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Sevelamer carbonate effervescent tablets and preparation method thereof

The technology of sevelamer carbonate and sevelamer carbonate is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, which can solve the problems of inconvenient tablet carrying, poor compressibility, and troublesome medication.

Inactive Publication Date: 2015-03-25
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage form of commercially available sevelamer carbonate is tablet and dry suspension at present, and these two kinds of dosage forms have advantages and disadvantages respectively, and tablet volume is less, and is convenient to carry, has incomparable advantage as long-term medication, but because this The drug dosage of the product is relatively large (2.4-4.8g / day), and the commercially available tablet specification is 800mg or 400mg. Due to the poor compressibility of the raw material of sevelamer carbonate, the high proportion of excipients results in a large tablet volume. For Medication for patients with dysphagia is more troublesome; although the dry suspension is dispersed in water to solve the disadvantages of dysphagia, but as a long-term medication, the single-dose package is larger and more inconvenient to carry than tablets

Method used

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  • Sevelamer carbonate effervescent tablets and preparation method thereof
  • Sevelamer carbonate effervescent tablets and preparation method thereof
  • Sevelamer carbonate effervescent tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prescription composition:

[0028] Table 1 The prescription dosage table of Example 1 (1000 batches)

[0029]

[0030] The preparation process is as follows:

[0031] 1) Pulverize sevelamer carbonate, control the particle size at 10-50 microns, and pulverize the remaining materials through an 80-mesh sieve for subsequent use;

[0032] 2) Weigh the prescribed amount of adhesive, add absolute ethanol, stir evenly, and prepare a solution with a solid content of 5% for subsequent use;

[0033] 3) Put the sevelamer carbonate, effervescent agent, and filler prepared in step 1) in the shear granulator, turn on the granulator, and spray into the 5% binder anhydrous ethanol solution prepared in step 2) Thoroughly mix to obtain mixture I;

[0034] 4) Granulate the mixture I in step 3) through a 16-30 mesh screen, dry at 55-60°C until the water content is less than 1.0%, and granulate with a 18-24 mesh screen to obtain mixture II;

[0035]5) Put the mixture II in st...

Embodiment 2

[0038] Prescription composition:

[0039] Table 2 The prescription dosage table of embodiment 2 (1000 batches)

[0040] Element Dosage (g) Proportion(%) effect Sevelamer Carbonate 750 50.0% active ingredient lactose 180 12.0% filler tartaric acid 150 10.0% Effervescent sodium bicarbonate 170 11.3% Effervescent Povidone K30 120 8.0% Adhesive Propylene glycol alginate 45 3.0% suspending agent polyethylene glycol 8000 75 5.0% lubricant Acesulfame K 5 0.33% flavoring agent Sweet Orange Flavor 5 0.33% flavoring agent Absolute ethanol Appropriate amount / D

[0041] The preparation process is the same as in Example 1.

Embodiment 3

[0043] Prescription composition:

[0044] Table 3 The prescription dosage table of embodiment 3 (1000 batches)

[0045] Element Dosage (g) Proportion(%) effect Sevelamer Carbonate 1400 70.0% active ingredient Mannitol 300 15.0% filler malic acid 100 5.0% Effervescent Sodium carbonate 100 5.0% Effervescent Povidone K30 29 1.5% Adhesive Propylene glycol alginate 20 1.0% suspending agent stearic acid 50 2.5% lubricant Stevioside 0.5 0.025% flavoring agent Sweet Orange Flavor 0.5 0.025% flavoring agent Absolute ethanol Appropriate amount / D

[0046] The preparation process is the same as in Example 1.

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Abstract

The invention relates to sevelamer carbonate effervescent tablets and a preparation process thereof. Each sevelamer carbonate effervescent tablet is characterized by comprising the following materials in weight percentage: 30-70% of sevelamer carbonate, 10-55% of effervescing agent, 10-40% of filling agent, 1.0-10% of adhesive, 0.1-5.0% of suspending agent, 0.5-5.0% of lubricating agent and 0.05-1.0% of corrigent. The sevelamer carbonate effervescent tablets are convenient for patients to carry and capable of overcoming patients' swallowing difficulty and has better taste, so that the patients' medication compliance can be improved. Compared with the original triturate, i.e., sevelamer carbonate tablets and dry suspension (product name: RENVELA), the sevelamer carbonate effervescent tablets have short disintegration and dispersing time in water and good dispersing effect and are easy to precipitate; and the acceleration test shows that the sevelamer carbonate effervescent tablets have good stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sevelamer carbonate effervescent tablet and a preparation method thereof. Background technique [0002] According to the latest epidemiological survey in my country, the incidence of chronic kidney disease (CKD) among adults in my country is as high as 10.8%. Turning to end-stage renal disease (ie uremia) requires dialysis or transplantation, and each person spends about 80,000 yuan per year. Hyperphosphatemia is widespread in patients with end-stage renal disease. More and more evidence shows that hyperphosphatemia is the main reason for the occurrence and progression of vascular calcification in patients with chronic kidney disease (CKD), and is closely related to the increase of cardiovascular disease morbidity and mortality. Renal hyperphosphatemia is one of the complications of maintenance hemodialysis patients and an independent risk factor for death. Actively ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/46A61K31/785A61P3/12
Inventor 张颖郭建军刘鹏杨延昆杨江勇赫红曲延伟
Owner JINAN KANGHE MEDICAL TECH
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