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Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed

The technology of oral disintegrating tablet and strontium ranelate is applied in the field of preparation of strontium ranelate oral disintegrating tablet, can solve the problems of low cost, complicated process, poor taste and the like, and achieves low cost, simple process and good taste Effect

Active Publication Date: 2012-07-04
天津药物研究院药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, special equipment is required, the cost is high, and the process is complicated
The powder direct compression method has the lowest cost and simple process, but the taste is poor and has a gritty feeling

Method used

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  • Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed
  • Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed
  • Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Prescription: (mass ratio)

[0036]

[0037] Preparation:

[0038] 1. Grind strontium ranelate, filler (mannitol) and pass through a 100-mesh sieve, binder (povidone K30), disintegrant (cross-linked povidone), flavoring agent (citric acid and stevioside ) and lubricant (magnesium stearate) directly pass through an 80 mesh sieve.

[0039] 2. Add the adhesive (Povidone K30) into purified water and stir to prepare a 10% solution for later use.

[0040] 3. Add the treated strontium ranelate and filler into the fluidized bed (a general-purpose fluidized bed granulator for pharmaceuticals: complete boiling mixing, spray granulation, and air drying), and adjust parameters: the inlet air temperature is 50-60 ℃, material temperature 30-40 ℃, atomization pressure 0.01-0.05Mpa, liquid spray speed 15-30 rpm, air intake 35-45 Hz, for granulation.

[0041] 4. After granulation, adjust the parameters: air inlet temperature 60-70°C, material temperature 30-40°C, air inlet volume ...

Embodiment 2

[0048] Prescription: (mass ratio)

[0049]

[0050]

[0051] Preparation:

[0052] 1. Grind strontium ranelate, filler (mannitol) and pass through a 100-mesh sieve, binder (hypromellose E5), disintegrant (crospovidone), flavoring agent (citric acid and stevioside) and lubricant (magnesium stearate) directly pass through 80 mesh sieve.

[0053] 2. Add the binder (hydroxypropylmethylcellulose E5) into purified water and stir to make a 3% solution for later use.

[0054] 3. Add the treated strontium ranelate and filler into the fluidized bed, adjust parameters: air inlet temperature 50-60°C, material temperature 30-40°C, atomization pressure 0.01-0.05Mpa, spray speed 15- 30 rev / min, air intake 35-45 Hz, for granulation.

[0055] 4. After granulation, adjust the parameters: air inlet temperature 60-70°C, material temperature 30-40°C, air inlet volume 35-50 Hz, and dry.

[0056] 5. Mix the dried granules with disintegrant (crospovidone), flavoring agent (citric acid and s...

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PUM

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Abstract

The invention provides a method for preparing strontium ranelate orally disintegrating tablets with a fluidized bed, which mainly comprises the following steps: pulverizing and sieving strontium ranelate, a filler, a binder, a disintegrant, a correctant and a lubricant, or directly sieving the above. The concrete method comprises the following steps: adding the binder into a proper solvent, and stirring to prepare into a solution; adding the treated strontium ranelate and filler into a fluidized bed, regulating parameters, spraying the binder into the fluidized bed with a spray gun for granulation; after granulation, regulating parameters, and drying; mixing the dried granules with the disintegrant, the correctant and the lubricant in a mixer; and tableting the mixed granules as required to obtain the strontium ranelate orally disintegrating tablets. Compared with other methods, the method for preparing strontium ranelate orally disintegrating tablets with the fluidized bed, provided by the invention, has the advantages of low cost, simple process, good mouthfeel, and the like.

Description

technical field [0001] The invention relates to the preparation of a strontium ranelate orally disintegrating tablet, in particular to a method for preparing the strontium ranelate orally disintegrating tablet using a fluidized bed. Background technique [0002] Strontium ranelate, English name strontium ranelate, also known as strontium ranelate. Its chemical name is distrontium 5-[bis(carboxymethyl)amino]-2-carboxy-4-cyano-3-thiophene acetate, CAS RN: 135459-87-1. It is mainly used for the treatment and prevention of osteoporosis in postmenopausal women. It has attracted much attention because of its unique dual effects of inhibiting bone resorption and promoting bone formation. [0003] Strontium ranelate was first developed by the French company Servier, and it was listed in the European Union in September 2004. The dosage form is dry suspension, the trade name is Protelos, and the specification is 2g / bag. [0004] There are many patents on the synthesis of strontium...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/381A61P19/10
Inventor 杨昕刘亚梅侯珏卓周学海
Owner 天津药物研究院药业有限责任公司