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US 10,501,577 B2Granted
Poloxamer composition free of long circulating material and methods for production and uses thereof
AssigneeLifeRaft Biosciences, Inc.
InventorsR. Martin Emanuele, Mannarsamy Balasubramanian, Stewart V. Smith
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Abstract
Provided herein are long circulating material free (LCMF) poloxamer compositions and uses thereof. In particular, provided are LCMF poloxamer 188 compositions and uses thereof. Also provided are supercritical fluid extraction (SFE) methods and high pressure (subcritical) methods for preparing poloxamer compositions, particularly the LCMF poloxamer compositions.
Claims29
A long circulating material free (LCMF) poloxamer 188, wherein:
- the LCMF poloxamer 188 is a polyoxyethylene/polyoxypropylene copolymer that has the formula HO(CH2CH2O)a′—[CH(CH3)CH2O]b—(CH2CH2O)aH, wherein:
- each of a and a′ is an integer such that the percentage of the hydrophile (C2H4O) is between approximately 60% and 90% by weight of the total molecular weight of the copolymer;
- a and a′ are the same or different;
- b is an integer such that the molecular weight of the hydrophobe (C3H6O) is between approximately 1,300 and 2,300 Daltons;
- no more than 1.5% of the total components in the polymeric distribution of the co-polymer are low molecular weight components having an average molecular weight of less than 4,500 Daltons;
- no more than 1.5% of the total components in the polymeric distribution of the co-polymer are high molecular weight components having an average molecular weight of greater than 13,000 Daltons;
- the polydispersity value of the copolymer is less than approximately 1.07 or less than 1.07;
- and
- following intravenous administration to a human subject, the circulating plasma half-life of any components not comprising the main peak in the distribution of copolymer is no more than 5.0-fold the circulating half-life of the main component in the distribution of the copolymer.
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Dependencies are inferred from the claim text.