US 2026/0216349 A1 · STABILIZED BIOPOLYMER COMPOSITION, THEIR MANUFACTURE AND USE

Abstract

The present invention relates to the field of stabilized biopolymer compositions, particularly to stabilized biopolymer compositions comprising a liquid mixture, in particular aqueous solution, of at least one biopolymer component and at least one stabilizing surfactant. More specifically, the present invention relates to stabilized biopolymer compositions comprising an ethylene oxide/butylene oxide block copolymer capable to confer to said biopolymer composition superior properties in comparison to the presently known formulations, particularly with regard to aggregation tendency, hemolytic activity and solubility. The invention further relates to said block copolymers, to methods for preparing said stabilized compositions and to the use of said block copolymers for stabilizing an aqueous composition of said biopolymer. The invention further relates said stabilized composition for use in medicine, in particular for diagnostic and/or therapeutic applications. The invention further relates to an essentially dry biopolymer composition, comprising said biopolymer and said block copolymers and to methods for preparing said essentially dry compositions. The invention further relates to said essentially dry biopolymer composition for use in medicine, in particular for diagnostic and/or therapeutic applications. Said compositions may be formulated as pharmaceutical compositions which may be delivered via suitable routes of administration such as via oral, rectal, transmucosal, topical, ophthalmic, otologic, or intestinal administration; parenteral delivery, including intramuscular, subcutaneous, intramedullary injections, as well as intrathecal, direct intraventricular, intravenous, intraperitoneal, intranasal, or intraocular injections, as the case may be.

Claims19

Dependent claims

-19. (canceled)

A biopolymer solution, comprising an aqueous solution, of at least one biopolymer component and at least one ethylene oxide/butylene oxide block copolymer of the general formula 1

in which
X represents —O— or a divalent organic moiety;
m independently of each other represents an integer in the range of 4 to 25;
and
n independently of each other represents an integer in the range of 15 to 100;
wherein
said biopolymer is selected from oligopeptides, polypeptides, proteins, antibody molecules or fragments or derivatives thereof, glycosylated proteins, proteoglycans, oligo- and polynucleotides, DNA and RNA molecules, oligosaccharides, polysaccharides, as well as adducts or conjugates of such biopolymers with a further constituent selected from payload molecules;
and
said block copolymer shows a combination of the following features:
a) a molecular weight of 2.500 to 12.500 g/mol, calculable from the sum of atomic masses of all atoms of the copolymer molecule of general formula 1;
b) an EO content of >50 to 85 wt.-%, based on the dry weight of said block copolymer, calculable from the atomic masses of all atoms of the copolymer molecule of formula 1;
c) a water solubility of at least 5 wt.-%, based on the total weight of the aqueous solution of the block copolymer;
and
d) less than 10% hemolytic activity caused by a solution of said block copolymer of 100 g/l.

11 more elements

Dependencies are inferred from the claim text.

Stabilized biopolymer composition, their manufacture and use

Life of this patent

Stabilized biopolymer composition, their manufacture and use

Life of this patent

Abstract

Claims19