The manufacture of hard
gelatin capsules consists of the dipping of stainless steel mold
pins into a gelatin solution drying stripping from the pins into a
collate trimming of the caps and bodies and joining together for
shipment. The strength and flexibility the clarity of the gelatin
and the movability of the gelatin provide unique characteristics
that allow the manufacture of various sizes colors and designs for
assuring a snap closure afte r filling.
Softgels as
they are commonly known today utilize a gelatin solution that is
plasticized with propylene glycol sorbitol glycerin or various
approved mixtures. Soft gelatin capsules are one-piece and
hermetically sealed to enclose a liquid or semi-liquid fill. Soft
gelatin capsules are manufacture-formed filled and sealed in one
continuous operation.
The soft gelatin encapsulation
process begins with the formation of two sheets called ribbons from
a molten gelatin mass each of which is passed over a die of the
desired capsule size and shape. At the point where the two rotating
dies meet the capsule is formed and filled with a liquid that
contains the active ingredient in a vehicle. The capsule is then
washed to remove the lubricants and dried.
In ***2 R. P. Scherer developed the
first rotary die encapsulation system: since that time the
technology has been refined into a completely automatic process.
The rotary die method has the advantage of producing a capsule with
highly accurate dosage levels can prevent photochemical
deterioration of the active ingredient and masks unpleasant
tastes.