USE OF A CONTAINER OF AN INORGANIC ADDITIVE CONTAINING PLASTIC MATERIAL

1 .- 12 . (canceled)

13 . A method for reducing physical/chemical interaction between a container manufactured with a plastic and a lipophilic testosterone nasal gel formulation, comprising the step of:

exposing the container to the lipophilic testosterone nasal gel formulation;

wherein the plastic comprises an inorganic additive;

wherein the lipophilic testosterone nasal gel 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; and

wherein the lipophilic testosterone gel formulation is used for mammalian nasal application, whereby the physical/chemical interaction between the container and the lipophilic testosterone gel formulation are reduced following said exposure.

14 . The method according to claim 13 wherein the physical/chemical interaction is an adsorption of the formulation to the plastic.

15 . The method according to claim 13 , wherein the inorganic additive is at least a pigment.

16 . The method according to claim 15 , wherein said pigment is selected from the group consisting of titanium dioxide (TiO 2 ), surface-treated titanium dioxide, or a mixture thereof.

17 . The method according to claim 13 , wherein the additive is present in the plastic in an amount of between about 0.1 and about 10% by weight based on the weight of the plastic.

18 . The method according to claim 13 , wherein the plastic comprises polyolefin.

19 . The method according to claim 18 , wherein the polyolefin is selected from the group of polyolefins consisting of polyethylene, polypropylene, copolymers of ethylene, propylene and mixtures thereof.

20 . The method according to claim 19 , wherein the plastic comprises low density polyethylene (LDPE).

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

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

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

24 . The method of claim 13 , wherein the container extends the shelf life and stability of the lipophilic testosterone gel formulation for a period of time longer than that of a container without the inorganic additive.

25 . A method for reducing physical or chemical interaction between a plastic container and a lipophilic testosterone nasal gel formulation, comprising the steps of:

(a) adding to a plastic material comprising polyolefin titanium dioxide (TiO 2 ) in an amount between about 0.1 and about 10% by weight, based on the weight of the plastic material; and

(b) exposing the plastic container to the formulation;

wherein the lipophilic testosterone nasal gel formulation comprises (i) at least one steroid hormone dissolved or suspended in a lipophilic or partially lipophilic carrier, and (ii) a compound or a mixture of compounds having surface tension decreasing activity;

wherein the formulation is used for mammalian nasal application; and

wherein the plastic container extends the shelf life and stability of the lipophilic testosterone nasal gel formulation for a period of time longer than that of a plastic container without the addition of titanium dioxide (TiO 2 ).

26 . The method according to claim 25 , wherein the polyolefin is selected from the group of polyoelfins consisting of polyethylene, polypropylene, copolymers of ethylene, propylene and mixtures thereof.

27 . The method according to 25 , wherein the plastic material comprises low density polyethylene (LDPE).

28 . The method according to claim 25 , wherein the plastic material is suitable for extrusion blow molding.

29 . The method according to claim 25 , wherein the titanium dioxide (TiO 2 ) is surface-treated titanium dioxide.

30 . The method according to claim 25 , wherein the titanium dioxide (TiO 2 ) is mixed with surface-treated titanium dioxide.

31 . The method according to claim 25 , wherein the titanium dioxide (TiO2) 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.

32 . The method according to claim 25 , wherein the titanium dioxide (TiO2) is present in the plastic material in an amount of about 2% by weight based on the weight of the plastic material.

33 . The method according to claim 25 , wherein the amount of the testosterone remaining in the lipophilic testosterone nasal gel formulation after long-term storage is about 100%, wherein the percentage of the remaining drug is determined by high performance liquid chromatography (HPLC) technique.

34 . A method for reducing adsorption of a lipophilic testosterone nasal gel formulation into a plastic material used to manufacture a plastic container, comprising the steps of:

storing the lipophilic testosterone gel formulation in the plastic container manufactured with the plastic material to reduce adsorption of a lipophilic testosterone nasal gel formulation into the plastic material used to manufacture a plastic container;

wherein the plastic material comprises polyolefin titanium dioxide (TiO2) in an amount of between about 0.1 and about 10% by weight, based on the weight of the plastic material;

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

wherein the lipophilic testosterone nasal gel formulation is applied nasally to a mammalian; and

wherein the plastic container extends the shelf life and stability of the lipophilic testosterone nasal gel formulation for a period of time longer than that of a plastic container without the addition of titanium dioxide (TiO 2 ).