Double-chamber osmotic pump type glipizide controlled release tablet and industrial production method

Abstract

The invention belongs to the technical field of glipizide controlled release tablets, and particularly relates to a double-chamber osmotic pump type glipizide controlled release tablet and an industrial production method. The double-chamber osmotic pump type glipizide controlled release tablet consists of a drug layer, a propelling layer, a rigid semi-permeable membrane, a drug release small holeand a moisture-proof layer; the drug layer takes polyethylene glycol 6000 as a carrier, granulation is carried out by a hot melting method, an organic solvent is not used, and low-power laser round punching is carried out to prepare the double-chamber osmotic pump type glipizide controlled release tablet. The double-chamber osmotic pump type glipizide controlled release tablet and the industrial production method have the advantages of simple granulation process, less equipment investment, high production efficiency, low energy consumption and suitability for industrial production. The produced controlled release tablet is good in stability and convenient to store and transport; organic solvent residues are completely avoided in a granulation process; in a double-layer tabletting process,the technical problem of color mixing is solved, the requirement on equipment performance is lowered, and the service life of the equipment is prolonged.

Description

technical field [0001] The invention belongs to the technical field of glipizide controlled-release tablets, and in particular relates to a double-chamber osmotic pump type glipizide controlled-release tablet and an industrial production method. Background technique [0002] The osmotic pump type controlled-release tablet fully mixes the drug and the osmotic solubilizing substance, and makes granules according to various granulation methods, and adopts double-layer compression to make a double-layer tablet core, one of which is a drug-containing layer, and the other is a drug-containing layer. Push layer, and then coat the tablet core with cellulose acetate to form a semi-permeable rigid outer membrane, and finally a drug release hole is made on the membrane by a laser. After the patient takes it, due to the penetration in the tablet core The active substance forms a high osmotic pressure, prompting water to enter the tablet from the semi-permeable membrane, and the propella...

AI Technical Summary

Problems solved by technology

It is greatly affected by light and heat conditions. Once the temperature exceeds 40°C, it will undergo obvious deterioration. In the production process, the drying temperature rises, the mechanical friction during tablet compression, and the temperature during coating can easily exceed this temperature. It is also prone to problems during long-term use and storage

[0010] 2. Due to the relatively large molecular weight of PEO, the speed of hydration and emulsification with water in the body is relatively slow, resulting in a long "time lag" for the drug to take effect, and it is difficult to take effect quickly after oral administration, which affects the drug's action time

And this property also makes it difficult to clean during the production process, which is not conducive to the maintenance of the production environment.

[0011] 3. The granulation method often used in the production process is generally wet granulation or dry granulation. When using wet granulation, due to its thermal instability and low drying temperature, it is easy to cause organic residues; when using dry granulation, industrialization During production, the equipment runs for a long time, and the temperature of the machine will rise significantly, and the material at the friction point of the mechanical transmission will be partially denatured, showing a "plastic"-like resin, which will affect the product quality and yield.

[0015] Because osmotic pump tablets need to be double-layered and double-colored, and the granules made by dry granulation or wet granulation, the colorant in it cannot be cured, and it is easy to scatter or adhere to the equipment. It is prone to color mixing of double-layer sheets, which affects product quality and interferes with the identification of subsequent laser drilling

[0016] 4. Organic residues

However, in the process of melting the small holes, a hard shell formed by melting the material will appear on the surface of the hole. When released in the body, the internal pressure formed by the propellant must first push away the hard shell to release smoothly. Aggravated the "time lag" phenomenon and delayed the onset time of drugs

In addition, the use of high-power lasers has relatively obvious laser intensity attenuation. In the process of industrial production, it is easy to cause batch-to-batch differences and unstable quality problems. Moreover, lasers with a power above 70W are subject to control when imported, equipment and equipment. There are certain obstacles in the subsequent maintenance and replacement of accessories

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