Iraqi Pharmaceutical Formula for Clonazepam Oral Drop 0.25% w/v to Treat Seizure Epilepsy in Infants and Children with its Stability Study. تركيبة صيدلانية عراقية لمستحضر كلونازيبام قطرة فموية 0.25 % وزن/حجم لعلاج التشنجات العصبية والصرع عند الرضع والاطفال مع دراسة ثباتيتها.

Abstract

This work has been carried out to develop national drug product contains (2.5 mg / ml) clonazepam as oral drop; it is used for the treatment of epilepsy in infants and children. Several gel formulations were prepared using different oral drop bases and preservatives. Selection of best formula relied solely on physic-chemical testing of sample exposed to thermal stresses. Stability study was conducted on the product for (6) months at different temperatures and relative humidity to determine the expiration date and the best storage conditions. From the study we obtained an oral drop of good clear thick solution. The expiry date calculated to be not less than (2) years.