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Method for preparing metoclopramide hydrochloride sustained-release capsule

A technology of metoclopramide hydrochloride and sustained-release capsules, which can be used in medical preparations containing active ingredients, pharmaceutical formulations, and devices for making medicines into special physical or taking forms, etc. Uniform, low drying efficiency, easy to break and other problems, to achieve the effect of good product quality, stable and reliable quality, and saving man-hours

Inactive Publication Date: 2009-06-24
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the particle coating method of multi-particle sustained-release preparations mainly adopts the coating pan coating method. This coating method is slow in preparation speed, easy to adhere, easy to break, low drying efficiency, and uneven coating layer.
Moreover, the working cycle is prolonged in actual large-scale production, and the release rate of the prepared micropills is not stable enough after filling the capsule.

Method used

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  • Method for preparing metoclopramide hydrochloride sustained-release capsule
  • Method for preparing metoclopramide hydrochloride sustained-release capsule
  • Method for preparing metoclopramide hydrochloride sustained-release capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Add 20 g of metoclopramide hydrochloride into 20 ml of purified water, stir to dissolve, and adjust the pH to 4.2 with dilute hydrochloric acid. Add 4g of hypromellose (species code: E15) to 70ml of ethanol and stir to disperse thoroughly, then add 10ml of purified water to dissolve. Mix the above two solutions, add talc powder 6g. Stir to suspend the talc powder in the coating solution of the main drug layer, fluidize and coat 200g of blank pellets, and control the coating conditions: the inlet air temperature is 65°C, and the air inlet volume is 20M 3 / h, the spraying speed is 2.0g / min, and the temperature range of the product measured by the fluidized bed is 50±5°C during the whole process. The final weight of the coated pellets was 220.3 g after drying.

[0020] Add 111.1 g of ethyl cellulose water dispersion (type number: E-7-19040) to the beaker, add purified water to 185.7 g, and stir for 15 minutes. Take 216g of the pellets coated with the drug-coated layer, ...

Embodiment 2

[0022] Add 70 g of metoclopramide hydrochloride to 70 ml of purified water, stir to dissolve, and adjust the pH to 5.0 with dilute hydrochloric acid. Measure 400ml of 80% ethanol, stir and add 40g of crospovidone, and stir for 20 minutes. Mix the above two solutions, fluidize and coat 500g blank pellets, control the coating conditions: air inlet temperature 70°C, air inlet volume 28M 3 / h, the spraying speed is 5.0g / min, and the temperature range of the product measured by the fluidized bed during the whole process is 55±5°C. The final weight of the coated pellets was 600.8g after drying.

[0023] Add 84.6 g of ethyl cellulose aqueous dispersion (type number: E-7-19040) to the beaker, add purified water to 142.8 g, and stir for 15 minutes. Take 300g of the pellets coated with the drug-coated layer, fluidize the coating, and control the coating conditions: the air inlet temperature is 40°C, and the air inlet volume is 20M 3 / h, the spray speed is 2.5g / min, and the temperatur...

Embodiment 3

[0025] Take 70g of metoclopramide hydrochloride and add 80ml of purified water, stir to dissolve, and adjust the pH to 3.8 with dilute hydrochloric acid. Measure 200ml of 80% ethanol, stir and add 30g of crospovidone, and stir for 20 minutes. Mix the above two solutions, add 6.6g of talcum powder, fluidize and coat 500g of blank pellets, control the coating conditions: air inlet temperature 50°C, air inlet volume 25M 3 / h, the spray speed is 7.0g / min, and the temperature range of the product measured by the fluidized bed is 40±5°C during the whole process. The final weight of the coated pellets was 592.2 g after drying.

[0026] Add 320 g of ethyl cellulose aqueous dispersion (species number: E-7-19040) to the beaker, add purified water to 533.3 g, and stir for 15 minutes. Take 400g of the pellets coated with the drug-coated layer, fluidize the coating, and control the coating conditions: the air inlet temperature is 40°C, and the air inlet volume is 20M 3 / h, the spraying ...

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Abstract

The invention discloses a method for preparing micropills in a metoclopramide hydrochloride slow release capsule through the coating by a fluidized bed. In the method, the coating of main medicine layers and slow release layers of the micropills is operated by the fluidized bed, and a preferred fluidized coating control scheme is provided. The method greatly improves coating speed and drying efficiency, shortens working period, can reach ideal release rate in a dissolution rate experiment, and is suitable for mass production.

Description

technical field [0001] The invention relates to a preparation method of metoclopramide hydrochloride sustained-release capsules. Background technique [0002] Metoclopramide Hydrochloride (Metoclopramide Hydrochloride), molecular formula: C 14 h 22 ClN 3 o 2 ·HCl·H 2 O, chemical name: 4-amino-5 chloro-N-[2-(diethylamino)ethyl]-2-benzyloxy hydrochloride, is a dopamine receptor antagonist. It has a pronounced gastrointestinal stimulant effect and the ability to promote synergy between the gastric pylorus and the small intestine. Therefore, metoclopramide hydrochloride is useful in the treatment and prevention of various types of emesis. In addition to other indications are: esophageal reflux disease, gastroparesis, dyspepsia and other gastrointestinal disorders. [0003] Oral sustained-release and controlled-release formulations are widely used to modify the release rate of pharmaceutically active substances. Among the many sustained-release dosage forms, the dosage fo...

Claims

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Application Information

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IPC IPC(8): A61K31/166A61K9/52A61P1/04A61P1/14A61J3/00
Inventor 杨戈
Owner YAOPHARMA CO LTD
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