Ipsen Pharma S.a.s.

Ipsen Pharma Biotech

Pharma Biotech

Chantal Roume

Roland Cherif-Cheikh

Martin Montes

Marc Pellet

Thomas Ciaran Loughman

A process for the preparation of injectable pharmaceutical compositions for the sustained release of somatostatin analogs and compositions prepared according to the process. The process may comprise lyophilizing a mixture of lanreotide acetate and acetic acid to form a lyophilizate and hydrating the lyophilizate, wherein the lyophilization is performed only once.

Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs

The invention relates to a process for the preparation of injectable pharmaceutical compositions for the sustained release of somatostatin analogues and to pharmaceutical compositions prepared according to the process. In a preferred aspect the process comprises the steps of combining lanreotide acetate and acetic acid, lyophilizing the resulting mixture only once, and hydrating the lyophilizate. Acetic acid may be added to a desired pH during the final step of the process.

The invention relates to compositions in the form of microcapsules or implants comprising a biodegradable polymeric or copolymeric excipient or a mixture of such excipients with an inherent viscosity of between 0.5 dl/g and 1.6 dl/g in CHCl , and one active substance or a mixture of active substances, it being possible for said microcapsules or implants to release the active substance or mixture of active substances over a prolonged period of up to three months or more. These compositions may also comprise an active principle having a high specific surface area.

Sustained release compositions and the process for their preparation

The invention relates to compositions in the form of microcapsules or implants comprising a biodegradable polymeric or copolymeric excipient or a mixture of such excipients with an inherent viscosity of between 0.5 dl/g and 1.6 dl/g in CHCl,, and one active substance or a mixture of active substances, it being possible for said microcapsules or implants to release the active substance or mixture of active substances over a prolonged period of up to three months or more. These compositions may also comprise an active principle having a high specific surface area.

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Signes, France

Chantal Roume