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Orally disintegrating tablet containing faropenem sodium and preparation method thereof

A technology of faropenem sodium and orally disintegrating tablets, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing the safety of injections, not being suitable for industrial production, and large specifications of sustained-release tablets, and achieves simple and feasible preparation process and small difference in tablet weight , good fluidity effect

Active Publication Date: 2017-01-11
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN 1236814C discloses a composition of faropenem sodium and glutathione. In this invention, glutathione is used as an antioxidant to improve the stability of faropenem sodium. The stability of glutathione is worse than that without glutathione
The application of above-mentioned antioxidant etc. has all increased the unsafety of injection
[0008] CN102133193A discloses a faropenem sodium powder injection, in which faropenem sodium raw material powder is used as the only component and directly packaged, but a filling machine is required for forced feeding, and the filling volume varies greatly
[0009] CN102920682A discloses a gastric floating sustained-release preparation of faropenem sodium and a preparation method thereof, wherein the waterproof airbag is made of a common gastric-soluble hard capsule shell and is made of a waterproof layer composed of stearic acid and ethyl cellulose, and the isolation coat layer is made of hydroxyl Composed of propyl methylcellulose, lactose and mannitol, the drug-containing layer is composed of faropenem sodium and hydroxypropyl cellulose-SL, and the slow-release coating layer is composed of ethyl cellulose N-100 and hydroxypropyl cellulose-SL. The preparation process is cumbersome and not suitable for industrial production
The sustained-release tablets prepared by this invention have larger specifications and need to be administered as a whole tablet, which is not suitable for patients with swallowing difficulties

Method used

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  • Orally disintegrating tablet containing faropenem sodium and preparation method thereof
  • Orally disintegrating tablet containing faropenem sodium and preparation method thereof
  • Orally disintegrating tablet containing faropenem sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prepare faropenem sodium orally disintegrating tablets as follows:

[0028]

[0029] Get the faropenem sodium raw material and pass through a 70-mesh sieve, and mix with mannitol Parteck M 200 (average particle size is 215 μm, BET specific surface area is 2.89m 2 / g) into the multi-directional motion mixer, set the stirring gear to 3 speeds, the shearing gear to low speed, mix for 15 minutes, add magnesium stearate, mix for 5 minutes, and the mixed material is compressed into tablets with a rotary tablet press.

Embodiment 2

[0031] Prepare faropenem sodium orally disintegrating tablets as follows:

[0032]

[0033]

[0034] Get the faropenem sodium raw material and pass through a 70-mesh sieve, and mix with mannitol Parteck M 200 (average particle size is 215 μm, BET specific surface area is 2.89m 2 / g) into the multi-directional motion mixer, set the stirring gear to 3 speeds, the shearing gear to low speed, mix for 15 minutes, add magnesium stearate, mix for 5 minutes, and the mixed material is compressed into tablets with a rotary tablet press.

Embodiment 3

[0036] Prepare faropenem sodium orally disintegrating tablets as follows:

[0037]

[0038] Get the faropenem sodium raw material and pass through a 70-mesh sieve, and mix with mannitol Parteck M 200 (average particle size is 215 μm, BET specific surface area is 2.89m 2 / g) into the multi-directional motion mixer, set the stirring gear to 3 speeds, the shearing gear to low speed, mix for 15 minutes, add magnesium stearate, mix for 5 minutes, and the mixed material is compressed into tablets with a rotary tablet press.

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Abstract

The invention belongs to the field of medicines and provides an orally disintegrating tablet containing faropenem sodium. The orally disintegrating tablet also contains mannitol and a lubricating agent. According to the orally disintegrating tablet, less auxiliary materials are used; the composition formula is simple; the orally disintegrating tablet which is prepared from powder through tabletting still has good fluidity; the obtained tablet is reliable in hardness and high in disintegrating speed; and the dissolution behavior of the main drug is excellent.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to an orally disintegrating tablet containing faropenem sodium. Background technique [0002] The abuse of antibiotics has become one of the most important medical problems in the 21st century. Since the 1940s, penicillin was used clinically, which opened the precedent for the use of antibiotics. Penicillins belong to β-lactam antibiotics. With the extensive clinical use and abuse, the resistance of bacteria to antibiotics is increasing. The reason is that a variety of bacteria produce β-lactamase, which decomposes antibiotics, which makes penicillin The scope of application of antibiotics continues to decrease. Humans need to continuously develop new antibiotics to fight against various drug-resistant bacteria (even superbugs), and penem antibiotics are just a new type of β-lactam compounds discovered by people. Peptidases and various β-lactamases are stable ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/26A61K31/431
Inventor 赵志全张丽萍冯中张瑜程战立
Owner SHANDONG NEWTIME PHARMA
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