Fenofibrate dispersible tablet formula and production process thereof
A technology of fenofibrate and production process, which is applied in the field of medicine, can solve the problems of inhibiting therapeutic effect, low bioavailability, slow disintegration speed, etc., and achieve the effects of ensuring drug efficacy, good moisture resistance, and moisture control
Inactive Publication Date: 2017-08-18
东莞市金美济药业有限公司
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Problems solved by technology
[0004] Fenofibrate products are traditionally produced in the form of tablets, which has poor controllability of the process, and because fenofibrate is almost insoluble in water, products of this type of structure produced in the traditional way The disintegration speed is slow and the time is long, generally more than 15 minutes, resulting in low bioavailability, affecting its clinical curative effect to some extent, and inhibiting the therapeutic effect
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[0033] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.
[0034] see figure 1 , a formulation of fenofibrate dispersible tablets, comprising micronized fenofibrate main drug substance and auxiliary materials meeting pharmaceutical standards, the particle size of the micronized fenofibrate main drug substance is ≤50 μm, By micronizing the raw materials, the dispersibility of the raw drug powder in the prescription preparation is increased to ensure the rapid disintegration and absorption of the drug; the auxiliary raw...
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Abstract
The invention discloses a fenofibrate dispersible tablet formula and a production process thereof. The fenofibrate dispersible tablet formula comprises a micronized fenofibrate main material and an auxiliary material in accordance with medicinal standards. The auxiliary material is prepared from filler, a wetting agent, an adhesive, a disintegrating agent and a lubricating agent. The main material and the auxiliary material are sequentially subjected to main production procedures including wet granulation, drying, size stabilizing, mixing, tabletting, aluminum plastic packaging, external packaging and the like through corresponding production devices. By making the best of the solid dispersion technique, a highly-dispersed state of medicines in a water-soluble polymer carrier can be formed, solubility and dissolution speed of indissolvable medicines can be effectively increased, and accordingly bioavailability of the medicines is improved. By solid dispersion, the disintegrating agent is added for preparation of granules to enable the medicines to be quickly disintegrated within 3min, and bioavailability of the medicines is improved.
Description
technical field [0001] The invention relates to the technical field of medicine, in particular to a formula of fenofibrate dispersible tablets and a production process thereof. Background technique [0002] With the change of people's lifestyle in our country, the average serum TC level of the population is gradually increasing, so the market size of blood lipid-lowering drugs in my country is expanding year by year. From 2002 to 2011, the compound growth rate of the amount of blood lipid-lowering drugs in my country reached 19.1%. It can be seen that hypolipidemic drugs have become the main varieties of urban hospitals in our country. Over the years, human beings have never ended their pursuit and exploration of lipid-regulating drugs, which has attracted great attention in many countries. Many pharmaceutical companies at home and abroad have also positioned their company's product structure in the cardiovascular field, taking the road of professional development. Thereby ...
Claims
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IPC IPC(8): A61K9/20A61K31/216A61K47/38A61K47/36A61K47/20A61P3/06
CPCA61K9/2095A61K9/2054A61K9/2059A61K31/216
Inventor 杨小兵
Owner 东莞市金美济药业有限公司