Oxcarbazepine dry suspension, and preparation method thereof

A dry suspension, oxcarbazepine hydroxypropyl technology, applied in the field of pharmaceutical preparations, can solve the problems of certain risk of API stability, long drying time of wet granulation, poor material fluidity, etc., to improve bioavailability, The effect of reducing the risk of delamination and improving compliance

Inactive Publication Date: 2017-05-03
ZHEJIANG POLY PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing preparation method of dry suspension mainly consists of wet granulation and direct mixing of powder. Wet granulation takes a long time to dry and the process is relatively severe, which has certain risks to the stability of API; the process of direct mixing of powder has poor material fluidity. Poor, and easy to stratify during the filling process

Method used

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  • Oxcarbazepine dry suspension, and preparation method thereof
  • Oxcarbazepine dry suspension, and preparation method thereof
  • Oxcarbazepine dry suspension, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: Preparation of oxcarbazepine dry suspension:

[0022]

[0023] Preparation process steps:

[0024] (1) Take 450g of hydroxypropyl-β-cyclodextrin in a colloid mill, add 3L of purified water to fully disperse, then add 300g of oxcarbazepine and grind it into a paste for 2h, freeze-dry to obtain oxcarbazepine hydroxypropyl-β -Cyclodextrin inclusions and solids;

[0025] (2) The prescription amount of mannitol, xanthan gum, titanium dioxide, magnesium stearate and oxcarbazepine hydroxypropyl-β-cyclodextrin package compound is mixed at 10-20rpm for 5-10min in the mixing tank;

[0026] (3) The above mixture is added to the dry granulator, the horizontal screw feeding speed is 25 rpm, the vertical feeding screw speed is 10 rpm, the roller gap is 2 mm, and the screen mesh is 40 meshes to obtain oxcarbazepine dry particles;

[0027] (4) The prescription amount of sodium saccharin, micro-powdered silica gel and lemon flavor are respectively passed through 40 sieves and added to...

Embodiment 2

[0029] Example 2: Preparation of oxcarbazepine dry suspension:

[0030] Use the following prescription:

[0031]

[0032] The preparation process steps are the same as in Example 1.

Embodiment 3

[0033] Example 3: Preparation of oxcarbazepine dry suspension:

[0034] Use the following prescription:

[0035]

[0036] The preparation process steps are the same as in Example 1.

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PUM

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Abstract

The invention relates to an oxcarbazepine dry suspension, and a preparation method thereof. The oxcarbazepine dry suspension comprises following ingredients, by weight, 30 to 70% of an oxcarbazepine hydroxypropyl-beta-cyclodextrin inclusion compound, 20 to 60% of a filling agent, 1 to 5% of a suspending agent, 0.5 to 5% of a flow aid, 0.3 to 3% of an opacifying agent, and 0.1 to 5% of a flavoring agent; wherein the oxcarbazepine hydroxypropyl-beta-cyclodextrin inclusion compound is prepared via inclusion of oxcarbazepine with hydroxypropyl-beta-cyclodextrin at a weight ratio of 1:1-3. Inclusion of main drug oxcarbazepine with hydroxypropyl-beta-cyclodextrin is capable of increasing the solubility of oxcarbazepine greatly, and increasing bioavailability; and in addition, inclusion of cyclodextrin is capable of covering the bitter taste of oxcarbazepine, and improving compliance of child patients. In preparation process, dry granulation is adopted, and compared with wet granulation, dry granulation possesses following advantages: technical process of dry granulation is stable, and layering risk is reduced.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to drugs for treating epilepsy, and particularly to a dry suspension of oxcarbazepine and a preparation method thereof. Background technique [0002] Oxcarbazepine is a neurological drug that can be used for localized and generalized seizures. The original manufacturer of oxcarbazepine oral suspension was Novartis, with the trade name "Trileptal" (Trileptal), which was applied for listing on May 25, 2001 in the FDA. It is used for the treatment of primary generalized tonic-clonic and partial, with or without secondary generalized seizures. It is suitable for adults and children with epilepsy over 2 years old. [0003] Oxcarbazepine is slightly soluble in chloroform, dichloromethane, acetone and methanol, and almost insoluble in ethanol, ether and water. The existing technology to improve its in vitro dissolution is mainly achieved by micronization or adding an appropriate amoun...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/55A61K47/69A61P25/08
Inventor 范敏华
Owner ZHEJIANG POLY PHARMA
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