Often on the board queries are made regarding suggestion of dissolution media for specific drugs or products. The choice of medium will become calibration of dissolution apparatus pdf and relevant if one considers the purpose of dissolution medium in dissolution testing.
The dissolution medium in the testing provides a means to show that drug is released from the product and would be available in solution form for absorption from the GI tract. Enter your username and password in the boxes provided to login, or click the ‘register’ button to create a profile for yourself. As the absorption happens from GI tract, therefore nature of the medium should be aqueous-based and pH in the range of 5-7. The reason of pH between 5-7 is that it represents pH of intestinal environment where most of the absorption of the drug occurs.
As a rule of thumb, one may use average of 5 to 7 i. Therefore, in my view, all dissolution testing may be conducted in aqueous buffer having pH 6, with or without solublizer. I believe this provides a simple, product independent and bio-relevant approach for selecting dissolution medium. I hope this approach provides answer to the queries regarding the choice of dissolution medium. Disclaimer: Views expressed here are for scientific discussion purposes only and may not be reflective of opinions and policies of my employer. SLS to be appropriate to use, in particular in case of Phenytoin Sodium.
If you can achieve such solubility without the addition of SLS that is well and good, otherwise determine what minimum percent of SLS is needed to dissolve freely your drug. If I am not mistaken, it appears that you should be able to do dissolution testing using water itself as per USP monograph. Please note that I am of the opinion that there is no need for trying different media because, if in some medium drug is not free soluble then doing dissolution in such medium is not appropriate or relevant. And if product is freely soluble in a medium then increasing solublizer amount may not impact dissolution any way. Therefore my suggestion usually is that use a simple dissolution medium.
These are in fact because of addressing the problem of poor interaction of drug-medium in dissolution vessels. If you are going to take this approach in obtaining dissolution results by trying out different conditions as noted, then you will be conducting IVIVM studies not IVIVC as I described in my other post. I do not think your results would be valuable. A simple way to check for poor drug-medium interaction in a dissolution vessel is to run a dissolution test in dissolution medium where solubility shows no problem in dissolving the complete drug. Let me know your opinion, I will be happy to discuss it further in more detail.
What you are asking certainly is very challenging question and I doubt that any one can provide a definite answer at the stage. However, it is always possible to approach the issue in a rational and logical manner. If you focus on the quality of your product, better assessment and development, I believe you will be able to know your product better and will be able to defend you approach efficiently. Basket and results show that complete drug is released in 15 minutes for both, your product and of innovator. First of all your drug cannot be BCS Class II drug as it is dissolving fast. To me it appears a Class I type drug, why are you saying it is a Class II drug?
15 minutes then you should not need IVIVC. Now coming to Narrow Therapeutic Range Drug category. However, if you like to take a second route based on IVIVC, I can see lot of problems. There will always be questions and even after spending so much time and money I do not think you will be any further ahead. The main reason for this frustration is that it has never been shown or established that apparatuses commonly used i. In fact, recent studies have clearly demonstrated that one cannot obtain bio-relevant results using these apparatuses.