News
from the Australian TGA, new guidance for tablets, capsules and pills (Guidance
for TGO 101).
This
guidance is to help sponsors and manufacturers of medicines understand the role
of the Therapeutic Goods Order No. 101 - Standard for tablets, capsules and
pills (TGO 101, the Order) in ensuring that these types of therapeutic goods
are of appropriate quality.
TGO
101 applies to three types of discrete oral dosage forms: tablets, capsules and
pills. Assuring the quality of medicines manufactured in this way is important
to ensure that they deliver their intended therapeutic effect and to provide a
measure of continuing consistency in performance over time. Various categories
of tablets are recognised dosage forms in Australian approved terminology for
therapeutic goods. These include coated and uncoated tablets, effervescent
tablets and modified release tablets. Compressed lozenges, which are designed
to dissolve or disintegrate in the mouth, are considered to be tablets. Capsules
can be hard or soft; the contents may be present as powders or liquids. Release
of the active ingredients from capsules can also be modified in several ways,
for example, enteric
capsules.
Pills differ from tablets as they are manufactured using wet massing, piping
and moulding. They can be coated, but usually contain only certain limited
excipient ingredients and are typically manufactured and supplied as part of
traditional medicine paradigms.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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Pharmaceutical Microbiology