Bioequivalence and Bioavailability Forum

Alcohol Dose Dumping: Requirments? [Regulatives / Guidelines]

posted by luvblooms  – India, 2014-09-10 08:25 (4304 d 11:51 ago) – Posting: # 13470
Views: 9,781

Hey John

❝

❝ Don't they understand this statement from the guidance? "Due to a concern of dose dumping of drug from this drug product when taken with alcohol, the Agency currently requests that additional in vitro dissolution testing be conducted using various concentrations of ethanol in the dissolution medium"

Tried my best but....!!

❝ No I meant we did the EtOH test on all strengths, not just at the highest strength. I was against this but then again the RA wanted a safe passage.

RA always want a safe passage

Just few more questions
a) Does one need to match the dissolution rate (At all time points 15, 30, 45, 60 , 90 and 120 min)or end release at 2 hrs will suffice the need???

b) What if my formulation is faster at 15 min and 30 min (let's BE product is relasing 15% in 15 min in 40% alcohol where as Innovator is releasing only 5%, at 30 min release from test is 40% from reference it is 30%) but after 30 min time point release from trest poduct is slower till end.

Complete thread:

• Alcohol Dose Dumping: Requirments? luvblooms 2014-09-04 09:47 
  • Alcohol Dose Dumping: Requirments? jag009 2014-09-04 20:23
    • Alcohol Dose Dumping: Requirments? luvblooms 2014-09-05 06:28
      • Alcohol Dose Dumping: Requirments? nobody 2014-09-05 08:47
      • Alcohol Dose Dumping: Requirments? jag009 2014-09-05 15:44
        • Alcohol Dose Dumping: Requirments?luvblooms 2014-09-10 06:25
          • Alcohol Dose Dumping: Requirments? nobody 2014-09-10 10:31
          • OGD's article in AAPS J may help Shuanghe 2014-09-10 11:39
            • OGD's article in AAPS J may help luvblooms 2014-09-11 05:56
              • OGD's article in AAPS J may help bharathi 2016-08-17 13:10