DELAMINATION RESISTANT PHARMACEUTICAL GLASS CONTAINERS CONTAINING ACTIVE PHARMACEUTICAL INGREDIENTS

摘要

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, NEUPOGEN (filgrastim), NEULASTA (pegfilgrastim), EPOGEN (epoetin alfa) or ENBREL (etanercept).

主权项

1. A pharmaceutical composition comprising:
an active pharmaceutical ingredient selected from the group consisting of filgrastim, pegfilgrastim, epoetin alfa, etanercept, recombinant human granulocyte-colony stimulating factor or an analog thereof, PEGylated recombinant human granulocyte-colony stimulating factor or an analog thereof, an erythropoiesis-stimulating glycoprotein, and a fusion protein of TNF Receptor 2 and IgG1; and a pharmaceutically acceptable excipient; wherein the pharmaceutical composition is contained within a delamination resistant glass container such that the pharmaceutical composition has increased stability, product integrity, or efficacy.