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Purpose
This guidance outlines the requirements for Australian market authorisation of tablets containing aspirin as a single active ingredient when applied for as an over-the-counter (OTC) New Medicine N2 application.
Proposed medicines must comply with all aspects of this monograph relevant to their strength and dosage form to qualify for evaluation as an N2 application.
This guidance should be read in conjunction with Requirements for OTC new medicine N2 applications.
Legislation
Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (29/10/2008)
Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines (22/09/2008)
Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008)
Active substance
This monograph only applies to medicines containing aspirin (acetylsalicylic acid; CAS No. 50-78-2) and excludes preparations containing any salts and derivatives of aspirin.
Dosage forms and strengths
Acceptable dosage forms and strengths are shown in the table below.
| Active substance | Dosage strengths | Dosage forms (excludes sustained release dosage forms) |
|---|---|---|
Aspirin
| 100 mg | Tablets* |
| 300 mg | Tablets* | |
| 500 mg | Tablets+ |
* Chewable, dispersible, effervescent, uncoated and enteric coated tablets only.
+ Chewable, dispersible, effervescent and uncoated tablets only.
Indications
Therapeutic indications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Required indications are shown in the table below.
| Dosage form and strength | Indications |
|---|---|
| 100 mg tablets | For the treatment of patients with known cardiovascular or cerebrovascular disease, as an antiplatelet agent for prophylaxis against acute myocardial infarction, unstable angina, transient ischaemic attack and cerebrovascular accident (stroke). |
| 300mg or 500 mg tablets | Temporary relief of pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow, and colds and flu. Reduces fever. |
Label indications
Acceptable label indications are shown in the table below.
| Dosage form and strength | Label indications |
|---|---|
| 100 mg tablets | Reduces the risk of heart attack and stroke in patients with known cardiovascular or cerebrovascular disease by helping to prevent blood clotting.* |
| 300 mg or 500 mg tablets | All or most of the indications below should be included on medicine labels. Label indications must not be restricted to, or emphasise, a single indication or subset of indications (e.g. cold and flu symptoms only, period pain only or headache only).
|
*Permission is required, under Section 42DK of the Therapeutic Goods Act 1989, for the use of claims relating to the cardiovascular or cerebrovascular systems on product labelling. Include a request for permission in the application cover letter.
Directions for use
Adults and children 12 years and over*
Dosages must be as shown in the table below.
| Dosage form and strength | Single dose | Dose interval | Maximum daily dose |
|---|---|---|---|
| 100 mg tablet | 1 tablet | One tablet daily | 100 mg |
| 300 mg tablet | 1-3 tablets | Every 4-6 hours as required | Do not exceed 12 tablets in 24 hours |
| 500 mg tablet | 1-2 tablets | Every 4-6 hours as required | Do not exceed 8 tablets in 24 hours |
*A higher minimum age can also be specified (e.g. Adults 18 years and over for 100 mg tablets).
- Include the statement Do not give to children under x years (where 'x' years is the youngest age for which dosage instructions are included on the labels).
- Enteric coated tablets should include the statement "Swallow whole. Do not crush or chew".
Labelling
Full scale, full colour draft labelling for each proposed pack size must be provided electronically with the application, for assessment of the product's presentation.
Labelling must comply with all relevant Australian requirements, as detailed in the document Requirements for OTC new medicine N2 applications, including all required warning statements.
Quality requirements
In addition to the requirements outlined in the document Requirements for OTC new medicines N2 applications, the following specific requirements apply to aspirin monograph medicines.
Finished product specifications
The finished product specifications must comply, at a minimum, with the relevant set of requirements below.
The requirements below include all relevant British Pharmacopoeia (BP) general monograph requirements and TGO 78 requirements. Further reference to these is not required. References to pharmacopeial monographs below refer to the current monograph at time of application.
Standard uncoated and chewable tablets
The tests and limits in the BP monograph Aspirin Tablets with the addition of:
- tablet appearance
- uniformity of dosage units (BP)
- dissolution (with a limit of ≥70 % after 45 minutes as specified in the BP's Supplementary Chapter 1E Dissolution Testing of Solid Oral Dosage Forms)
- microbiological quality, in compliance with TGO 77.
Dispersible tablets
The tests and limits in the BP monograph Dispersible Aspirin Tablets with the addition of:
- tablet appearance
- uniformity of dosage units (BP)
- disintegration (as per the requirements for dispersible tablets in the BP general monograph Tablets)
- fineness of dispersion (as per the requirements for dispersible tablets in the BP general monograph Tablets)
- microbiological quality, in compliance with TGO 77.
Effervescent tablets
The tests and limits in the BP monograph Effervescent Soluble Aspirin Tablets with the addition of:
- tablet appearance
- uniformity of dosage units (BP)
- microbiological quality, in compliance with TGO 77.
Enteric coated tablets
The tests and limits in the BP monograph Gastro-resistant Aspirin Tablets with the addition of:
- tablet appearance
- uniformity of dosage units (BP)
- dissolution (with a limit of ≤ 5 % after 2 hours in acid and ≥ 70 % after 45 minutes+ in phosphate buffer)
- microbiological quality, in compliance with TGO 77.
Container
Aspirin products must be sold in containers that comply with Therapeutic Goods Order No 80, Child Resistant Packaging Requirements for Medicines.
Page history
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