Tuesday, 30 July 2019

Australia - Standard for tablets, capsules and pills


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.

See: https://www.tga.gov.au/sites/default/files/guidance-tgo-101.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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