paracetamol dissolution

[amitavaghosh]

generally we are performing dissolution at 37+-0.5°c, but we are taking paracetamol during high fever(higher temp), so can anybody tell me how we are correlating the thing?

[AdrianF]

Dissolution is a QC procedure to compare batches and check if it meets the required specification; therefore it is always carried under standard conditions.

[amitavaghosh]

thanks for your reply, but my question how we specify the specification,because in our body paracetamol will work in higher temperature.dissolution is not only for qc analysis , it is required for analytical and research development people also. it is required for discrimination purpose, comparison studies with innovator also. so once again i am asking the same question?

[shaun78]

USP specified a temperature range in which dissolution testing should be run under. I believe, if the USP does it, then that also means that the EP does as well given the current harmonization process.

Additionally, SUPAC (Scale-Up and Post Approval Changes) should also specify a temperature range in which dissolution testing should be performed under.

If my memory serves me correctly, all of the afore mentioned ragulatory bodies state that dissolution tests are recomended to be performed in a temperature range of 32 - 37C.

You are correct, if sick with a fever, the body temperature is higher than 37. However, the regulators do not recomend exceeding this temperature, so you set your dissolution testing at the upper limit.

I worked with creams and lotions a lot when I had to do dissolution testing. When I ran those, I generally used 32C because creams are applied and used outside the body. Sure, it might be a little cooler (or maybe not!) but 32C is the lowest recomended temperature....

[Dan]

Several things to consider:

1) Use of paracetamol (acetaminophen) is not only for when you have a fever. Aches and pains are not always accompanied by a fever.

2) The "normal" body temperature is 37 degrees C. It is "normal" in that it is an average as the value can change from person to person and within the body of an individual during the day.

3) It is not always possible to have dissolution results correlated to what happens in the body. This is the "IVIVC" aspect of dissolution testing and it is really nice to have but not always attainable. Thus, dissolution testing is most commonly used as a QC analysis for product quality and performance.

4) Finally, the requirement for the dissolution is to have the media temperature at 37 degrees C. This is the standard from the USP, EP, JP, etc.

Regards,
Dan