JPH02221232A - Readily drinkable medicine composition - Google Patents

Abstract

PURPOSE:To obtain a readily drinkable medicine composition reduced in unpleasant feeling in mouth by blending a water soluble fiber alone or in combination of reduced malt sugars. CONSTITUTION:A water soluble fiber, e.g. polydextrose or pine fiber or the water soluble fiber and reduced malt sugar are blended into a solid preparation, semi-solid preparation and liquid preparation. When the above-mentioned ingredient is used as a binder for solid agent or disintegrator, medicine is readily dissolved and further bitter taste of main medicine added can be masked.

Description

[Detailed Description of the Invention] [Industrial Field of Application] The present invention provides a formulation that can be easily taken by young children, the elderly, etc. by incorporating the above-mentioned ingredients into solid, semi-solid, and liquid preparations. The present invention relates to a composition that can be used.

[Conventional technology]

Currently, pharmaceutical formulations include tablets (uncoated tablets, film-coated tablets, and coated tablets), powders, granules, lozenges, syrups, lozenges, and oral refills, which usually contain a fixed amount of the active ingredient. It is manufactured by mixing the main drug with auxiliary agents such as excipients, binders, lubricants, disintegrants, flavoring agents, and flavoring agents.

[Problem that the invention seeks to solve]

However, although these preparations contain lactose, starch, microcrystalline cellulose, etc. as binders, disintegrants, and excipients, they have been found to have undesirable texture, taste, odor, etc. It will be done.

In particular, for young children and the elderly, dosage forms that are unfavorable in terms of taste, solubility, hardness, etc., especially powders, may stick to the mouth and throat of young children and the elderly when they are taken, and may be undesirable due to dispersion in the mouth. It gives a pleasant sensation and often causes people to refuse to take it.

Also, for patients who are on calorie restriction, such as those with gastrointestinal disorders or diabetes, Cheapul tablets, lozenges, syrups, and oral fluid rehydration, which are mainly formulated with sugar and glucose, may not be desirable. Conceivable.

The composition provided by the present invention contains water-soluble fiber and reduced maltose as main ingredients to improve taste, solubility, ease of swallowing, and discomfort in the mouth. A composition characterized by:

Here, this composition refers to semi-solid compositions (pudding, jelly, yogurt) that are solid in their rich form, but not necessarily solid (pudding, jelly, yogurt), and liquid (water preparations, silage agents).

This includes compositions such as elixirs, oral rehydration fluids, infusions, tube feedings), and lozenges.

The water-soluble fiber is polydextrose or 9-in-fiber, etc. Polydextrose is a trade name provided by Pfizer Inc. in Japan, and is made of edible polycargenic acid (for example, citric acid) as a total catalyst and a crosslinking agent. It is a water-soluble polysaccharide with a molecular weight of 1500 to 1800 obtained by polymerizing glucose or maltose in a molten state. (The manufacturing process patent is U.S. Patent No. 375616.
It is described in the specification of No. 5. ) Pine fiber is the trade name of Matsutani Chemical Industry Co., Ltd., and is a highly purified product that is hydrated during the industrial roasted dextrin gold production process and is an indigestible f-xtrin containing 55% of indigestible components. It is.

Reduced maltose refers to reduced maltose (including anhydrous) and reduced maltose starch syrup, and as necessary, sorbitol, marpit, D-mannite, glucose, ascorbic acid, citric acid, DL-malic acid, erythorbic acid, Sodium bicarbonate can be added.

Water-soluble fiber is a binder or disintegrant for solids, a flavoring agent,
It can be used as a flavoring agent at 0.5 to 80%.

The appropriate blending ratio of water-soluble fiber and reduced maltose is 0.5 to 80% for the former and 2 to 80% for the latter.

As adjuvants to be incorporated into the formulation of the present invention, those conventionally used as internal preparations can be included, particularly within a range that does not interfere with achieving the objectives of the present invention. Specifically, as a binder, lactose, barley starch, corn starch, gakistrin, gum arabic, gelatin, N shellac, hydroxypropyl cellulose, hydroxyglobil methyl cellulose, sorbitol, hydroxypropyl starch, calxexy methyl cellulose sodium, Crystalline cellulose, ethyl cellulose, polyvinylpyrrolidone, triglyceride, polyethylene glycol, fatty acid glycerin ester, etc.

9. As a lubricant, Merck, beeswax, hydrogenated oil, light anhydrous silicic acid, hydrated silicon dioxide, smear, as a disintegrant, sodium carboxymethyl starch, agar powder, bentonite, etc. Other fragrances. Other materials.

[Effect]

The formulation of the present invention reduces discomfort in the mouth, and when used as a binder or disintegrant for solid formulations, it dissolves easily, and is more effective than conventional methods in masking the bitterness of the added active ingredient. This invention is particularly useful for young children and the elderly.

