Preparation method for slow-release tablet of indapamide-containing medicament

A technology for indapamide and sustained-release tablets, which is applied in the field of preparing a sustained-release preparation containing indapamide medicines, can solve the problem of increased difficulty in preparation quality control, increased cost and prescription complexity, and easy re-partitioning of compressed tablets. layer and other problems, to achieve the effect of simple and easy production process, reduced mutual influence and low cost

Inactive Publication Date: 2012-07-18
CHONGQING KERUI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using the conventional mixing method, the drug and HPMC are mixed directly, which is difficult to mix evenly, and a large amount of other excipients with good fluidity need to be added to improve performance, which not only limits the use of HPMC, but also increases the cost and complexity of the prescription. Due to the density difference of the drug and various excipients, it is easy to re-layer in the tablet, which makes the quality control of the preparation more difficult
For example, patent application CN1943564 discloses a prescription composition and preparation process of indapamide sustained-release tablets. HPMC is used as the sustained-release material, and a relatively large amount of other excipients are required as fillers. The preparation process adopts direct powder compression. It is more difficult to implement in production

Method used

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  • Preparation method for slow-release tablet of indapamide-containing medicament
  • Preparation method for slow-release tablet of indapamide-containing medicament
  • Preparation method for slow-release tablet of indapamide-containing medicament

Examples

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preparation example Construction

[0018] In an embodiment, a method for preparing a sustained-release tablet containing indapamide, comprising the following steps:

[0019] 1) Wetting: A conventional wet granulator with an atomizing device is used, and the purified water enters the mixing tank of the closed wet granulator in an atomized form through the atomizing device. At the same time, the hydroxypropyl methylcellulose Add the prime (HPMC) powder into the mixing tank, and keep stirring to make the surface of the HPMC powder fully contact with the water mist to obtain the HPMC wet material;

[0020] 2) Granulation: Use a swinging granulator to granulate the HPMC wet material obtained in step 1), and the obtained granules are dried and sized to obtain HPMC granules.

[0021] 3) Mixing: uniformly mix the HPMC granules obtained in step 2) with indapamide and lubricant in a weight ratio of 50-100:1.5:0.25-1, and compress the mixture into tablets to obtain indapamide sustained-release tablets.

[0022] In the em...

Embodiment 1

[0027] Compared the results of wet granulation of HPMC E5 (5 mPa s), K4M (4000mPa s) and K100M (100000mPa s) with different viscosities by using the granulation method of the present invention and directly adding water and adding absolute ethanol. It can be seen that adopting the method of the present invention can produce granules with good appearance and fluidity for HPMC with different viscosities, and adding more water can also improve the viscosity of the material and enable normal granulation. However, directly adding water or absolute ethanol to granulate high and low viscosity HPMC cannot uniformly wet it. Even if a small amount is added, gel "pimples" of varying degrees will be formed rapidly, and granules cannot be obtained by sieving.

[0028] Add 10kg of HPMC with different viscosity specifications into the high-efficiency wet granulator, add atomized water (particle size ≤ 5μm), non-atomized water and absolute ethanol at a speed of 60g / min, and granulate. The part...

Embodiment 2

[0034] Compared the results of wet granulation of the mixture containing 30% HPMC (K4M) and 70% lactose as diluent by directly adding water and adding absolute ethanol by using the granulation method of the present invention, it can be known from the results that by using this method, Granules with good appearance and flow properties can be obtained, and the granulation process is easier to carry out than in Example 1. By directly adding absolute ethanol, it can basically be evenly wetted, with only a small amount of gel "pimples", most of which can be sieved to obtain better particles. If water is added directly, severe gel "pimples" are still formed, and granules cannot be obtained by sieving. The granules made with absolute ethanol are looser, brittle when granulated, and have more fine powders.

[0035] Add 10 kg of K4M HPMC and lactose (3:7) mixture into the high-efficiency wet granulator, and add atomized water (particle size ≤ 5 μm), non-atomized water and absolute eth...

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Abstract

The invention aims to provide a preparation method for a slow-release tablet of an indapamide-containing medicament. In the method, water is taken as a wetting agent for performing HPMC (Hydroxy Propyl Methyl Cellulose) wet granulation, and the prepared HPMC particles are compact and regular, are porous on the surface and have high liquidity. HPMC particles and a small amount of indapamide can be uniformly mixed by adopting the conventional mixing way, so that preparation of the slow-release tablet is finished. A plurality of other auxiliary materials are not required to be added additionally, an organic solvent is not required for granulating, the slow release controlling effect on the releasing degree of the prepared tablet is good, and granulation can be completed by adopting the conventional granulation equipment.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to preparing a slow-release preparation containing indapamide. Background technique [0002] The currently used indapamide sustained-release tablets usually only contain a small dose of about 1.5 mg of indapamide. Many formulations of indapamide sustained-release tablets use high-viscosity hydroxypropylmethylcellulose (HPMC) as sustained-release excipients. As a commonly used pharmaceutical polymer excipient, HPMC will swell and form a gradually eroded gel group when encountering a large amount of water, which can play a good slow-release control effect. However, during production, when the formulation contains high viscosity and (or) a large amount of HPMC, if the wet granulation process is adopted, many restrictions will be imposed. Water cannot be used as a wetting agent or binder solvent granulation is one of them, because whether water is poured directly into the ma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/404A61K47/04A61J3/00
Inventor 马滔刘睿斌苏其果刘俊敏罗川萍王平郑磊
Owner CHONGQING KERUI PHARMA GRP
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