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Pharmaceutical composition containing bisphosphates and preparation method thereof

A technology of bisphosphonates and compositions is applied in the field of pharmaceutical compositions containing bisphosphonates and the preparation thereof, and can solve the problems of high requirements for production equipment, reduction of production equipment, complicated processes and the like

Inactive Publication Date: 2009-09-16
北京德众万全医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The use of wet granulation process has a great impact on bisphosphonates; the use of spray drying, coating and fluidized bed one-step granulation reduces the chance of the drug and metal contacting to form complexes during the wet granulation process, effectively avoiding the The content of the active ingredient of the drug is reduced due to the granulation process, but the process is cumbersome and requires high production equipment

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] prescription composition

[0018] Name Percentage (%)

[0019] Minodronic acid 1.00

[0020] EDTA-2Na 1.00

[0021] Lactose 61.0

[0022] Microcrystalline Cellulose 30.0

[0023] Low-substituted hydroxypropyl cellulose 5.00

[0024] Micronized silica gel 1.00

[0025] Magnesium stearate 1.00

[0026] Process:

[0027] After the raw and auxiliary materials are sieved, mixed evenly, directly placed in a tablet machine for tableting.

[0028] The content of the active ingredient in the finished product was detected to be 99.96%.

Embodiment 2

[0030] prescription composition

[0031] Name Percentage (%)

[0032] Alendronate 10.0

[0033] EDTA-2Na 1.00

[0034] Lactose 52.0

[0035] Microcrystalline Cellulose 30.0

[0036] Low-substituted hydroxypropyl cellulose 5.00

[0037] Micronized silica gel 1.00

[0038] Magnesium stearate 1.00

[0039] Process:

[0040] After the raw and auxiliary materials are sieved, mixed evenly, directly placed in a tablet machine for tableting.

Embodiment 3

[0042] prescription composition

[0043] Name Percentage (%)

[0044] Sodium Iban Phosphate 20.0

[0045] Triethylenetriaminepentaacetic acid 1.00

[0046] Lactose 42.0

[0047] Microcrystalline Cellulose 30.0

[0048] Low-substituted hydroxypropyl cellulose 5.00

[0049] Micronized silica gel 1.00

[0050] Magnesium Stearate 1.00

[0051] Process:

[0052] After the raw and auxiliary materials are sieved, mixed evenly, directly placed in a tablet machine for tableting.

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PUM

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Abstract

The invention discloses an oral pharmaceutical composition containing bisphosphates and a preparation method thereof, wherein the oral pharmaceutical composition comprises bisphosphates drugs, a metal-ion complexing agent and other pharmaceutically acceptable drug carriers. The composition has good stability and pharmacokinetics property and is applied to the treatment of bone diseases and certain metabolic calcium disorders.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing bisphosphonates and a preparation method thereof. A metal ion complexing agent is added to the composition, which effectively avoids the chelation of metal ions and bisphosphonates and enhances the drug activity ingredient absorption. For the treatment of bone diseases and certain disorders of calcium metabolism. Background technique [0002] Bisphosphonate compounds, which contain (P-C-P) bonds in their molecular structure, have strong affinity with divalent metal ions such as calcium ions, and will combine with these metal ions to form insoluble Complex. Therefore, after the bisphosphonate compound is taken, or when it is taken together with calcium, an insoluble complex will be formed in the digestive tract, thereby greatly reducing the absorption of the bisphosphonate compound in the digestive tract. [0003] CN01812935 discloses a kind of pharmaceutical composition of bisphosphona...

Claims

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Application Information

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IPC IPC(8): A61K31/662A61K31/675A61P19/10A61P3/14
Inventor 袁筝
Owner 北京德众万全医药科技有限公司
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