JP3031509U - Oral drugs and processed foods - Google Patents

Abstract

(57) [Summary] [Purpose] To eliminate the pains of taking oral medicines and ingesting processed foods. [Structure] Oral pharmaceuticals and processed foods characterized in that a bulk drug or a drug containing a substance or a nutrient having a physical condition-regulating function is protected by a coating layer having appropriate elasticity and strength and added to a food material. .

Description

[Detailed description of the device]

[0001]

[Field of Industrial Application] The present invention relates to an oral drug and a processed food, and is used in the field of medical care or food industry.

[0002]

2. Description of the Related Art Oral pharmaceuticals include various solid preparations such as capsules, pills, tablets, fine granules, granules, powders, troches and buccal preparations, and syrups and drinks as liquid preparations. Taken in different dosage forms. Heretofore, in order to make it easier to take, a method of providing an appropriate size or imparting a taste or a fragrance (for example, addition of sugar coating or a fragrance) has been used.

In the case of pediatric preparations, powders and liquids are the mainstream, and some of the tablets are crushed and some of the capsules are opened and used as a powder for the preparation of medicines (Journal of Medicine, 583). Pp. 587, Volume 30, No. 2, 1994).

Conventionally, many pharmaceutical additives used as coating agents in the formulation process have been developed and have already been industrially produced, and these are used as gastric-soluble coating agents, enteric-coated coating agents and controlled-release coating agents. They are classified (Pharmacia Review, No. 22, pp. 75-81, 1987).

[0005]

[Problems to be Solved by the Invention] One of the important characteristics of oral drugs is ease of administration. This property becomes more important in the case of pediatric drugs. Many children dislike taking oral medications. One of the causes of dislike taking the medicine is the discomfort of the appearance, taste, aroma, texture, or texture of oral medicines. Among the conventional oral pharmaceuticals, there is a problem that it is difficult or difficult to take due to the aforementioned discomfort. When a syrup and a solid preparation are mixed and used, there is a problem that it is difficult to stably maintain a constant dose due to a precipitate. There was also the problem of having to crush tablets and open capsules.

[0006] Foods processed using substances having a physical condition-regulating function (hereinafter referred to as functional foods: Pharmacia, pages 47 to 49, Vol. 31, No. 1, 1995) and nutrients such as vitamins and minerals. Foods with added (hereinafter referred to as fortified foods) are useful, but if the substances and nutrients to be added are easily decomposed or if the flavor is extremely unpleasant, these processed foods that are easy to ingest by a simple addition method are used. It was difficult to produce food.

An object of the present invention is to solve the above problems and provide an oral drug which can be easily taken and can reliably control a constant dose, and a functional food or a fortified food which is easy to take. .

[0008]

[Means for Solving the Problems] In order to facilitate taking or ingesting, it can be taken or ingested by chewing like foods, in a form that does not release unpleasant taste and aroma components in the oral cavity. Creatively devised. The drug was protected with an edible covering layer of appropriate elasticity and strength, and it was added to foodstuffs.

[0009]

(B) A drug containing one or two or more kinds of bulk drug or a substance or a substance having a physical condition-regulating function as a core is designated as nucleus A. (B) One or two or more nuclei A 1 are coated with an edible material having appropriate elasticity and strength to form particles B having a size of 5 mm or less, preferably 1 mm or less. (C) One or two or more kinds of the particles B are contained in the food such as confectionery at a predetermined number of one or two or more. The present invention provides an oral pharmaceutical product and a processed food, characterized in that the food B such as confectionery contains the particles B coated with the edible material having appropriate elasticity and strength as configured above. It is a thing. To prevent the decomposition of bulk drug in the nucleus A or substances or nutrients having a physical condition-regulating function, to mask the taste and aroma of the nucleus A, and to prevent the nucleus A from being exposed in the oral cavity and to elute in the stomach or intestine. The core A was coated with a gastric or enteric edible material. Furthermore, by imitating solid confectionery, it became possible to make it easier to take or take and to control certain doses with certainty. Hereinafter, the configuration of the present invention will be described in detail.

