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RegisterOGD's article in AAPS J may help [Regulatives / Guidelines]
Hi,
According to the authors from OGD (published in AAPS J. 2008):
Methods.
The assay was implemented for several MR drug products under review at the Office of Generic Drugs (OGD). The assay
employs USP Apparatus I or II and 900 mL of 0.1 N HCl media containing ethanol (v/v) at: 0%; 5%; 20%; and 40%,
sampling every 15 minutes until 2 hours. Applicants conduct these studies on all drug product strengths.
The dissolution results are categorized as
Case I: If at 2 hours, % dissolved of the generic product in 40% ethanol is ≤ in 0% ethanol, the generic product is considered
robust (does not dose-dump); if not
Case II: at 2 hours, % dissolved of the generic product in ethanol solution is less or comparable to that of the reference, the
potential for dose-dumping is similar for the two products and the generic product is acceptable; if not
Case III: the generic product releases more drug in ethanol than the reference and is unacceptable.
You can download the abstract here
I guess that your is case II.
❝ 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.
According to the authors from OGD (published in AAPS J. 2008):
Methods.
The assay was implemented for several MR drug products under review at the Office of Generic Drugs (OGD). The assay
employs USP Apparatus I or II and 900 mL of 0.1 N HCl media containing ethanol (v/v) at: 0%; 5%; 20%; and 40%,
sampling every 15 minutes until 2 hours. Applicants conduct these studies on all drug product strengths.
The dissolution results are categorized as
Case I: If at 2 hours, % dissolved of the generic product in 40% ethanol is ≤ in 0% ethanol, the generic product is considered
robust (does not dose-dump); if not
Case II: at 2 hours, % dissolved of the generic product in ethanol solution is less or comparable to that of the reference, the
potential for dose-dumping is similar for the two products and the generic product is acceptable; if not
Case III: the generic product releases more drug in ethanol than the reference and is unacceptable.
You can download the abstract here
I guess that your is case II.
—
All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- Alcohol Dose Dumping: Requirments? luvblooms 2014-09-04 09:47
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- 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 helpShuanghe 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
- OGD's article in AAPS J may help luvblooms 2014-09-11 05:56
- Alcohol Dose Dumping: Requirments? luvblooms 2014-09-10 06:25
- Alcohol Dose Dumping: Requirments? luvblooms 2014-09-05 06:28
- Alcohol Dose Dumping: Requirments? jag009 2014-09-04 20:23
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