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Stable sevelamer carbonate tablet and preparation method thereof

A stable technology of sevelamer carbonate, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pill delivery, which can solve the problems of poor formability of tablets

Active Publication Date: 2017-11-28
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the composition obtained by this method has poor tablet formability

Method used

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  • Stable sevelamer carbonate tablet and preparation method thereof
  • Stable sevelamer carbonate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Tablets were prepared according to the prescription in Table 1 and the following process, and the hardness, friability and disintegration time of the tablets were determined.

[0025] After mixing sevelamer carbonate with sodium bicarbonate, mix it with crospovidone; add about 6-13 parts by weight of water, and use a swing granulator to granulate; add silicon dioxide and lubricant to the granules, mix and press to form Plain tablets, determination of hardness and friability of plain tablets, and tablet core disintegration at pH 1.2, with dish and sieve at 0, 1, 3 weeks for tablets stored at 60 Average time (minutes).

[0026] Table 1

[0027]

[0028] Studies have found that after adding 0.5-2 parts by weight of sodium bicarbonate, the hardness and brittleness and hardness of the pharmaceutical composition do not change much, but the storage stability is greatly affected. When using a single magnesium stearate, glyceryl behenate Or when PEG4000 is used as a lubrica...

Embodiment 2

[0030] Depend on Sevelamer carbonate tablets prepared with glyceryl behenate and PEG4000 as lubricants showed good stability. The next experiment will further optimize the ratio of glyceryl behenate and PEG4000, and determine the hardness, friability Friability and average tablet core disintegration time (minutes) at pH 1.2, with dish and sieve, at 0, 1, and 3 weeks for tablets stored at 60°C.

[0031] Tablets were prepared according to the proportioning in Table 2, and the preparation method was the same as in Example 1.

[0032] The results showed that when the ratio of polyethylene glycol 4000 and glyceryl behenate was 10:1-20:1, the stability of the tablet was better, and when the ratio of the two was 1:1, the stabilizer took second place. The applicant screened the lubricant through a large number of experiments. During the screening process, it was unexpectedly found that when the lubricant is a combination of polyethylene glycol 4000 and glyceryl behenate, the stabili...

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Abstract

The invention relates to a stable sevelamer carbonate composition which contains sevelamer carbonate, cross-linked polyvinylpyrrolidone, silicon dioxide, sodium bicarbonate, polyethylene glycol 4000 and glyceryl behenate. The composition has the characteristics of good formability and long-term storage stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a stable sevelamer carbonate tablet and a preparation method thereof. Background technique [0002] 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 parathyroid glands when necessary. First of all, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/10A61K47/14A61K31/785A61P3/12
CPCA61K9/2013A61K9/2031A61K9/2806A61K31/785
Inventor 陈阳生王明刚刘晓霞孙桂玉臧云龙
Owner CP PHARMA QINGDAO CO LTD
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