Preparation method of drug for hyperphosphatemia

A technology for hyperphosphatemia and drugs, which is applied in drug combinations, pharmaceutical formulations, and medical preparations with inactive ingredients, etc., can solve the problems of low tablet hardness, prone to pockmarking, and soft crystal structure, etc. The effect of smooth drug filling, improved production controllability, and improved hardness

Active Publication Date: 2015-12-09
CONSUN PHARML NEI MENG GU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, experiments have found that for lanthanum carbonate hydrate, dry granulation has a large content of water molecules, and the crystal structure is soft, the hardness of the tablet is not high, and pitting is prone to appear after a certain period of time.

Method used

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  • Preparation method of drug for hyperphosphatemia
  • Preparation method of drug for hyperphosphatemia
  • Preparation method of drug for hyperphosphatemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] a. Weigh the following raw materials in proportion:

[0025]

[0026] Wherein the lanthanum carbonate hydrate has a water content approximately equal to 4 to 5 moles of water.

[0027] b. Mix 954g lanthanum carbonate hydrate with 10g polylactic acid, 1000g glucose binder, 40g colloidal silicon dioxide, put into dry granulation machine to make granules, the extrusion pressure is 4MPa, and the drug tablet bulk density is 0.8g / ml; crushed into granules by vibration, select 30% of the particle size below 60 mesh; 70% of the sieve above 60 mesh;

[0028] c. Mix the drug granules and 20g of magnesium stearate evenly, and press into tablets to obtain lanthanum carbonate chewable tablets.

Embodiment 2

[0030] a. Weigh the following raw materials in proportion:

[0031]

[0032] Where the lanthanum carbonate is hydrated, it has a water content approximately equal to 4 to 5 moles of water.

[0033] b. Mix 477g of lanthanum carbonate with 5g of polylactic acid, 500g of glucose, and 20g of colloidal silicon dioxide, and put them into a dry granulator to obtain granules. The extrusion pressure is 4MPa, and the drug tablet bulk density is 0.8g / ml; after shaking Broken into granules, select 30% of the particle size below 60 mesh; screen and intercept 70% of the particle size above 60 mesh;

[0034] c. Mix the drug granules and 10g of magnesium stearate evenly, and press into tablets to obtain lanthanum carbonate chewable tablets.

Embodiment 3

[0036] a. Weigh the following raw materials in proportion:

[0037]

[0038] Wherein the lanthanum carbonate hydrate has a water content approximately equal to 4 to 5 moles of water.

[0039] b. Mix 954g of lanthanum carbonate hydrate with 1000g of dextrose binder and 40g of colloidal silicon dioxide, and put it into a dry granulator to obtain granules. The extrusion pressure is 4MPa, and the bulk density of the drug tablet is 0.8g / ml; Broken into granules, select 30% of the particle size below 60 mesh; screen and intercept 70% of the particle size above 60 mesh;

[0040] c. Mix the drug granules and 20g of magnesium stearate evenly, and press into tablets to obtain lanthanum carbonate chewable tablets.

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Abstract

The invention relates to a drug composition for hyperphosphatemia and a preparation method of the drug composition. The drug composition, as chewable tablets, comprises 477-954g of lanthanum carbonate hydrate, 5-10g of polylactic acid, 500-1000g of dextrates, 20-40g of colloidal silicon dioxide and 10-20g of magnesium stearate.

Description

Technical field: [0001] The invention relates to a preparation method of a drug for treating hyperphosphatemia, and more particularly to a method for preparing a drug for treating hyperphosphatemia through dry granulation. Background technique: [0002] Hyperphosphatemia is a unique problem in patients with chronic renal insufficiency or chronic kidney disease (CKD). Approximately 70% of patients with end-stage renal disease (ESRD) undergoing renal dialysis treatment require treatment for hyperphosphatemia. The condition can lead to severe bone problems and metastatic calcification of the skin and major organs, and is associated with significant morbidity and mortality. Regular dialysis does not reduce phosphate levels in the blood, so levels rise over time. Elevated phosphate levels are treated with a combination of dietary restriction and phosphate binders. [0003] WO96 / 30029 discloses that selected lanthanum carbonate hydrates can be administered gastrointestinally fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/24A61K9/20A61K47/34A61P7/08A61P3/12
Inventor 曹晴葛志敏郑兆广陈建红
Owner CONSUN PHARML NEI MENG GU
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