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Solid preparation

A solid preparation and drug technology, applied in the field of dissolution improvement, can solve the problem of drug dissolution reduction and other problems

Inactive Publication Date: 2012-02-22
LINTEC CORP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when a water-swellable gel-forming layer is formed using an anionic or acidic polymer, and a cationic or basic drug is contained in the drug-containing layer, the drug-eluting property decreases.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0022] The solid preparation of the present invention includes: a drug-containing part containing a drug, and a gel-forming layer that directly or indirectly covers the drug-containing part and absorbs water to swell to form a gel. An intermediate layer may exist between them.

[0023] figure 1 It is a schematic cross-sectional view showing an example of the solid preparation of the present invention.

[0024] shown in figure 1 The solid preparation (oral preparation) 1 of the present invention comprises: a drug-containing part (or drug-containing layer) 2 containing a drug, an intermediate layer (or adhesive layer) 3 covering the drug-containing part, covering the intermediate layer, and absorbing The gel-forming layer 4 swells with water to form a gel, and the water-soluble anti-adhesion layer (or outermost layer) 5 covers the gel-forming layer to prevent adhesion to the oral cavity. The drug-containing portion 2 contains a cationic drug, and the gel-forming layer 4 conta...

Embodiment 1

[0134] (a) Adhesion prevention layer preparation step

[0135] The coating solution A containing the constituent components of the adhesion prevention layer was prepared as follows

[0136]To purified water: 380 parts by mass, calcium chloride (Calcium chloride H, manufactured by Tomita Pharmaceutical Co., Ltd.): 0.27 parts by mass was added as a viscosity reducer, and stirred to dissolve. To this solution was slowly added a carboxyvinyl polymer (polyacrylic acid, Carbopol 974P, manufactured by Noveon, 0.2% by mass aqueous solution viscosity (20°C): 12100 mPa·S): 10.0 parts by mass, stirred for 1 hour, and each The mixture of ingredients was heated at 80°C. Slowly add hydroxypropylmethylcellulose (TC-5E, manufactured by Shin-Etsu Chemical Co., Ltd., 2% by mass aqueous solution viscosity (20°C): 3mPa·S) as an antiadhesive agent to the mixed liquid while stirring: 81.63 parts by mass, and add Then, stir for 15 minutes, lower the temperature of the liquid to 30° C., and stir fo...

Embodiment 2

[0149] A solid preparation (oral administration preparation) in which the drug-containing layer and the intermediate layer contained an electrolyte was prepared in the same manner as in Example 1 above except that the following coating solution C-2 was used as the intermediate layer.

[0150] To water: 190 parts by mass, slowly add anhydrous calcium hydrogen phosphate as an electrolyte: 14.2 parts by mass, and glycerin (Japanese Pharmacopoetic Glycerin, manufactured by Asahi Denka Co., Ltd.) as a plasticizer: 22.3 parts by mass as an electrolyte dissolve. To this solution, 63.5 parts by mass of polyvinylpyrrolidone (PVP K-90, manufactured by ISP Japan Co., Ltd.) as a base was slowly added with stirring, and the coating liquid C-2 was obtained by stirring for 60 minutes.

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PUM

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Abstract

Disclosed is a solid preparation (1) which comprises: a drug-containing part (2) that contains a cationic drug; a gel-forming layer (4) that contains an anionic polymer and covers the drug-containing part (2), while forming a gel by absorbing water; and if necessary, an intermediate layer (3) that is interposed between the drug-containing part (2) and the gel-forming layer (4). In the solid preparation (1), the dissolvability of a drug is improved by having the drug-containing part (2) and / or the intermediate layer (3) contain an electrolyte (such as calcium chloride). The gel-forming layer (4) may be formed from a carboxyvinyl polymer and a polyvalent metal compound. The gel-forming layer (4) may be covered with a surface layer (adhesion preventing layer) (5).

Description

【Technical field】 [0001] The present invention relates to methods for improving the dissolution properties of solid preparations (especially solid preparations suitable for oral administration) and drugs. 【Background technique】 [0002] As oral administration preparations, for example, solid-state solid preparations, jelly-like (or gel-like) semi-solid preparations, and the like are known. Solid preparations (eg, lozenges, capsules, etc.) are generally taken with a large amount of water because they are difficult to swallow directly. In particular, it is often difficult for elderly people or young children to swallow solid preparations. In addition, solid preparations may accidentally block the respiratory tract or adhere to the esophagus. [0003] On the other hand, since the semisolid preparation is jelly-like, it is easy to swallow, and it is easy to take it by the elderly or young children. However, since the semisolid preparation contains a large amount of water, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/70
CPCA61K9/2886A61K9/7007A61K9/28A61K9/70
Inventor 高野阳一杉浦裕作
Owner LINTEC CORP