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Metformin hydrochloride controlled release tablet and preparation method thereof

A technology of metformin hydrochloride and controlled-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. Problems such as large tablet volume, to avoid high cost, simplify the preparation process, and achieve the effect of good uniformity

Inactive Publication Date: 2017-10-20
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Metformin hydrochloride monopharmaceuticals currently on the market include ordinary tablets, enteric-coated tablets, capsules, sustained-release tablets and controlled-release tablets marketed abroad. As far as the disclosed technology of metformin sustained-release tablets is concerned, there are two aspects. Disadvantages: First, because metformin hydrochloride is a kind of drug with good water solubility, and the raw material drug is too large for a single daily dose. After adding a large amount of excipients, the total weight of the developed drug is large, the size of the tablet is too large, and it is inconvenient to take orally; The existing film-controlled and controlled-release tablet process is relatively complicated, and the cost of process and equipment is high

Method used

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  • Metformin hydrochloride controlled release tablet and preparation method thereof
  • Metformin hydrochloride controlled release tablet and preparation method thereof
  • Metformin hydrochloride controlled release tablet and preparation method thereof

Examples

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Comparison scheme
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Embodiment 1

[0030] A metformin hydrochloride controlled-release tablet, comprising a tablet core and a coating semipermeable membrane, wherein the coating semipermeable membrane is 3.5% of the weight of the tablet core;

[0031] The components of the tablet core include by weight percentage: 80% of metformin hydrochloride, 10% of binder, 9.3% of penetration aid, and 0.7% of lubricant;

[0032] The components of the coated semi-permeable membrane include by weight percentage: 60% of film-forming material and 40% of porogen.

[0033] The preparation method of the above-mentioned metformin hydrochloride controlled-release tablet comprises the following steps: mixing the tablet core components evenly, granulating, and compressing tablets to obtain the tablet core; A transmembrane coating solution; the tablet core is coated with a semipermeable membrane coating solution, and then dried and matured to coat the semipermeable membrane to obtain metformin hydrochloride controlled-release tablets. ...

Embodiment 2

[0035] A metformin hydrochloride controlled-release tablet, comprising a tablet core and a coating semipermeable membrane, where the coating semipermeable membrane is 2% of the weight of the tablet core;

[0036] The components of the tablet core include by weight percentage: 90% of metformin hydrochloride, 1% of povidone, 8.5% of laurozone, and 0.5% of lubricant;

[0037] The components of the coating semipermeable membrane include by weight percentage: 50% of cellulose acetate, 45% of polyethylene glycol 6000, and 5% of polyethylene glycol 400.

[0038] The preparation method of the above-mentioned metformin hydrochloride controlled-release tablet comprises the following steps: mixing the tablet core components evenly, granulating, and tableting to obtain the tablet core; adding the coating semipermeable membrane component into acetone to dissolve to obtain the semipermeable membrane Coating solution: coating the tablet core with a semi-permeable membrane coating solution, t...

Embodiment 3

[0040] A metformin hydrochloride controlled-release tablet, comprising a tablet core and a coating semipermeable membrane, wherein the coating semipermeable membrane is 5% of the weight of the tablet core;

[0041] The components of the tablet core include by weight percentage: 70% of metformin hydrochloride, 15% of hydroxypropyl cellulose, 14% of propylene glycol, and 1% of lubricant;

[0042] The components of the coating semi-permeable membrane include: 70% of ethyl cellulose and 30% of hydroxypropyl cellulose Klucel LF by weight percentage.

[0043] The preparation method of the above-mentioned metformin hydrochloride controlled-release tablet comprises the following steps: mixing the tablet core components evenly, granulating, and tableting to obtain the tablet core; adding the coating semipermeable membrane component into acetone to dissolve to obtain the semipermeable membrane Coating solution: coating the tablet core with a semipermeable membrane coating solution, adju...

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Abstract

The invention discloses a metformin hydrochloride controlled release tablet which comprises a tablet core and a coating semipermeable membrane and is characterized in that the weight of the coating semipermeable membrane is 2-5 percent of that of the tablet core; the tablet core is prepared from the following components in percentage by weight: 70-90 percent of metformin hydrochloride, 1-15 percent of an adhesive, 1-15 percent of an infiltration-aid and 0.5-1 percent of a lubricant; and the coating semipermeable membrane is prepared from the following components in percentage by weight: 50-70 percent of a membrane forming material and 30-50 percent of a pore-foaming agent. The invention also discloses a preparation method of the metformin hydrochloride controlled release tablet. According to the preparation method, by selecting proper components for mutual matching, the metformin hydrochloride controlled release tablet is good in homogeneity of drug release and small in dosage of an auxiliary material, and thus being light in weight, small in size and convenient to take. The preparation method is simple to operate, omits steps of laser drilling and the like, simplifies a technology and is low in production cost and high in finished product rate of production.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a metformin hydrochloride controlled-release tablet and a preparation method thereof. Background technique [0002] With the development of pharmacy, the therapeutic advantages of oral sustained and controlled release preparations over ordinary immediate release preparations have been widely recognized. The release time of sustained and controlled release preparations is longer and the drug release is more stable. After taking the medicine, the plasma drug concentration in the patient's body fluctuates. It is very small, which not only reduces the number of times of taking medicine, but also improves the therapeutic effect and reduces the occurrence of side effects. Therefore, during the research and development of pharmaceutical preparations, more and more drugs for the treatment of chronic diseases are designed as sustained and controlled release dosage forms. [0003] Metfo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/155A61K47/10A61K47/18A61K47/38A61P3/10
CPCA61K9/0002A61K9/2072A61K9/2866A61K31/155A61K47/10A61K47/18A61K47/38
Inventor 吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH