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1. (WO2018051312) IN-LINE FILTER FOR PROTEIN/PEPTIDE DRUG ADMINISTRATION

Pub. No.:    WO/2018/051312    International Application No.:    PCT/IB2017/055656
Publication Date: Fri Mar 23 00:59:59 CET 2018 International Filing Date: Wed Sep 20 01:59:59 CEST 2017
IPC: A61M 5/178
A61M 5/31
B01D 39/00
A61M 5/38
A61F 9/00
A61K 39/00
Applicants: LUPIN LIMITED
Inventors: DEVARANENI, Prasanna, Kumar
MODY, Rustom, Sorab
Title: IN-LINE FILTER FOR PROTEIN/PEPTIDE DRUG ADMINISTRATION
Abstract:
The present invention relates to incorporation of in-line filter into the drug administration device to minimize the entry of particulates into the human body during injection of therapeutic proteins/peptides. Particulate matter can be of non-proteinaceous and/or proteinaceous and/or mixture thereof. Particles such as undissolved or precipitated solids, fibers, glass flakes, rubber fragments, silicone oil etc. represent non proteinaceous particles while protein aggregates (amorphous and fibrils) represent proteinaceous particles. Although particulate matter in injectable formulation required to be controlled within various regulatory and compendial limits, methods to mi nimize particulate matter further are beneficial as proteinaceous particulates poses the risk of immunogenicity.