Pharmaceutical composition containing tamsulosin or hydrochloride thereof and preparation method therefor
A composition, tamsulosin technology, applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve problems such as spray gun clogging, particle size change, etc., to achieve the effect of improving productivity and shortening process time
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preparation Embodiment 1
[0126] Preparation Example 1: Preparation of sustained-release core particles
[0127] Core particles containing tamsulosin hydrochloride and coated with a sustained release coating layer were prepared.
[0128] First, tamsulosin hydrochloride, hydroxypropylmethylcellulose (HPMC) serving as a binder, ethanol, and pure water were mixed in a high-speed mixer at the content ratios shown in Table 1, and then talc was added to the mixture to prepare the first coating solution. Microcrystalline cellulose (MCC, 175, particle size 150 μm to 200 μm) into the fluidized bed system and bottom spray the first coating solution onto the inert seeds. After the spraying of the first coating solution was finished, the obtained seeds were dried to prepare core particles containing tamsulosin hydrochloride.
[0129] In order to form a sustained-release coating layer on the surface of each core particle, the SR 30D(EP) was dissolved in water, and talc was added thereto to prepare a sustained...
experiment example 1
[0132] Experimental Example 1: Comparison of Physical Properties of Tablets with Different Talc Contents
[0133] Tablets include an enteric coating formed on the sustained release core granules using a fluidized bed spray process. In this case, there were differences in process time and tablet quality depending on the content of talc used as an anti-adhesive agent in the enteric coating layer. In this Experimental Example, tablets were prepared using various enteric coating solutions having different contents of talc, and the physical properties of the prepared tablets were compared.
[0134]
[0135] Tablets were prepared according to the composition shown in Table 2. As the core particles, the sustained-release core particles prepared in Preparation Example 1 were used.
[0136] To prepare an enteric coating solution, use L30-D55 (methacrylic acid-ethyl acrylate 1:1 copolymer contained at a concentration of 30%) and NE30D (ethyl acrylate-methyl methacrylate copolyme...
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