Dissolution comparison

[prasanna]

Dear friends,
Please help me reg, this. My acidic drug is matching with that of reference in 0.1N Hcl, but it completly fails in acetate and Phostate buffer. So what will be the reason. Please tell me what are the tests to be planned for the Drug suitability before going for Dissolution comparison.

[sagarprasanna]

if u r able to tell the product name i will help u
kindly look in to drug Tmax, pKa etc
with regards

[natrajank]

Do a check on the reference products inactive ingredients. Try to match the pH of tablet. Otherwise for a generic equivalent , once your drug is available in solution it should behave similiarly as innovator within the confines of the pKa fundamentals of the active. You can also do a study on particle sizes. Probably the release in acid medium is fast that particle size effects are not pronounced while the same are highlighted in the slow and discriminatory "near" alkaline media.

Hope this helps.