Metformin hydrochloride floating sustained-release tablet and preparation method thereof

Abstract

The invention provides a metformin hydrochloride floating sustained-release tablet and a preparation method thereof. The metformin hydrochloride floating sustained-release tablet comprises a tablet core and a non-gastric-soluble coating film wrapped outside the tablet core, wherein the tablet core comprises metformin hydrochloride, a floating material, an adhesive and other excipients, and non-gastric-soluble coating film comprises a film forming material and other excipients. The tablet core is prepared by matching the above materials, and is matched with the non-gastric-soluble coating filmoutside the tablet core, and the density of the tablet core is less than 1g / cm<3>, so that the metformin hydrochloride floating sustained-release tablet can immediately float in water or gastric juice, thereby reducing the possibility of the tablet being discharged from the stomach into the duodenum, and prolonging the time in which the metformin hydrochloride sustained-release tablet floats in the stomach; the metformin hydrochloride floating sustained release tablet can float until the contents of the stomach are emptied, thereby ensuring that the medicine is released in the stomach; the metformin hydrochloride floating sustained-release tablet provided by the invention does not swell substantially in water or gastric juice, thereby reducing the possibility of abdominal distension feeling of a patient.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a metformin hydrochloride gastric floating sustained-release tablet and a preparation method thereof. Background technique [0002] Metformin is the drug of choice for the treatment of type 2 diabetes, and it is also recognized as a first-line drug and basic drug worldwide. Its absorption site is mainly at the upper end of the small intestine, so if it is made into an ordinary sustained-release preparation, when the preparation has passed through the main absorption site and the drug contained in it has not been released, part of the drug will not be fully absorbed, resulting in a decrease in bioavailability . The metformin hydrochloride gastric floating sustained-release preparation floats in the stomach for a long time and slowly releases the drug, so that almost all the drug can be absorbed through the main absorption site in the upper small intestine, so it has the a...

AI Technical Summary

Problems solved by technology

This kind of floating tablet usually has a floating time, that is, the tablet itself cannot float when it just contacts with water (or liquid in the stomach), usually this floating time is several minutes to ten minutes, which causes A potential risk is that the tablet may be excluded from the pylorus and enter the duodenum before floating, thus losing the effect of gastric floating; another disadvantage of this kind of gastric floating tablet is that due to its main The ingredients are matrix controlled-release materials. During the drug release process, with the erosion of the matrix controlled-release materials, the tablets gradually become smaller and the floating ability gradually decreases, so many tablets lose their floating ability after 8-12 hours

[0004] CN101536989A discloses a metformin hydrochloride intragastric floating sustained-release tablet, the sustained-release tablet is composed of the following components in weight ratio: metformin hydrochloride 55-65%, skeleton material 25-35%, gas generating agent: 4-8 %, Lubricant: 0.5-2%, Binder: 0.5-4%, however, this slow-release tablet can only generate carbon dioxide under the action of gastric acid with the help of a gas generating agent, so that the tablet will float, which still takes a few seconds When it takes more than ten seconds to float, it cannot float immediately

A disadvantage of this kind of metformin hydrochloride sustained-release tablet that expands in the stomach is that some patients report a feeling of gastric distension after taking the medicine. This side effect may be due to the large volume of the expanded tablet, which brings discomfort to the patient.

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