Method for determining release of a peptide from a sustained...

Details Method for determining release of a peptide from a sustained... Method for determining release of a peptide from a sustained...

2007-07-24

2007-07-24

Warden, Jill (Department: 1743)

Chemistry: analytical and immunological testing

Peptide, protein or amino acid

C424S457000, C424S468000

Reexamination Certificate

active

10398791

ABSTRACT:
A method for determining the release of a peptide from a sustained release polylactide formulation which can be carried out in a shorter time than a real-time method by accelerating the release of the peptide from the formulation. It can be used to discriminate between batches of formulations for quality control purposes and to discriminate between formulations, for example, having different drug loadings.

REFERENCES:
patent: 5702716 (1997-12-01), Dunn et al.
patent: 5736152 (1998-04-01), Dunn
Herrmann et al., “Biodegradable, somatostatin acetate containing microspheres prepared by various aqueous and non-aqueous solvent evaporation methods,” European Journal of Pharmaceutics and Biopharmaceutics 45:75-82 (1998).
McDaniel, “In vitro and in vivo release of pulsitile microsphere formulations,” Proceed. Int'l. Symp. Control Rel. Bioact. Mater., 25:443-444 (1998).
Shameem et al., “A short-term (accelerated release) approach to evaluate peptide release from PLGA depot formulations,” AAPS Pharmsci 1(3):1-12 (1999).

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