There is no limitation on the bulk drug substance or the substance or nutrient having a physical condition regulating function, which is to be blended with the core A of the present invention. Examples of the bulk drug include various uses such as for the neuropsychiatric, digestive organs, circulatory organ / blood, respiratory organs, urogenital organs, nutritional tonics, women, allergies, otolaryngology, etc. Oral drug bulk powder used is mentioned. Substances that have a physical condition-regulating function include substances that have an immune-enhancing effect, substances that contribute to the prevention and recovery of disease, substances that contribute to obesity prevention such as appetite suppressants, metabolic promoters, digestive enzyme inhibitors, and hormones. It is possible to cite such things as those having a biological rhythm adjustment function. Nutrients include minerals such as calcium and iron and vitamins. To the nucleus A, one or more kinds of bulk drug or substances or nutrients having a physical condition regulating function are blended. The shape of the nucleus A is not limited.

One or more cores A are coated with an edible material having appropriate elasticity and strength to obtain particles B having a size of 5 mm or less, preferably 1 mm or less. The shape of the particles B is not limited.

Examples of the edible material forming the coating layer of the particles B include foods, food additives used in the food industry, and pharmaceutical additives used as coating agents or capsule bases in the formulation process. To be For example, gastric-soluble edible materials include cellulose ether derivatives represented by hydroxypropyl cellulose and hydroxypropylmethyl cellulose, polyvinyl derivatives represented by polyvinyl acetal diethylaminoacetate, and dimethylaminoethyl methacrylate / methacrylic acid. Aminoalkyl methacrylic acid copolymer derivatives typified by methyl copolymers, sucrose, gelatin, etc. are mentioned, and enteric-coated edible materials include cellulose acetate phthalate, hydroxypropylmethyl cellulose phthalate, hydroxypropylmethylcellulose acetate succinate, Cellulose derivatives such as carboxymethyl ethyl cellulose, and methacrylic acid copolymer typified by methacrylic acid ethyl acrylate copolymer Body, such as chitin Contact and chitosan. Examples of controlled release coatings, including but a combination of gastric or enteric coating agent and a water-insoluble polymer is not limited to those on the following.

The method of forming the coating layer of the edible material of the particles B may be a usual coating method. For example, a method of spraying a solution of an edible material on the core A and a method of mixing a solution of an edible material or a paste with the core A are mentioned, but the method is not limited to the above.

When two or more kinds of components are decomposed by being mixed with each other, if they are blended in different cores A and coated with each other to form particles B, they can be prevented from contacting and decomposition.

The food containing the particles B is not particularly limited, but is preferably solid, and more preferably those having a long shelf life and a soft texture. Although the shape of the food is not limited, it is preferable that the shape of the food is not significantly different from the original shape. Examples include Western confectioneries such as chocolates, cakes, castellas, cream puffs, and Japanese confectionery such as pastes, sao (yokan), mochi, and punches, but are not limited to the above. Not done. The method of including the particles B in the food is not limited, but the particles are usually mixed in the course of the production of the food.

[0016]

The present invention will be described in detail with reference to the following examples, which do not limit the scope of the present invention.

Example 1 A drug having a particle size of 0.1 mm to 0.4 mm (corresponding to the core A) containing 1 or 2 or more kinds of bulk drug substances was mixed with an aqueous gelatin solution in a paste form to prepare a thick film. A plate having a size of 0.6 mm to 0.8 mm is formed. This is cut to a width of 0.6 mm to 0.8 mm and then cut to a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers to be molded to cover the core A on the cut surface. The melted chocolate and the required amount of particles B are mixed, poured into a mold, and cooled and solidified.

