Abiogen Pharma S.p.a.

Laura Dini

Fabio Neggiani

Stefano Luca Giaffreda

Alex Petrolati

Michael Roeder

Kesheng Zhang

Michel Chiarucci

Serena Fabbroni

Patrizia Chetoni

Barbara Politi

Silvia Tampucci

Samuele Zanatta

The present invention relates to a formulation in the form of an aqueous suspension comprising calcium citrate. Said formulation exhibits excellent stability and compliance and finds use in calcium supplementation in subjects in need of such supplementation.

Composition for calcium supplementation

The present invention relates to a novel crystalline hemihydrate polymorph of neridronic acid sodium salt, and a novel process for the preparation thereof comprising the steps of: 1) dissolving solid sodium neridronate in any crystalline form in water, at a temperature in the range from 70 to 90&#xb0; C., to obtain an aqueous solution of sodium neridronate; 2) adding a solvent selected from the group consisting in ethanol, 1-propanol, and 2-propanol to the aqueous solution obtained from step (1), so that the final water:solvent volume ratio is in the range from 1:0.5 to 1:1, thus obtaining a suspension; 3) placing the suspension obtained from step (2) under mechanical stirring, at a temperature in the range from 60 to 95&#xb0; C.; 4) recovering the crystalline hemihydrate form F of sodium neridronate formed in the previous step (3). The crystalline hemihydrate form F of sodium neridronate, particularly stable, may be employed in the preparation of solid oral pharmaceutical forms for use in the treatment of musculoskeletal and calcium metabolism disorders.

Polymorph of sodium neridronate and preparation process thereof

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Pisa, Italy

Laura Dini