Industrial pharmacy-I note on topic.inprocess and final quality control of soft gelatin capsule

2.  Introduction:-
 Soft capsules are a single-unit solid dosage form.
 Soft gelatin capsules are one piece, hermetically
sealed elastic outer shell.
 They are drug delivery systems made of a liquid
or a semisolid matrix inside a one-piece outer
gelatin shell.
 Also known or abbreviate to ‘Softgels’
 example:- Declomycin , vitamin E

3.  Capsules which contains drug(s) in a liquid or
at least dissolved, solubilised or dispersed form
by encapsulation process.
 Soft gelatin capsules are one piece, hermetically
sealed, soft gelatin shells containing a liquid, a
suspension, or a semisolid.
 Soft gelatin is mainly composed of gelatin,
plasticizer, preservative, coloring and
opacifying agents, flavouring agents and
sugars.

4. It is well said that quality is not an accident but
is result of intelligent effort. As per GMP and
cGMP , quality control concerns with sampling
,specifications ,testing with the organization ,
documentation and release procedures to ensure
product safety.

5. During the encapsulation process, important tests are:-
The gel ribbon thickness.
Soft seal thickness at the time of encapsulation.
Fill matrix weight and capsule shell weight.
Soft gel shell moisture level and soft gel hardness at the end of the drying
stage.
Description
Identification
Impurities
Size and shape
Unique Identification Marking

6. The soft gelatin capsules are subjected
to FPQC tests such as
-Weight variation
-Content uniformity
-Dissolution test
-Disintegration test
-Moisture permeation test
-Stability tests.

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. Randomly select 30 capsule and weight 10 capsules individually
Then cut and open the capsules
Remove the contents by washing a suitable solvents
Allow the solvent to evaporate from the shells at room temperature
Atleast 9 of these contain 85-115% of drug and non-contain outside
75-125% limit of drug. If 1 to 3 of them falls outside of 85-115% limit
The remaining 20 capsules are individually assayed and the
requirement met. If no , few of 27 must contain 85-115%of drug and
all must contain 75-125% of drug.

9. The capsule is placed in a basket formed from 40 mesh
stainless steel fabric.
A stirrer is attached to the basket and the basket is
immersed in the dissolution medium and made to
rotate the specified speed
The dissolution medium is held in a covered 1000mL
glass vessel and maintained at 37+(-)0.5 degree celsius
and the stirrer speed and type of dissolution medium
are specified in the individual monograph
The sample passes the test if the amount of active
ingredients in the solution is not less then 70% of the
stated amount

10. Introduce one capsule in each tube and suspend the apparatus in
a beaker containing water at 37dc
If capsule is float on surface of water, disc may be added.
Operate apparatus for 30min,
28-32cycle(strokes) per min. IP
Remove the assembly from the liquid.
Capsules pass the test if all of them have disintegrated (no
remain in mesh no.10)
If 1 or 2 capsules fail to disintegrate, repeat the test on 12
addition capsules;not less than 16 of the total of 18 capsules
tested disintegrate

11. The permeation can be determined by
packing the dosage unit together with
the color revealing desiccant pellet and
exposing the packed unit to known
relative humidity over a specified time.
The desiccant pellet is observed for
colour change and compared the pre
and post weights of the packed unit.