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RegisterFDA’s guidances, lightsensitive drugs [Design Issues]
Dear Phanni
The dosing procedure for chewable and film coated tablets is different as both fall into a different class of formulation.
As HS has said, it is always good to refer the FDA guidance on individual drugs before initiation of any study.
Dear HS
i do have a literature wherein it is mentioned that Montelukast shows instability when exposed to light leading to formation of cis-isomer as a major photoproduct and the degradation rate is least in sodium light then in UV or daylight. therefore it is better to carry out the trial in dark conditions to avoid exposure to direct light. the link which you have provided in last reply is also quiet helpful in this regard.
The dosing procedure for chewable and film coated tablets is different as both fall into a different class of formulation.
As HS has said, it is always good to refer the FDA guidance on individual drugs before initiation of any study.
Dear HS
i do have a literature wherein it is mentioned that Montelukast shows instability when exposed to light leading to formation of cis-isomer as a major photoproduct and the degradation rate is least in sodium light then in UV or daylight. therefore it is better to carry out the trial in dark conditions to avoid exposure to direct light. the link which you have provided in last reply is also quiet helpful in this regard.
Complete thread:
- Montelukast study Phaneendra.K 2010-12-31 15:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Chewable tablets (EMA) jagdish 2012-01-12 11:12
- Chewable tablets (EMA) Helmut 2012-01-11 14:19
- tablets jagdish 2012-01-11 13:43
- 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 drugsmanan 2011-01-03 05:52
- Lightsensitive drugs Helmut 2011-01-03 15:22
- FDA’s guidances, lightsensitive drugsmanan 2011-01-03 05:52
- FDA’s guidances, lightsensitive drugs Helmut 2011-01-02 15:13
- Montelukast study Phaneendra.K 2011-01-02 09:32
- Montelukast study Helmut 2010-12-31 15:35
Ing. Helmut Schütz