Methods of assessing suitability of use of pharmaceutical compositions of albumin and paclitaxel
Inventors
Peykov, Viktor • Foss, Willard • Pierce, Daniel W. • Desai, Neil P.
Assignees
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Publication Number
US-10900951-B1
Publication Date
2021-01-26
Expiration Date
Abstract
The present invention provides methods of assessing suitability of a pharmaceutical composition for medical use. The pharmaceutical composition comprises nanoparticles comprising paclitaxel coated with albumin and a non-nanoparticle portion comprising albumin and paclitaxel.
Core Innovation
The invention relates to validating and releasing a commercial batch of a pharmaceutical composition for medical use in a human individual. The pharmaceutical composition comprises nanoparticles comprising paclitaxel coated with a coating comprising albumin, and a non-nanoparticle portion comprising albumin and paclitaxel. A suitability-assessment method is used to evaluate whether the composition is suitable for medical use before validating or releasing the batch.
The core suitability indicator is the albumin structural composition in the nanoparticle coating. After obtaining a sample and separating the nanoparticles from the non-nanoparticle portion, the method measures 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. Suitability is assessed such that the measured weight percentage of albumin polymers is from about 15% to about 40% as indicative of suitability of the pharmaceutical composition for medical use.
The method includes validating the commercial batch if the pharmaceutical composition is suitable for medical use, and releasing a commercial batch if the pharmaceutical composition is suitable for medical use. A related processing method is also provided to process a sample from a commercial batch to assess suitability for medical use in a human individual using the same separating and albumin polymers weight-percentage assessment.
Claims Coverage
This document contains three independent claims. Across these independent claims, a shared inventive core consists of separating nanoparticles from a non-nanoparticle portion and using a defined weight-percentage threshold for albumin polymers within the nanoparticle albumin coating to indicate suitability for medical use, followed by validating or releasing the commercial batch.
Albumin-polymers suitability threshold in nanoparticle coating after separation
Assessing suitability for medical use in a human individual by 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, wherein the weight percentage is from about 15% to about 40% being indicative of suitability of the pharmaceutical composition for medical use.
Validate commercial batch when suitability is met
Validating the commercial batch if the pharmaceutical composition is suitable for medical use, where suitability is assessed by separating the nanoparticles from the non-nanoparticle portion and measuring the weight percentage of albumin polymers in the nanoparticle coating among total albumin in that coating, with suitability indicated by the weight percentage being from about 15% to about 40%.
Release commercial batch when suitability is met
Releasing the commercial batch if the pharmaceutical composition is suitable for medical use, where suitability is assessed by separating the nanoparticles from the non-nanoparticle portion and measuring the weight percentage of albumin polymers in the nanoparticle coating among total albumin in that coating, with suitability indicated by the weight percentage being from about 15% to about 40%.
Process a sample to assess suitability using albumin-polymers threshold
Processing a sample to assess suitability for medical use in a human individual by 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, wherein the weight percentage being from about 15% to about 40% is indicative of suitability of the pharmaceutical composition for medical use.
All independent claims are anchored to the same suitability assessment: separating nanoparticles from a non-nanoparticle portion and measuring the weight percentage of albumin polymers in the nanoparticle coating relative to total albumin in that coating, where 15% to 40% indicates suitability. The downstream action is validating or releasing a commercial batch, or processing a sample to assess suitability.
Stated Advantages
Allows validating and/or releasing a commercial batch for medical use in a human individual based on an albumin-coating suitability indicator defined by a weight percentage of albumin polymers.
Provides an explicit quantitative indicator of suitability for medical use in a human individual based on albumin polymers among total albumin in the nanoparticle coating.
Indicates suitability for medical use based on a measured weight percentage of albumin polymers in the nanoparticle coating (about 15% to about 40%).
Reports an enhanced intratumoral paclitaxel spread after direct tumor injection and enhanced radial tumor distribution versus TAXOL®.
Documented Applications
Use of the disclosed suitability-assessment framework to validate a commercial batch of an albumin-coated paclitaxel nanoparticle pharmaceutical composition for medical use in a human individual.
Use of the disclosed suitability-assessment framework to release a commercial batch of the pharmaceutical composition for medical use in a human individual.
Use of the disclosed method to process a sample from a commercial batch to assess suitability for medical use in a human individual.
Assessment of pharmaceutical composition suitability correlated with enhanced tumor distribution after direct intratumoral injection versus TAXOL® in a pancreatic MIA PaCa-2 xenograft tumor context [procedural detail omitted for safety].
Assessing how albumin structural distribution and nanoparticle structural properties relate to enhanced intratumoral paclitaxel spread after direct tumor injection.
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