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Sevelamer carbonate medical tablet composition and preparation method thereof

A carbonic acid sevelamer tablet, a technology of carbonic sevelamer, which is applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., and can solve the problems of many conditions, inconvenient use, inability to achieve effects, and the like

Active Publication Date: 2013-02-06
NANJING LIFENERGY R & D +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] We have found through research that the above-mentioned solution to improve the compressibility of sevelamer carbonate and the technical scheme of controlling the water content range of the main drug cannot achieve the effect it claims; while other technologies with too strict restrictions on the main drug or process The scheme has high requirements on the raw materials of sevelamer carbonate, many conditions, and it is inconvenient to use, and it is also not convenient for industrialization and production promotion.

Method used

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  • Sevelamer carbonate medical tablet composition and preparation method thereof
  • Sevelamer carbonate medical tablet composition and preparation method thereof
  • Sevelamer carbonate medical tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prepare tablet according to prescription in table 1 and following process, and tablet measures hardness and friability, is listed in the following table:

[0032] The raw and auxiliary materials, except silicon dioxide, are mixed in a wet mixing granulator according to the above ratio, mixed evenly with water, granulated with a swing granulator at 20 mesh, and then silicon dioxide is added to the granules, mixed evenly, and pressed into Vegetable tablets, determine the hardness and friability of the plain tablets.

[0033] Table 1

[0034]

[0035] The study found that using different types of excipients mixed with sevelamer carbonate for granulation and tableting, only when crospovidone was used as the main filler, the hardness and friability of plain tablets could meet the basic requirements of tablets. The friability of plain tablets obtained from other types of auxiliary materials cannot meet the requirement of less than 1%.

Embodiment 2

[0037] Preparation of tablets according to the ratio in Table 2: mix sevelamer carbonate with crospovidone, add purified water to mix, granulate with a 20-mesh swing granulator, mix the granules with silicon dioxide, and press into plain tablets, and determine the hardness and friability of the plain tablets.

[0038] Table 2

[0039]

[0040]

[0041] The results of comparative experiments show that: without adding silicon dioxide and using in combination with crospovidone, the friability and hardness of the prepared plain tablets cannot meet the requirements; moreover, adding 50-200 mg of crospovidone and 1-50 mg With each formulation of silicon dioxide, the plain tablets prepared can meet the requirements of friability and hardness.

Embodiment 3

[0043] Tablets are prepared according to the ratio in Table 3: mix sevelamer carbonate and crospovidone, add purified water to mix, granulate with a 20-mesh swing granulator, and then mix the granules with silicon dioxide and stearic acid Magnesium, stearic acid, glyceryl behenate, PEG6000, talcum powder, etc. were mixed evenly, pressed into plain tablets, and the hardness and friability of the plain tablets were measured.

[0044] table 3

[0045]

[0046] The experimental results show that adding a lubricant to the basic formulation can improve the fluidity of the intermediate granules without affecting the hardness and friability of plain tablets.

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Abstract

The invention discloses a sevelamer carbonate medical tablet composition and a preparation method thereof. The tablet composition comprises the following components in parts by weight: 60-95 parts of sevelamer carbonate, 5-30 parts of crospovidone and 0.1-10.0 parts of silicon dioxide. The preparation method of the tablet composition comprises the following steps: a. sevelamer carbonate is mixed with crospovidone; b. the mixture obtained in step a is pelletized; c. silicon dioxide is mixed with the particles produced in step b to form tablets; d. the tablets obtained is film-coated by water-soluble coating materials. The tablet composition provided by the invention is characterized in that the formability is good, the rigidity is high, the disintegration is quick, and the disintegration is less affected by the rigidity.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical tablet composition of sevelamer carbonate and a preparation method thereof. Background technique [0002] It is well known that hyperphosphatemia is common in patients with end-stage renal disease, and hyperphosphatemia can cause hyperparathyroidism and osteodystrophy. Recent studies have found that hyperphosphatemia can still induce soft tissue and vascular calcification, which is an important factor for the increased mortality and cardiovascular disease in patients with end-stage renal disease. Therefore, effective control of serum phosphorus levels has become an important measure to reduce the mortality and incidence of cardiovascular diseases in patients with end-stage renal disease. At present, the treatment of hyperphosphatemia mainly includes dietary phosphorus restriction, dialysis treatment, application of phosphorus binders and removal of parat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/30A61K47/32A61K47/04A61K31/785A61P3/12
CPCA61K31/785A61K9/20A61K47/32A61K9/2027A61P3/12
Inventor 韦超唐云王芳方文
Owner NANJING LIFENERGY R & D
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