TH92852B - Solid pharmaceutical components consisting of amlodipine and losartan, and manufactured using the same process. - Google Patents

Abstract

DC60 (August 27, 2015) This invention relates to a solid pharmaceutical compound for the prevention or treatment of cardiovascular disease, composed of amlodipine or its pharmaceutically acceptable salts and losartan or its pharmaceutically acceptable salts, which exhibits a high dissolution rate of amlodipine and losartan even at low pH conditions and increased stability during storage. Revised Invention Summary August 27, 2015 This invention relates to a solid pharmaceutical compound for the prevention or treatment of cardiovascular disease, composed of amlodipine or its pharmaceutically acceptable salts and losartan or its pharmaceutically acceptable salts, which exhibits a high dissolution rate of amlodipine and losartan even at low pH conditions and increased stability during storage. ----------------------------------------------------------------------------------------- Revised Invention Summary August 27, 2016 This invention relates to a solid pharmaceutical compound for the prevention or treatment of cardiovascular disease. It consists of amlodipine or its pharmaceutically acceptable salts, and losartan or its pharmaceutically acceptable salts, exhibiting high dissolution rates of amlodipine and losartan even at low pH conditions, and increased stability during storage.

Claims (6)

Revised 27/08/58 1. Solid pharmaceutical composition, comprising amlodipine or its pharmaceutically acceptable salts and losartan or its pharmaceutically acceptable salts, where both amlodipine or its pharmaceutically acceptable salts and losartan or its pharmaceutically acceptable salts are in the form of separate granules. This composition contains granules of losartan, with a percentage of fine granules filtered through a 75 µm mesh of less than 50%, a dissolution rate of amlodipine under physical temperature conditions of 80% or more in 30 minutes at pII of 1.0 to 2.0, and the composition contains losartan or its pharmaceutically acceptable salts in an amount ranging from 3 to 25% by weight, depending on the total weight of the composition. 2. Composition of claim 1, comprising losartan or its pharmaceutically acceptable salts. In quantities ranging from 5 to 22.3% by weight, depending on the total weight of the components. 3. The component of claim 1 or 2, which includes granules of losartan, where the percentage of fine granules filtered through a 75 µm mesh is less than 25%. 4. The component of claim 3, which includes granules of losartan, where the percentage of fine granules filtered through a 75 µm mesh is less than 10%. 5. Any one of the components of claim 1 to 4, where the pharmaceutically acceptable salt of amlodipine is amlodipine camselac. 6. The method for preparing any one of the components of claim 1 to 5, which includes granules of amlodipine and losartan, comprising the steps of: a) Granulation and drying of the losartan mixture. or its pharmaceutically acceptable salts and pharmaceutically acceptable excipients to obtain losartan granules; b) Granulation and drying of the mixture of amlodipine or its pharmaceutically acceptable salts and pharmaceutically acceptable excipients to obtain amlodipine granules; c) Mixing the losartan granules obtained in step a) with the amlodipine granules obtained in steps b); and d) Granulation of losartan, where the percentage of fine granules filtered through a 75 µm mesh is less than 50%. -------------------------------------------------------------------------------------------- Edited 27/08/2015 1. Solid pharmaceutical compounds consisting of amlodipine or its pharmaceutically acceptable salts and losartan or its pharmaceutically acceptable salts, where both amlodipine or its pharmaceutically acceptable salts and losartan or its pharmaceutically acceptable salts are in the form of separate granules. This compound contains granules of losartan, with a percentage of fine granules filtered through a 75 µm mesh of less than 50%. The dissolution rate of amlodipine under physical temperature conditions is 80% or more in 30 minutes at a pII of 1.0 to 2.0, and the compound contains losartan or its pharmaceutically acceptable salts in an amount ranging from 3 to 25% by weight, depending on the total weight of the compounds. 2. The composition of claim 1, which includes losartan or its pharmaceutically acceptable salts, in an amount ranging from 5 to 22.3% by weight, depending on the total weight of the components. 3. Components of claim 1 or 2, which include granules of losartan, where the percentage of fine granules filtered through a 75 µm mesh is less than 25%. 4. The third claim's components include granules of losartan, the percentage of fine granules filtered through a 75 µm mesh is less than 10%. 5. Any one of the components of claims 1 through 4, whereby the pharmaceutically acceptable salt of amlodipine is amlodipine camselac. 6. A method for preparing any one of the components of claims 1 through 5, consisting of separate granules of amlodipine and losartan, comprising the following steps: a) Granulation and drying of a mixture of losartan or its pharmaceutically acceptable salts and pharmaceutically acceptable excipients to obtain losartan granules; b) Granulation and drying of a mixture of amlodipine or its pharmaceutically acceptable salts and pharmaceutically acceptable excipients to obtain amlodipine granules; c) Mixing the losartan granules obtained in step a) with the amlodipine granules obtained in steps b); and d) Granulation of losartan such that the percentage of fine granules filtered through a 75 µm mesh is less than 50%.