Methods for quantifying drug concentration in a prodrug composition
AssigneeGenzyme Corporation
InventorsKim Alving, Bing Wang
Life of this patent
Estimating the term…
Abstract
Methods for quantifying the amount of drug present in a crosslinked hyaluronic acid-linker-peptide (xHA-L-P) prodrug composition are provided. Disclosed are steps of contacting a sample of the xHA-L-P prodrug formulation with a hyaluronoglucosidase to generate oligomeric hyaluronic acid-linker-peptide drug (oHA-L-P), contacting the oHA-L-P with a second enzyme to generate peptide digest products of the drug, and detecting the peptide digest products to determine the amount of the drug present in the xHA-L-P prodrug formulation.
Claims20
A method for determining the amount of drug present in a crosslinked hyaluronic acid-linker-peptide (xHA-L-P) prodrug formulation, the method comprising:
- contacting a sample of the xHA-L-P prodrug formulation with a hyaluronoglucosidase to generate oligomeric hyaluronic acid-linker-peptide drug (oHA-L-P);
- contacting the oHA-L-P with a second enzyme to generate peptide digest products of the drug;
- and
- detecting the peptide digest products to determine the amount of the drug present in the xHA-L-P prodrug formulation.
A method for determining the amount of drug present in a crosslinked hyaluronic acid-linker-peptide (xHA-L-P) prodrug formulation, the method comprising:
- contacting a sample of the xHA-L-P prodrug formulation with a hyaluronoglucosidase to generate oligomeric hyaluronic acid-linker-peptide drug (oHA-L-P);
- contacting the oHA-L-P with an endoproteinase to generate peptide digest products of the drug;
- and
- detecting the peptide digest products to determine the amount of the drug present in the xHA-L-P prodrug formulation.
A method for determining the amount of drug present in a crosslinked hyaluronic acid-linker-peptide (xHA-L-P) prodrug formulation, the method comprising:
- contacting a sample of the xHA-L-P prodrug formulation with HA lyase EC 4.2.2.1 to generate oligomeric hyaluronic acid-linker-peptide drug (oHA-L-P);
- contacting the oHA-L-P with Asp-N to generate peptide digest products of the drug;
- and
- detecting the peptide digest products to determine the amount of the drug present in the xHA-L-P prodrug formulation.
Dependencies are inferred from the claim text.