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US 11,633,409 B2Granted
Solid preparation comprising dutasteride and method for preparing same
AssigneeJw Pharmaceutical Corporation
InventorsSuk Lee, Min-Uk Cha, Won-Kyu Yang, Min-Seok Choi
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Abstract
The present invention provides a solid preparation comprising, based on 100 parts by weight of the solid preparation, a self-emulsifying composition comprising 0.1 to 0.5 parts by weight of dutasteride, 6 to 110 parts by weight of oil and 6 to 110 parts by weight of a surfactant, and 5 to 185 parts by weight of a coating excipient having pores accommodating the self-emulsifying composition formed in a surface thereof, and a method of manufacturing the solid preparation.
Claims12
A solid preparation, comprising:
- a self-emulsifying composition comprising 0.5 parts by weight of dutasteride;
- 30 to 110 parts by weight of oil;
- and 30 to 110 parts by weight of a surfactant, and
- 25 to 185 parts by weight of a coated porous excipient comprising a porous excipient and a coating agent,
- wherein the porous excipient has pores accommodating the self-emulsifying composition formed in a surface thereof,
- wherein the porous excipient is coated with the coating agent, in the absence of the self-emulsifying composition, by forming a mixture comprising the porous excipient and a coating solution, the coating solution comprising an organic solvent and the coating agent, then drying the mixture to form the coated porous excipient, and
- wherein the coating agent is 10 to 40 parts by weight based on 83.5 parts by weight of the porous excipient, and
- wherein the solid preparation comprises the self-emulsifying composition in the pores of the coated porous excipient.
5 more elements
A method of manufacturing a solid preparation, comprising:
- manufacturing a self-emulsifying composition by mixing dutasteride, oil and a surfactant;
- obtaining a coated porous excipient having pores for accommodating the self-emulsifying composition formed in a surface thereof by coating a porous excipient having pores, with a coating agent, in the absence of the self-emulsifying composition, by forming a mixture comprising the porous excipient and a coating solution, the coating solution comprising an organic solvent and the coating agent, then drying the mixture to form the coated porous excipient;
- and
- manufacturing solid particles in which the self-emulsifying composition is accommodated in the pores of the coated porous excipient by mixing the self-emulsifying composition and the coated porous excipient,
- wherein the self-emulsifying composition contains 0.5 parts by weight of the dutasteride, 30 to 110 parts by weight of the oil and 30 to 110 parts by weight of the surfactant,
- wherein the coated porous excipient is in an amount of 25 to 185 parts by weight of the solid preparation, and
- wherein the coating agent is an amount of 10 to 40 parts by weight based on 83.5 parts by weight of the porous excipient.
4 more elements
Dependencies are inferred from the claim text.