topic Re: tablet dissolution profile in Discussions

tablet dissolution profile

bambi — Mon, 12 Feb 2018 11:35:43 GMT

Hi,

I have a set of tablets in which one component determines how slowly the active is released (measured at 1, 2, 3, 4, 5 and 6hours).

If I have the results for tablets containing 10, 15, 20 and 25% of this component how can I create a model that will tell me how much of that component is needed to obtain a target profile (target release values at target timepoints)?

Thanks

Re: tablet dissolution profile

Peter_Bartell — Mon, 12 Feb 2018 12:34:04 GMT

One JMP platform you may want to take a look at is the Fit Curve platform for the type of problem you are trying to address. Here is the link to the JMP online documentation for the Fit Curve platform.

https://www.jmp.com/support/help/13-2/Fit_Curve.shtml

Re: tablet dissolution profile

bambi — Mon, 12 Feb 2018 12:59:09 GMT

I have no problems with fitting the curves. My problem is that each concentration/fit has a different slope/equation and I'd like to have a model that would tell me what concentration of the excipient is needed to obtain a given profile – that is to say I have a target fit of curve and I'd like to know how I can achieve that based on the results of the other fits.

Re: tablet dissolution profile

Peter_Bartell — Mon, 12 Feb 2018 16:39:22 GMT

I guess I'm a bit confused then. For your example, are you trying to predict any one curve as a function of the slope/intercept of the other 3 curves?

Re: tablet dissolution profile

Mark_Bailey — Mon, 12 Feb 2018 16:52:39 GMT

You might also try using Analyze > Reliability > Degradation. Use the excipient level as X. You can try transforms on Y and X with a linear path or use a nonlinear path.

Re: tablet dissolution profile

bambi — Tue, 13 Feb 2018 10:46:05 GMT

I probably do not fully understand how the degradation model works but...

When I have a target profile it means that I have target values for the various timepoints (e.g. timepoint 100: 10%, 200: 15%, 400: 45%, etc.) so not just one point. And I would need a model that would tell me what concnetration of X would give me a closest match.

My best shot so far was to create a single factor DOE where I set the timepoints as the responses and simply overwrote the parameters in the provided table with the parameters and results of my experiments and used the profilers.

But there must be a better way to do that, I guess.

Re: tablet dissolution profile

Mark_Bailey — Tue, 13 Feb 2018 14:21:11 GMT

Please don't be put off by the terminology. The 'degradation path' in the Degradation platform is just a model of the change in the response (dissolution) over time under the influence of a factor (excipient level). You can then profile the response under different conditions to find the target profile. You can use inverse prediction to find the condition that achieves a desired response level, too.

Re: tablet dissolution profile

Mark_Bailey — Tue, 13 Feb 2018 14:31:53 GMT

Also, you might try saving the model and creating a new response to optimize. A good choice would be the root mean square error (RMSE). A column formula could compare the predicted response with the target response using something like this

Sqrt(
	Sum(
		(P(t1,X) - T(t1))^2 +
		(P(t2,X) - T(t2))^2 +
		(P(t3,X) - T(t3))^2 +
		(P(t4,X) - T(t4))^2 +
		(P(t5,X) - T(t5))^2
	)
)

where the P(t,X) is the fitted model of the predicted response at time t and excipient level X. T(t) is the target level at time t. You could use the Graph > Profiler with this column to optimize X (minimize response with desirability function).