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Oral pharmaceutical composition of Fenofibrate

A fenofibrate and composition technology, applied in the field of hard capsule or soft capsule preparation, can solve the problems of incomplete dissolution, incomplete preparation method, and inability to lead to bioavailability of active ingredients and the like

Inactive Publication Date: 2010-05-26
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation method in this patent is not entirely satisfactory since it does not lead to complete bioavailability of the active ingredient and has several disadvantages
The technology of co-micronization of fenofibrate and solid surfactant does improve the dissolution rate of active ingredients, but this dissolution rate is still incomplete
That is, in the prior art, the dissolution rate of fenofibrate in a relatively short period of time is still difficult to achieve close to complete, for example, it reaches more than 80% within 30 minutes, preferably more than 85% within 30 minutes, and more 90% within 30 minutes. % above the level

Method used

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  • Oral pharmaceutical composition of Fenofibrate
  • Oral pharmaceutical composition of Fenofibrate
  • Oral pharmaceutical composition of Fenofibrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1, the oral pharmaceutical composition of fenofibrate

[0047] Ingredient Amount

[0048] Fenofibrate 50mg

[0049] MCT 300mg

[0050] Oleic acid 100mg

[0051] EL-35 400mg

[0052] 1,2-propanediol 200mg

[0053] Mix the prescribed amount of MCT, oleic acid and EL-35 evenly to obtain a mixed solution, add the prescribed amount of fenofibrate to the mixed solution, stir and dissolve to obtain a transparent solution, and then add the prescribed amount of 1,2-propanediol , to obtain a transparent solution, which becomes the fenofibrate oral pharmaceutical composition of the present invention.

[0054] The above pharmaceutical composition is further divided into soft capsules or hard capsules, each equivalent to 50 mg of fenofibrate, that is, the pharmaceutical composition of the present invention is in the form of a unit dose of pharmaceutical preparations.

Embodiment 2

[0055] Embodiment 2, the oral pharmaceutical composition of fenofibrate

[0056] Ingredient Amount

[0057] Fenofibrate 50mg

[0058] MCT 100mg

[0059] Oleic acid 200mg

[0060] EL-35 500mg

[0061] PEG-400 200mg

[0062]According to the method similar to that described in Example 1, the MCT, oleic acid and EL-35 of the prescription amount are mixed uniformly to obtain a mixed solution, and the fenofibrate of the prescription amount is added to the mixed solution, stirred and dissolved to obtain a transparent solution , then add the prescribed amount of PEG-400 to obtain a transparent solution, and then divide the obtained transparent solution into soft capsules, each equivalent to 50 mg of fenofibrate, which is the pharmaceutical combination of the present invention in the form of unit dose soft capsules thing.

Embodiment 3

[0063] Embodiment 3, the oral pharmaceutical composition of fenofibrate

[0064] Ingredient Amount

[0065] Fenofibrate 10mg

[0066] MCT 125mg

[0067] Oleic Acid 175mg

[0068] EL-35 450mg

[0069] PEG-400 250mg

[0070] The above-mentioned components are processed in a similar manner to that described in Example 1 to obtain a transparent solution, and then the obtained transparent solution is divided into soft capsules, each equivalent to 10 mg of fenofibrate, which is in the form of a unit dose of soft capsules The pharmaceutical composition of the present invention.

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Abstract

The invention provides an oral pharmaceutical composition of Fenofibrate, containing: (i) melted Fenofibrate; (ii) churning oil; (iii) a surface active agent; and (v) an aid surface active agent. The invention also provides a preparation method of the pharmaceutical composition. The pharmaceutical composition has high dissolution within short time and has obviously higher bioavailability in an animal body.

Description

technical field [0001] The present invention relates to the field of pharmaceutical preparations, in particular to a fenofibrate oral pharmaceutical composition, a method for preparing the pharmaceutical composition and a preparation containing the fenofibrate oral pharmaceutical composition, especially a hard capsule or a soft capsule preparation . Background technique [0002] Many drugs have the disadvantage of low solubility and insufficient dissolution in aqueous media, resulting in low bioavailability in organisms after oral administration. Thus, the required therapeutic dose must be increased to overcome this disadvantage. This is especially true for many active ingredients for lowering blood lipids, such as those belonging to fibrates. [0003] Fenofibrate (fenofibrate, chemical name: 2-(4-(4-chlorobenzoyl)phenoxy)-2-isopropyl methylpropionate) is a well-known hypolipidemic drug of clofibrate esters , its lipid-lowering effect is clear, and repeated medication has...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K9/66A61K31/215A61P3/06
Inventor 全东琴葛蔓
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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