Study Set Content:
Water-miscible and relatively non-volatile
ex. Propylene glycol, Isopropyl Alcohol (IPA)
Punch Method
Powder is placed on a sheet of
paper/glass/porcelain plate
Powder mix is formed into a cake having a depth of approx.
1/4 to 1/3 the length of the capsule body.
An empty capsule body is held between the
thumb and forefinger
An empty capsule body is held between the thumb and forefinger and punched vertically into the powder cake repeatedly until
filled
The body may be (blank) to distribute some powder to the cap end to give the capsule a full appearance.
e squeezed or tapped gently
last step in punch method
Cleaning and polishing
When potent drugs are being used, each capsule should be(blank) after filling to ensure accuracy
weighed
Filling of HGC: techniques
Punch method
Feton capsule filling machine
Automatic capsule filling machine
The USP requires adherence to standards for (blank)and weight variation for capsules to ensure the accuracy of dosage units
content uniformity
HGC capsule sealing
Heat-welding process ● Z-Weld's gelatin seal
Use of a(blank)that lowers the (blank) in the contact areas of the capsule's cap and body and then thermally bonds the two parts using low temperatures
liquid wetting agent, melting point
low temperatures
(40°C to 45°C)
are tamper evident capsules
Kapseals
SGC capsule sealing
1. Plate process
2. Rotary or reciprocating die process
SGCs are produced, filled, and sealed in a continuous operation
Rotary or reciprocating die process
using a set of molds to form the capsules
Plate process
Acronym for SGC capsule sealing
Bottom-pour-top-press-remove and was
Analytical tests performed to check the quality of our commercial capsules
Compendial Requirements
Compendial requirements for capsules
1. Disintegration test
2. Dissolution test
3. Weight variation and/or content uniformity
4. Stability testing
5. Moisture permeation test
