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http://www.youtube.com/watch?v=0EwaIQ-U6QQ
Properties of empty shells
Flexibility:
Important as it allows the shell to absorb mechanical handling without any
adverse effect
Related to the moisture content of the gelatin shell which acts as a plasticizer
Properties of empty capsule
Moisture content:
The standard moisture content specification for hard gelatin capsules is
between 13% and 16% w/w
This value can vary depending upon the conditions to which they are
exposed:
At low % RH: they will lose moisture and become brittle
At high % RH: they will gain moisture and soften
Moisture content can be maintained by controlling the storage conditions in
sealed containers at an even temperature
Properties of empty capsule
Solubility and disintegration:
Capsules are readily soluble in water at 37 °C. When the temperature falls
below this temperature, the rate of dissolution decreases
Below 30°C, capsules are insoluble and simply absorb water, swell and distort
Temperature is an important factor to take into account during disintegration
and dissolution testing
The pharmacopeia has set a limit of 37 ±1 °C for the media for carrying out
these tests
Capsules made from HPMC have a different solubility profile, being soluble at
temperature as low as 10 °C
Capsule sizes
Hard gelatin capsules are made in a range of fixed sizes; the standard
industrial sizes in use today for human use are from 0 to 4
Estimation of fill weight:
For a powder:
The simplest way to estimate the fill weight is to multiply body volume by its bulk density
For liquids:
The fill weight is calculated by multiplying the specific gravity of the liquid the capsule
body volume 0.8
Capsule sizes
Sizes (contd)
Elongated sizes:
To accommodate special needs, some intermediate sizes are produced – they have an
extra 10% of fill volume over the standard sizes
Example: for 500 mg doses of antibiotics (relatively large) elongated size 0 capsules
are commonly used
Capsule sizes
Capsule no: 000 00 0 1 2 3 4 5V
Content (mg): 950 650 450 300 250 200 150 100
Capsule sizes
Self-locking capsules
Introduced when automatic filling and packaging machines were
introduced
Filled capsules are subjected to strong vibration during this process,
causing some to come apart and lose their contents
What to do in order to overcome this?
Modern capsule shells have a series of indentations on the inside of the cap
and on the external surface of the body
Self-locking capsules
Traditional capsule open and closed, Snap-fit capsule open and locked
with and without sealing band Coni-Snap capsule open and locked
Capsule filling
Hard gelatin capsules can be filled with a large variety of materials of
different physicochemical properties
Types of material for filling into hard gelatin capsules:
Dry solids: powders, pellets, granules, tablets
Semisolids: thermo-softening mixtures, thixotropic mixture, pastes
Liquids: non-aqueous liquids
Capsule filling
Capsule filling
Gelatin is a relatively inert material
The substances to avoid are:
Those which cause cross-linking reactions that make the capsule shell
insoluble (formaldehyde)
Those that interfere with the integrity of the shell, e.g., substances containing
free water, which can be absorbed by gelatin causing it to soften and distort
Capsule filling
Limitations of the properties of materials for filling into capsules:
Should not react with gelatin
Should not contain a high level of free moisture
The volume of the unit dose should not exceed the sizes of capsule available
Capsule filling machines
https://www.youtube.com/watch?v=x
wGPielvFFE
Manual filling
Capsule filling machines
Industrial scale
In your future industrial pharmacy course
https://www.youtube.com/watch?v=R9-wIoHvZrM
Formulation
All formulations for filling into capsules have to meet the same basic
requirements:
Should be capable of being uniformly filled to give a stable product
Should release their active ingredients contents in a predictable manner
Should comply with the requirements of the pharmacopeia and regulatory
authorities, e.g., dissolution tests
Formulation
Active
Excipients
Ingredient