Recordati Industria Chimica E Farmaceutica S.p.a.

Recordati Ireland Limited

Fabio Berlati

Amedeo Leonardi

Gianni Motta

Marco Barchielli

Sergio Menegon

Diego Provvedini

Alberto Mattei

Pierluigi Farina

The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKfrom 5.5 to 9.0 at 25&#xb0; C.; according to an embodiment, the buffering agent may have a pKfrom 7.5 to 8.5, preferably a pKof about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKfrom 5.5 to 9.0 at 25&#xb0; C., preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.

Pharmaceutical parenteral formulation containing carglumic acid

The invention provides a substantially pure amorphous lercanidipine hydrochloride having a purity of at least 95% pure, preferably at least about 97% pure, more preferably at least about 99% pure, and still more preferably at least about 99.5% pure. The invention further relates to methods of preparing substantially pure amorphous lercanidipine, as well as methods of providing rapid relief from hypertension by administering the substantially pure amorphous lercanidipine hydrochloride of the present invention to a patient in need of such treatment.

Amorphous lercanidipine hydrochloride and uses thereof

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Rho, Italy

Fabio Berlati