Dapoxetine hydrochloride orally disintegrating tablet, preparation method thereof an application of orally disintegrating tablet

A technology of hydrochloric acid and tablet disintegration, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of complicated process and low operability, and achieve simple preparation process and easy use Convenience, bioavailability enhancement effect

Inactive Publication Date: 2020-02-25
盖天力医药控股集团制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN201510827956.3 discloses the preparation process of preparing dapoxetine hydrochloride into solid dispersion and then directly compressing tablets with auxiliary materials. Although the tablets prepared by this process dissolve quickly and can be released quickly, organic solvents are used in the process , we need to pay attention to issues such as organic solvent residues in the later stage, and the process is complicated, and the actual operability is not high

Method used

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  • Dapoxetine hydrochloride orally disintegrating tablet, preparation method thereof an application of orally disintegrating tablet
  • Dapoxetine hydrochloride orally disintegrating tablet, preparation method thereof an application of orally disintegrating tablet
  • Dapoxetine hydrochloride orally disintegrating tablet, preparation method thereof an application of orally disintegrating tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Dapoxetine Hydrochloride 34g Mannitol 45g Crospovidone 8g Croscarmellose Sodium 3g Hydroxypropyl Cellulose 8g Menthol 1g Magnesium stearate 1g

[0035] Preparation:

[0036] (1) Pass dapoxetine hydrochloride and various auxiliary materials through an 80-mesh sieve, and set aside;

[0037] (2) Mix the prescribed amount of dapoxetine hydrochloride, mannitol, crospovidone, croscarmellose sodium, and hydroxypropyl cellulose for 20 minutes to obtain a uniformly mixed premixed powder;

[0038] (3) Add the prescribed amount of menthol and magnesium stearate, and mix for 2 minutes to obtain the total mixed powder;

[0039] (4) The total mixed powder is compressed into tablets by direct compression technology, and the tablet weight is controlled to 100mg, and the hardness is 40N.

Embodiment 2

[0041] Dapoxetine Hydrochloride 20g Mannitol 60g Crospovidone 2.5g Croscarmellose Sodium 10g Hydroxypropyl Cellulose 5g Menthol 1g Magnesium stearate 4g

[0042] Preparation:

[0043] (1) Pass dapoxetine hydrochloride and various auxiliary materials through an 80-mesh sieve, and set aside;

[0044] (2) Mix the prescribed amount of dapoxetine hydrochloride, mannitol, crospovidone, croscarmellose sodium, and hydroxypropyl cellulose for 20 minutes to obtain a uniform premixed powder;

[0045] (3) Add the prescribed amount of menthol and magnesium stearate, and mix for 2 minutes to obtain the total mixed powder;

[0046] (4) The total mixed powder is compressed into tablets by direct compression technology, and the tablet weight is controlled to 100mg, and the hardness is 20N.

Embodiment 3

[0048] Dapoxetine Hydrochloride 60g Mannitol 45g Croscarmellose Sodium 22.5g Hydroxypropyl Cellulose 15g Menthol 2.25g Magnesium stearate 2.25g Micropowder silica gel 3g

[0049] Preparation:

[0050] (1) Pass dapoxetine hydrochloride and various auxiliary materials through an 80-mesh sieve, and set aside;

[0051] (2) Mix the prescribed amount of dapoxetine hydrochloride, mannitol, croscarmellose sodium, and hydroxypropyl cellulose for 20 minutes to obtain a uniform premixed powder;

[0052] (3) Add the prescribed amount of menthol, magnesium stearate and micropowder silica gel, and mix for 2 minutes to obtain the total mixed powder;

[0053] (4) The total mixed powder is compressed into tablets by direct compression technology, and the tablet weight is controlled to 150mg, and the hardness is 60N.

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Abstract

The invention discloses a dapoxetine hydrochloride orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet comprises dapoxetine hydrochloride, fillers, disintegrating agents, dried binding agents, penetration promoting flavoring agents and lubricating agents. The orally disintegrating tablet is prepared by a direct tablet pressing method. The orally disintegrating tablet has the advantages that the orally disintegrating tablet is simple in preparation process, low in cost and convenient to take and has high effect on male premature ejaculation. The orally disintegrating tablet contains 0.1%-2% of penetration promoting flavoring agents, the taste of the orally disintegrating tablet is improved, stability of the orally disintegrating tablet is improved, absorption of the orally disintegrating tablet is further improved, the maximum plasma concentration (Cmax) is achieved within 0.5-1 hour after the orally disintegrating tablet is taken, effect taking time becomes earlier, and bioavailability is remarkably improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a dapoxetine hydrochloride orally disintegrating tablet and a preparation method and application thereof. Background technique [0002] Dapoxetine hydrochloride is a white to off-white crystalline powder that is easily oxidized. The chemical name is (S)-(+)-N,N-dimethyl-3-(1-naphthyloxy)amphetamine hydrochloride, and its structural formula is as follows: [0003] [0004] Dapoxetine, which was first researched and developed by Eli Lilly in the United States, was used for the treatment of antidepressant and underwent phase I clinical trials. The antidepressant effect was not satisfactory, and then this product was transferred to PP Tian Pharmaceutical Group, After the discovery of its subsidiary PP Tian Genu Pro, it was used to treat premature ejaculation patients, and a phase II clinical trial was carried out; finally, all this product was transferred to Alza, a div...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/10A61K47/26A61K47/32A61K47/38A61K31/138A61P15/08
CPCA61K9/0056A61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K9/2095A61K31/138A61P15/08
Inventor 李庆华
Owner 盖天力医药控股集团制药股份有限公司
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