5 results about "Solifenacin Succinate" patented technology

The present invention relates to pharmaceutical compositions, specifically bilayer tablet formulations containing mirabegron and solifenacin succinate. The invention particularly addresses improvements in in-vitro release of solifenacin succinate in immediate release layer by improved manufacturing processes.

The invention belongs to the technical field of pharmaceutical preparations, and relates to a solifenacin succinate taste-masking composition and a preparation method thereof. Comprising solifenacin succinate and an auxiliary material for preparing the oral suspension, the auxiliary material comprises polacrilin potassium, and the mass ratio of solifenacin succinate to polacrilin potassium is (0.5-2): (1-4); the particle size condition of the polacrilin potassium is as follows: D90 is 110-180 [mu] m, and D50 is 30-80 [mu] m. The solifenacin succinate taste-masking composition provided by the invention not only has a good taste-masking effect, but also can improve the dissolution curve of solifenacin succinate, so that the medication compliance of a patient is improved, side effects are reduced, and the curative effect of solifenacin succinate is further ensured.

The invention belongs to the technical field of pharmaceutical analysis, and more specifically, a nitrosamine impurity can appear in the process of synthesizing and preparing solifenacin succinate by using a solifenacin succinate intermediate 01, and the invention develops a trace detection and analysis method for the nitrosamine impurity. The detection method is based on high performance liquid chromatography, quantitative detection of the nitrosamine impurity in solifenacin succinate is realized for the first time, the sensitivity is very high, the detection limit is 0.1130 mu g / mL, the quantification limit is 0.2260 mu g / mL, and strict requirements of trace analysis are met. In addition, according to the detection method, the peak area and the concentration of the target impurities are in a good linear relation, and the reliability of quantitative analysis is ensured. The detection and analysis method provided by the invention provides powerful technical support for safety and quality guarantee of solifenacin succinate drugs, and has good application prospects and application values.

A solifenacin succinate pharmaceutical composition comprises solifenacin succinate 5mg, sodium hexametaphosphate 0.25-0.75mg, sorbitol 72-108mg, microcrystalline cellulose 36-72mg, magnesium stearate 0.75-2.25mg. The solifenacin succinate pharmaceutical composition has high stability, reduces the generation of impurity I, and has good total mixture material fluidity, effectively improving the content uniformity.

The present invention relates to bilayer tablet pharmaceutical compositions comprising an immediate-release layer comprising solifenacin succinate as active ingredient, a binder, a distintegrant and at least one pharmaceutically acceptable excipient, a prolonged-release layer comprising mirabegron as active substance and at least one pharmaceutically acceptable excipient.