Nitrofurantoin BE study [Regulatives / Guidelines]

posted by pjs – India, 2015-07-30 10:55 (3215 d 05:04 ago) – Posting: # 15173
Views: 12,211

Dear all,

we are developing Nitrofurantoin oral suspension for EMA submission.

As per OGD SD fed study is required. As per RLD (Furadantin oral suspension) Furadantin should be given with food to improve drug absorption and, in some patients, tolerance.

In literature there has been mention of the food effect. BA is reported to enhance by 20% to 400% when taken with food.

For other dosage form (capsule) of the Nitrofurantoin both fed and fasting studies have been submitted in the published UKPAR. The innovator Smpc suggest “The dose should be taken with food or milk.”

Now in the Smpc of the innovator of oral suspension (Furadantin) in pososlogy there is no specific mention of the drug intake with food. The statements included are “Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.” And “Increased absorption with food or agents delaying gastric emptying.” As per PIL “Nitrofurantoin Oral Suspension should be taken with food or milk.”

For generic submission in EMA which study should be conducted fasting or fed or both?

Regards,
PJS

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