I am starting an experiment to evaluate the effect of excipients on the behaviour of a cream. However, I don't know the suitable quantity of the cream for the formulation of the development study in general. My test for validation only needs about 50 mg of cream. I am the newcomer of this field.
I understand that I have to try many combinations of excipients and active ingredients with replicate to statiscally evaluate. However, I don't know whether I should make 5, 10, 15 or more g of cream for each combination (total weight of formulation like the batch size in industrial scale)
How accurate is your scale, you should not weigh less than 10 mg for each compound. increase the quantities up to a reasonable amount for each excipient to weigh.
Formulation development can achieved via successful execution
of a meticulous formulation program. Averagely/ approximately 2% is required.
Many factors may have effect while deciding the total quantity of cream to be prepared, like no of tests to be carried out, no of batches you are going to prepare and one more thing which I would like to state is that scale of scrutiny i.e. size of individual dose should also be kept in mind.
The objective is to evaluate the effect of excipients on cream formulation. In this case you would be using various excipients with your ointment base and medicament in appropriate pre-decided ratio. One thing as you stated the minimum quantity that is required by you must always be kept in mind including limit of detections and number of trials sufficient enough to calculate statistical figure. Second is your cream texture analysis, description, content, viscosity and stability study etc., which are all very essential parameters to be considered while developing any cream formulation. For example if you had emulsified your preparation than optimization of surface active agents with respect to not only their quantity but HLB value in your formulation will be your prime objective. Thus adding all these at end point for evaluation purpose, you can get to the quantity required. I recommend you to first make a list of "critical parameters" to be accessed and thereafter, other important parameters and studies, in formulation development to decide the batch size. Neve forget to include packaging evaluation in your formulation development, with respect to stability and shelf-life estimation. Good Luck.
It basically depends on the dose of the drug and the batch size. Batch size depends on the different parameters you want to evaluate. effective plan for the same should be charted. Even while considering all those, you can include DOE as part i.e. how many trials you require for different factors and levels of the same.
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