Why Empty Hard Gelatin Capsules are stored in Temperature & Humidity controlled area

Empty Hard Gelatin Capsules

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^oC (68-75^oF) 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. Hard Gelatin Capsule Soft Gelatin Capsule Made of hard gelatin Made of soft gelatin Produced in two halves consisting of a body and cap Produced as a single piece of gelatin, rather than two halves attached Mainly used for filling dry and powdered content Mainly used for oil-based formulations They’re manufactured using different machines, for shell production and encapsulation. A different process is employed in manufacturing Manufacturing and filling is done using the same machine, as part of a single process Hard gel capsules usually are cylindrical Can be made in a variety of shapes such as the oval, round, tube-like, fish-like, etc. These are made of only hard gelatin, colorings, plasticizer and titanium dioxide Lots of ingredients are used, i.e. soft gelatin, plasticizer, sugars, preservatives, colorings, opacifier, etc. The ratio of gelatin and plasticizer is 1:0.4 The ratio of gelatin to plasticizer is 1:0.8 Available in a range of sizes Size variety is limited 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

1.Gelatin Preparation 2.Dipping 3.Drying 4.Stripping and Trimming 5.Printing 6.Packing

Common Defects in Hard Gelatin Capsules

Shape	Dent,Bent,Double Cap,Mashed,Short and long caps & Bodies
Colour	Different colour, Discolour
Appearance	Dirt, Hole, Crack, Split, Telescoped, Foreign particle, edge, scrape
Printed Mark	No mark, Improper mark

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