USE OF A CONTAINER OF AN INORGANIC ADDITIVE CONTAINING PLASTIC MATERIAL
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.
1 - 12 . (canceled)
13 . A method for reducing physical/chemical interaction between a plastic container and a lipophilic testosterone gel formulation, comprising:
(a) adding an inorganic additive to a plastic material during manufacture; and
(b) exposing the plastic container to the formulation;
wherein the lipophilic testosterone gel formulation comprises testosterone and at least one oil, fat, wax, lipophilic or partially lipophilic carrier; and a compound or a mixture of compounds having surface tension decreasing activity, in an amount effective for in situ generation of an emulsion upon contact of the formulation with water; and
wherein the lipophilic testosterone gel formulation is used for mammalian nasal application.
14 . The method according to claim 13 wherein the physical/chemical interaction is an adsorption of the formulation to the plastic material.
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 material in an amount between about 0.1 and about 10% by weight based on the weight of the plastic material.
18 . The method according to claim 13 , wherein the plastic material comprises polyolefin.
19 . The method according to claim 18 , wherein the polyolefin is selected from the group of polyethylene, polypropylene, copolymers of ethylene and propylene, or a mixture thereof.
20 . The method according to claim 19 , wherein the plastic material comprises low density polyethylene (LDPE).
21 . The method according to claim 13 , wherein the plastic material is suitable for extrusion blow molding.
22 . The method according to claim 13 , wherein the additive is present in the plastic material in an amount 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 material in an amount of about 2% by weight based on the weight of the plastic material.
24 . The method of claim 13 , wherein the plastic container extends the shelf life and stability of the formulation for a period of time longer than that of a plastic container without the addition of the inorganic additive.
25 . A method for reducing physical or chemical interaction between a plastic container and a lipophilic testosterone gel formulation, comprising:
(a) adding to a plastic material comprising polyolefin titanium dioxide (TiO2) 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 formulation comprises (i) at least one steroid hormone dissolved or suspended in an oil, fat, wax, lipophilic or partially lipophilic carrier, and (ii) a compound or a mixture of compounds having surface tension decreasing activity, in an amount effective for in situ generation of an emulsion upon contact of the formulation with water;
wherein the formulation is used for mammalian nasal application; and
wherein the plastic container extends the shelf life and stability of the formulation for a period of time longer than that of a plastic container without the addition of titanium dioxide (TiO2).
26 . The method according to claim 25 , wherein the polyolefin is selected from the group of polyethylene, polypropylene, copolymers of ethylene and 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 (TiO2) is surface-treated titanium dioxide.
30 . The method according to claim 25 , wherein the titanium dioxide (TiO2) 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 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.