Bioequivalence and Bioavailability Forum • Chewable tablets (EMA)

Chewable tablets (EMA) [Design Issues]

posted by Helmut – Vienna, Austria, 2012-01-13 18:26 (5267 d 08:32 ago) – Posting: # 7934
Views: 9,355

Dear Jagdish!

❝ As per PIL, the tablet should be chewed and swallowed. But it is not clear whether it should be swallowed with water or without, […]

Do I get you right that nothing is stated in the reference’s SmPC? If yes, the first bullet point of the GL is applicable:

If the reference medicinal product can be taken with or without water, bioequivalence should be demonstrated without water as this condition best resembles the intended use of the formulation. This is especially important if the substance may be dissolved and partly absorbed in the oral cavity. If bioequivalence is demonstrated when taken without water, bioequivalence when taken with water can be assumed.

❝ as there is concern of chewed tablet particle getting stuck in teeth if swallowed without water?

Reminder: BE = similar rate and extent of absorption. If both products stick to teeth, what is the problem? If not, products might not be BE without water. Easy.

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Complete thread:

Montelukast study Phaneendra.K 2010-12-31 15:06 [Design Issues]
- Montelukast study Helmut 2010-12-31 15:35
  - tablets jagdish 2012-01-11 13:43
    - Chewable tablets (EMA) Helmut 2012-01-11 14:19
      - Chewable tablets (EMA) jagdish 2012-01-12 11:12
        
        Chewable tablets (EMA)Helmut 2012-01-13 17:26
- Montelukast study manan 2011-01-01 06:16
  - Montelukast study Phaneendra.K 2011-01-02 09:32
    - FDA’s guidances, lightsensitive drugs Helmut 2011-01-02 15:13
      - FDA’s guidances, lightsensitive drugs manan 2011-01-03 05:52
        
        Lightsensitive drugs Helmut 2011-01-03 15:22