Preparation of tolerizing nanoparticles for the treatment of primary biliary cholangitis
AssigneeCour Pharmaceuticals Development Company, Inc.
InventorsAdam Elhofy, Tushar Murthy, Michael Boyne
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Abstract
The present disclosure relates to a process for the preparation of tolerizing immune modifying nanoparticles encapsulating antigens associated with primary biliary cholangitis (PBC), compositions comprising the particles and use thereof for the treatment of PBC.
Claims83
A method for preparing a composition comprising particles encapsulating one or more primary biliary cholangitis (PBC)-associated antigens, the method comprising:
- a. generating an aqueous solution of one or more PBC associated antigens;
- b. generating a primary emulsion by mixing an aqueous solution of step (a) with a polymer resulting in a primary emulsion;
- c. mixing the primary emulsion with a mixture comprising one or more surfactants and/or stabilizers to form a secondary emulsion;
- and
- d. hardening the secondary emulsion by evaporation resulting in hardened polymeric nanoparticles encapsulating one or more PBC associated antigens within their cores.
A method for manufacturing a composition comprising negatively charged particles encapsulating pyruvate dehydrogenase complex E2 subunit (PDC-E2)155-185 peptides comprising:
- (a) generating an aqueous solution of PDC-E2155-185 peptide between pH 1.0 and pH 7.0
- (b) generating a primary emulsion by homogenizing the aqueous solution of PDC-E2155-185 peptides of step (a) with an oil phase including PLGA dissolved in ethyl acetate;
- (c) homogenizing the primary emulsion of step (b) with a mixture comprising PAA, PVA and ethyl acetate to form a secondary emulsion;
- and
- (d) hardening the secondary emulsion of step (c) by evaporation resulting in hardened polymeric nanoparticles encapsulating PDC-E2155-185 peptides within their cores.
The method of any one of the preceding claims, wherein the manufacturing batch size is between 0.01 g to 100 kg.
A pharmaceutical composition comprising negatively charged particles encapsulating pyruvate dehydrogenase complex E2 subunit (PDC-E2)155-185 peptide, sucrose, mannitol, and sodium citrate.
Dependencies are inferred from the claim text.