IPQC
As is known that soft gelatin capsules are used as a dietary supplement which is very essential for daily life. Generally, soft gelatin capsules are formulated to fill the nutritional gap in the human diet. Soft gelatin capsules are recommended for those people who are not able to take enough nutrients into their diet due to their busy life schedules.
IPQC Full Form
In-process quality control TestsBase Adsorption
While formulating the suspension for soft gelatin capsules, some of the basic information must be created to determine the minimum capsule size.Read more - Soft gelatin capsules
The Base adsorption of solid is determined by;
Particle size and shape
Its physical state is either amorphous or crystalline
Moisture content, density as well as hydrophilic nature
Determination of Base Adsorption
Step 1- Weigh a suitable amount that is 40 gm appropriate of a solid into 150 ml of the tared beaker.Step 2- Gradually add a small amount of base to the solid.
Step 3- With the help of a spatula continue to stir the base into the solid after each addition until the solid is completely wetted and coated with the base uniformly.
Step 4- It gives a mixture that has a soft ointment-like consistency.
Step 5- Now, add liquid continuously.
Step 6- Then, stir until the mixture flows continuously from the spatula blade when held at a 45° angle above the mixture.
Base Adsorption = Weight of base/Solid weight
Minim Per Gram Factor (M/g)
The base adsorptions were used to find out the "minim per gram" factor (M/g) of the solid.The minims volume that is employed by the one gram of the solid as well as the weight of the liquid base which is required to make a capsulate mixture is known as the minim per gram factor.
The minim per gram factor is calculated by dividing the weight of the base plus including 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
Hence, if the base adsorption of the solids will be lower and the density of the mixture will higher, the size of the capsule will be smaller.
In-Process Testing
During the process of encapsulation of soft gelatin capsules, four important tests are;1) Thickness of soft gelatin capsule at the time of encapsulation.
2) Capsule shell weight as well as fill matrix weight.
3) The thickness of the gel ribbon.
4) Moisture level of soft gelatin capsule shell and at the end of the drying stage hardness of the soft gelatin capsules.
For the calculation of the fill weight, each capsule is weighed, and removed the contents by cutting open the capsule.
The capsule shell is then washed with the help of petroleum ether, and again the empty shell is reweighed.
If it is required then an adjustment can be made to obtain the proper fill weight of the soft gelatin capsules.
Read more - Soft gelatin capsule manufacturing
Finished Product Testing
The parameters for testing the soft gelatin capsules are similar to that are used in the hard gelatin capsules.Read more - Good Health Capsule - Quality Control Test
Quality Control Test on Soft Gelatin Capsules
Seal Thickness
The seal thickness is measured under the microscope.The thickness of the seal should be one-half (1/2) to two-thirds (2/3) of the ribbon thickness.
Shell Moisture Test
With the help of the toluene distillation method, the moisture content is determined. Over one hour the distillate should be collected.Capsule Fragility or Rupture Test
The force should be determined which is required to rupture the capsule.Determination of Freezing and High-Temperature Effect
These tests are performed just like the shell integrity test and the temperature should be 45° c for 30 days.Packaging and Storage of Capsule
The main reason for packaging filled soft gelatin capsules is to prevent contamination as well as during the long term of storage to prevent either loss or gain of moisture.Various types of packaging technology like the strip, as well as blister packaging and many plastic containers, are used for the packaging of soft gelatin capsules.
In some containers dehydrating powder is deposited which retard the excessive moisture absorption by the capsule.
Storage
For a long period, storage of hard gelatin capsule shells requires proper maintenance of temperature and humidity.Storage Conditions of Capsule
| Storage Condition | Relative Humidity % | Temperature °C |
|---|---|---|
| Minimum | 35 | 15 |
| Best Possible | 50 | 20 |
| Maximim | 65 | 25 |
Very High Humidity
If the humidity is very high then there are a few conditions that may occur with the soft gelatin capsules;a) The capsule can lose its shape.
b) The capsules can stick together.
c) The capsules may become softened.
Very Low Humidity
If the humidity is very low then the capsules shrink up or contract in size as well as become fragile.High or Fluctuated Temperatures
Due to the high or fluctuating temperature capsule may form lumps and in some cases, condensation may also be seen on the surface of the container.Capsule Physical Stability
The susceptible soft gelatin capsule quickly gains equilibrium with atmospheric conditions under which Capsule is stored.The physical stability of soft gelatin capsules is mainly related to the loss of water by the capsule shell.
With the help of proper packaging they are prevented, if the capsules have acceptable physical stability at a temperature that is ranging from above the freezing point means as high as 60ยบ C.
If the humidity increases, the capability of gaining moisture in the capsules also increases.
As the moisture is getting absorbed, the capsule becomes thicker, softer, and swollen or enlarged.
1) At room temp in an open container, the RH should be 80%.
2) In an open container it should be 40°c.
3) In closed containers that are glass bottles with a tight screw cap it should be 40°c.
Effect of Temperature and Humidity on Capsule Shell
| Temperature | Humidity | Effect on Capsule Shell |
|---|---|---|
| 21-25 °C | 60% | Capsule become softer and tackier |
| >24°C | >45% | More rapid and pronounced effect-unprotected capsule melt and fuse together |
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