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Hard (two-piece) capsules were developed as an edible container of
medicine(s), mainly for oral use. These two-piece capsules have been
used for over a century for pharmaceutical purposes. J. C. Lehuby, a
Frenchman, is credited with the invention of the two-piece capsule. He
was granted a French patent in 1846 for a method of making 'medical
coverings'. However, J. Murdoch of London, in 1848, was the first to create
two-piece capsule, which was made from the sole use of animal-based
gelatin. The design of this original hard shell capsule has remained
unchanged over the decades except for changes in shape to create selflocking tamper-resistant capsules and in sealing process to allow pastes
and liquids to be filled into capsules. In addition to having the advantages
of elegance, ease of use, capsules (especially hard shells) enjoy widespread popularity, because of their relative ease of manufacturing and
their ability to efficiently mask the taste and odour of the medicines. As a
result of the advances made in drug delivery technology during the last 20
to 30 years, the importance of capsules as delivery device has increased
enormously.
Substitute for gelatin
Until recently capsules refer to 'gelatin' capsules i.e. the capsule shells are
made from gelatin. The default material for the two-piece hard capsules is
gelatin. The raw material gelatin is derived from animal source, primarily
collagen. The collagen, a fibrillary protein, forms the connective and
supportive tissues of mammalian (bovine and swine) body. Gelatin has
been the raw material of choice due to its ability to undergo a reversible
phase change from a solution to gel at a temperature only few degrees
above ambient, which enables a homogenous film of gelatin to be
prepared easily. Today, however, several materials have been investigated
as a substitute for the classic gelatin in the two-piece hard shell capsules.
Hydroxypropyl methylcellulose (HPMC), also known as hypromellose, has
become a successful alternative material for hard shell gelatin capsules
and is actually on the market. HPMC capsules are made of plant-derived
(cellulose derivatives) material and do not contain components of animal
origin. Another non-animal capsule material pullulan, a water-soluble
polysaccharide produced through a fermentation process, has achieved
regulatory acceptance.
Emergence of gelatin substitute
The success achieved by the hard gelatin capsules, popularly known as
HGC, is well known and is reflected by the fact that hard gelatin capsule
shells have been used in the pharmaceutical field for more than 100 years
and continue to grow in acceptance as the preferred oral dosage form.