quality control test for soft gelatin capsule and minim per gram factor

quality control test for soft gelatin capsule and minim per gram factor

1. Prepared By-
Dinisha Sharma
17HPH044

2. It is the dept. in the Pharmaceutical Company
where the quality analyst attempts to
determine the concerntration of a specific
substance in the sample

3. It is a solid capsule surrounding a liquid or
semisolid center.
API can be incorporated in the outer shell,
inner fill or both
Shells of the SGC are combination of gelatin,
water, plasticizers and additional ingredients
such as preservatives,colouring
agent,flavoring,sugars,acids and medication
to achieve desired effects.

4. Soft gelatin capsules are subjected for
following tests during quality control:
1.Shape and size
2.Colour
3.Thickness of the capsule shell
4. Leaking test
5.Disintegration tests
6.Weight variation test
7.Percentage of medicament test

5. To check content uniformity of soft gelatin capsules we
need to follow the steps below:
Weight the capsules individually
Then cut & open the capsules
Remove the contents by washing with a suitable solvent
Allow the solvent to evaporate from the shells at room
temperature
Weight the individual shells
Calculate the net contents

6. Disintegration test apparatus is used.
One capsule is placed in each tube which are
suspended in the beakers to move up and
down for 30 minutes.
The capsule pass the test if no drug or
fragments of shell remains on #10 mesh

7. 20 capsules are taken at random and
weighed.
Average weight is calculated
Each capsule is weighed individually and their
weight noted.
The capsule passes the test if the weight of
individual capsule falls within 90-110% of the
average weight

8. The leakage of soft gelatin capsules are determined
by :
1.Bloom or gel strength-It is a cohesive strength of
cross-linking that occurs between gelatin
molecules and is proportional to the mol. wt.
2. Viscosity of gelatin-It is a measure of molecular
chain length & determines manufacturing
charactersticof gelatin film.
3.Iron content-It is present in raw gelatin as well as
water used in manufacture. Excess qty. of iron can
effect the formulation and react with organic
compounds

9. The test is perfomed to find out the integrity
of capsule shell. The standard capsule shells
are kept at room temperature 40°C and 80%
RH becomes more soft, sticky and swollen

10. Base adsorption is expressed as the number of grams of
liquid base required to produce a capsulatablemixture
when mixed with one gram of solids.
The base adsorption of a solid is influenced by such
factors
The solids particle size and shape,
Its physical state
Its density
Its moisture content, and
Its lipophilicor hydrophilic nature
The base adsorption is obtained by-
weight of the base/weight of the solid = Base Adsorption

11. Weight the definite amount(40g is convenient) of the solid
substance into a 150ml taredbeaker
In a separate 150ml taredbeaker place 100g of the solid base
Add small amount of liquid base into the solid and stir it with
spatula until consistent soft ointment is produced
Continue to add liquid until the mixture flows steadily from
the spatula blade when held at a 45 degree angle above the
mixture
Calculate the base adsorption using the above given formula

12. The base adsoorptionis used to determine the “minim per gram”
factor (M/g) of the solid(s).
The minim per gram factor is the volume in minims that is
occupied by one gram of the solid plus the weight of the liquid
base(BA) required to make capsulatablemixture.
The minim per gram factor is calculated by dividing the weight
of the base plus the gram of solid base (BA+S) by the weight of
the mixture (W) per cubic centimeter or 16.23 minims (V).
(BA+S) x V/W = M/g
Thus lower the base absorption of the solids and higher the density
of the mixture, the smaller the capsule will be.