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Tadalafil tablet and preparation method thereof

A technology of danafil tablet and dalafil tablet, which is applied in the field of medicine, can solve problems such as unguaranteed product quality, difficult process control, and gastrointestinal irritation, so as to improve bioavailability, simplify preparation process, improve The effect of solubility

Active Publication Date: 2022-04-12
FUJIAN COSUNTER PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Correspondingly, the present invention also provides a kind of preparation method of tadalafil tablet, and it solves the problem that the mixing inhomogeneous and product quality that crude drug micronization causes can't guarantee, and add surfactant in tadalafil dosage form Technical issues such as difficulty in controlling the process and irritating the gastrointestinal tract during application

Method used

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  • Tadalafil tablet and preparation method thereof
  • Tadalafil tablet and preparation method thereof
  • Tadalafil tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] In 1000 tadalafil tablets, 2.5g of tadalafil, 1g of hydroxypropyl cellulose, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium, and 0.5g of magnesium stearate.

[0051] The preparation method of the tadalafil tablet of the present embodiment is:

[0052] S1 After adding hydroxypropyl cellulose into purified water and stirring to dissolve, adding tadalafil and stirring to disperse evenly to obtain a tadalafil suspension;

[0053] S2 put lactose and croscarmellose sodium into the fluidized bed, spray the tadalafil suspension onto the mixture of lactose and croscarmellose sodium in a boiling state to granulate and dry;

[0054] S3 sieves the dried granules and mixes them evenly with microcrystalline cellulose, croscarmellose sodium, and magnesium stearate, and compresses and coats to obtain tadalafil tablets;

[0055] Wherein, the addition of purified water in step S1 is 35g;

[0056] The addition amount of the croscarmellose sodium in step ...

Embodiment 2

[0058] In 1000 tadalafil tablets, 2.5g of tadalafil, 1g of hypromellose, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium, and 0.5g of magnesium stearate.

[0059] The preparation method of the tadalafil tablet of the present embodiment is:

[0060] In S1, hypromellose was added into purified water and stirred to dissolve, then tadalafil was added and stirred to disperse uniformly to obtain a tadalafil suspension; steps S2 and S3 were the same as in Example 1.

Embodiment 3

[0062] In 1000 tadalafil tablets, there are 2.5g of tadalafil, 1g of povidone, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium, and 0.5g of magnesium stearate.

[0063] The preparation method of the tadalafil tablet of the present embodiment is:

[0064] In S1, add povidone into purified water and stir to dissolve, then add tadalafil and stir to disperse evenly to obtain a tadalafil suspension; steps S2 and S3 are the same as in Example 1.

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Abstract

The invention relates to the technical field of medicines, in particular to a tadalafil tablet and a preparation method thereof. The tadalafil tablet is mainly composed of a suspension containing tadalafil and an excipient, the suspension comprises tadalafil and a dispersing solvent; the dispersing solvent is an aqueous solution or an ethanol solution of a combination of one or more than two of chitosan, carbomer, sodium caprate, sodium alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose and povidone. The preparation method comprises the following steps: adding tadalafil into a dispersing solvent, and homogenizing and dispersing to obtain a suspension; spraying the suspension onto a hydrophilic filling agent and a disintegrating agent, granulating and drying; and mixing the dried particles with a non-hydrophilic filler, a disintegrating agent and a lubricant, tabletting, and coating to obtain the tadalafil tablet. The suspension is prepared from the tadalafil and the corresponding dispersing solvent, so that the solubility and bioavailability of the tadalafil are effectively improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a tadalafil tablet and a preparation method thereof. Background technique [0002] Tadalafil is a selective and reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase 5 (PDE5). The original Tadalafil agent was developed by Eli Lilly and Company of the United States, and it was launched in the United States in 2003 and in China in 2004. It is mainly used clinically for the treatment of male erectile dysfunction and pulmonary hypertension. Its molecular structure is: [0003] [0004] Tadalafil is a white, odorless, tasteless powder that is almost insoluble in water and alcoholic solvents. [0005] Tadalafil is a poorly soluble drug with relatively low bioavailability. Some techniques or methods are often used in the preparation process to increase the solubility of tadalafil, such as raw material micropowder and adding surfactants to improve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/36A61K47/32A61K47/12A61K47/38A61K31/4985A61P15/10A61P9/12A61P11/00
Inventor 毛昌元许顺才周巧云温莹陈庆植姚建堤马萃婷
Owner FUJIAN COSUNTER PHARMA CO LTD