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Enteric hard capsule

An enteric-coated, hard capsule technology, applied in the direction of capsule delivery, organic active ingredients, non-central analgesics, etc., can solve the problem that there is no special regulation on the temporary dissolution characteristics

Pending Publication Date: 2021-03-26
QUALICAPS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, there are no special regulations for the transient dissolution properties in the intestine

Method used

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Examples

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preparation example Construction

[0354] In the preparation solution of the present invention and the method for preparing the preparation solution of the present invention, a step C of adding component iii can be added to step A or step B. Alkyl (meth)acrylate copolymers as component iii have little interaction with component i or component ii affecting viscosity or chemical stability and can thus be added after step A or step B as an aqueous dispersion .

[0355] In addition, aspect 3-1 may further include: step D of maintaining the solution obtained in step B or C at a third temperature T3 lower than the cloud point of component i. In addition, the third temperature T3 is preferably higher than T2 and not lower than the cloud point T0 by more than 10°C. As a result, the partially dissolved state of component i can be stably maintained. For example, temperature T3 may be in the range of 30°C to 60°C. Preferably, the temperature T3 may be in the range of 50°C to 60°C.

[0356] Component iv of the preparat...

Embodiment

[0431] I. Materials used

[0432] Materials used in Examples, Reference Examples, and Comparative Examples are as follows.

[0433] 1. Water-soluble cellulose compound

[0434] As methylcellulose (MC) and hydroxypropylmethylcellulose (HPMC), METOLOSE (trademark) series, TC-5 (trademark) series, and SH series manufactured by Shin-Etsu Chemical Co., Ltd. were used. As hydroxypropylcellulose (HPC), NISSO HPC series from Nippon Soda Co., Ltd. was used. Specific product names and their substitution types and "viscosity values" (labeled viscosity or viscosity grades) are shown in Table 2.

[0435] The particle size distribution of TC-5 series and SH series HPMC was measured with a laser diffraction particle size distribution analyzer ("Microtrack particle size distribution diameter MT3300IIEX" manufactured by Microtrack BEL). The average particle size is in the range of 50-100 μm. The volume fraction of particles having a particle size of 100 μm or more is 50% or more.

[0436] [...

preparation example V-1

[0492] In the following examples and comparative examples, capsule preparation liquids were prepared according to Preparation Example III-1 (preparation method of aspect 3-1), and molded according to molding method IV. Based on their total mass (the total mass of the polymer components) expressed as 100% by mass, the mass percentages of the solid content of component i, component ii, component iii and component iv are expressed as α, β, γ, respectively and δ. Based on the total mass of the above-mentioned polymer components, the mass ratio of the basic neutralizer (NaOH) to other salts and the mass ratio of titanium oxide (opacifier) ​​are expressed as ε (%) and σ (%), respectively. The mass ratio of the polymer components of components i to iv is defined as the polymer component concentration (%) based on the total mass of purified water as a solvent and the solid contents of components i to iv. Each specific composition is shown in Table 3. Furthermore, in these tables, th...

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Abstract

The present invention provides a hard capsule that can be formed by means of a cold gelation process and comprises a hard capsule coating that is enterosoluble. Provided is an enteric hard capsule comprising a coating which contains (a) a first component and a second component or (b) contains a first component and a second component and further contains at least one component from among a third component and a fourth component, wherein: the first component is methylcellulose and / or hydroxypropyl methylcellulose having a viscosity value of 6 mPa*s or higher, the second component is an enterosoluble methacrylic acid copolymer, the third component is a water-insoluble alkyl (meth)acrylate copolymer and / or ethylcellulose, and the fourth component is at least one compound selected from the group consisting of plasticizers that are acceptable pharmaceutically and as food additives and surfactants; and when 100 mass% is the total mass of the first component, the second component, the third component, and the fourth component included in the coating, the ratio of the first component is 30-70 mass%, the ratio of the second component is 30-60 mass%, and the total of the ratios of the first component and the second component is 70 mass% or higher.

Description

technical field [0001] The invention relates to an enteric hard capsule, an enteric hard capsule preparation, a method for preparing the enteric hard capsule preparation and a method for preparing the enteric hard capsule. Background technique [0002] The term "enteric" generally refers to the characteristics of a dosage form of a preparation that is administered orally and hardly dissolves in the stomach. Furthermore, the preparation has the characteristic of being easily dissolved after being transferred into the intestine. Enteric-coated formulations do not release the pharmaceutically active ingredient in the stomach, which has a strongly acidic environment, but release the pharmaceutically active ingredient after the formulation moves into the intestinal tract. Therefore, enteric-coated preparations are mainly used to protect the pharmaceutical active ingredient from damage by gastric acid or gastric enzymes, or for the purpose of continuously releasing the pharmaceut...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K9/48A61K31/381A61K31/4439A61K31/616A61K47/32A61P1/00A61P25/24A61P29/00
CPCA61P29/00A61P25/24A61P1/00A61K31/167A61K9/4816A61K9/4883A61K9/48A61K31/381A61K31/4439A61K31/616A61K47/32A61K47/38A61K47/02
Inventor 大崎芳朗麻生慎上野皓辉
Owner QUALICAPS CO LTD
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