公开(公告)号：US20190008873A1

公开(公告)日：2019-01-10

申请号：US15737676

申请日：2016-06-17

Applicant: Sage Therapeutics, Inc.

Inventor： Francesco G. Salituro ,  Albert Jean Robichaud ,  Paul Steven Watson ,  William Hunke

IPC: A61K31/573 ,  A61K47/69 ,  A61K47/12 ,  A61K9/00 ,  A61K9/08

Abstract: Provided herein are pharmaceutically acceptable aqueous solution comprising a neuroactive steroid, a sulfobutyl ether beta cyclodextrin and a buffer; wherein: the solution is a stable solution between a pH of about 3 and about 9, e.g., at room temperature, for at least 1, 2, 3, 4 weeks; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months; 1, 2, 3 years or more; the buffer is present at a concentration of at least 0.1 mM; or the solution remains substantially free of impurities (e.g., the solution is substantially free of impurities at room temperature for at least 1, 2, 3, 4 weeks; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months; 1, 2, 3 years or more).

公开(公告)号：US20230141665A1

公开(公告)日：2023-05-11

申请号：US18087870

申请日：2022-12-23

Applicant: Sage Therapeutics, Inc.

Inventor： Francesco G. Salituro ,  Albert J. Robichaud ,  Paul Steven Watson ,  William Hunke

IPC: A61K31/573 ,  A61K9/00 ,  A61K9/08 ,  A61K47/69 ,  A61K31/57 ,  C08B37/16 ,  A61K31/724 ,  A61K47/12

CPC classification number: A61K31/573 ,  A61K9/08 ,  A61K9/0019 ,  A61K31/57 ,  A61K31/724 ,  A61K47/12 ,  A61K47/6951 ,  C08B37/0015 ,  A61P25/24

Abstract: Provided herein are pharmaceutically acceptable aqueous solution comprising a neuroactive steroid, a sulfobutyl ether beta cyclodextrin and a buffer; wherein: the solution is a stable solution between a pH of about 3 and about 9, e.g., at room temperature, for at least 1, 2, 3, 4 weeks; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months; 1, 2, 3 years or more; the buffer is present at a concentration of at least 0.1 mM; or the solution remains substantially free of impurities (e.g., the solution is substantially free of impurities at room temperature for at least 1, 2, 3, 4 weeks; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months; 1, 2, 3 years or more).

公开(公告)号：US20190350944A1

公开(公告)日：2019-11-21

申请号：US16423976

申请日：2019-05-28

Applicant: Sage Therapeutics, Inc.

Inventor： Francesco G. Salituro ,  Albert Jean Robichaud ,  Paul Steven Watson ,  William Hunke

IPC: A61K31/573 ,  A61K47/12 ,  A61K47/69 ,  A61K31/724 ,  A61K31/57 ,  C08B37/16 ,  A61K9/08 ,  A61K9/00

Abstract: Provided herein are pharmaceutically acceptable aqueous solution comprising a neuroactive steroid, a sulfobutyl ether beta cyclodextrin and a buffer; wherein: the solution is a stable solution between a pH of about 3 and about 9, e.g., at room temperature, for at least 1, 2, 3, 4 weeks; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months; 1, 2, 3 years or more; the buffer is present at a concentration of at least 0.1 mM; or the solution remains substantially free of impurities (e.g., the solution is substantially free of impurities at room temperature for at least 1, 2, 3, 4 weeks; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months; 1, 2, 3 years or more).