Simeticone soft gel capsule dissolution problem [Dissolution / BCS / IVIVC]
Hi all,
We are currently working on a new project in which reference product is a soft gel capsule (orally administered) and has 300 mg of simeticone (USP) and class III API in combination. Simeticone (viscous oily liquid, API grade) and class III API is mixed and filled into soft gel capsules in the reference product formulation. As generic, we are working on developing a tablet formulation. Considering information below we would like to develop a dissolution medium/method:
Dissolution rate of class III API after 45 minutes, Apparatus II, (900 or 1000 ml volume):
Questions are:
Kind Regards,
We are currently working on a new project in which reference product is a soft gel capsule (orally administered) and has 300 mg of simeticone (USP) and class III API in combination. Simeticone (viscous oily liquid, API grade) and class III API is mixed and filled into soft gel capsules in the reference product formulation. As generic, we are working on developing a tablet formulation. Considering information below we would like to develop a dissolution medium/method:
- Capsule shell of reference product consists of gelatin, glycerin and colorant.
- Simeticone is not absorbed, therefore, it has waiver for BE study.
- Class III compound is not absorbed (or very limited); only 0.15% is absorbed and locally acts in intestins according to SPC, therefore, it has waiver for BE study.
Dissolution rate of class III API after 45 minutes, Apparatus II, (900 or 1000 ml volume):
- 0.1 N HCl, 50 rpm: 2%
- pH 4.5, 50 rpm: 1%
- pH 6.8, 50 rpm: 1%
- 0.1 N HCl (+3% SLS), 100 rpm: 10%
- 0.1 N HCl (+3% Tween 80), 100 rpm: 7%
- 0.1 N HCl (+20% Ethanol), 100 rpm: 3%
- 0.1 N HCl (+5% PEG 40 Hydrogenated Castor Oil), 150 rpm: 2%
- 0.1 N HCl (+4% cetrimide), 150 rpm: 2%
- 0.1 N HCl (+30% tetrahydrofuran), 150 rpm: 30%
- 0.1 N HCl (+30% tetrahydrofuran + 10% SLS), 150 rpm: 30%
Questions are:
- Can anyone give a clue to overcome this situation?
- Is it possible to give only disintegration test in specification for FDF? Can it be accepted by MoH?
Kind Regards,
—
Mahonny
Mahonny
Complete thread:
- Simeticone soft gel capsule dissolution problemmahonny 2015-03-31 13:12
- Simeticone soft gel capsule dissolution problem TusharC 2021-01-04 08:21