Example 2 A drug having a particle size of 0.1 mm to 0.4 mm (corresponding to the core A) containing one or more kinds of bulk drug substances was mixed with a gelatinous aqueous solution in a paste form. With a diameter of 0. It is extruded from a hole of 6 mm to 0.8 mm and formed into a thread shape. This is cut to a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers to be molded to cover the core A on the cut surface. The required amount of melted chocolate and particles B are mixed, poured into a mold, cooled and solidified.

Example 3 A drug having a particle size of 0.1 mm to 0.4 mm (corresponding to the core A) containing one or more kinds of bulk drug powders and containing hydroxypropylmethylcellulose acetate succinate and triethyl citrate. Spray coating the water suspension with a spray gun. This is mixed with a pasty gelatin aqueous solution to form a plate having a thickness of 0.6 mm to 0.8 mm. This is cut to a width of 0.6 mm to 0.8 mm and then cut to a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers and molded to cover the cores A on the cut surface. The required amount of melted chocolate and particles B are mixed, poured into a mold, cooled and solidified.

Example 4 A drug having a particle size of 0.1 mm to 0.4 mm (corresponding to the core A) containing one or more kinds of bulk powders of powder and containing hydroxypropylmethylcellulose acetate succinate and triethyl citrate. Spray coating the water suspension with a spray gun. This is mixed with a pasty gelatin aqueous solution, and this is extruded from a hole having a diameter of 0.6 mm to 0.8 mm to form a thread. This is cut into a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers to be molded, and the core A on the cut surface may be covered. The required amount of melted chocolate and particles B are mixed, poured into a mold, and cooled to solidify.

Example 5 Spraying an aqueous solution of hydroxypropylmethyl cellulose and polyethylene glycol on a drug (corresponding to the core A) having a particle size of 0.1 mm to 0.4 mm containing one or more kinds of bulk drug powders. Spray coating with a gun. This is mixed with an aqueous gelatin solution in the form of a paste to form a plate having a thickness of 0.6 mm to 0.8 mm. This is cut into a width of 0.6 mm to 0.8 mm and then cut into a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers and molded to cover the core A on the cut surface. The melted thiocholate and the required amount of particles B are mixed, poured into a mold, and cooled and solidified.

Example 6 A drug having a particle size of 0.1 mm to 0.4 mm (corresponding to the core A) containing 1 or 2 or more kinds of bulk drug powders is sprayed with an aqueous solution of hydroxypropylmethyl cellulose and polyethylene glycol. Spray coating with a gun. This is mixed with a gelatinous aqueous solution in the form of paste, and this is extruded through a hole having a diameter of 0.6 mm to 0.8 mm to form a thread. This is cut into a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers and molded to cover the core A on the cut surface. The melted chocolate and the required amount of particles B are mixed, poured into a mold, and cooled and solidified.

Example 7 A sustained-release coated drug having a particle diameter of 0.1 mm to 0.4 mm, which was prepared by mixing one or more kinds of bulk drug substances, was mixed with a gelatinous aqueous solution in a paste form to prepare a thick film. It is formed into a plate having a size of 0.6 mm to 0.8 mm. This is cut to a width of 0.6 mm to 0.8 mm and then cut to a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers and molded to cover the core A on the cut surface. The required amount of melted chocolate and particles B are mixed, poured into a mold, and cooled and solidified.

Example 8 A sustained-release coated drug having a particle size of 0.1 mm to 0.4 mm containing one or more kinds of bulk drug substances was mixed with a gelatinous aqueous solution in a paste form, and This is extruded from a hole having a diameter of 0.6 mm to 0.8 mm to form a thread. This is cut into a length of 0.6 mm to 0.8 mm to obtain particles B. The particles B may be sandwiched between rollers and molded to cover the cores A on the cut surface. The required amount of melted chocolate and particles B are mixed, poured into a mold, cooled and solidified.

