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Oral preparation containing tebipenem pivoxil

A technology of tibipenem and oral preparations, which is applied in the field of pharmaceutical preparations containing tibipenem as an active ingredient, can solve problems such as inconsistencies in crystal forms, affecting curative effect and safety, and affecting drug dissolution, and achieve good results. The effect of stability

Active Publication Date: 2013-01-23
NANJING HUAWE MEDICINE TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Different synthetic routes, different extraction and refining processes may produce different crystal forms of raw materials, and may even obtain a mixture of multiple crystal forms, which will affect the quality and stability of the preparation. On the other hand, some oral preparations , inconsistent crystal forms may affect the dissolution of the drug, resulting in differences in drug absorption, to a certain extent affect its efficacy and safety

Method used

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  • Oral preparation containing tebipenem pivoxil
  • Oral preparation containing tebipenem pivoxil
  • Oral preparation containing tebipenem pivoxil

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0024] The production of the formulation of the present invention is described by the following examples, which explain the present invention in more detail and do not constitute a limitation to the present invention.

[0025] Implementation Example A (Example)

[0026] Based on the weight of granules containing 50 mg tibipenem

[0027]

[0028] Production: Mix tibipenem, sucrose, and microcrystalline cellulose in a wet mixing granulator, and add 10% hydroxypropyl cellulose aqueous solution to make granules. The prepared granules were coated with an aqueous coating solution containing Eudragit L30D-55 aqueous dispersion. Finally, the aspartame, the powdered essence and the coated granules are evenly mixed, and divided into granules each containing 50 mg of tibipenem.

[0029] Implementation example B (comparative example)

[0030] Based on the weight of granules containing 50 mg tibipenem

[0031]

[0032]

[0033] Production: Mix tibipenem, sucrose, and microcrys...

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Abstract

An oral preparation containing tebipenem pivoxil is characterized by comprising the following components in percentage by weight: 1 to 20 percent of tebipenem pivoxil, 60 to 98 percent of filler, 0.5 to 10 percent of adhesive and 3 to 50 percent of coating agent; and only water is taken as a solvent in the preparation of the oral preparation. The bitter taste of raw medicines is covered by using a taste-covering technology, and the oral preparation is suitable for children. In a whole preparation process, only water is taken as the solvent, so that stability and safety of the preparation in preparation and storage processes are guaranteed.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a pharmaceutical preparation combination containing tibipenem ester as an active ingredient. Background technique [0002] Tibipenem is a new broad-spectrum antibiotic of the carbapenem class. Its structural characteristics are that the side chain at the C3 position is a thiazolyl-substituted azetidine group, and at the same time, it is formed by forming a pivyl ester from a carboxylic acid at the C2 position. Prodrugs that enhance oral absorption. The oral absorbability of this product is better than most of the β-lactam antibiotics that are already on the market. Tibipenem has a broad antibacterial spectrum. For most of the clinically isolated strains (except for a small number of strains such as Enterococcus faecium (Enterococcus faecium) and Pseudomonas aeruginosa (Pseudomonas aeruginosa)), tibipenem has shown stronger antibacterial activity than penicillin ser...

Claims

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Application Information

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IPC IPC(8): A61K31/427A61K9/16A61P31/04
Inventor 程晓佳蒋玉伟张孝清吴琳
Owner NANJING HUAWE MEDICINE TECH DEV
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