Use of a container of an inorganic additive containing plastic material

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.

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 ).