A. What is Soft gel capsule? What kind of products is suitable to be manufactured into Soft gel?
Soft gel capsule can encapsulate oil, liquid, suspension, paste,
even powder, into capsules of different shape and different size.
Comparing with other dosage forms, it has the advantage of high
bioavailability, accurate content, even shape and nice appearance.
Soft gel capsule is the best dosage form for oil medicine and
health food. Besides, it is also suitable for products of low
melting point, low bioavailability, with a bitter or disagreeable
taste, being unstable to light, humidity or heat, or easily oxidized.
Soft gel capsule form is widely used in medicine, food supplements
and cosmetics.
B. What is shell material comprised of? Is it safe?
Shell
material is mainly comprised of gelatin, glycerin and purified water.
Gelatin is one kind of natural protein derived from animal hides or
bones. It is by nature a nutritious food. A number of daily foods, such
as jelly and candy, are made with gelatin. Glycerin is also a natural
product abstracted from vegetable oil through hydrolysis process. It is
a widely used food additive. Therefore, shell material itself is a
nutritious food.
C. Why
Soft gel capsule? What is the advantage?
A survey carried out in America shows that 44.2% of the consumers
like Soft gel capsule better than other dosage forms.
Soft gel capsule has the following advantages:
1. Absorbed directly and swiftly after disintegrating in the intestine. No dissolving course;
2. Accurate content weight;
3. High bioavailability;
4. Stable and low moisture absorbing;
5. Good airtight, masking the disagreeable taste of drugs;
6. Easy carrying and nice looking can be made at will into
various attractive shapes.
D. What
products are suitable for soft gel capsule form?
There is a vast range of application for the form of Soft gel
capsule:
1. Medicine. Most oil drugs, herbal extract and natural
products are manufactured into Soft gel capsule.
2. Dietary supplement. More and more dietary supplements
appear as a Soft gel capsule.
3. Food. Breath fresh bead is a Soft gel capsule.
4. Cosmetics. Much facial oil, facial cream and hair
oil products Soft gel capsule form. In addition, bath oil
beads are also gel capsules.
E. How
is the development of soft gel capsule dosage form? Why to choose contract manufacturing?
Soft gel capsule develops rapidly in the world. It is widely used
in medicines, nutritional products, cosmetics and home appliances.
The United States is the biggest Soft gel capsule manufacturer
and seller in the world. Next are Germany and U.K.
Soft gel capsule manufacture requires special technology and equipment.
There are fewer factories engaged in manufacture of Soft gel capsules
comparing with other dosage forms. Now it is common in the world
that professional factories accept other organizations assign
to make for them.
To build a Soft gel capsule production line needs big money input
and well-trained workforce. Investment is big and recouping period
is long. It is not economical to build a production line for just
one or a few products. That is why contract manufacturing of Soft
gel capsules prevails in the world.
F. How
to evaluate the quality of soft gel capsule ?
Quality of a Soft gel capsule can be evaluated according to the
following criteria ::
1. Disintegration. This is an important criterion
to estimate whether human body will absorb a product. Chinese
Pharmacopoeia stipulates Soft gel capsule must be completely disintegrated
within 60 minutes, and time required by British Pharmacopoeia
and US Pharmacopoeia is within 30 minutes.
2. Fill variation, one of the important criteria. Chinese
Pharmacopoeia, British Pharmacopoeia and US Pharmacopoeia have
relative requirements. Generally fill variation should not exceed
7.5% for Soft gel capsule under 500mg, and not exceed 5% for Soft
gel capsule above 500mg. Missing the requirement means that active ingredient content of a product is not accurate. This will affect
the efficacy of the products.
3. Homogeneity. There are different homogeneity requirements
for different Soft gel capsule products. If a Soft gel capsule,
especially that contains solid contents like plant extract, cannot
be emulsified evenly, it means content of active ingredient is
not accurate, some contains more, and some contains less. This
will seriously affect of the product.
4. Microbial limit. Bacteria count is one of the important
criteria to the quality of a Soft gel capsule. In case
the bacteria exceeds the limit,not only this product cannot
have or healthcare effect, but also may cause disease.
All these should be tested with related experimental instruments, and be done by professionals.
G. How to select a soft gel contract manufacturer?
Selecting
a right contract manufacturer is of critical importance for your
success. You need to take into consideration not only the price, but
also their production environment. This includes:
1. Whether the workshop can meets GMP requirements.
GMP, as a regulation governing the
manufacturing of medicine and health food, sets
strict stipulation on the production environment.
Being GMP certified means a factory's
production environment meets the requirements
for manufacturing medicine or health food.
2. Whether a factory has necessary test instruments and skilful personnel.
Soft gel capsule manufacturing is a specialized
trade. Sufficient test instruments and qualified technical personnel
are closely related to quality of products.
3. Quality of production line operators.
Production line operators play an important
roll in Soft gel capsule quality. A few
key factors to judge if the operators are qualified include: educational
level; experience; job training; and whether they receive
periodic health check-up;
4. Whether rules and regulation are complete and effective.
Rules and regulations are very important in
controlling quality of products. These may
include: operating procedures for all position
and all machines and instruments, cleaning and
management procedures, various records, etc.
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