Glipizide controlled release tablet and preparation method thereof

Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a glipizide controlled release tablet and a preparation method thereof. The preparation method comprises the steps of mixing together a water-soluble matrix component with the moderate glass transition temperature for hot melt extrusion, and then mixing prepared solid dispersion with one or more adhesives; mixing an osmotic pressure promoter in a boosting layer, one or more adhesives, and optionally, a lubricant; and respectively pouring total mixed particles of a drug-containing layer and the boosting layer into a hopper, tabletting by adopting a tablet press cast with shallow dents, firstly pressing the drug-containing layer, then pressing the boosting layer, enabling the shallow dents to be positioned on the surface of the drug-containing layer, and then coating with a semipermeable membrane coating, so as to realize the continuous release of the glipizide controlled release tablet and have an acceptable dissolution curve.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a glipizide controlled-release tablet and a preparation method thereof. Background technique [0002] Glipizide is a second-generation sulfonylurea oral hypoglycemic agent. It mainly promotes the secretion of insulin by pancreatic β cells, especially the glucose-stimulated insulin secretion. It also enhances the action of insulin, thereby effectively reducing blood sugar concentration and glycosylated hemoglobin; it can also improve hyperlipidemia, reduce triglyceride and cholesterol levels, and increase the ratio of high-density lipoprotein cholesterol in total cholesterol; it can also inhibit platelets Aggregation and promotion of fibrinolysis, so it may have a certain preventive effect on vascular lesions. In 1984, Pfizer's trade name drug Glucotrol was listed for the first time, including a variety of specifications. In addition, there are many companies in the U...

AI Technical Summary

Problems solved by technology

The disadvantages are: laser perforation equipment is very expensive, the manufacturing cost is high, and in the mass production process, it is limited by the cycle time of laser light speed irradiation, and the attenuation of laser intensity can easily cause batch-to-batch differences and unstable quality

The disadvantages are: laser drilling is required, the manufacturing cost is high, and the mass production speed will be limited to a certain extent. In addition, it is necessary to control the laser perforation on the surface of the semi-permeable film coat measured on the drug layer, which further increases the complexity of the preparation process.

The disadvantages are: laser drilling is required, the manufacturing cost is high, and the product quality is greatly affected by the attenuation of laser intensity

[0012] Although the relevant preparation processes provided above are beneficial to improve the storage period of the product and realize industrialized production to a certain extent, these processes are for the controlled-release tablets of glipizide-controlled drugs. The laser perforation equipment used in the drug channel is very expensive, and the manufacturing cost is high. In the mass production process, it is limited by the cycle time of laser light speed irradiation, and the attenuation of laser intensity can easily cause batch-to-batch differences and unstable quality.

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