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Granules

What are granules?

Granules are powderized medicinal products or foodstuffs in the form of pharmaceutical productions whose grain size is as consistent as possible.

Types of granules

Type Production method name (granulation type) Dissolution properties Bulk
Spherical granule Stirring (rolling motion) granulation method Quite poor solubility Quite high
Irregular-shaped granule Flow layer granulation method Easy to dissolve Low
Pellet granule Extruding granulation method Poor solubility high

Strengths of granules

1. Large capacity intake is possible

Large single doses can be configured.

2. High blending ratio of active ingredients

A high blending ratio of active ingredients can be configured.
3. Easy to make best use of flavors of raw materials
This form of preparation preserves the flavors of active ingredients (main ingredients).

4. Quick crumble/absorption

Granules have excellent crumbling/absorption properties.
Granules

5. High level of freedom in product design

Granules are less prone to scattering or choking than powders. There are also granule products that can be drunk by dissolving in cold or hot water.

6. Coating is also possible

Granules can also be coated.

Granule manufacturing method

Stirring (rolling motion) granulation method

This is a method of aggregating spherical grains by wetting powder, adding a binding agent if necessary, and applying a rolling motion.

Flow layer granulation method

This is a method of aggregated granulation by means of a binding agent sprayed onto powders, whereby the powder layer is kept in a flow state and solution containing a binding agent is sprayed.

Extruding granulation method

This is a method of granulation where a binding agent solution is added to powder in order to make a pressurized liquid mixture (refined), and this is extruded from a screen (a board with holes of a uniform size).

Granule manufacturing process

General preservation/storage conditions for health-foods

Except for special items, health-foods (soft capsules, hard capsules, seamless capsules, tablets, granules, jellies and mini-drinks) are normally kept at room temperature, and even from the perspective of the composition of contents and changes in appearance, etc., it is necessary to avoid high temperatures and high humidity, as well as sudden changes in temperature, and as with general foodstuffs, efforts should be made to keep health-foods in stable and secure conditions. In general, the following conditions are desirable.

◎Temperature 30℃ max. (avoid placing inside vehicle, on vehicle dashboard/trunk, or in bag, etc.)

◎Humidity RH60% max. (Avoid kitchens/drainage area and places where rust/mold easily occur)

◎Light. (Avoid direct sunlight)

◎Oxygen (air) . (After opening, firmly close stopper or fastener, etc. to prevent contact with air)

Detailed preservation/storage conditions are described below.

Granules

(1) Changes in the appearance of granules

In general, granules should preferably be stored at normal temperatures (15-25 °c) with a relative humidity of 40-60%. However, unsuitable storage conditions and external impacts, etc., may cause the appearance to change, as shown in the following examples.
① The aluminum sachets used to package general granules provide long-term stability as they block oxygen, light and moisture. However, if a hole or scratch appears on the aluminum sachets, oxygen and moisture in the air will enter and the granule contents will deteriorate.
② Granules that are not sealed during and are exposed to the air may absorb the moisture in the air and become sticky or harden, depending on the ingredients.
③ Depending on the structure of the granules, some granules may crumble into a powder due to external vibrations and impacts.

(2) Granule stability

The stability of the ingredients in the granules varies according to the ingredients. Caution is required when using highly absorbent ingredients because they are highly susceptible to the effects of humidity. However, the contents will be stable in packaging formats such as aluminum sachets.

(3) Summary of granule preservation and storage

As mentioned above for other formulations, granule products should preferably be stored at normal temperatures (15-25°c) with a relative humidity of 40-60%. As far as possible, please avoid high temperature/high humidity and low temperature/low humidity conditions.
Please be sure to seal packaging containers after use in order to prevent contact with the air, and handle sachets carefully in order to avoid scratching the sachet.

Granule Q&A

1. What is a granule?
2. Why use granules?
3. Does the storage/handling of granules require special attention?
4. The color of the granules seems to be slightly different from the previous product…
5. The flavor of the granules seems to be slightly different from the previous product…
6. Is powder mixed inside granules?

Q1. What is a granule?

A. Granules are powders of the same or different varieties hardened together into a grain tens or hundreds of times bigger than the powder. Hardening is performed by means of mechanical compression, or by soaking the powder in water and alcohol to make it stick together, after which it is dried.
Compared to powders, granules are low in adhesion and agglutination, and high in liquidity and filling properties. They are also easy to handle once removed from the container because they do not scatter easily. When dissolved in water, the powder floats to the surface, so it must be mixed in, but it dissolves easily as the grains in the granule separate from each other.
Due to such characteristics, granules are used in a wide range of fields, including foodstuffs such as instant soups and flavorings, through to tropical fish feed, agricultural chemicals and detergents, in addition to medicinal products and health foods.

Q2. Why use granules?

A. In comparison to tablets, the production process for granules is simple and mass production is relatively easy. Also, the quantity of ingredients in each dosage is generally more than that of tablets.
Granules can be dissolved in various drinks, including water, which enables the medication to be taken in a way that suits the lifestyle of each individual.
It is also possible to mask flavors and smells and to delay solubility by adding a coating to the surface of the granule.

Q3. Does the storage/handling of granules require special attention?

A. Granules should be stored away from the direct sunlight and protected from high temperatures and high humidity. Granules should also be consumed quickly after opening as, depending on the ingredients, they can harden or become sticky by absorbing the moisture in the air.

Q4. The color of the granules seems to be slightly different from the previous product…

A. Products containing raw materials derived from natural materials may vary in color at the time of arrival. Colors are not regulated using colorings, etc., so the appearance of the granules may be different to that of previous products. We appreciate your understanding as such minor differences in color do not affect the composition or quality of the granules.

Q5. The flavor of the granules seems to be slightly different from the previous product…

A. The taste may seem a little different depending on the physical condition of the consumer and the environment at the time. Minor differences in taste do not affect the composition or the quality of the product.

Q6. Is powder mixed inside granules?

A. Even when hardened into a grain, granules are inferior to tablets in terms of strength. The strength cannot be increased to an unreasonable degree because the solubility of the granules during consumption must be taken into account. Therefore, granules may partially break off into powder due to vibrations and impacts during transport, but this is not a safety hazard and they can be consumed with peace of mind.
The above details are general information based on various publications, literary information, and internal research publications and experience. Depending on the product, there may be some differences, so please contact our Sales Department.

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