〔Example〕

EXAMPLES Next, the present invention will be explained in more detail with reference to Examples, but the present invention is not limited thereto.

Example 1 Pediatric antidepressant (chewable tablet) Contains meclizine hydrochloride, diameter 5.7 m, weight 100 m
g tablets were compressed into tablets. In addition, as a comparative product, tablets containing hydroxyglobil cellulose (RPC-L), which is used as a conventional binder or disintegrant, were molded. The hardness of the obtained tablets was measured using a tablet hardness tester. As a result of performing a disintegration test based on the Japanese Pharmacopoeia, the product of the present invention had better hardness and disintegrability than comparative products and commercially available products.

As a result, the product of the present invention had better disintegration properties than the comparative product, and the results of a sensory test (2015), which was conducted on 9 people (15 people), showed that the unique taste of pihizusu was masked, It was also easy to swallow.

Example 2 Bifidobacterium tablet (composition) Bifidobacteria powder 25% by weight reduced maltose 40 l Polydextrose 30 N Sodium bicarbonate IN Ascorbic acid 3 Magnesium stearate IN Yogurt flavor
0.1 1 Mix each of the above compositions, then 13 m diameter
It was compressed into tablets with flat rounded corners and a weight of 1500 m5. As a comparison product, a commercially available bifidobacterial agent was pulverized into fine particles, and the resultant was compressed into tablets.

The hardness of the resulting nine tablets was measured using a tablet hardness tester, and based on the Japanese Pharmacopoeia, disintegration test sensory test Example 3 Calcium agent calcium powder was prototyped using a conventional method and compared with the conventional product in Panel 15. All sensory tests were conducted on humans.

Table: Sensory Evaluation From the results of the sensory test table, the product of the present invention has sufficiently satisfactory results in both taste and ease of swallowing when compared to conventional products.

Example 4: Prototype Chuagle tablets of vitamin C were made and compared with conventional products.
A sensory test was conducted with a panel of seven people.

According to the results, the product of the present invention was the most preferred, and the product of the present invention had sufficiently satisfactory results in terms of hardness, taste, and ease of dissolution compared to the conventional product.

Example 5 Syrup The following Silon F was prepared in a conventional manner, and the invention product and the next comparative product were split with simple syrup and a sensory test was performed on a panel of 10 people.

As a result of comparing a conventional syrup of acetaminophen having a bitter taste with the product of the present invention, it was found that the product of the present invention had a clearly reduced bitterness compared to the comparative product.

Example 6 Malt extract, which is in the form of a candy, is a treatment for infant constipation, and is made by gelatinizing starch with malt, adding potassium carbonate,
Concentrated under reduced pressure, it is made into a candy-like substance containing more than 60% maltose gold. After adding polydextrose to this malt extract,
Water is added and dissolved, and this is freeze-dried to obtain a powdery mixture.

Invention products 2 and 4 and conventional product (candy-like malt extract)
When compared with human glossy gels, all of the products melted more easily during the day than conventional products, and were both better in taste and ease of swallowing.

Sensory test example 7 Jelly gelatin 3% by weight Acetamin 7ene 0.165 If reduced maltose 15 〃 Polybu-V strose 1 〃
Sodium hydrogen carbonate 0.1/f water
The remaining acetaminophen, reduced maltose, and polydextrose '1100- were dissolved in water while keeping warm at about 70°C.
Add sodium bicarbonate to this and mix with gelatin, 4
Store at ℃ for 30-60 minutes to solidify.

The product of the present invention has a reduced bitter taste and is a composition that is extremely easy for young children and the elderly to swallow.

Example 8 Acetaminophen tablets with a bitter taste (diameter 5
．． 7 m) Put in 'k 500 fi, blow out the air from the slit air while rotating the disk at the bottom of the tank,
The tablets were fluidized while controlling the temperature in the fluidized bed at 45 to 50°C, and a coating agent having the composition shown in the following file was applied at 12 to 14 g/min using an air jet 4 type spray gun.
It was sprayed at a rate of

Compared to conventional water-soluble coating agents, the coating agent with the composition of the present invention had better masking of bitterness, lower friability, and lower number of adhesive tablets. (Table 2
) [Effects of the Invention] The water-soluble fiber matrix of the present invention shows that the formulation made from water-soluble fiber and reduced maltose has less discomfort during the day compared to the next drug formulation containing conventional excipients. It is an easy-to-take formulation with reduced calorie intake, and is suitable for infants, children, the elderly, and diabetic patients who require a low calorie diet.

Inoku, 7 principles for each person = A rough measure of scale Table 1 Coating solution composition All parts indicate weight %.

Table 2 Evaluation of Coach 4 Fufu Tablets Ikkoji I tongue body t- recognized

Claims (2)

[Claims] (1) A pharmaceutical composition characterized by containing water-soluble fiber or water-soluble fiber and reduced maltose. (2) A composition characterized by containing water-soluble fiber and reduced maltose.