IP Library Granted Patent US 8,609,043
Granted Patent B2
US 8,609,043 · App. 13/567,878 · Granted Dec 17, 2013

Use of a container of an inorganic additive containing plastic material

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Quick Facts
Patent No.
US 8,609,043
App. No.
13/567,878
Granted
Dec 17, 2013
Kind
B2
Abstract

The present invention relates to the use of a container, made of an inorganic additive containing plastic material, for reducing physical/chemical interaction between the container and an oil, fat and/or wax containing formulation contained therein.

Claims (29)

1. A method for reducing physical or chemical interactions between a nasal testosterone formulation and a plastic container comprising:

providing the nasal testosterone formulation in the container, wherein the container is made of a plastic material that comprises an inorganic additive;

wherein the nasal testosterone formulation comprises (i) testosterone, (ii) a lipophilic or partially lipophilic carrier, and (iii) a compound or a mixture of compounds having surface tension decreasing activity.

2. The method according to claim 1 wherein the method reduces adsorption of the formulation to the plastic material.

3. The method according to claim 1 , wherein the inorganic additive comprises a pigment.

4. The method according to claim 3 , wherein the pigment is selected from the group consisting of titanium dioxide (TiO 2 ), surface-treated titanium dioxide, and mixtures thereof.

5. The method according to claim 1 , wherein the inorganic additive is present in the plastic material in an amount between about 0.1 and about 10% by weight based on the weight of the plastic material.

6. The method according to claim 1 , wherein the plastic material comprises polyolefin.

7. The method according to claim 6 , wherein the polyolefin is selected from the group consisting of polyethylene, polypropylene, copolymers of ethylene and propylene, and mixtures thereof.

8. The method according to claim 7 , wherein the plastic material comprises low density polyethylene (LDPE).

9. The method according to claim 1 , wherein the plastic material is suitable for extrusion blow molding.

10. The method according to claim 1 , wherein the inorganic additive is present in the plastic material in an amount of between about 0.1% to about 5% by weight based on the weight of the plastic material.

11. The method according to claim 1 , wherein the inorganic additive is present in the plastic material in an amount of about 2% by weight based on the weight of the plastic material.

12. The method of claim 1 , wherein the method extends the shelf life and stability of the nasal testosterone gel formulation for a period of time longer than that of a method wherein the formulation is provided in a plastic container that does not comprise the inorganic additive.

13. A method for reducing physical or chemical interactions between a nasal testosterone formulation and a plastic container comprising:

providing the nasal testosterone formulation in the container, wherein the container is made of a plastic material that comprises polyolefin and titanium dioxide, wherein the titanium dioxide is present in the plastic material in an amount between about 0.1 and about 10% by weight, based on the weight of the plastic material;

wherein the nasal testosterone formulation comprises (i) testosterone dissolved or suspended in a lipophilic or partially lipophilic carrier, and (ii) a compound or a mixture of compounds having surface tension decreasing activity.

14. The method according to claim 13 , wherein the polyolefin is selected from the group consisting of polyethylene, polypropylene, copolymers of ethylene and propylene, and mixtures thereof.

15. The method according to claim 13 , wherein the plastic material comprises low density polyethylene (LDPE).

16. The method according to claim 13 , wherein the plastic material is suitable for extrusion blow molding.

17. The method according to claim 13 , wherein the titanium dioxide is surface-treated titanium dioxide.

18. The method according to claim 13 , wherein the titanium dioxide comprises titanium dioxide mixed with surface-treated titanium dioxide.

19. The method according to claim 13 , wherein the titanium dioxide is present in the plastic material in an amount of between about 0.1% to about 5% by weight based on the weight of the plastic material.

20. The method according to claim 13 , wherein the titanium dioxide is present in the plastic material in an amount of about 2% by weight based on the weight of the plastic material.

21. The method according to claim 13 , wherein about 100% of the testosterone in the nasal testosterone formulation remains after 22 hours of storage in the container, as determined by high performance liquid chromatography (HPLC) technique.

22. A method for reducing adsorption of a nasal testosterone formulation onto a plastic container, comprising:

storing the nasal testosterone formulation in the plastic container

wherein the plastic container comprises a plastic material comprising polyolefin and titanium dioxide, wherein the titanium dioxide is present in an amount of between about 0.1 and about 10% by weight, based on the weight of the plastic material;

wherein the nasal testosterone formulation comprises (i) testosterone; (ii) a lipophilic or partially lipophilic carrier, and (ii) a surfactant having surface tension decreasing activity.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Oct 9, 2018
From: MIDCAP FUNDING V TRUST
To: ACERUS PHARMACEUTICALS SRL
Reel/Frame 047207/0254 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 20, 2017
From: MATTERN PHARMA AG
To: M ET P PHARMA AG
Reel/Frame 041645/0897 →
CORRECTIVE ASSIGNMENT TO CORRECT THE TO CORRECT THE ASSIGNOR FROM M & P PATNT AKTIENGESELLSCHAFT TO M & P PATENT AKTIENGESELLSCHAFT PREVIOUSLY RECORDED ON REEL 032291 FRAME 0349. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER EFFECTIVE 02/04/2014. Recorded Mar 10, 2014
From: M & P PATENT AKTIENGESELLSCHAFT
To: MATTERN PHARMA AG
Reel/Frame 032422/0169 →
MERGER Recorded Feb 25, 2014
From: M & P PATNT AKTIENGESELLSCHAFT
To: MATTERN PHARMA AG
Reel/Frame 032291/0349 →