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Desvenlafaxine hydrochloride pharmaceutical composition and preparation method thereof

A technology of desvenlafaxine and composition, which is applied in the directions of drug combination, pharmaceutical formula, sugar-coated pill, etc., can solve the problems of inability to coat, uneven particle size, low hardness of plain tablet, etc., and achieves overcoming uneven addition , The production process is easy to operate, and the effect of good stability

Inactive Publication Date: 2019-05-21
连云港恒运药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In addition, since desvenlafaxine hydrochloride is very soluble in water, the ordinary wet granulation process can easily cause uneven addition of the binder, resulting in uneven particle size, too high hardness, and difficulty in tableting, or The hardness of the prepared plain tablets is extremely small, which makes it impossible to coat and it is difficult to realize industrial production

Method used

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  • Desvenlafaxine hydrochloride pharmaceutical composition and preparation method thereof
  • Desvenlafaxine hydrochloride pharmaceutical composition and preparation method thereof
  • Desvenlafaxine hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0041] Six experiments were designed to investigate the effect of the concentration of wetting agent on the state of the obtained granules, the difficulty of sieving and the bulk density of the dried granules, and the ratio of ethanol / water was determined.

[0042] (a) Prescription of plain tablets

[0043] Table 1 Unit: mg

[0044]

[0045] (b) Prepare above-mentioned prescription according to A, preparation method, investigate the degree of difficulty of the granulation process in the preparation process, each test mainly takes the uniformity of granules, the degree of difficulty during granulation, and the bulk density of dry granules as evaluation indicators Make an evaluation.

[0046] Table 2: Evaluation Results

[0047]

[0048]

[0049] As shown in Table 2, when the concentration of ethanol is 60% to 95% or absolute ethanol, the obtained particles are uniform, easy to sieve, and the bulk density of the material is moderate, which is beneficial to the filling...

Embodiment 7-10

[0051] 4 experiments were designed to investigate the influence of different dosages of hypromellose on dissolution, and the dissolution characteristics were determined by f 2 factors are evaluated.

[0052] (a) Prescription of plain tablets

[0053] Table 3 Unit: mg

[0054]

[0055] (b) prepare above-mentioned prescription according to A, preparation method, f 2 Factors are used to evaluate the evaluation indicators.

[0056] Table 4: Evaluation Results (Unit: %)

[0057]

[0058]

[0059] As shown in Table 4, the release curves of hypromellose at 50%-80% dosage were similar. When the amount of hypromellose is less than 50%, the release curve is not similar; when the amount of hypromellose is greater than 80%, it is difficult to prepare tablets according to A, the preparation method.

Embodiment 11-14

[0061] 4 experiments were designed to investigate the influence of different dosages of hypromellose on dissolution, and the dissolution characteristics were determined by f 2 factors are evaluated.

[0062] (a) Prescription of plain tablets

[0063] Table 5 Unit: mg

[0064]

[0065] (b) prepare above-mentioned prescription according to A, preparation method, f 2 Factors are used to evaluate the evaluation indicators.

[0066] Table 6: Evaluation Results (Unit: %)

[0067]

[0068] As shown in Table 6, the release curves of hypromellose at 60%-80% dosage are similar.

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Abstract

The invention relates to a desvenlafaxine hydrochloride pharmaceutical composition and a preparation method thereof. The desvenlafaxine hydrochloride pharmaceutical composition contains desvenlafaxinehydrochloride, a gel matrix material, a filler, a lubricant and an anti-adhesive agent. The pharmaceutical composition is prepared by wet granulation and tabletting. The in-vitro release curves of the desvenlafaxine hydrochloride pharmaceutical composition provided by the present invention is substantially consistent with that of a reference preparation, and the desvenlafaxine hydrochloride pharmaceutical composition has good stability. The preparation process is simple and easy to operate, and the preparation process is smooth and easy to industrialize.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a tablet containing desvenlafaxine hydrochloride and a preparation method thereof. Background technique [0002] Venlafaxine is a new type of phenethylamine antidepressant. It is the first strong dual reuptake inhibitor of serotonin and norepinephrine and a weak inhibitor of dopamine. Compared with similar drugs, it has a rapid onset of action. , less adverse reactions and other advantages, it is the first-line treatment drug for severe depression. Desvenlafaxine is the main metabolite of venlafaxine, which achieves antidepressant effect by selectively blocking the reuptake of serotonin and norepinephrine. Desvenlafaxine was developed by Wyeth and marketed as its succinate; US Patent No. 2004044241 discloses desvenlafaxine succinate. Several companies have submitted generic applications for this salt to the FDA, such as Anchen, Apotex, Dr. Reddy’s Laboratories, Intell...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K47/38A61K31/137A61P25/24
Inventor 葛婷婷陈中亚周炳城
Owner 连云港恒运药业有限公司
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