I am currently working on a project on sustained release formulation using matrix tablets. I am curious as to how much binder I should put into the formulation.
Generally, we use binders in concentrations ranging from 5 - 15%, but in case of sustained release, their concentrations maybe reached to 50%.
There is no exact or restricted amount of binder in case of natural gums or polymers normally they are used upto 20%.
The amount of binder used in the formulation are depend upon the binding capacity and the release of drug so we want to trail from 5- 35%by the result obtained,we can fix amount of binder,the maximum percentage used in formulation is upto 40%
It depends upon the type of binder (chemistry, physicochemical properties etc) and drug to be formulated for tablet. Generally 2-10% binder is ok for granulation and higher concentrations are used for controlled release formulations.
All above researchers have addressed the points related to binding capacity, release profile desired. Generally for controlled release the amount of binder, which will now be the release retardant - the levels required will be quite high.
In addition, one also has to consider the maximum permitted concentration allowed for that particular binder excipient as per guidelines.
Binder concentration ranges from 5-15% in general cases and for control release formulation it ranges higher about 30-40%
You can use as per your formulation requirement but it should not be exceed as per IID limit.
Hi Fatimae,
FDA has created a database called IIG (Inactive Ingredients) Search. Just search the binder(s) you are willing to use in your formulation and they will let you know that what is the maximum amount you can use and in which kind of dosage form. Find the link below...
https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
The concentration is not restricted by official measures. As long as the binder level does not effect the other tablet properties (such as disintegration and dissolution), it`s not an issue what is its concentration. You can find the recommended levels of all the excipients at the Handbook of Pharmaceutical Excipients.
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