Abstract

CHARACTERISATION OF SPECIFIC POTENTIAL DEGRADATION PRODUCT DUE TO INTERACTION OF LEACHABLE FROM PRODUCT LABEL IN CONTAINER CLOSURE SYSTEM OF OPHTHALMIC DRUG PRODUCT CONTAINING BRIMONIDINE TARTRATE

Dr. Sandeep Zokande*, Dr. Kavita Inamdar and Amit Kale

ABSTRACT

Extractable and leachable studies for semipermeable containers are carried out using various polar and non-polar solvents. If extractables are above AET; those are probable leachable and need to be estimated using end products till end of the shelf life. This study demonstrates that; leachable from label can migrate in the drug product packed in semipermeable container closure system and reacts with the product component. Brimonidine tartrate and timolol maleate ophthalmic solution as a drug product is selected in this study. Acrylic acid used in the composition of adhesive of label and also present in printing inks and varnish; hence, acrylic acid is selected as a slow migrant in this study. The reaction of acrylic acid with brimonidine tartrate is confirmed using placebo i.e. a mixture of all components except brimonidine tartrate with acrylic acid. The reaction is conducted with the aim of formation of potential degradation product due to slow migration of acrylic acid from secondary packaging material i.e. product label in container closure system. The product related impurities are ruled out through forced degradation, stress study and stability study of drug product. The degradation product generated due to reaction between acrylic acid and brimonidine tartrate is identified and characterized. The intention of this study is to demonstrate the possibility of interaction between slow migrant / leachable in component of ophthalmic drug product packed semi permeable containers which may be a safety concern.

Keywords: Extractables, Leachable, Container closure system, Impurity, Migration.