Purification and stabilization of peptide and protein pharmaceutical agents
US6652885B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Aug 20, 2002 |
| Grant date | Nov 25, 2003 |
| Priority date | — |
| Expiry date | Aug 20, 2022 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC07K14/62
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, i.e. undesirable components, from the peptide or protein. In a preferred embodiment, a peptide, such as insulin, containing one or more impurities, e.g., zinc ions, is entrapped in diketopiperazine to form a precipitate of peptide/diketopiperazine/impurity, which is then washed with a solvent for the impurity to be removed, which is a nonsolvent for the diketopiperazine and a nonsolvent for the peptide. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In a preferred embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine a…
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.