Example 9 A processed food in which one or more pharmaceutical bulk powders of Example 1 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 10 A processed food in which one or more pharmaceutical bulk powders of Example 2 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 11 A processed food in which one or more pharmaceutical bulk powders of Example 3 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 12 A processed food in which one or more pharmaceutical bulk powders of Example 4 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 13 A processed food in which one or more pharmaceutical bulk powders of Example 5 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 14 A processed food in which one or more pharmaceutical bulk powders of Example 6 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 15 A processed food in which one or more pharmaceutical bulk powders of Example 7 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

Example 16 A processed food in which one or more pharmaceutical bulk powders of Example 8 are one or more nutrients such as vitamins and minerals or substances having a physical condition adjusting function.

[0033]

[Effect of device]

 The oral drug product provided by the present invention contains a drug particle coated with an edible material having appropriate elasticity and strength so as not to damage the drug particle in the oral cavity. It is easy to take because it has the same or similar appearance, taste, scent, texture, or texture to the confectionery of. Furthermore, since it is a solid preparation, it is possible to reliably control a fixed dose. Especially in pediatric formulations, instead of relatively unsuitable tablets and capsules, by adopting the present invention, crushing of tablets and opening of capsules can be avoided. Further, the decomposition of the bulk drug substance can be prevented by the covering. Similarly, for functional foods and fortified foods, processed foods that are easy to ingest can be obtained even when substances and nutrients having a physical condition-regulating function are easily decomposed or the taste is extremely unpleasant.

The gist of the present application is to eliminate the pain when taking a drug. Whether or not the therapeutic effect is medically proven should belong to future problems and should not be the main point of the present application. However, the disintegration of gastric-soluble edible material in the stomach and the disintegration of enteric-soluble edible material in the intestine are the basis of pharmaceutics. Therefore, the core A is selectively released in the stomach or intestine unless the coating layer of the particles B is damaged in the oral cavity. In the next step, it is easily conceivable that the drug in the nucleus A will be eluted and absorbed.

[Brief description of drawings]

FIG. 1 is a perspective view of the present invention.

FIG. 2 is a sectional view taken along line a of FIG.

[Explanation of symbols]

 1 is an edible material such as chocolate 2 is a particle B 3 is a coating layer 4 is a core A

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[Procedure amendment]

[Submission date] June 17, 1996

[Procedure Amendment 2]

[Document name to be amended] Statement

[Name of item to be amended] Scope of utility model registration request

[Correction method] Change

[Correction content]

[Scope of utility model registration request]

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁶ Identification code Internal reference number FI Technical display area A61K 47/32 A61K 47/32 D 47/36 47/36 D 47/38 47/38 D

Claims (3)

[Scope of utility model registration request] 1. (a) A drug containing one or more kinds of bulk drug substances as the core A. (B) One or two or more cores A are covered with an edible material to obtain particles B having a size of 5 mm or less, preferably 1 mm or less. (C) One or two particles B of one kind or two kinds or more
A predetermined number of pieces or more is included in food such as confectionery. An oral drug having the above-mentioned constitution, which is easy to take, characterized in that when taken, the nucleus A does not elute in the oral cavity. 2. The edible material is (1) a cellulose ether derivative represented by hydroxypropylcellulose or hydroxypropylmethylcellulose, a polyvinyl derivative represented by polyvinyl acetal diethylaminoacetate, or a dimethylaminoethyl methacrylate / methyl methacrylate copolymer. Or a gastric-soluble edible material such as aminoalkyl methacrylic acid copolymer derivative, sucrose, gelatin or the like, or (2)
Cellulose acetate phthalate, hydroxypropylmethyl cellulose phthalate, hydroxypropylmethyl cellulose acetate succinate, carboxymethyl ethyl cellulose and other cellulose derivatives, methacrylic acid copolymer derivatives represented by methacrylic acid ethyl acrylate copolymer, enteric edible materials such as chitin and chitosan In some cases, or (3) a controlled release coating agent such as a combination of a gastric or enteric coating agent and a water-insoluble polymer. 3. One or two of claim 1 or claim 2.
Processed food in which one or more pharmaceutical bulk powders are one or more nutrients such as vitamins and minerals or substances having a physical condition regulating function