Paracetamol (acetaminophen) is a widely available over-the-counter analgesic antipyretic. It has a long history of use in the general public, however, it has a number of classical toxicities associated with it. It is loosely classified as a non-steroidal anti-inflammatory drug (NSAID).
You have been asked by management to compare a potential topical preparation of Paracetamol (acetaminophen) with one containing diclofenac. The objectives are to
• Compare potential toxicities particularly considering topical administration
o Both are known oral products; how might topical administration affect toxicity?
• To indicate if any new testing of the proposed paracetamol product might be needed – or to say why it is not needed
• Are there any potential non-clinical or clinical issues or problems that may be associated with this project?
• To make a recommendation as to whether to develop a topical formulation of paracetamol.
This should follow this contents list; comment may be brief but you need to show that you have considered each point.
1. INTRODUCTION
2. METHODS
3. PHARMACOLOGY – brief comparative summary
4. PHARMACOKINETICS
5. TOXICOLOGY
5.1 Single-dose toxicity
5.2 Repeat-dose toxicity
5.3 Genotoxicity
5.4 Carcinogenicity
5.5 Reproductive and Developmental toxicity
5.6 Local Tolerance / Other toxicity studies (what do you expect here?)
6. CLINICAL EXPERIENCE (just a summary, including clinical dosage)
7. DISCUSSION & RECOMMENDATION
8. REFERENCES