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Ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly and preparation method thereof

A technology of ferric citrate and high drug loading, which is applied in the direction of drug combination, drug delivery, and pharmaceutical formulation to achieve the effect of product quality satisfaction

Active Publication Date: 2015-06-10
CHENGDU XINJIE HIGH TECH DEV CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] From the analysis of the above patents, it can be seen that in order to meet the requirements of the relevant indicators of the coated tablet for the tablet under the high drug loading, it also needs to meet the requirements of rapid dissolution in vitro and meet the requirements of its immediate release preparation, but these patents Published formulations and manufacturing processes have their own limitations

Method used

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  • Ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly and preparation method thereof
  • Ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly and preparation method thereof
  • Ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Weigh the material according to formula 1, adopt mechanical crushing, pass through a 100-mesh sieve, and set aside; the gelatin-xanthan gum mixture is prepared with purified water; the ferric citrate hydrate and powdered cellulose after mechanical crushing are mixed in multiple Mix in a motion mixer for 20 minutes, collect the material, and set aside.

[0037] Put the mixed material in a high-efficiency wet granulator, shear at high speed for 60 seconds, stop high-speed shearing, start low-speed shearing, add gelatin-xanthan gum mixture aqueous solution to granulate, and adjust the binder according to the condition of the granules The dosage; place the wet granules in an electric oven for drying, and control the moisture content of the granules within 8% to 12%. Particles that meet this moisture requirement are collected and set aside.

[0038] The dry granules were sized with a 20-mesh sieve, calcium stearate was added, mixed in a multi-sport mixer for 5 minute...

Embodiment 2-4

[0042] The materials were weighed according to formula 2-4, and the preparation method was the same as in Example 1.

Embodiment 5

[0043] The assay method of embodiment 5 dissolution in vitro

[0044] Dissolution method: paddle method, 100 rpm; solvent: pH 1.2 solution (sodium chloride 2.0g, concentrated hydrochloric acid 7ml, add water to 1000ml) 1000ml; time: 15min, Q value ≥ 90%.

[0045] Concentration of reference substance solution: 0.45mg / ml.

[0046] Drug concentration detection method: UV method; 220nm.

[0047] Evaluation methods of other indicators: ChP2010. Part II Appendix IB.

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Abstract

The invention discloses a ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly. The ferric citrate composition comprises, by weight, 1200-1500 parts of ferric citrate aquo-complex, 110-160 parts of filling agents, 90-150 parts of disintegrating agents, 5-10 parts of binding agents, 10-20 parts of pure water and 10-30 parts of lubricating agents. The invention further discloses a preparation method of the ferric citrate composition. The ferric citrate composition can guarantee smooth industrial production of ferric citrate tablets at high drug loading capacity, meanwhile, the quality of products can meet the requirements of in vitro quick dissolving out and satisfy demands of fast-release preparations.

Description

technical field [0001] The invention relates to a ferric citrate composition with high drug loading and fast dissolution and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Hyperphosphatemia is a common complication in patients with chronic kidney disease (CKD), especially end stage renal disease (ESRD), and can be found in 80% of dialysis patients. Hyperphosphatemia stimulates the parathyroid gland to secrete a large amount of parathyroid hormone, which is an important factor causing secondary hyperparathyroidism, changes in calcium and phosphorus deposition, vitamin D metabolism disorders, and renal bone disease. Hyperphosphatemia is also closely related to severe cardiovascular complications such as coronary artery disease and heart valve calcification. Regulating reasonable phosphorus metabolism is the key to reducing cardiovascular complications, improving the quality of life of dialysis patients, and re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/194A61P3/00A61P13/12
Inventor 蒲洪陈小宁许娟
Owner CHENGDU XINJIE HIGH TECH DEV CO LTD