Solid Pharmaceutical Composition Comprising Amorphous Sofosbuvir
AssigneeSandoz Ltd.
InventorsStefano Seminara, Agnieszka Tajchert, Franz Schwarz
Life of this patent
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Abstract
It is provided a solid pharmaceutical composition comprising sofosbuvir, one or more pharmaceutically acceptable excipients and optionally at least one pharmaceutically acceptable matrix compound, wherein at least 99 weight-% of the sofosbuvir comprised in the solid pharmaceutically composition are present in amorphous form. Sofosbuvir amorphous form is stable in the solid pharmaceutical composition.
Claims21
A solid pharmaceutical composition wherein the solid pharmaceutical composition comprises sofosbuvir according to formula (I)
- and one or more pharmaceutically acceptable excipient(s), wherein at least 99 weight-% of the sofosbuvir comprised in the solid pharmaceutical composition are present in amorphous form, and at least 99 weight-% of the solid pharmaceutical composition consists of the sofosbuvir and the one or more pharmaceutically acceptable excipient(s).
A solid pharmaceutical composition wherein the solid pharmaceutical composition comprises sofosbuvir according to formula (I)
- at least one pharmaceutically acceptable matrix compound and one or more pharmaceutically acceptable excipient(s), wherein at least 99 weight-% of the sofosbuvir comprised in the solid pharmaceutical composition are present in amorphous form, and at least 99 weight-% of the solid pharmaceutical composition consists of the sofosbuvir, the at least one matrix compound and the one or more pharmaceutically acceptable excipient(s).
A process for preparing a solid pharmaceutical composition, the process comprising:
- (i) preparing a mixture comprising sofosbuvir, at least one pharmaceutically acceptable matrix compound and one or more pharmaceutically acceptable excipient(s), wherein at least 99 weight-% of the mixture consists of the sofosbuvir, the at least one matrix compound and the one or more pharmaceutically acceptable excipient(s);
- (ii) processing the mixture obtained from (i) to the solid pharmaceutical composition.
A process for preparing a solid pharmaceutical composition, the process comprising:
- (i′) preparing a mixture of sofosbuvir and the at least one pharmaceutically acceptable matrix compound and at least one solvent;
- (ii′) subjecting the mixture of (i′) to drying the mixture of (i′), obtaining a dried mixture-1;
- (iii′) mixing the mixture-1 of (ii′) with the one or more pharmaceutically acceptable excipient(s), obtaining a mixture-2;
- (iv′) processing the mixture-2 of (iii′) to the solid pharmaceutical composition.
Dependencies are inferred from the claim text.