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Composition of pranlukast-containing solid preparation with improved bioavailability and method for preparing same

A composition and drug technology, applied in the directions of non-active ingredients medical preparations, drug combinations, heterocyclic compound active ingredients, etc., can solve problems such as increased preparation cost, and achieve the effects of improved bioavailability and improved release rate

Inactive Publication Date: 2018-05-08
SAM A PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, the spray-dried granules disclosed in the patent require a suspension method that strongly suspends pranlukast in the solvent, there are various variables in the preparation process according to the spray-drying method, and due to the Said complex preparation process increases said preparation cost

Method used

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  • Composition of pranlukast-containing solid preparation with improved bioavailability and method for preparing same
  • Composition of pranlukast-containing solid preparation with improved bioavailability and method for preparing same
  • Composition of pranlukast-containing solid preparation with improved bioavailability and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～10

[0057] [Example 1~10] Preparation of prankast wet granules

[0058] The active ingredient (Pranlukast) and diluent were placed in a high speed mixer and mixed. The binder and the surfactant are stirred and dissolved in the solvent to obtain a binder solution. The binding solution was put into the mixture and kneaded in a high speed mixer. A granulation process using a sieve may be added as needed, and the solvent is evaporated using a tray drier. The dried material was sieved with a sieve to obtain wet granules of prankast. Its specific composition is shown in Table 1 below.

[0059] [Table 1]

[0060]

[0061]

Embodiment 11～17

[0062] [Examples 11-17] Preparation of Prankast-containing Tablets

[0063] Tablets were prepared with the ingredients shown in Table 2 below by using the granules prepared in Examples 1, 6, 8 and 10. Specifically, wet granules and disintegrant are put into a mixer and mixed, and lubricant is put and further mixed. After that, Examples 11 to 17 were prepared by performing tablet compression and coating. Examples 11 to 16 were prepared so that each tablet contained 70 mg of pranlukast, and Example 17 was prepared so that each tablet contained 50 mg of pranlukast.

[0064] [Table 2]

[0065]

[0066]

experiment experiment example 1

[0067] [Experimental example 1] comparative dissolution test

[0068] A tablet and two Onon capsules (pranlukast 112.5 mg / capsule, single dose of 2 capsules) were prepared according to the method 2 dissolution test of Korean Pharmacopoeia (Korean Pharmacopoeia) for each of Examples 11, 14 and 16 , Donga-ST Co., Ltd.) for a comparative dissolution test.

[0069] 900 mL of the pH 6.8 solution was put into dissolution vessels respectively, and stirred at a rotation speed of 50 rpm while maintaining a temperature of 37±0.5° C. to measure the release rate. At each point, approximately 5 mL of the solution was withdrawn, filtered through a 0.45 μm filter and analyzed by HPLC. The result is as figure 1 shown.

[0070] Depend on figure 1 It can be seen that the release rate of the tablet prepared from the wet granulation according to the invention is significantly increased compared to Onon capsules as a commercial formulation.

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PUM

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Abstract

The present invention relates to a pharmaceutical composition containing pranlukast and a method for preparing the same. The present invention has a significantly improved pranlukast release rate andbioavailability compared with conventional pranlukast-containing products.

Description

technical field [0001] The present invention relates to a formulation containing pranlukast as an insoluble drug and a process for its preparation. More specifically, the present invention relates to a solid preparation containing pranlukast and a preparation method thereof, which have improved bioavailability and release rate by using only preparation equipment and preparation methods commonly used in the pharmaceutical field without using the Any special equipment and methods that would be relatively costly to prepare the formulations described, thereby reducing the single dose of pranlukast as much as possible compared to commercially available products, and improving patient compliance with the drug and reducing the risk of administering high doses of the drug. The resulting side effects. Background technique [0002] The present invention relates to preparations containing pranlukast and its preparation method, characterized in that, by adopting a preparation technolog...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/26A61K47/38A61K47/36A61K47/10A61K47/32A61K31/41A61P11/06A61P11/02A61P37/08
CPCA61K9/1617A61K9/1623A61K9/1635A61K9/1641A61K9/1652A61K31/41A61K9/1647A61K9/2027A61K9/2059A61K9/2054
Inventor 李揵熙金寿陈安炳佶朴尚满黄用渊
Owner SAM A PHARMA
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