Tenofovir disoproxil fumarate tablet and preparation method thereof

A technology for tenofovir fumarate and pyrifurate tablets, applied in the field of tenofovir disoproxil fumarate composition and its preparation, to achieve good controllability, good fluidity and stable products good sex effect

Inactive Publication Date: 2015-01-21
NANJING CAVENDISH BIO ENG TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent application CN103705478A discloses an oral tablet containing tenofovir disoproxil fumarate, which contains mannitol and low-substituted hydroxypropyl cellulose, thereby solving the problem of tenofovir fumarate Stability issues with dipyridamole
However, the application is related to the crystal form of tenofovir disoproxil fumarate

Method used

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  • Tenofovir disoproxil fumarate tablet and preparation method thereof
  • Tenofovir disoproxil fumarate tablet and preparation method thereof
  • Tenofovir disoproxil fumarate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Tenofovir Disoproxil Fumarate Tablets

[0043] Component

%(w / w)

tenofovir disoproxil fumarate

30

microcrystalline cellulose

30

anhydrous lactose

30

Sodium carboxymethyl starch

5

Crospovidone

4.6

Talc powder

0.2

colloidal silica

0.2

[0044] 1. Preparation process:

[0045] 1.1 Preparation before ingredients

[0046] 1.1.1 Drying

[0047] The microcrystalline cellulose and the sodium carboxymethyl starch are dried at 105 DEG C and the water content is controlled between 0.5% and 2.0%.

[0048] 1.1.2 Screening

[0049] Take the pulverized tenofovir disoproxil fumarate and pass through an 80-mesh sieve for subsequent use.

[0050] 1.2 Ingredients

[0051] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0052] 1.3 Hybrid

[0053] Weigh the prescribed amount of tenofovir disoproxil fumarate, microcrystalline cellulose, anhydrous la...

Embodiment 2

[0062] Tenofovir Disoproxil Fumarate Tablets

[0063] Component

%(w / w)

tenofovir disoproxil fumarate

35

microcrystalline cellulose

25

[0064] anhydrous lactose

30

Sodium carboxymethyl starch

6

Crospovidone

3

Talc powder

0.5

colloidal silica

0.5

[0065] 1. Preparation process:

[0066] 1.1 Preparation before ingredients

[0067] 1.1.1 Drying

[0068] The microcrystalline cellulose and the sodium carboxymethyl starch are dried at 105 DEG C and the water content is controlled between 0.5% and 2.0%.

[0069] 1.1.2 Screening

[0070] Take the pulverized tenofovir disoproxil fumarate and pass through a 60-mesh sieve for subsequent use.

[0071] 1.2 Ingredients

[0072] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0073] 1.3 Hybrid

[0074] Weigh the prescribed amount of tenofovir disoproxil fumarate, microcrystalline cellulo...

Embodiment 3

[0083] Tenofovir Disoproxil Fumarate Tablets

[0084] Component

%(w / w)

tenofovir disoproxil fumarate

40

microcrystalline cellulose

10

anhydrous lactose

30

Sodium carboxymethyl starch

15

Crospovidone

3

Talc powder

0.5

colloidal silica

1.5

[0085] 1. Preparation process:

[0086] 1.1 Preparation before ingredients

[0087] 1.1.1 Drying

[0088] The microcrystalline cellulose and the sodium carboxymethyl starch are dried at 105 DEG C and the water content is controlled between 0.5% and 2.0%.

[0089] 1.1.2 Screening

[0090] Take the pulverized tenofovir disoproxil fumarate and pass through a 40-mesh sieve for subsequent use.

[0091] 1.2 Ingredients

[0092] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0093] 1.3 Hybrid

[0094] Weigh the prescribed amount of tenofovir disoproxil fumarate, microcrystalline cellulose, anhydrous lact...

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Abstract

The invention discloses a tenofovir disoproxil fumarate tablet and a preparation method thereof. The tenofovir disoproxil fumarate tablet is prepared from tenofovir disoproxil fumarate, anhydrous lactose, microcrystalline cellulose, crospovidone, sodium carboxymethyl starch, colloidal silica and talcum powder. Compared with dosage forms of tenofovir disoproxil fumarate in the prior art, the tenofovir disoproxil fumarate tablet has the advantages of good stability, simple preparation technology and controllable quality.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and more specifically relates to a stable tenofovir disoproxil fumarate composition and a preparation method thereof. Background technique [0002] Tenofovir disoproxil fumarate (PMPA DF for short, or bis(POC)PMPA, trade name Vilead TM ) is a prodrug of tenofovir, a non-cyclic nucleotide reverse transcriptase inhibitor developed by Gilead Sciences of the United States, which is used in combination with other antireverse transcriptase drugs to treat HIV infection and chronic hepatitis B. Tenofovir disoproxil fumarate tablets were approved for marketing in the United States in 2001 and in China in 2008. [0003] Chinese patent application CN1264387A discloses a crystal form of tenofovir disoproxil fumarate, its X-ray powder diffraction pattern is expressed at about 4.9, 10.2, 10.5, 18.2, 20.0, 21.9, 24.0 in terms of 2θ angle , 25.0, 25.5, 27.8, 30.1 and 30.4 have diffraction p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/675A61K47/04
Inventor 许永翔侯雯杨浩
Owner NANJING CAVENDISH BIO ENG TECH
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