Alcohol Dose Dumping: Requirments? [Regulatives / Guidelines]

posted by luvblooms  – India, 2014-09-04 11:47 (4309 d 13:59 ago) – Posting: # 13456
Views: 11,497

Dear Gurus

Need some suggestions for Alcohol dose dumping issue!!!:crying:

For Alcohol dose dumping (for FDA submission) my understanding is as given below:

Requirement:
Testing Conditions: 900 mL/500 mL, 0.1 N HCl, Apparatus II (Paddle) at 50 rpm, with and without the alcohol:
  1. Test 1: 12 units tested according to the proposed method (with 0.1 N HCl), with data collected every 15 minutes for a total of 2 hours.
  2. Test 2: 12 units analysed by substituting 5% (v/v) of test medium with Alcohol USP, and data collection every 15 minutes for a total of 2 hours.
  3. Test 3: 12 units analysed by substituting 20% (v/v) of test medium with Alcohol USP, and data collection every 15 minutes for a total of 2 hours.
  4. Test 4: 12 units analysed by substituting 40% (v/v) of test medium with Alcohol USP, and data collection every 15 minutes for a total of 2 hours.
Both test and RLD products must be tested accordingly and data must be provided on individual unit, means, range and %CV on both strengths.

Criteria to be met: The dissolution of Test product should be either similar or slower to that of Reference product. (this is as per QBD MR guidance and also as per the Wockhardt Metoprolol Approval)

Now coming to the questions:
  1. Does one need to match the F2 for dose dumping? (In my opinion NO, would love to hear others experience and understanding on the same)
  2. Should I need to worry if RLD is releasing 90% in 2hrs in 40% alcohol where as my bioequivalent product is releasing almost 20%? (As per my limited knowledge, lower release in 40% alcohol will always mean lesser chance of dose dumping and increased safety. Am I right or just being knuckle head?)
  3. If there are multiple strengths available one need to compare
    1. Higher strengths of test product vs other strengths (IMHO, this makes sense as since test formulations are dose proportional, I need to show the similarity with Test product only)
    2. Individual strengths of test product vs individual reference strengths

Thanks a ton in Advance!!

P.S: HS, There were some threads for ADD studies but I couldn't find the relevant answers over there so starting a new thread. If required you can merge them
—
~A happy Soul~

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