Pharmaceutical compositions of lenvatinib
The present invention relates to a pharmaceutical composition comprising lenvatinib mesylate and a stabilizer in an amount of about 10% to about 20% based on the total weight of the composition, wherein the stabilizer is selected from the group consisting of calcium hydroxide and potassium hydroxide; and its process for preparation thereof.
1. A pharmaceutical composition comprising lenvatinib mesylate and a stabilizer in an amount of about 10% to about 20% based on the total weight of the composition, wherein the stabilizer is selected from the group consisting of calcium hydroxide and potassium hydroxide.
2. A pharmaceutical composition according to claim 1 , wherein the composition further comprises
a) at least one diluent in an amount of about 30% to about 60% based on the total weight of the composition;
b) at least one binder in an amount of about 1% to about 5% based on the total weight of the composition;
c) at least one disintegrating agent in an amount of about 10% to about 30% based on the total weight of composition; and
d) lubricant in an amount of about 1% to about 5% based on the total weight of the composition.
3. A pharmaceutical composition according to claim 2 , wherein diluent is selected from group consisting microcrystalline cellulose, mannitol, or mixtures thereof.
4. A pharmaceutical composition comprising lenvatinib mesylate, calcium hydroxide and potassium hydroxide.
5. A pharmaceutical composition according to claim 4 , wherein the composition comprises calcium hydroxide in an amount of about 10% to about 15% based on the total weight of the composition.
6. A pharmaceutical composition accord claim 4 , wherein the composition comprises potassium hydroxide in an amount about 1% to about 5% based on the total weight of the composition.
7. A pharmaceutical composition according to claim 4 , wherein the composition further comprises
a) microcrystalline cellulose in an amount of about 15% to about 25% by weight;
b) mannitol in an amount of about 20% to about 35% by weight;
c) low-substituted hydroxypropyl cellulose in an amount of about 20% to about 30% by weight;
d) hydroxypropyl cellulose in an amount of about 1% to about 5% by weight; and
e) talc in an amount of about 1% to about 5% by weight.
8. A pharmaceutical composition comprising
a) lenvatinib mesylate in an amount of about 4% to about 15% by weight;
b) calcium hydroxide in an amount of about 10% to about 15% by weight;
c) potassium hydroxide in an amount of about 1% to about 5% by weight;
d) microcrystalline cellulose in an amount of about 15% to about 25% by weight;
e) mannitol in an amount of about 20% to about 35% by weight;
f) low-substituted hydroxypropyl cellulose in an amount of about 20% to about 30% by weight;
g) hydroxypropyl cellulose in an amount of about 1% to about 5% by weight; and
h) talc in an amount of about 1% to about 5% by weight.
9. A pharmaceutical composition according to claim 8 , wherein the composition comprises of about 40% low-substituted hydroxypropyl cellulose based on total weight of low-substituted hydroxypropylcellulose as intragranular, and about 60% low-substituted hydroxypropyl cellulose based on total weight of low-substituted hydroxypropyl cellulose with whole amount of talc as extragranular.