Ares Trading S.a.

Eurand International S.p.a.

Maria Dorly Del Curto

Pierandrea Esposito

Fabio Carli

Daniela Chicco

Silvia Pompili

Ilaria Zambaldi

Nicoletta Coceani

The present invention is related to pharmaceutical Poloxamer hydrogel formulations containing an interferon. In particular, the invention relates to sustained release hydrogel formulations of interferon-beta, method of preparation and use thereof.

Hydrogel interferon formulations

Stabilized liquid pharmaceutical composition comprising an interferon (IFN) or an isoform, mutein, fused protein, functional derivative, active fraction or salt thereof, wherein said formulation is a solution that comprises a buffer, a cyclodextrin, an isotonicity agent and an anti-oxidant are described here. Preferably the interferon is interferon beta-1a and the cyclodextrin is HPBCD. These formulations are stable at room temperature, thus bringing the advantage of lower costs for formulation storage and increased safety for the patient with respect to possible 'errors' during handling. As a matter of fact, having such formulations stable at room temperature reduces the risk of formation of degradation products potentially responsible for adverse events (e.g. immunogenicity).

Stabilized interferon liquid formulations

This invention relates to Lipid Microparticles consisting of lipids enriched in amphiphilic components, which promote the incorporation of peptides and/or protein, process for obtaining them as well as use thereof. A cryogenic micronization manufacturing process for their preparation is also disclosed.

Lipid microparticles by cryogenic micronization

The invention provides a biphasic multicomponent pharmaceutical composition consisting of an oil phase and a water phase, comprising one or more lipophilic or oil carrier, one or more hydrophilic or aqueous carrier, one or more ionic or nonionic type surfactant, one or more cosurfactant, one or more active principle for pharmaceutical use, and a compound able to modify the partition of the active principle between said phases selected from the group consisting of N- methyl pyrrolidone (NMP), isopropyl alcohol, propylene glycol, ethoxy-di-glycol, &bgr;-cyclodextrin, hydroxypropyl &bgr;-cyclodextrin and dimethyl &bgr;-cyclodextrin. The invention also provides a method for making the composition.

Growing community of inventors

San Quirico, Italy

Maria Dorly Del Curto