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Alfacalcidol dispersible tablet and preparation method thereof

A technology of alfacalcidol and dispersible tablets, which is applied in the direction of non-active ingredients of polymer compounds, medical preparations containing active ingredients, bone diseases, etc., and can solve the problem of poor solubility of alfacalcidol and poor disintegration and dissolution effects , low bioavailability and other issues, to achieve the effect of rapid dissolution, convenient administration and high bioavailability

Active Publication Date: 2013-05-22
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Alfacalcidol is poorly soluble in water, resulting in low bioavailability
Existing alfacalcidol dispersible tablets have the defects of poor disintegration and dissolution effect and low bioavailability, which affects its clinical therapeutic effect. Therefore, it is necessary to develop an alfacalcidol with short disintegration time and rapid drug dissolution. Calciferol Dispersible Tablets

Method used

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  • Alfacalcidol dispersible tablet and preparation method thereof
  • Alfacalcidol dispersible tablet and preparation method thereof
  • Alfacalcidol dispersible tablet and preparation method thereof

Examples

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Effect test

preparation example Construction

[0028] Preparation of Preliminary Example Alfacalcidol Inclusion Compound

[0029] Make 2,6-dimethyl-β-cyclodextrin into a saturated solution, add alfacalcidol; the molar ratio of alfacalcidol to 2,6-dimethyl-β-cyclodextrin inclusion complex The ratio is 1:0.8; mix for more than 30 minutes to form clathrates and separate clathrates. The precipitated clathrate is filtered, washed and dried.

Embodiment 1

[0030] The preparation of embodiment 1 alfacalcidol dispersible tablet

[0031] (1) Weigh each component according to the following weight percentage:

[0032]

[0033] Mix the filler, disintegrating agent, flavoring agent and alfacalcidol inclusion complex uniformly in equal increments, then add magnesium stearate, micronized silica gel, mix well, pulverize through a 100-mesh sieve, and press into tablets. Alfacalcidol dispersible tablets were obtained.

Embodiment 2

[0034] The preparation of embodiment 2 alfacalcidol dispersible tablets

[0035] (1) Weigh each component according to the following weight percentage:

[0036]

[0037]

[0038] Mix the filler, disintegrating agent, flavoring agent and alfacalcidol inclusion complex uniformly in equal increments, then add magnesium stearate, micronized silica gel, mix well, pulverize through a 100-mesh sieve, and press into tablets. Alfacalcidol dispersible tablets were obtained.

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Abstract

The invention discloses an alfacalcidol dispersible tablet and a preparation method of the alfacalcidol dispersible tablet. The alfacalcidol dispersible tablet is prepared from an alfacalcidol clathrate compound and a preparation supplementary material, wherein the preparation supplementary material comprises a filling agent, a disintegrating agent, a diluting agent, a lubricating agent, a flow aid and a flavouring agent; and the alfacalcidol clathrate compound is prepared by carrying out clathration on alfacalcidol and 2,6-dimethyl-Beta-cyclodextrin based on the molar ratio of 4: 1 to 0.5: 3. The alfacalcidol dispersible tablet has the advantages of being quick to dissolve out, fast to absorb, high in bioavailability, excellent in stability, convenient to take, etc.

Description

technical field [0001] The invention relates to dispersible tablets, in particular to alfacalcidol dispersible tablets and a preparation method thereof, and belongs to the field of alfacalcidol dispersible tablets. Background technique [0002] Alfacalcidol regulates the balance of calcium and phosphorus in the body, increases the absorption of calcium and phosphorus in the intestine, reduces the level of parathyroid hormone in plasma, and improves women's menopause and osteoporosis caused by hormone drugs . It is suitable for the prevention and treatment of osteoporosis, nephrogenic bone disease (nephrotic rickets, hyperparathyroidism (with bone disease), hypoparathyroidism, rickets and osteomalacia caused by nutritional and absorption disorders, false Rickets and osteomalacia due to calcium deficiency (D-dependent type I). [0003] The dispersible tablet can disintegrate rapidly after being put into water to form a uniformly dispersed suspension, which has the characteri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/592A61K47/40A61P3/02A61P19/10A61P19/08
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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