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Preparation process for sevelamer hydrochloride tablet

A technology of sevelamer hydrochloride tablets and sevelamer hydrochloride, which is applied in the field of medicine, can solve the problems of difficulty in taking tablets, large tablet weight and volume, and limitation of the amount of added auxiliary materials, and achieve low manufacturing cost, Ease of acceptance, reduced aggregation effects

Active Publication Date: 2015-08-12
WUXI APPTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Existing sevelamer hydrochloride is made into tablet by conventional method, has used more adjuvant material, because the clinical treatment dose of sevelamer hydrochloride is bigger, so the specification of its preparation is also correspondingly bigger, such as its tablet The dosage specification is 800mg / tablet or 400mg / tablet. The amount of excipients added to such a large-sized tablet will inevitably be greatly restricted, otherwise the weight and volume of the tablet will be too large and the patient will suffer from symptoms when taking the tablet. difficulty

Method used

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  • Preparation process for sevelamer hydrochloride tablet
  • Preparation process for sevelamer hydrochloride tablet
  • Preparation process for sevelamer hydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A preparation method of sevelamer hydrochloride tablet adopts following processing steps: its component (prescription amount) ratio is by weight parts:

[0025] 1. First, take 100 parts of Sevelamer hydrochloride, 3 parts of micropowdered silica gel, and 2 parts of stearic acid in the prescribed amount and add them to 1000 parts of absolute ethanol for later use;

[0026] 2. Stir and mix the above mixture homogeneously, the homogenization time is 30 minutes, and the speed in the homogenizer is: 10000r / min;

[0027] 3. After the suspension is placed in the reflux tower to recover the dispersant, it is dried under reduced pressure to form a powder. The drying temperature is 60°C and the drying time is 4 hours;

[0028] 4. Put the dry granules into the fast pulverizer, pulverize, granulate with 30 mesh, the speed of the pulverizer: 15r / min, and set aside;

[0029] 5. Put the granules into the hopper of the tablet press, press the tablets, pack them airtightly, and store t...

Embodiment 2

[0050] A preparation method of sevelamer hydrochloride tablet adopts following processing steps: its component (prescription amount) ratio is by weight parts:

[0051] 1. First, take 100 parts of Sevelamer hydrochloride, 5 parts of micropowdered silica gel, and 4 parts of stearic acid in the prescribed amount and add them to 2000 parts of absolute ethanol, and set aside;

[0052] 2. Stir and mix the above mixture homogeneously, the homogenization time is 20 minutes, and the speed in the homogenizer is: 5000r / min;

[0053] 3. After the suspension is placed in the reflux tower to recover the dispersant, it is dried under reduced pressure to form a powder. The drying temperature is 60°C and the drying time is 4 hours;

[0054] 4. Put the dry granules into the fast pulverizer, pulverize, granulate with 30 mesh, the speed of the pulverizer: 15r / min, and set aside;

[0055] 5. Put the granules into the hopper of the tablet press, press the tablet, seal the package, and store in a d...

Embodiment 3

[0072] A preparation method of sevelamer hydrochloride tablet adopts following processing steps: its component (prescription amount) ratio is by weight parts:

[0073] 1. First, take 100 parts of Sevelamer hydrochloride, 2 parts of micropowdered silica gel, and 1 part of stearic acid in the prescribed amount and add them to 500 parts of absolute ethanol for later use;

[0074] 2. Stir and mix the above mixture homogeneously, the homogenization time is 30 minutes, and the speed in the homogenizer is: 10000r / min;

[0075] 3. After the suspension is placed in the reflux tower to recover the dispersant, it is dried under reduced pressure to form a powder. The drying temperature is 60°C and the drying time is 4 hours;

[0076] 4. Put the dry granules into the fast pulverizer, pulverize, granulate with 30 mesh, the speed of the pulverizer: 15r / min, and set aside;

[0077] 5. Put the granules into the hopper of the tablet press, press the tablets, pack them airtightly, and store the...

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Abstract

The invention especially relates to a preparation process for a sevelamer hydrochloride tablet, which belongs to the technical field of medicine. The preparation process comprises the following steps: (1) weighing 100 parts of sevelamer hydrochloride, 1 to 5 parts of a flow aid and 1 to 3 parts of a lubricant according to a prescription, adding the above-mentioned substances into 100 to 2000 parts of a dispersant and standing the obtained mixture for subsequent usage; (2) subjecting the mixture obtained in the step (1) to homogenization, stirring and mixing so as to obtain turbid liquor; and (3) placing the turbid liquor obtained in the step (2) into a reflux column for recovery of the dispersant, carrying out pressure-reduced drying to obtain powder and preparing the sevelamer hydrochloride tablet according to a conventional tablet preparation process. The sevelamer hydrochloride tablet employs a manner of all-component liquid dispersion and crystallization; the usage amount of accessory materials only accounts for less than 5% of all the components; all the components form a uniform solid minicrystal system after drying of a disperse system; obtained granules have good compressibility, high phosphorus bonding capability and in-vitro disintegration time of less than 10 min; and clinical safety of the tablet provided by the invention is higher than clinical safety of conventional overseas common tablets.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a process for preparing sevelamer hydrochloride tablets. Background technique [0002] Hyperphosphatemia is the most common condition in patients with end-stage renal disease (ESRD) and affects 80% of dialysis patients. In addition to causing skeletal diseases, the disease can also cause damage to the cardiovascular system, soft tissue calcification, secondary hyperparathyroidism and various possible complications, and 50% of patients die as a result. [0003] 85% of the phosphorus in the human body exists in the skeleton, and the rest is distributed in the membrane and tissue structure of skeletal muscle, skin, nerve tissue and organs. 14% of phospholipids, nucleic acids, and proteins are phosphorylated into cell membranes, serve as signal transduction, and play an important role in energy metabolism. The remaining 1% exists in the extracellular fluid, mainly parathyroid hor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/785A61P3/12
Inventor 贾祥波陆继好
Owner WUXI APPTEC