Unlock instant, AI-driven research and patent intelligence for your innovation.

A kind of preparation technology of sevelamer hydrochloride tablet

A sevelamer hydrochloride tablet and a technology for sevelamer hydrochloride, which are applied in the field of medicine, can solve the problems of large weight and volume of the tablet, difficulty in taking the tablet, restriction on the amount of added auxiliary materials, etc. Good compressibility, easy to accept results

Active Publication Date: 2018-04-13
WUXI APPTEC
View PDF2 Cites 0 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of preparation technology of sevelamer hydrochloride tablet
  • A kind of preparation technology of sevelamer hydrochloride tablet
  • A kind of preparation technology of 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...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a preparation process of Sevelamer Hydrochloride Tablets, which comprises the following steps: (1), taking 100 parts of Sevelamer Hydrochloride in the prescribed amount, 1-5 parts of glidants and lubricating Add 1-3 parts of the agent into 100-2000 parts of the dispersant, and set aside; (2), homogeneously stir and mix the mixture obtained in step (1) to obtain a suspension; (3), mix the mixture obtained in step (2) The obtained suspension is placed in a reflux tower to recover the dispersant, dried under reduced pressure to form powder, and sevelamer hydrochloride tablets are obtained according to the conventional tablet preparation process. The sevelamer hydrochloride tablet of the present invention adopts full-component liquid dispersion crystallization, and the amount of auxiliary materials only accounts for less than 5% of the whole component. After the dispersion system is dried, the whole component forms a uniform solid microcrystalline system, and the particles have good stability. The compressibility is due to the high phosphorus binding capacity, and the disintegration time in vitro is less than 10 minutes; the clinical safety is also higher than that of ordinary tablets abroad.

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/785A61P3/12
Inventor 贾祥波陆继好
Owner WUXI APPTEC