Latest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]

posted by Achievwin – US, 2017-07-25 01:23 (2438 d 17:47 ago) – Posting: # 17606
Views: 10,881

(edited by Ohlbe on 2017-07-25 09:52)

❝ - Aspirin+Omeprazole delayed release tablet: BE for ASS based on both, ASS and SS

❝ - Aspirin ER capsule or Aspirin capsule (from 2015): BE based on ASS alone


❝ Any obvious reason for this?


Yosprola is •81 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with 81/40, Asprin delayed release is provides increased Asprin levels and minimal salicylic acid levels presence of Omeprazole will facilitate some aspirn break down that must be the reason in this combination product both Acetyl salicylic acid and salicylic acid and also omeprazole are required to for BE.

❝ - Tiopronin tablet (Shkreli compound): Only 1 study in fasted state


❝ Are there more compounds not requiring fed state study?


there are several drugs that doesn't require Fed BE study.

❝ - Metoprolol tartrate: BCS-biowaiver requires data other than "peer-reviewed articles"


❝ Plausible to me, own experimental data on solubility might be required. Has anybody identified a PAR with successful BCS-biowiaver? :-D


For Biowaiver: you need to document Highly soluble over the specified pH range and rapidly dissolving as deined under BCS class III (85% by 15 mins) and the biggest challenge you run into is in documenting reliable report on permeability If you can find a ADME paper documenting it is more than 80% bioavailable then that might work.

❝ - Propafenon: Highly variable.


❝ Is CYP2D6 substrate, poor/ultrarapid metabolizers might be the reason for high variability? Why not pheno/genotype the volunteers for BE-trial, to minimize variability?


❝ ...just asking ;-)


Phenotype is not advisable in generic arena (IMHO) as we want to document that this drug is BE in general populating (meaning any breathing soul)....


Edit: quotes corrected [Ohlbe]

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