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Summary for Patent: 10,166,181
|Title:||Slow release pharmaceutical composition made of microgranules|
|Abstract:||Pharmaceutical composition made of microparticles for the slow release of an active substance at least during a period covering the 6th month after injection of said composition, said composition comprising a group of microparticles made of a copolymer of the PLGA type which incorporate an active substance in the form of a water insoluble peptide salt; said copolymer furthermore comprising at least 75% of lactic acid and an inherent viscosity between 0.1 and 0.9 dl/g, as measured in chloroform at 25.degree. C. and at a polymer concentration of 0.5 g/dL; said microparticles furthermore having a size distribution defined as follows: --D (v,0.1) is between 10 and 30 micrometers, --D (v,0.5) is between 30 and 70 micrometers, --D (v,0.9) is between 50 and 1 10 micrometers.|
|Inventor(s):||Ducrey; Bertrand (Martigny, CH), Garrouste; Patrick (Saxon, CH), Curdy; Catherine (Riehen, CH), Bardet; Marie-Anne (Maracon, CH), Porchet; Herve (Cugy, CH), Lundstrom; Eija (Lutry, CH), Heimgartner; Frederic (Marin-Epagnier, CH)|
|Assignee:||Debiopharm Research & Manufacturing SA (CH)|
1. A pharmaceutical composition of microgranules comprising 22.5 mg triptorelin in the form of triptorelin pamoate, wherein the pharmaceutical composition comprises:
a) a first formulation of microgranules comprising approximately 20% (w/w) of triptorelin pamoate mixed with approximately 80% (w/w) PLGA, wherein the PLGA in the first formulation contains approximately 85% lactide and 15% glycolide; and b) a second
formulation of microgranules comprising approximately 12% (w/w) triptorelin pamoate mixed with approximately 88% (w/w) poly(D,L lactide-co-glycolide) (PLGA), wherein the PLGA in the second formulation contains approximately 75% lactide and 25% glycolide,
wherein the triptorelin is released from the pharmaceutical composition in an immediate amount within hours following injection and then constantly released over a period of at least 168 days.
2. The pharmaceutical composition of claim 1, wherein the first formulation of microgranules and the second formulation of microgranules are mixed to have a 50:50 dose ratio of triptorelin.
3. The pharmaceutical composition of claim 2, wherein the pharmaceutical composition induces chemical castration in patients over a six-month period of time.
4. The pharmaceutical composition of claim 2, wherein the pharmaceutical composition induces chemical castration in patients with advanced prostate cancer.
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