Glasses and glass products suitable for pharmaceutical packaging are provided and methods of making and using such glass and glass products are provided. The glasses combine chemical temperability with very good hydrolytic resistance as well as reduced color tinge. The invention also includes methods for the production of such glasses and their uses.

A method for producing a glass article having high hydrolytic resistance is provided. A glass tube consisting of borosilicate glass and having an Al.sub.2O.sub.3 content of less than 1 weight-%, a ZrO.sub.2 content of 2-12 weight-%, and a glass transition temperature T.sub.g is reshaped into a glass article and is subsequently subjected to a thermal post-treatment. To reduce the alkali release of the glass article, the glass article is subjected to a treatment temperature of T.sub.B≥T.sub.g+5° K over a treatment time of t.sub.B≥5 min and is subsequently cooled during the thermal post-treatment.

A method for producing a glass article having high hydrolytic resistance is provided. A glass tube consisting of borosilicate glass and having an Al.sub.2O.sub.3 content of less than 1 weight-%, a ZrO.sub.2 content of 2-12 weight-%, and a glass transition temperature T.sub.g is reshaped into a glass article and is subsequently subjected to a thermal post-treatment. To reduce the alkali release of the glass article, the glass article is subjected to a treatment temperature of T.sub.B≥T.sub.g+5° K over a treatment time of t.sub.B≥5 min and is subsequently cooled during the thermal post-treatment.

According to one embodiment, a glass composition may include from 67 mol. % to about 75 mol. % SiO.sub.2; from about 6 mol. % to about 10 mol. % Al.sub.2O.sub.3; and from about 5 mol. % to about 12 mol. % alkali oxide. The alkali oxide may include K.sub.2O in an amount less than or equal to 0.5 mol. %. The glass composition may further include from about 9 mol. % to about 15 mol. % of alkaline earth oxide. The alkaline earth oxide may include greater than about 0 mol. % and less than or equal to 3 mol. % MgO, from 2 mol. % to about 7 mol % CaO, at least one of SrO and BaO. The glass composition may further include less than 1 mol. % B.sub.2O.sub.3. A ratio of a concentration of MgO to the sum of the concentration of divalent cations (MgO:ΣRO) may be less than 0.3.

According to one embodiment, a glass composition may include from 67 mol. % to about 75 mol. % SiO.sub.2; from about 6 mol. % to about 10 mol. % Al.sub.2O.sub.3; and from about 5 mol. % to about 12 mol. % alkali oxide. The alkali oxide may include K.sub.2O in an amount less than or equal to 0.5 mol. %. The glass composition may further include from about 9 mol. % to about 15 mol. % of alkaline earth oxide. The alkaline earth oxide may include greater than about 0 mol. % and less than or equal to 3 mol. % MgO, from 2 mol. % to about 7 mol % CaO, at least one of SrO and BaO. The glass composition may further include less than 1 mol. % B.sub.2O.sub.3. A ratio of a concentration of MgO to the sum of the concentration of divalent cations (MgO:ΣRO) may be less than 0.3.

The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, daclizumab (ZENAPAX®).

The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, daclizumab (ZENAPAX®).

The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, Prolia® (denosumab), Xgeva® (denosumab), Aranesp® (darbepoetin alfa), AMG-145, romosozumab (AMG-785), ganitumab (AMG-479), trebananib (AMG-386), brodalumab (AMG-827), and rilotumumab (AMG-102).

The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, Prolia® (denosumab), Xgeva® (denosumab), Aranesp® (darbepoetin alfa), AMG-145, romosozumab (AMG-785), ganitumab (AMG-479), trebananib (AMG-386), brodalumab (AMG-827), and rilotumumab (AMG-102).

A pharmaceutical packaging is provided including a glass, comprising at least the following components (given in mol % on oxide basis): SiO.sub.2:59-84, Al.sub.2O.sub.3:7-18.5, CaO:1-25, SrO:0-6.5, BaO:0-5, ZrO.sub.2:0-3, TiO.sub.2:0-5, B.sub.2O.sub.3:0-1, wherein the ratio (CaO+SrO+BaO)/Al.sub.2O.sub.3<2.8, wherein the ratio (CaO+SrO+BaO)/SiO.sub.2≦0.39, wherein the hydrolytic resistance according to DIN ISO 720 is class HGA 1, and wherein the glass, apart from unavoidable contaminations, is free of alkali oxides and magnesium oxides.