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Storage of Empty Hard Gelatin Capsules in Temperature & Humidity controlled area




Why Empty Hard Gelatin Capsules are stored in Temperature & Humidity controlled area?
  • Capsules are solid dosage forms in which medicinal agents are enclosed in a small shell. Depending on the composition capsules may be hard or soft. 
  • Hard gelatin capsules are made from gelatin (Gelatin is a translucent, colorless, brittle (when dry), flavorless solid substance, derived from the collagen - an animal protein).
  • Empty Hard Gelatin Capsules contain 12 - 16% moisture. But the moisture content can vary up on the storage conditions.


Recommended Storage conditions for Hard Gelatin Capsules
  • Store capsules away from direct sunlight (e.g. windows and skylights)
  • Store capsules away from hot water/air radiators, hot water pipes and steam pipes.
  • Store capsules on pallets off the ground.
  • Store capsules away from potential sources of water condensation e.g. under water pipes.
  • Do not store empty capsules in freezers.
  • Hard gelatin capsules shall be stored between 15 - 25°C (68-75°F) and 45-55% relative humidity to maintain the 12-16% moisture content of capsules.

It is important that this moisture content is maintained and exposure to high temperatures or cycling between high/low temperatures is avoided. When humidity is low capsules become brittle, if stored at high humidity, the capsules become flaccid and the excess moisture content can interact with encapsulated product and can cause stability problems.

If capsules stored at high temperature following defects can occur
  • Stucking of capsules together in lumps and do not come apart.
  • Brittle or shatter capsules.
  • Capsules with distorted shape.
  • Stucking of capsule cap to body and resists separation. 

What is the difference between Hard Gelatin and Soft Gelatin Capsules?


Both the hard and softgel capsules are made of gelatin. Thus the difference between these two types of capsules lies in the design and manufacturing technology which are detailed below.


Size range of Hard Gelatin Capsules?
The capsule size ranges from 0.16 mils to 28 mils capacity (000,00,0,1,2,3,4,5)

Ingredients of Hard Gelatin Shell Capsules?
Gelatin,  Dye,  Plasticizer,  Sugar,  Edible colours, Opacifier, Glycerin, Preservatives

Hard Gelatin Capsules Disintegration Time?
Depending on the size of the capsules disintegration ranges from 3-13 minutes.

Major Steps in Hard Gelatin Capsule Shell Manufacturing
Gelatin Preparation 
Dipping 
Drying 
Stripping and Trimming 
Printing 
Packing

Common Defects in Hard Gelatin Capsules

Shape

Dent, Bent, Double Cap, Mashed, Short and long caps & Bodies

Colour

Different colour, Discolor

Appearance

Dirt, Hole, Crack, Split, Telescoped, Foreign particle, edge, scrape

Printed Mark

No mark, Improper mark


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