Method for preparation of liquid oral composition of l-thyroxin
AssigneeFtf Pharma Private Limited
InventorsVijay PATEL, Sandip MEHTA, Manoj KALAVADIYA, Manish UMRETHIA, Jayanta Kumar MANDAL
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Abstract
The present invention discloses a processes for the preparation of a stable liquid pharmaceutical composition comprising levothyroxine or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients wherein the liquid composition of the present invention is used for oral administration. The present invention also discloses stable liquid compositions comprising levothyroxine or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients prepared according to the processes of the present invention.
Claims18
A process for the preparation of an oral liquid pharmaceutical composition comprising levothyroxine or pharmaceutically acceptable salt thereof, the process comprising steps of:
- (i) adding levothyroxine or pharmaceutically acceptable salt thereof in one or more non-aqueous solvent with or without adding an aqueous solvent;
- (ii) adjusting pH of a mixture obtained in step (i) between 8.0 and 10.0 using one or more pH adjusting agents;
- (iii) adding one or more pharmaceutically acceptable preservatives into a mixture obtained in step (ii) followed by pH adjustment between 5.0 and 6.0 using one or more pH adjusting agents;
- and
- (iv) adding one or more aqueous solvents into a mixture obtained in step (iii) to make up final required volume and followed by mixing.
A process for the preparation of an oral liquid pharmaceutical composition comprising levothyroxine or pharmaceutically acceptable salt thereof, the process comprising steps of:
- (i) dissolving one or more pharmaceutically acceptable preservatives in a mixture of one or more aqueous solvents and one or more non-aqueous solvents;
- (ii) adjusting pH of a mixture obtained in step (i) between 7.0 and 8.0 using one or more pH adjusting agents;
- (iii) dispersing levothyroxine or pharmaceutically acceptable salt thereof in a non-aqueous solvent without adding an aqueous solvent;
- (iv) adding mixture of step (iii) into step (ii) and mixing till levothyroxine or pharmaceutically acceptable salt thereof gets dissolved;
- (v) adjusting pH of a mixture obtained in step (iv) between 5.0 and 6.0 using one or more pH adjusting agents;
- and
- (vi) adding one or more aqueous solvent to a mixture obtained in step (v) to make up final required volume.
An oral liquid composition comprising levothyroxine or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients prepared using a process comprising:
- (i) adding levothyroxine or pharmaceutically acceptable salt thereof in one or more non-aqueous solvent with or without adding an aqueous solvent;
- (ii) adjusting pH of a mixture obtained in step (i) between 8.0 and 10.0 using one or more pH adjusting agents;
- (iii) adding one or more pharmaceutically acceptable preservatives into a mixture obtained in step (ii) followed by pH adjustment between 5.0 and 6.0 using one or more pH adjusting agents;
- and
- (iv) adding one or more aqueous solvents into a mixture obtained in step (iii) to make up final required volume and followed by mixing.
An oral liquid composition comprising levothyroxine or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients prepared using a process comprising:
- (i) dissolving one or more pharmaceutically acceptable preservatives in a mixture of one or more aqueous solvents and one or more non-aqueous solvents;
- (ii) adjusting pH of a mixture obtained in step (i) between 7.0 and 8.0 using one or more pH adjusting agents;
- (iii) dispersing levothyroxine or pharmaceutically acceptable salt thereof in a non-aqueous solvent without adding an aqueous solvent;
- (iv) adding mixture of step (iii) into step (ii) and mixing till levothyroxine or pharmaceutically acceptable salt thereof gets dissolved;
- (v) adjusting pH of a mixture obtained in step (iv) between 5.0 and 6.0 using one or more pH adjusting agents;
- and
- (vi) adding one or more aqueous solvent to a mixture obtained in step (v) to make up final required volume.
Dependencies are inferred from the claim text.