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Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet

A technology of dapoxetine hydrochloride and tadalafil, which is applied in the field of preparation of tadalafil and dapoxetine hydrochloride mixed tablets, can solve problems such as no research on mixed tablets, and achieve good application prospects and experimental results. Simple operation effect

Pending Publication Date: 2021-07-30
苏州康恒研新药物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] At present, the original drugs or generic drugs marketed in China are common release preparations, and there is no related research on mixed tablets

Method used

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  • Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet
  • Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet
  • Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] The prescribing information is as follows:

[0060]

[0061] (1) Tadalafil, PVP K 90 Sorbitol 188 was dissolved in 80mL dimethyl sulfoxide in sequence according to the above prescription ratio (tadalafil: PVP: sorbitol = 5:13:2), and rotatively evaporated in a water bath at 60°C until the liquid became viscous , evaporate the solvent completely at 80°C, place it in a refrigerator at -20°C for 4 hours, then dry it in a vacuum oven at 50°C for 24 hours, take it out, crush it, pass through a 60-mesh sieve, and store it in a desiccator for later use.

[0062] (2) Take tadalafil solid dispersion (tadalafil content 40% w / w), dapoxetine hydrochloride, microcrystalline cellulose, lactose, croscarmellose after calculating according to the prescription quantity Mix with sodium for 15 minutes, then add micronized silica gel, and mix for 3 minutes to obtain the total mixed powder.

[0063] (3) Press the tablet with a 6mm round punch, and the hardness is controlled at 7-11kgf. ...

Embodiment 2

[0066] The prescribing information is as follows:

[0067]

[0068] (1) Tadalafil, PVP K 90 Sorbitol 188 was dissolved in 80mL dimethyl sulfoxide in sequence according to the above prescription ratio (tadalafil: PVP: sorbitol = 5:13:2), and rotatively evaporated in a water bath at 60°C until the liquid became viscous , evaporate the solvent completely at 80°C, place it in a refrigerator at -20°C for 4 hours, then dry it in a vacuum oven at 50°C for 24 hours, take it out, crush it, pass through a 60-mesh sieve, and store it in a desiccator for later use.

[0069] (2) Take tadalafil solid dispersion (tadalafil content 40% w / w), dapoxetine hydrochloride, microcrystalline cellulose, lactose, croscarmellose after calculating according to the prescription quantity Mix with sodium for 15 minutes, then add micronized silica gel, and mix for 3 minutes to obtain the total mixed powder.

[0070] (3) Press the tablet with a 5mm round punch, and the hardness is controlled at 5-9kgf. ...

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Abstract

The invention discloses a preparation method of a tadalafil and dapoxetine hydrochloride mixed tablet, and belongs to the field of pharmaceutical preparations. The tadalafil and dapoxetine hydrochloride mixed tablet disclosed by the invention is prepared from, by weight, 10.00 to 30.00 percent of tadalafil solid dispersion, 30.00 to 55.00 percent of dapoxetine hydrochloride, 8.00 to 57.00 percent of a filler, 2.00 to 6.00 percent of a disintegrating agent and 1.00 to 3.00 percent of a lubricating agent. The prepared tadalafil and dapoxetine hydrochloride mixed tablet can be used for synergistically treating erectile dysfunction and premature ejaculation, and integrates the delay effect of dapoxetine and the erection assisting effect of tadalafil. The mixed tablet formed by mixing the tadalafil and the dapoxetine has a better treatment effect.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of a tadalafil and dapoxetine hydrochloride mixed tablet. Background technique [0002] Erectile dysfunction (ED) is the most common male sexual dysfunction, which refers to the persistent inability of the penis to achieve or maintain sufficient erection to complete a satisfactory sexual life. cause, which accounts for nearly 50% of ED cases. [0003] Tadalafil is a long-acting phosphodiesterase type 5 (PDE-5) inhibitor. Chinese chemical name: (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-[3,4-methylenedioxyphenyl]pyrazino[1 , 2,:1,6]pyrido[3,4-b]indole-1,4-dione, the structural formula is as follows: [0004] [0005] Developed by Eli Lilly and Company in the United States for the treatment of erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia. When sexual stimulation results in local release of nitr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4985A61K9/30A61P15/10A61P15/08A61K31/138
CPCA61K31/4985A61K31/138A61K9/2095A61K9/282A61P15/10A61P15/08A61K2300/00
Inventor 冯超孙玉侠霍文峰
Owner 苏州康恒研新药物技术有限公司
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