2020
Grant date	Apr 21, 2020

Abstract

Disclosed in certain embodiments is a system and method of providing a dronabinol oral solid dosage form with increased stability.

First claim

What is claimed:

1. A packaging system comprising a plastic or glass container housing:
(i) at least one soft gelatin capsule comprising dronabinol and an oxygen scavenger; and
(ii) a separate iron-based oxygen scavenger that does not comprise silicon,
wherein the system provides not more than 0.3% by weight of degradant×(Relative Retention Time 0.85) of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity.

2. The packaging system of claim 1 , wherein the separate iron-based oxygen scavenger is contained in a canister or packet.

3. The packaging system of claim 1 , wherein the separate iron-based oxygen scavenger is incorporated into integral components of the container.

4. A method of packaging a dronabinol oral solid dosage form comprising placing into a plastic or glass container:
(i) at least one soft gelatin capsule comprising dronabinol and an oxygen scavenger; and
(ii) a separate iron-based oxygen scavenger that does not comprise silicon,
wherein the system provides not more than 0.3% by weight of degradant×(Relative Retention Time 0.85) of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity.

5. The method of claim 4 , wherein the separate iron-based oxygen scavenger is contained in a canister or packet.

6. The method of claim 4 , wherein the separate iron-based oxygen scavenger is incorporated into integral components of the container.

7. The method of claim 4 , wherein the oxygen scavenger in the at least one soft gelatin capsule is selected from the group consisting of organic-based scavengers, non-organic-based scavengers, polymer-based scavengers, enzyme-based scavengers and mixtures thereof.

8. A method of increasing stability of a dronabinol oral solid dosage form comprising placing in a plastic or glass container:
(i) at least one soft gelatin capsule comprising dronabinol and an oxygen scavenger; and
(ii) a separate iron-based oxygen scavenger that does not comprise silicon,
wherein the system provides not more than 0.3% by weight of degradant×(Relative Retention Time 0.85) of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity.

9. The method of claim 8 , wherein the separate iron-based oxygen scavenger is contained in a canister or packet.

10. The method of claim 8 , wherein the separate iron-based oxygen scavenger is incorporated into integral components of the container.

11. The packaging system of claim 1 , wherein the packaging system provides stability of the at least one soft gelatin capsule at room temperature for a time period of at least three months.

12. The packaging system of claim 1 , wherein the system provides less than 0.5% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity.

13. The packaging system of claim 1 , wherein the system provides less than 0.35% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 25° C. and 60% relative humidity.

14. The packaging system of claim 1 , wherein the system provides less than 0.2% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 25° C. and 60% relative humidity.

15. The packaging system of claim 1 , wherein the at least one soft gelatin capsule comprises trans-(−)-Δ 9 -tetrahydrocannabinol.

16. The packaging system of claim 15 , wherein the at least one soft gelatin capsule comprises at least 98% by weight trans-(−)-Δ 9 -tetrahydrocannabinol.

17. The packaging system of claim 1 , wherein the system provides less than 1.0% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity.

18. The packaging system of claim 1 , wherein the oxygen scavenger in the at least one soft gelatin capsule comprises sesame oil.

Assignees

• Rhodes Tech

Inventors

• Kupper Robert J

Classifications

• A61K31/353

  3,4-Dihydrobenzopyrans, e.g. chroman, catechin · CPC title

• C07D311/80

  Dibenzopyrans; Hydrogenated dibenzopyrans · CPC title

• A61K9/48 Primary

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

• A61K31/352 Primary

  condensed with carbocyclic rings, e.g. methantheline  {(cannabinoids A61K31/658)} · CPC title