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Silodosin composition

A technology of silodosin and composition, applied in the field of composition containing silodosin solid dispersion, capable of solving problems such as cracking of coating film, complex process, and large coating particles

Pending Publication Date: 2021-06-11
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although powder coating or granule coating can mask taste, it requires high coating equipment; in addition, because the coating substrate is powder or granule, its shape is irregular, and the coating uniformity is poor. If you want to obtain better masking Taste effect, the weight gain of the coating needs to be large, which will lead to a long coating time
In addition, the increase in coating size will inevitably lead to larger coating particles, and large insoluble coating particles will easily produce a gritty feeling in the mouth, resulting in an unpleasant taste
In addition, because the coated taste-masking granules are prepared into orally disintegrating tablets, they need to be compressed. Under a certain pressure, the coating film of the taste-masking granules may rupture, resulting in the dissolution of the drug in the oral cavity and a strong bitter taste.
Patent application CN105142633A also discloses that in order to prevent the agglomeration of masking particles during manufacturing, a layer of coating layer to prevent particle agglomeration is continuously wrapped outside the masking particles. Although this solves the problem of particle agglomeration during manufacturing, it also complicates the process again

Method used

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  • Silodosin composition
  • Silodosin composition
  • Silodosin composition

Examples

Experimental program
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Effect test

preparation example Construction

[0042] A kind of preparation method of silodosin solid dispersion, adopts spray drying process, comprises the following steps:

[0043] (1) Disperse silodosin, non-enteric carrier material and optional anti-adhesive agent in a solvent, and stir evenly to obtain a solution or suspension;

[0044] (2) Spray drying the solution or suspension obtained in step (1) to obtain a solid dispersion of silodosin.

[0045] The silodosin solid dispersion prepared by the spray-drying process has a small particle size, and after being made into an orally disintegrating tablet, it will not produce a gritty feeling. Spray drying is a drying method that uses an atomizer to disperse the raw material liquid into mist droplets, and uses hot gas (air, nitrogen or superheated steam) to dry the mist droplets to obtain a product. The process is simple and can be directly dried in the drying tower The solution or suspension is made into a powder product, and by adjusting the prescription and process pa...

Embodiment 1

[0049] Table 1: Prescription Form

[0050]

[0051]

[0052] Preparation method: Dissolve aminoalkyl methacrylate copolymer E and silodosin in a mixed solution of ethanol and acetone, add micropowder silica gel, pass through a 100-mesh sieve after homogenization, spray dry with a spray dryer, spray The dry powder passes through a 40-mesh sieve to obtain a spray-dried solid dispersion; the solid dispersion is mixed with mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropyl cellulose, sucralose, orange flavor and stearic acid Magnesium was mixed and tabletted to obtain 4 mg silodosin orally disintegrating tablets.

Embodiment 2

[0054] Table 2: Prescription Form

[0055]

[0056] The preparation method is the same as in Example 1.

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Abstract

The invention relates to a silodosin composition. The composition comprises a silodosin solid dispersion, a filler and other auxiliary materials, and the solid dispersion comprises silodosin and a non-enteric carrier material. After the non-enteric carrier material and silodosin are prepared into a solid dispersion, the taste masking effect is very good, and after the solid dispersion is prepared into an oral preparation, the oral preparation basically has no bitter taste and good taste and has the dissolution property of effectively treating blood concentration. Meanwhile, the invention also provides a method for preparing the silodosin solid dispersion, and the method adopts a spray drying or hot melt extrusion process, has good reproducibility and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition containing silodosin solid dispersion. Background technique [0002] Silodosin is a drug for dysuria, has selective urethral smooth muscle contraction inhibitory activity, and does not cause strong hypotensive activity, and is widely used as a therapeutic drug for dysuria associated with benign prostatic hypertrophy. The chemical structural formula of silodosin is as follows: [0003] [0004] Currently, the formulations of silodosin listed at home and abroad include capsules, regular tablets and orally disintegrating tablets. Dosage forms such as capsules and ordinary tablets must be taken with water, and for patients with dysphagia such as elderly patients, the compliance of taking medicine is poor. In recent years, with the aging of the population, there is an increasing demand for the development of orally disintegrating tablets, which can be take...

Claims

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Application Information

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IPC IPC(8): A61K31/4045A61K9/14A61K47/32A61K47/04A61K47/02A61K47/14A61K9/20A61K9/48A61P13/08A61P7/10
CPCA61K31/4045A61K9/146A61K9/143A61K9/145A61K9/2095A61K9/0056A61K9/2027A61K9/2009A61K9/2013A61K9/4866A61K9/4858A61K9/485A61P13/08A61P7/10
Inventor 李雪王丽荣黄心游劲松黄芳芳
Owner SUNSHINE LAKE PHARM CO LTD