Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
AssigneeCorning Incorporated
InventorsWendell P. Weeks, Robert Anthony Schaut, Steven Edward DeMartino, John Stephen Peanasky
Life of this patent
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Abstract
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, LEVEMIR, NOVOLOG, NOVOLIN 70-30, NOVOLIN R, NOVOLIN N, NOVOLOG MIX 70-30 and NOVOLIN L.
Claims21
A pharmaceutical composition comprising:
- an active pharmaceutical ingredient selected from the group consisting of human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart, and lente insulin;
- 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.
A method of enhancing the stability, product integrity, or efficacy of a pharmaceutical composition comprising an active pharmaceutical ingredient selected from the group consisting of human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart, and lente insulin, wherein the method comprises containing the pharmaceutical composition in a delamination resistant glass container.
Dependencies are inferred from the claim text.