Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
AssigneeAbraxis BioScience, LLC
InventorsViktor Peykov, Willard Foss, Daniel W. Pierce, Neil P. Desai
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Abstract
The present invention provides methods of assessing suitability of a pharmaceutical composition for medical use. The pharmaceutical composition comprises nanoparticles comprising rapamycin coated with albumin and a non-nanoparticle portion comprising albumin and rapamycin.
Claims33
A method of assessing suitability of a pharmaceutical composition for medical use in a human individual, wherein the pharmaceutical composition comprises (a) nanoparticles comprising rapamycin coated with a coating comprising albumin and (b) a non-nanoparticle portion comprising albumin and rapamycin, the method comprising:
- separating the nanoparticles from the non-nanoparticle portion;
- measuring a weight percentage of albumin in the form of albumin polymers in the coating of the separated nanoparticles among the total albumin in the coating of the separated nanoparticles;
- and
- assessing the suitability of the pharmaceutical composition for medical use in a human individual, wherein the weight percentage of albumin in the form of albumin polymers in the coating of the separated nanoparticles among the total albumin in the coating of the separated nanoparticles being from about 15% to about 40% is indicative of suitability of the pharmaceutical composition for medical use.
A method of assessing suitability of a pharmaceutical composition for medical use in a human individual, wherein the pharmaceutical composition comprises (a) nanoparticles comprising rapamycin coated with a coating comprising albumin and (b) a non-nanoparticle portion comprising albumin and rapamycin, the method comprising:
- separating the nanoparticles from the non-nanoparticle portion;
- measuring a weight percentage of albumin in the form of albumin monomers in the coating of the separated nanoparticles among the total albumin in the coating of the separated nanoparticles;
- and
- assessing the suitability of the pharmaceutical composition for medical use in a human individual, wherein the weight percentage of albumin in the form of albumin monomers in the coating of the separated nanoparticles among the total albumin in the coating of the separated nanoparticles being from about 40% to about 60% is indicative of suitability of the pharmaceutical composition for medical use.
Dependencies are inferred from the claim text.