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Oral solid preparation of tipipenem axetil and preparation method thereof

A technology for tipipenem ester and solid preparation, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., to achieve the effects of ensuring stability, ensuring stability and reducing risks

Active Publication Date: 2015-12-02
NANJING CAVENDISH BIO ENG TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite several approaches disclosed in the prior art, there remains a need for stable oral solid formulations of tipipenem axetil with satisfactory dissolution

Method used

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  • Oral solid preparation of tipipenem axetil and preparation method thereof
  • Oral solid preparation of tipipenem axetil and preparation method thereof
  • Oral solid preparation of tipipenem axetil and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Tipipenem axetil granules

[0093]

[0094]

[0095] 1. Preparation before ingredients

[0096] 1.1 Material and equipment verification

[0097] To ensure that the materials are accurate and available, the equipment operates normally, and some parameters are set according to the instructions.

[0098] 1.2 Humidity Control

[0099] Detect ambient humidity and fluidized bed inlet humidity requirements are 30±10%

[0100] 2 Dosing

[0101] 2.1 Configuration of the adhesive

[0102] Weigh ethyl cellulose according to the adhesive formula, dissolve it in absolute ethanol by stirring (or ultrasonically) until it becomes clear, and pass the solution through a 60-mesh sieve for later use.

[0103] 2.2 Configuration of barrier coating material

[0104] According to the prescription of the isolation layer, ethyl cellulose and triethyl citrate were weighed and dissolved in absolute ethanol by stirring (or ultrasonically) until they became clear, and the solution was pa...

Embodiment 2

[0137] Tipipenem axetil granules

[0138]

[0139]

[0140] 1. Preparation before ingredients

[0141] 1.1 Material and equipment verification

[0142] To ensure that the materials are accurate and available, the equipment operates normally, and some parameters are set according to the instructions.

[0143] 1.2 Humidity Control

[0144] Detect ambient humidity and fluidized bed inlet humidity requirements are 30±10%

[0145] 2 Dosing

[0146] 2.1 Configuration of the adhesive

[0147] Weigh shellac according to the adhesive formula, dissolve it in absolute ethanol by stirring (or ultrasonically) until it becomes clear, and pass the solution through a 60-mesh sieve for later use.

[0148] 2.2 Configuration of barrier coating material

[0149] According to the prescription of the isolation layer, ethyl cellulose and castor oil were weighed and dissolved in absolute ethanol by stirring (or ultrasonically) until they became clear, and the solution was passed through a...

Embodiment 3

[0182] Tipipenem axetil granules

[0183]

[0184]

[0185] 1. Preparation before ingredients

[0186] 1.1 Material and equipment verification

[0187] To ensure that the materials are accurate and available, the equipment operates normally, and some parameters are set according to the instructions.

[0188] 1.2 Humidity Control

[0189] Detect ambient humidity and fluidized bed inlet humidity requirements are 30±10%

[0190] 2 Dosing

[0191] 2.1 Configuration of the adhesive

[0192] Weigh povidone according to the adhesive formula, dissolve it in purified water by stirring (or ultrasonically) until it becomes clear, and pass the solution through a 60-mesh sieve for use.

[0193] 2.2 Configuration of barrier coating material

[0194] According to the prescription of the isolation layer, zein and castor oil were weighed and dissolved in absolute ethanol by stirring (or ultrasonication) until they became clear, and the solution was passed through a 60-mesh sieve fo...

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Abstract

The invention discloses a tebipenem pivoxil oral solid preparation and a preparation method thereof. The oral solid preparation disclosed by the invention comprises particles, an isolation coating layer, a taste masking coating layer and a coloring tender taste coating layer, wherein the particles are prepared from tebipenem pivoxil, microcrystalline cellulose and binders. According to the invention, the preparation can be used for overcoming the problem that a part of water in main medicines and excipients has an interaction to affect the quality of a finished product, and is suitably prepared into a medicine.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and more particularly relates to a stable oral solid preparation of tipipenem etexilate and a preparation method thereof. Background technique [0002] Tebipenem ester, English name Tebipenem Pivoxil, chemical name is (+)-hydroxymethyl (4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7- Oxo-3-{[1-(2-thiazolin-2-yl)-3-aza]thio}-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid- 2-Pivoxil ester, the chemical structure is as follows: [0003] [0004] Tipipenem etexilate is an oral carbapenem antibiotic developed by Meiji Seika Co., Ltd., and is the first of its kind to be approved for the treatment of ENT and upper respiratory tract infections in pediatric patients. [0005] WyethLederle Japan Co., Ltd. disclosed tipipenem ester compound and its preparation method and use in European patent EP0632039 filed on June 30, 1994. [0006] CSPC Zhongqi Pharmaceutical Technology (Shijiaz...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/36A61K9/48A61K31/427A61K47/38A61K47/44A61K47/32A61P31/04
Inventor 程浩许馨文刘歆袁士发
Owner NANJING CAVENDISH BIO ENG TECH
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