FIELD: medicine, pharmaceutics.
SUBSTANCE: claim describes a standard solid dosage form for oral administration which represents a mini-tablet having a core and an outer coating, wherein the core contains a therapeutically effective amount of aliskiren or its pharmaceutically acceptable salt, while the outer coating represents a film coating containing a taste masking material specified in polyacrylates, and/or a release modifying ingredient of the coating specified in cellulose derivatives and acryl copolymers, and a mixture thereof. The above mini-tablet has a size of 1 mm to 4 mm and contains aliskiren in an amount making 2 mg/tablet to 4 mg/tablet. The oral solid dosage form is preferentially applied in paediatrics.
EFFECT: according to the invention, the dosage form of aliskiren can be dosed and possesses a taste that makes it applicable for children, and maintains a biological availability at a level comparable to that of the available medicinal product for adults.
19 cl, 13 dwg, 5 tbl, 3 ex
Title | Year | Author | Number |
---|---|---|---|
HALENIC COMPOSITIONS OF ORGANIC COMPOUNDS | 2005 |
|
RU2384328C2 |
GALENIC COMPOSITIONS OF ORGANIC COMPOUNDS | 2009 |
|
RU2438661C2 |
ORAL SOLID DOSAGE FORM AND METHOD OF TREATING | 2011 |
|
RU2480210C1 |
GALENA COMPOSITION OF ALISKIREN AND HYDROCHLOROTHIAZIDE | 2007 |
|
RU2491058C2 |
GALENIC FORMULATIONS OF ALISKIREN | 2008 |
|
RU2483718C2 |
CRYSTALLINE FORMS OF ALISKIREN HEMIFUMARATE | 2007 |
|
RU2466982C2 |
GALENIC COMPOSITIONS OF ORGANIC COMPOUNDS | 2017 |
|
RU2773029C2 |
ADMINISTRATION OF RENIN INHIBITORS FOR PREVENTION OR TREATMENT OF DIASTOLIC DYSFUNCTION OR DIASTOLIC HEART FAILURE | 2005 |
|
RU2407523C2 |
CEFUROXIMAXETIL-CONTAINING COMBINATIONS | 1999 |
|
RU2248794C2 |
PEDIATRIC CAPECITABINE-CONTAINING TABLETS | 2007 |
|
RU2455979C2 |
Authors
Dates
2014-12-10—Published
2010-01-27—Filed