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Tebipenem pivoxil oral solid preparation and preparation method thereof

A technology of tipipenem ester and solid preparation, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., to achieve good compatibility, good stability, and prevent the intrusion of water. Effect

Active Publication Date: 2013-04-24
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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  • Tebipenem pivoxil oral solid preparation and preparation method thereof
  • Tebipenem pivoxil oral solid preparation and preparation method thereof
  • Tebipenem pivoxil oral solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Tipipenem granules

[0093]

[0094]

[0095] 1. Preparation before ingredients

[0096] 1.1 Material and equipment verification

[0097] Ensure that the materials are accurate and available, and the equipment is operating normally, and complete the setting of some parameters according to the instructions.

[0098] 1.2 Humidity Control

[0099] Detect ambient humidity, fluidized bed inlet air humidity requirement is 30±10%

[0100] 2 dosing

[0101] 2.1 Configuration of adhesive liquid

[0102] Weigh ethyl cellulose according to the adhesive solution prescription, stir (or ultrasonically) dissolve in absolute ethanol until clear, pass the solution through a 60-mesh sieve, and set aside.

[0103] 2.2 Configuration of the coating material of the isolation layer

[0104] Weigh ethyl cellulose and triethyl citrate according to the isolation layer prescription, stir (or ultrasonically) dissolve in absolute ethanol until clear, pass the solution through a 60-mesh ...

Embodiment 2

[0137] Tipipenem granules

[0138]

[0139]

[0140] 1. Preparation before ingredients

[0141] 1.1 Material and equipment verification

[0142] Ensure that the materials are accurate and available, and the equipment is operating normally, and complete the setting of some parameters according to the instructions.

[0143] 1.2 Humidity Control

[0144] Detect ambient humidity, fluidized bed inlet air humidity requirement is 30±10%

[0145] 2 dosing

[0146] 2.1 Configuration of adhesive liquid

[0147] Weigh the shellac according to the adhesive solution prescription, stir (or ultrasonically) dissolve it in absolute ethanol until clear, pass the solution through a 60-mesh sieve, and set aside.

[0148] 2.2 Configuration of the coating material of the isolation layer

[0149] Weigh ethyl cellulose and castor oil according to the isolation layer prescription, stir (or ultrasonically) dissolve in absolute ethanol until clear, pass the solution through a 60-mesh sieve, ...

Embodiment 3

[0182] Tipipenem granules

[0183]

[0184]

[0185] 1. Preparation before ingredients

[0186] 1.1 Material and equipment verification

[0187] Ensure that the materials are accurate and available, and the equipment is operating normally, and complete the setting of some parameters according to the instructions.

[0188] 1.2 Humidity Control

[0189] Detect ambient humidity, fluidized bed inlet air humidity requirement is 30±10%

[0190] 2 dosing

[0191] 2.1 Configuration of adhesive liquid

[0192] Weigh povidone according to the adhesive solution prescription, stir (or ultrasonically) dissolve in purified water until clear, pass the solution through a 60-mesh sieve, and set aside.

[0193] 2.2 Configuration of the coating material of the isolation layer

[0194] Weigh corn gluten and castor oil according to the prescription of the isolation layer, stir (or ultrasonically) dissolve in absolute ethanol until clear, pass the solution through a 60-mesh sieve, and s...

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PUM

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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 specifically relates to a stable oral solid preparation of tipipenem axetil and a preparation method thereof. Background technique [0002] Tebipenem Pivoxil, the English name is Tebipenem Pivoxil, the 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-Pivyl ester, the chemical structure is as follows: [0003] [0004] Tipipenem is an oral carbapenem antibiotic developed by Japan's Meiji Seika Co., Ltd., and it is the first product of this type to be approved for marketing. It is used for the treatment of ear, nose, throat and upper respiratory tract infections in pediatric patients. [0005] Wyeth Lederle Japanese company disclosed tipipenem ester compound and its preparation method and use in the European patent EP0632039 submitted on June...

Claims

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Application Information

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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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