Novel process for the purification of sugammadex sodium
AssigneeBiophore India Pharmaceuticals PVT. Ltd.
InventorsManik Reddy PULLAGURLA, Bhaskar Reddy PITTA, Suresh Babu NAMANA, Maheswara Rao GOKADA, Jagadeesh Babu RANGISETTY
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Abstract
The present invention relates to an improved process for the preparation of Sugammadex sodium (1). It further relates to a novel process for the purification of Sugammadex sodium (1) having impurity A less than 2% (w/w) and impurity E less than 0.1% (w/w)
Claims10
A process for the preparation of Sugammadex sodium (1), comprising:
- a) reacting gamma cyclodextrin (4)
- with suitable halogenating agent in a suitable organic solvent to provide 6-per-deoxy-6-perchloro gamma cyclodextrin (3);
- b) reacting the 6-per-deox-6-perchloro gamma cyclodextrin (3) with mercaptopropionic acid (2) or its salt or its ester
- in presence of base to yield Sugammadex sodium (1);
- and
- c) purifying Sugammadex sodium (1), wherein the purification comprises;
- i. providing a solution of Sugammadex sodium (1) in a suitable solvents or mixture thereof;
- ii. isolating Sugammadex sodium (1) by adding suitable solvent at a suitable temperature;
- iii. optionally, converting Sugammadex sodium (1) to free acid (5) and dissolving in a suitable biphasic solvent;
- iv. isolating Sugammadex free acid (5) by cooling to a suitable temperature;
- v. optionally, converting Sugammadex free acid (5) to sodium salt (1) and dissolving in water;
- vi. passing aqueous Sugammadex sodium (1) solution through flash column chromatography loaded with reverse phase silica gel;
- and
- vii. isolating pure Sugammadex sodium (1) by evaporating the pure fractions.
A compound of Sugammadex sodium (1) having purity greater than 98.0% by HPLC and one or more of the following:
- i. impurity A less than 2.0% (w/w);
- and
- ii. impurity E less than 0.1% (w/w)
A process for the purification of Sugammadex sodium (1) having purity greater than 98%, which comprises of:
- a. providing a solution of Sugammadex sodium (1) in water at suitable temperature;
- b. passing aqueous Sugammadex sodium (1) solution through flash column chromatography loaded with reverse phase silica gel;
- and
- c. isolating pure Sugammadex or its salt by evaporating the pure fractions.
Dependencies are inferred from the claim text.