Long-acting solid formulation comprising triptorelin acetate

Details Long-acting solid formulation comprising triptorelin acetate Long-acting solid formulation comprising triptorelin acetate

A - Human Necessities

61

K

A61K 47/34 (2006.01) A61K 38/09 (2006.01)

Patent

CA 2554870

The invention relates to a long-acting solid formulation for parenteral administration, comprising a) triptorelin acetate and b) one or more excipients comprising a polymer or copolymer of lactic and/or glycolic acid or a mixture of polymers and/or copolymers of lactic acid and/or glycolic acid, said formulation containing 10 to 99 % of triptorelin acetate by weight with relation to the total weight of the formulation. Said formulation is obtained by means of a method comprising the fusion of a mixture of triptorelin acetate and the excipient(s) on the fusion/extrusion of the triptorelin acetate with the excipient(s), said formulation being embodied such as to release the triptorelin acetate over a duration of at least one week, once administered parenterally to a patient.

L~invention concerne en particulier une formulation retard solide pour administration parentérale comprenant : a) de l~acétate de triptoréline, et b) n ou des excipients comprenant un polymère ou copolymère d~acide lactique et/ou d~acide glycolique ou un mélange de polymères et/ou copolymères d~acide lactique et/ou d~acide glycolique, ladite formulation contenant de 10 à 99% d~acétate de triptoréline en poids par rapport au poids total de la formulation et étant obtenue par un procédé comportant la fusion du mélange de l~acétate de triptoréline et du ou des excipients lors de la fusion-exrrusion de l~acétate de triptoréline avec le ou les excipients, ladite formulation étant telle qu~elle libère l~acétate de triptoréline sur une durée d~au moins une semaine une fois administrée par la voie parentérale à un patient.

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