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US 7,790,466 B1Granted
Evaluating mixtures of low molecular weight heparins by chain profiles or chain mapping
AssigneeMomenta Pharmaceuticals, Inc.
InventorsZachary Shriver, Daniela Beccati, Ishan Capila, Nur Sibel Gunay, Jennifer Ozug, Steve Wudyka
Life of this patent
Estimating the term…
Abstract
Methods for analyzing mixtures of polysaccharides, for example heparin such as unfractionated heparin and enoxaparin are described. In some instances, the mixtures are analyzed using fast performance liquid chromatography (FPLC) and high liquid performance chromatography (HPLC), e.g., strong anion exchange HPLC.
Claims8
A method of analyzing an enoxaparin preparation, comprising:
- providing an isolated tetrasaccharide fraction from a size fractioned enoxaparin preparation;
- analyzing the tetrasaccharide fraction using strong anion exchange high performance liquid chromatography (HPLC) to determine if one or more chains shown in the following table is present or is present in amount identified in the following table:
- Range A
- Range B
- Range C
- % Area
- % Area
- % Area
- Peak
- under HPLC
- under HPLC
- under HPLC
- #
- Tetrasaccharide
- curve
- curve
- curve
- 1
- ΔUHNS6SI2SHNS6S
- 0.1
- 0.6
- Present or
- Present or
- Detectable
- Detectable
- 2
- ΔUHNS6SI2SHNS6S
- 0.6
- 1.2
- 0.6
- 1.2
- 0.4
- 1.4
- ΔUgalHNS6SI2SManNS6S
- 3
- ΔU2SHNS6SI2SHNS (α)
- 0.6
- 1.2
- 0.4
- 1.0
- 0.2
- 1.2
- 4
- ΔU2SHNS6SI2SHNS (β),
- 1.8
- 3.6
- 1.7
- 4.1
- 0.9
- 4.9
- ΔU2SHNS6SI2SManNS
- (β)
- 5
- ΔU2SHNS6SI2SManNS
- 2.1
- 3.7
- 2.2
- 4.0
- 1.6
- 4.6
- (α),
- ΔU2SHNSI2SHNS6S
- (α)
- 6
- ΔU2SHNSI2SHNS6S
- 0.5
- 1.6
- 0.4
- 1.6
- 0.0
- 2.0
- (β)
- 7
- ΔU2SHNS6SI2SManNS
- 5.9
- 9.0
- 5.6
- 9.2
- 4.4
- 10.4
- (1,6 anhydro)
- 8
- ΔU2SHNS6SI2SHNS
- 7.0
- 9.9
- 6.6
- 10.2
- 5.4
- 11.4
- (1,6 anhydro)
- 9
- ΔU2SHNS6SG2SHNS (α)
- 0.9
- 1.6
- 0.8
- 1.4
- 0.6
- 1.6
- 10
- ΔU2SHNS6SGHNS6S (α)
- 5.0
- 6.2
- 4.9
- 6.7
- 4.3
- 7.3
- 11
- ΔU2SHNS6SGManNS6S
- 1.2
- 1.9
- 1.0
- 2.2
- 0.6
- 2.6
- (α, β)
- 12
- ΔU2SHNS6SI2SHNS6S
- 39.7
- 48.0
- 38.1
- 48.9
- 34.5
- 52.5
- (α),
- ΔU2SHNS6SI2SManNS6S
- (β)
- 13
- ΔU2SHNS6SI2SHNS6S
- 18.1
- 20.7
- 17.8
- 20.8
- 16.8
- 21.8
- (β),
- ΔU2SHNS6SI2SManNS6S
- (α)
- 14
- ΔU2SHNS6SG2SHNS6S
- 2.3
- 4.0
- 1.9
- 4.3
- 1.1
- 5.1
- (α)
- 15
- ΔU2SHNS6SG2SHNS6S
- 0.6
- 1.4
- 0.4
- 1.6
- 0.0
- 2.0
- (β)
- and
- if one or more of said chains is present or is present in an amount identified in the table, processing said preparation, wherein processing includes one or more of selecting, accepting, processing into drug product, shipping, formulating, labeling, packaging or selling said preparation,
- thus analyzing the enoxaparin preparation.
155 more elements
A method of processing an enoxaparin preparation comprising:
- providing a high performance liquid chromatography (HPLC) determination of whether a tetrasaccharide structure is present in an enoxaparin preparation in an amount provided in the following table:
- Range A
- Range B
- Range C
- % Area
- % Area
- % Area
- Peak
- under HPLC
- under HPLC
- under HPLC
- #
- Tetrasaccharide
- curve
- curve
- curve
- 1
- ΔUHNS6SI2SHNS6S
- 0.1
- 0.6
- Present or
- Present or
- Detectable
- Detectable
- 2
- ΔUHNS6SI2SHNS6S
- 0.6
- 1.2
- 0.6
- 1.2
- 0.4
- 1.4
- ΔUgalHNS6SI2SManNS6S
- 3
- ΔU2SHNS6SI2SHNS (α)
- 0.6
- 1.2
- 0.4
- 1.0
- 0.2
- 1.2
- 4
- ΔU2SHNS6SI2SHNS (β),
- 1.8
- 3.6
- 1.7
- 4.1
- 0.9
- 4.9
- ΔU2SHNS6SI2SManNS
- (β)
- 5
- ΔU2SHNS6SI2SManNS
- 2.1
- 3.7
- 2.2
- 4.0
- 1.6
- 4.6
- (α),
- ΔU2SHNSI2SHNS6S (α)
- 6
- ΔU2SHNSI2SHNS6S (β)
- 0.5
- 1.6
- 0.4
- 1.6
- 0.0
- 2.0
- 7
- ΔU2SHNS6SI2SManNS
- 5.9
- 9.0
- 5.6
- 9.2
- 4.4
- 10.4
- (1,6 anhydro)
- 8
- ΔU2SHNS6SI2SHNS
- 7.0
- 9.9
- 6.6
- 10.2
- 5.4
- 11.4
- (1,6 anhydro)
- 9
- ΔU2SHNS6SG2SHNS (α)
- 0.9
- 1.6
- 0.8
- 1.4
- 0.6
- 1.6
- 10
- ΔU2SHNS6SGHNS6S (α)
- 5.0
- 6.2
- 4.9
- 6.7
- 4.3
- 7.3
- 11
- ΔU2SHNS6SGManNS6S
- 1.2
- 1.9
- 1.0
- 2.2
- 0.6
- 2.6
- (α, β)
- 12
- ΔU2SHNS6SI2SHNS6S
- 39.7
- 48.0
- 38.1
- 48.9
- 34.5
- 52.5
- (α),
- ΔU2SHNS6SI2SManNS6S
- (β)
- 13
- ΔU2SHNS6SI2SHNS6S
- 18.1
- 20.7
- 17.8
- 20.8
- 16.8
- 21.8
- (β),
- ΔU2SHNS6SI2SManNS6S
- (α)
- 14
- ΔU2SHNS6SG2SHNS6S
- 2.3
- 4.0
- 1.9
- 4.3
- 1.1
- 5.1
- (α)
- 15
- ΔU2SHNS6SG2SHNS6S
- 0.6
- 1.4
- 0.4
- 1.6
- 0.0
- 2.0
- (β)
- and
- if said structures are present in an amount provided in the table, processing said preparation, wherein processing includes one or more of selecting, accepting, processing into drug product, shipping, formulating, labeling, packaging or selling said preparation.
151 more elements
Dependencies are inferred from the claim text.