Analytical method
AssigneeR.P. Scherer Technologies, LLC
InventorsWilliam Derek Bush, Ryan Scott Cormier, Karunakar Sukuru
Life of this patent
Estimating the term…
Abstract
Disclosed herein are methods, systems, and kits for determining the total amount of a coating polymer in a dosage form. The coating polymer may be a polydisperse polymer having a plurality of molecular weights. The instant disclosure enables to accurately, reliably, and efficiently determine the total amount of a polydisperse polymer in a dosage form that includes one or more other constituents that have a molecular weight range that overlap with at least some of the polydisperse polymer's molecular weight.
Claims22
A method for determining a total amount of a coating polymer in a dosage form, the method comprising:
- analyzing a sample that has been subject to separation of the coating polymer from one or more other constituents in the dosage form, wherein the one or more other constituents of the dosage form have a molecular weight range that overlaps with a molecular weight range of the coating polymer.
A method of determining a total amount of a coating polymer in a dosage form, the method comprising:
- preparing a sample by separating the coating polymer from one or more other constituents of the dosage form, and
- analyzing the sample,
- wherein the one or more other constituents of the dosage form have a molecular weight range that overlaps with a molecular weight range of the coating polymer.
A method of preparing a sample for quantification of a total amount of a coating polymer in a dosage form, the method comprising:
- separating a coating polymer from one or more other constituents in a dosage form,
- wherein the one or more other constituents of the dosage form have a molecular weight range that overlaps with a molecular weight range of the coating polymer.
A system for quantifying the total amount of a coating polymer in a dosage form, the system comprising:
- a dosage form comprising a coating polymer and one or more other constituents;
- a diluent capable of selectively dissolving the coating polymer but not the one or more other constituents of the dosage form;
- and
- one or more analytical tools for preparing a sample to have its total amount of coating polymer quantified and/or for analyzing the sample.
-23. (canceled)
A kit for quantifying the total amount of a coating polymer in a dosage form, the kit comprising:
- a diluent capable of selectively dissolving the coating polymer but not one or more other constituents of the dosage form;
- one or more analytical tools for preparing a sample to have its total amount of coating polymer quantified and/or for analyzing the sample;
- and
- instructions for preparing a sample to have its total amount of coating polymer quantified and/or for analyzing the sample.
-30. (canceled)
Dependencies are inferred from the claim text.