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US 11,077,099 B2Granted
Oral tablet formulation of lenalidomide
AssigneeSamyang Holdings Corporation
InventorsSang Yeob Park, Hye Jung Lim, Sa Won Lee, Min Hyo Seo
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Abstract
The present disclosure relates to an oral tablet composition comprising lenalidomide and a method for preparing the same. More particularly, the present disclosure relates to a tablet-type composition and a method for preparing the same wherein the composition exhibits physicochemical equivalence with lenalidomide preparations of hard capsules, has the same pharmacological, therapeutic effect in non-clinical studies and bioequivalence studies, and also has improved ease of taking, handling, safety and the like.
Claims11
An oral tablet composition, comprising:
- lenalidomide as an active ingredient;
- a diluent selected from the group consisting of sugars, sugar alcohols, celluloses, starches and mixtures thereof;
- a disintegrant selected from the group consisting of croscarmellose sodium, sodium starch glyconate and mixtures thereof;
- and
- a lubricant selected from the group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate and mixtures thereof;
- wherein 3 to 30 parts by weight of the diluent, 0.1 to 2.5 parts by weight of the disintegrant and 0.03 to 0.75 part by weight of the lubricant per 1 part by weight of lenalidomide are comprised;
- AUC (area under curve) is 140 to 7100 ng·hr/mL;
- Cmax is 42 to 2100 ng/mL;
- the disintegration time in a buffer solution of pH 1.2 is 2 to 10 minutes;
- and
- the tablet is a direct compression tablet.
8 more elements
Dependencies are inferred from the claim text.