10 mg USP prednisone tablets

[Archives]

Poster: Ulrik
Date Originally Posted: 5/18/00

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"I´m experiencing high results with the new 10 mg prednisone tablets - only when performing the test with baskets - not with paddles.
We have measured the vibration level and the level is OK.
We degass with Helium and have never had any problems with this before.

The vessels are covered during the testing period, so evaporation shouldn´t be an issue.

The vessels are thoroughly cleaned manually between each run.

We have performed the testing on two different SR-8-Plus dissolution apparatuses. The test has failed twice with one of the apparatuses (results about 90%dissolved). The test passed the first time with the other apparatus.

Has any one experienced problems with baskets (different mesh-size)?


Has anyone tried the degassing method recommended by the USP(Vacuum filtration) ?
"

[Archives]

Poster: IM
Date Originally Posted: 5/18/00

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"We also had problems with Prednisone (basket method). This is a very sensitive product. You have to be very carefull as to how you drop the tablets, how you draw the samples, how you degas the medium, how you measure and dispense the medium etc. Our's also failed on the high end border line. However, after checking every step, it passed the second time around.

Also check if the heat is distributed evenly throughout the ****** baths. We had problems with the older models.

Good Luck!

>>> 5/18/00 6:49:48 AM User ""Ulrik"" wrote <<<
I´m experiencing high results with the new 10 mg prednisone tablets - only when performing the test with baskets - not with paddles.
We have measured the vibration level and the level is OK.
We degass with Helium and have never had any problems with this before.

The vessels are covered during the testing period, so evaporation shouldn´t be an issue.

The vessels are thoroughly cleaned manually between each run.

We have performed the testing on two different SR-8-Plus dissolution apparatuses. The test has failed twice with one of the apparatuses (results about 90%dissolved). The test passed the first time with the other apparatus.

Has any one experienced problems with baskets (different mesh-size)?


Has anyone tried the degassing method recommended by the USP(Vacuum filtration) ?
"

[Archives]

Poster: jhb
Date Originally Posted: 5/18/00

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"The acceptance limits for these tablets were established using only the USP degassing method.

The new tablets have been shown to be more sensitive to degassing than the previous lots. Helium degassing actually displaces the normal gasses (primarily nitrogen, oxygen, and CO2. The medium is then saturated with helium. If you begin the dissolution test immediately after degassing, it is possible that there has been insufficient time for the helium to spontaneously 'outgas'. Helium bubbles would form on the drug particles as they drifted to the bottom of the vessel. Because they are suspended, the dissolution results will be higher.

This effect would not be as apparent with the paddle apparatus since most of the particles stay in the mound on the bottom of the vessel and do not have an opportunity to become suspended by a helium bubble.

>>> 5/18/00 6:49:48 AM User ""Ulrik"" wrote <<<
I´m experiencing high results with the new 10 mg prednisone tablets - only when performing the test with baskets - not with paddles.
We have measured the vibration level and the level is OK.
We degass with Helium and have never had any problems with this before.

The vessels are covered during the testing period, so evaporation shouldn´t be an issue.

The vessels are thoroughly cleaned manually between each run.

We have performed the testing on two different SR-8-Plus dissolution apparatuses. The test has failed twice with one of the apparatuses (results about 90%dissolved). The test passed the first time with the other apparatus.

Has any one experienced problems with baskets (different mesh-size)?


Has anyone tried the degassing method recommended by the USP(Vacuum filtration) ?
"

[Archives]

Poster: ladychem
Date Originally Posted: 8/11/00

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"USP deaeration is strongly recommended.

>>> 5/18/00 6:49:48 AM User ""Ulrik"" wrote <<<
I´m experiencing high results with the new 10 mg prednisone tablets - only when performing the test with baskets - not with paddles.
We have measured the vibration level and the level is OK.
We degass with Helium and have never had any problems with this before.

The vessels are covered during the testing period, so evaporation shouldn´t be an issue.

The vessels are thoroughly cleaned manually between each run.

We have performed the testing on two different SR-8-Plus dissolution apparatuses. The test has failed twice with one of the apparatuses (results about 90%dissolved). The test passed the first time with the other apparatus.

Has any one experienced problems with baskets (different mesh-size)?


Has anyone tried the degassing method recommended by the USP(Vacuum filtration) ?
"

[Archives]

Poster: nholland
Date Originally Posted: 10/30/00

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"Take a look at the way FDA degasses thier media they get passing results from the NCDA#2 10mg prednisone calibrator tablets. Read up on the literature offered on this website it offers up alot of information about this calibrator tablet controversy.
NAH

>>> 5/18/00 6:49:48 AM User: Ulrik Wrote<<<
I´m experiencing high results with the new 10 mg prednisone tablets - only when performing the test with baskets - not with paddles.
We have measured the vibration level and the level is OK.
We degass with Helium and have never had any problems with this before.

The vessels are covered during the testing period, so evaporation shouldn´t be an issue.

The vessels are thoroughly cleaned manually between each run.

We have performed the testing on two different SR-8-Plus dissolution apparatuses. The test has failed twice with one of the apparatuses (results about 90%dissolved). The test passed the first time with the other apparatus.

Has any one experienced problems with baskets (different mesh-size)?


Has anyone tried the degassing method recommended by the USP(Vacuum filtration) ?
"