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Sevelamer carbonate tablet and preparation method thereof

A technology of sevelamer carbonate tablet and sevelamer carbonate, which is applied in the field of medicine and can solve problems such as excessive dosage of excipients, impact on disintegration, and large tablets

Inactive Publication Date: 2015-04-29
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] The present inventor has conducted research on the existing preparation technology of sevelamer carbonate tablets, and compared the methods disclosed in CN102641251A, CN102908325A, and CN103393610A patents. It can only solve some of the problems in the preparation process, such as improving the compressibility or stability or the diameter and particle size of raw materials, etc., and cannot take care of all problems; and the amount of excipients in the prescription is too large, resulting in too large tablets, which in turn affects Disintegration, inconvenient to use, not suitable for large-scale industrial production

Method used

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  • Sevelamer carbonate tablet and preparation method thereof

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Effect test

Embodiment 1

[0017] A sevelamer carbonate tablet with a specification of 400 mg, and its prescription composition is as follows:

[0018] Sevelamer Carbonate400 Microcrystalline cellulose80 Sodium chloride1.0 Potassium chloride1.0 Stearic acid4 Silica4

[0019] The composition of the coating liquid is as follows:

[0020] Opadry (gastric dissolving type) film coating premix8g purified water92ml

[0021] The preparation method is as follows:

[0022] a. The raw materials are crushed and passed through a sieve of 80 mesh; the sodium chloride crushed, stearic acid, and silica are respectively passed through an 80 mesh sieve;

[0023] b. After the raw materials are evenly watered and dispersed, add the prescribed amount of microcrystalline cellulose, sodium chloride, stearic acid, and silicon dioxide in sequence, and mix them to make 1000 tablets;

[0024] c. Take the Opadry dry powder and add it to the purified water under stirring, stir until it is dispersed, and filter until it is unifo...

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Abstract

The invention provides a sevelamer carbonate tablet and a preparation method thereof, belonging to the technical field of medicines. The sevelamer carbonate tablet mainly comprises a diluent, a modifier, a lubricant, a flow aid, and a coating agent. The sevelamer carbonate is an unabsorbable crosslinked polymer capable of binding with phosphorus, and is used for treating hyperphosphatemia. The sevelamer carbonate tablet is safe and effective, stable in quality, low in cost, and convenient to take, and the compliance of patients is enhanced.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to a sevelamer carbonate tablet and a preparation method thereof. The invention provides a safe, effective, stable quality, low cost, convenient administration, strong patient compliance, and can treat hyperphosphatemia. Tablets. Background technique [0002] Hyperphosphatemia is a common complication of chronic kidney disease. It is an important factor that causes secondary hyperparathyroidism, changes in calcium and phosphorus deposition, vitamin D metabolism disorders, renal bone disease, and calcification of coronary arteries and heart valves. Severe cardiovascular complications are closely related. Commonly used drugs include aluminum preparations such as aluminum hydroxide gel, which can bind to phosphorus in the intestinal tract, but can cause constipation. Long-term medication can cause aluminum accumulation and poisoning; calcium preparations such as calcium carbonate and calciu...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/785A61K47/38A61P3/12
Inventor 王明刚任莉陈阳生孙桂玉刘晓霞翟翠云
Owner CP PHARMA QINGDAO CO LTD
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