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Coating composition, drug-containing granules, solid formulations, and methods for preparing drug-containing granules

A technology for coating compositions and drugs, used in drug delivery, pharmaceutical formulations, coatings, etc., to achieve the effect of excellent drug solubility

Active Publication Date: 2018-01-16
SHIN ETSU CHEM IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this method has a problem that the dissolved amount of the drug in the digestive organs is also suppressed, and prevents the drug from exerting its sufficient effect

Method used

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  • Coating composition, drug-containing granules, solid formulations, and methods for preparing drug-containing granules
  • Coating composition, drug-containing granules, solid formulations, and methods for preparing drug-containing granules

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0034] The preparation method may further comprise the step of undercoating the drug-containing core with various coating substrates conventionally available in this field, such as HPMC, so that an undercoat layer is formed between the drug-containing core and the film of the coating composition . Therefore, several films are formed.

[0035] Coating equipment is not particularly limited. For example, pan coating equipment, fluidized bed granulators, or rotating fluidized bed coating equipment can be used.

[0036] Coating the core containing a drug having an unpleasant taste with the coating composition makes it possible to suppress the drug from dissolving the drug in the oral cavity and thereby suppressing the unpleasant taste of the drug. When passing the Syringe Erection / Inversion Test (which is a simple dissolution test for reproducing the dissolution of a drug in the oral cavity) (refer to PharmTech Japan, Vol. 21 (5), 163-169, 2005) When evaluating the drug-containi...

Embodiment 1

[0049] (preparation of core)

[0050] Cores were prepared in the following manner under the following layering conditions.

[0051] By dissolving 324 g of paracetamol (product of Yamamoto Co.) and 36 g of hydroxypropylmethylcellulose (methoxyl substitution: 29% by weight, hydroxypropoxyl substitution: 10% by weight, in a solution of 1008 g of ethanol and 432 g of purified water, Viscosity of 2% by weight aqueous solution at 20°C: 3mPa·s) to prepare a drug layering solution. Next, 600 g of crystalline cellulose spherical particles ("CELPHERE CP-102", product of Asahi Kasei Chemicals) were placed in a fluidized bed granulator ("MP-01", SPC, product of Powrex Corp). Subsequently, the layering solution was sprayed in an amount of up to 50 parts by weight of paracetamol based on 100 parts by weight of the crystalline cellulose spherical particles under the following conditions to obtain a drug-containing core. The drug-containing core has an average particle size of about 200 μm....

Embodiment 2

[0068] A coating solution was prepared in the same manner as in Example 1, except that 4.8 parts by weight of HPMCAS, 1.2 parts by weight of MC (ratio of MC to HPMCAS: 25% by weight), 0.098% by weight of ammonia aqueous solution (92.11% by weight) of ammonia were used. 0.09 parts by weight of ammonia in purified water) and 1.8 parts by weight of talc. Subsequently, drug-containing particles were obtained in the same manner as in Example 1.

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Abstract

Provided are a drug-containing particle that can suppress the dissolution of the drug in the oral cavity to suppress its unpleasant taste and has excellent drug solubility in the digestive tract after passing through the oral cavity; a method for preparing the drug-containing particle; a A coating composition for preparing the drug-containing particles; and a solid preparation comprising the drug-containing particles. More specifically, there is provided a coating composition comprising 100 parts by weight of a cellulose-based enteric substrate and 50 parts by weight or less of a water-soluble cellulose ether; a drug-containing particle comprising a drug-containing core and a coating portion obtained by coating the core with the coating composition; a solid preparation comprising the drug-containing particles; and a method for producing drug-containing particles comprising applying the coating composition The step of material coating this drug-containing core.

Description

technical field [0001] The present invention relates to a coating composition capable of masking the unpleasant taste of a drug in the oral cavity and releasing the drug smoothly after passing through the oral cavity; a drug-containing particle; a solid preparation containing the drug-containing particle; and a drug-containing particle In the method for preparing the drug-containing particles. Background technique [0002] In recent years, there has been a need to develop orally disintegrating tablets that can be easily accepted without water by elderly or pediatric patients with low swallowing ability. Since the drug sometimes starts to dissolve in the oral cavity, when the drug contained in the orally disintegrating tablet has an unpleasant taste such as a bitter taste, it makes administration thereof difficult. In order to suppress the dissolution of a drug in the oral cavity, a method of coating the drug with a water-insoluble coating base may be considered. However, t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K9/16A61K9/20
CPCA61K9/0056A61K9/2081A61K9/5042A61K9/5047A61K9/5078C09D101/32C08L1/26C08L1/28C08L1/284
Inventor 横泽拓也西山裕一丸山直亮
Owner SHIN ETSU CHEM IND CO LTD
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