| 摘要 |
The invention relates to a solid pharmaceutical dosage form comprising at least a first portion comprising telmisartan or a pharmaceutically acceptable salt thereof, and at least a second portion comprising amlodipine or a pharmaceutically acceptable salt thereof, and at least one non-hygroscopic pharmaceutically acceptable excipient having an equilibrium moisture content of 6 wt.% or less as determined by dynamic vapor sorption (DVS) at a relative humidity of 60% and a temperature of 25°C and selected from the group of fillers consisting of glucose, fructose, saccharose, raffinose, trehalose, dextrates, mannitol, erythritol, sorbitol, maltitol, xylitol, lactitol, calcium hydrogen phosphate, calcium carbonate, calcium lactate and mixtures thereof, wherein the second portion comprises less than 2 wt.% by weight of the second portion of a disintegrant. The invention also relates to a process for the preparation of said dosage form. The dosage form by the invention exhibits high chemical and physical stability, it can be prepared from inexpensive excipients and can be manufactured using a simple and economical process. |
