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Pharmaceutical composition containing tenofovir disoproxil fumarate

A technology of tenofovir disoproxil fumarate and disoproxil, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, medical preparations without active ingredients, etc., and can solve the problem of tenofovir disoproxil Easily hydrolyzed and other problems, to achieve the effect of improving stability and oral bioavailability

Active Publication Date: 2015-06-10
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the problem that tenofovir disoproxil is easily hydrolyzed during storage, the present invention provides an oral solid preparation of tenofovir disoproxil fumarate, which has better stability

Method used

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  • Pharmaceutical composition containing tenofovir disoproxil fumarate
  • Pharmaceutical composition containing tenofovir disoproxil fumarate
  • Pharmaceutical composition containing tenofovir disoproxil fumarate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] Preparation Process:

[0030] 1. Mix the internally added materials except magnesium stearate evenly, then add magnesium stearate and mix evenly;

[0031] 2. Add suitable equipment (such as rolling granulator) to dry granulation;

[0032] 3. Add microcrystalline cellulose and crospovidone to the granules, mix well, then add magnesium stearate and mix well;

[0033] 4. Tablet pressing to obtain the desired product.

Embodiment 2

[0035]

[0036] Preparation Process:

[0037] 1. Mix tenofovir disoproxil fumarate, succinic acid, and sodium carboxymethyl starch (internal addition) evenly;

[0038] 2. Add povidone K30 solution to granulate;

[0039] 3. Dry the obtained granules;

[0040] 4. Add microcrystalline cellulose and sodium carboxymethyl starch (additional) to the dry granules and mix well;

[0041] 5. Add stearic acid and mix evenly;

[0042] 6. Tablet pressing to obtain the desired product.

[0043]

Embodiment 3

[0045]

[0046] Preparation Process:

[0047] 1. Mix pregelatinized starch, croscarmellose sodium (internal addition) and lactose (internal addition) in a mixer, add water to granulate;

[0048] 2. Dry the granules until the water content is not higher than 3%;

[0049] 3. Mix dry granules with croscarmellose sodium (additional) and lactose (additional) in a mixer;

[0050] 4. Add stearic acid and mix evenly;

[0051] 5. Tablet pressing to obtain the desired product.

[0052]

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Abstract

The invention relates to a pharmaceutical composition containing tenofovir disoproxil fumarate, succinic acid, a filler, and a lubricant. Succinic acid is taken as a stabilizing agent so as to increase stability of the pharmaceutical composition containing tenofovir disoproxil fumarate, reducing degradation of tenofovir disoproxil fumarate, reducing impurity content, and improving product quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition and a preparation method thereof, in particular to a tenofovir disoproxil fumarate pharmaceutical composition containing succinic acid and a preparation method thereof. Background technique [0002] Tenofovir disoproxil fumarate is a ring-opening nucleoside phosphine diester analogue of adenosine monophosphate. Tenofovir disoproxil fumarate is converted in vivo to tenofovir by diester hydrolysis, and then phosphorylated by cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase by competing with the natural substrate deoxyadenosine 5'-triphosphate and terminating the DNA chain after integration with DNA. Tenofovir disoproxil fumarate is used in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children over 12 years old, and can also be used to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/675A61K47/12A61P31/18A61P31/20
Inventor 江月王姣姣张毅
Owner YAOPHARMA CO LTD