Oral Tablet Formulation of Lenalidomide with various doses
The present invention relates to an oral tablet composition comprising lenalidomide and a method for manufacturing same. More specifically, the present invention relates to a composition in a tablet form showing physicochemical equivalence with a lenalidomide preparation which is prepared in a hard...
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Main Authors | , , , |
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Format | Patent |
Language | English Korean |
Published |
23.10.2019
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Subjects | |
Online Access | Get full text |
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Summary: | The present invention relates to an oral tablet composition comprising lenalidomide and a method for manufacturing same. More specifically, the present invention relates to a composition in a tablet form showing physicochemical equivalence with a lenalidomide preparation which is prepared in a hard capsule and securing equivalence in a non-clinical test and a bioequivalence test as well, thereby exhibiting equivalent pharmacological therapeutic effects, while having further improved administration convenience, handling, safeness and the like.
본 발명은 레날리도마이드를 포함하는 경구용 정제 조성물 및 이의 제조 방법에 대한 것으로, 보다 상세하게는, 경질 캡슐로 제조된 레날리도마이드 제제와 이화학적 동등성을 보이고, 또한 비임상시험과 생물학적 동등성 시험에서도 동등성이 확보되어 동등한 약리학적 치료 효과를 보이면서, 복용의 편의성, 취급성, 안전성 등은 더욱 개선된 정제 형태의 조성물에 관한 것이다. |
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Bibliography: | Application Number: KR20190043374 |