Folic acid Granulation and Evaluation for pediatric diseases
Baha Majdi Abd Alrahman Sabri
بهاء مجدي عبدالرحمن صبري
Folic acid is water-soluble vitamin. It is an important compound involved in many necessary biochemical processes in humans. It is broadly used to treat many diseases of pediatric like megaloblastic anemia and neural tube defects. The lack of suitable folic acid dosage form for children creates a need to cover this category. This research aims to develop a new formula of folic acid that suits pediatric needs and study the effect of heat, light, and pH on specific formula. Three different formulas of folic acid were prepared as granules by using two methods dry and wet granulation. HPLC was used to determine folic acid concentration during the stability study period. UV-visible spectrophotometer was used to measure the absorbance of folic acid after exposure to UV light at different pH in order to study the extent of degradation. Results showed wet formula reached to 97.84% of the concentration of folic acid at the beginning, but after six months at stress condition (40°C ± 2°C & 75% RH ± 5%), it reaches 70.46%. On the other hand, the results of dry formula at the beginning reached 105.30% of the concentration of folic acid. Also, after six months at stress condition (40°C ± 2°C & 75% RH ± 5%) reached 97.00%. The results of the effect of light and pH showed folic acid at acidic medium (pH= 1.47 and 5.50) to have degradation actions, the folic acid lost (16% and 8%), respectively, of its concentration after two hours of exposure to 365 nm light. However, folic acid at basic medium (pH= 8.36 and 10.60) had different actions; the loss of concentration of folic acid reached (3.5% and 2.6%), respectively, after two hours of exposure to 365 nm light. The presence of water in the wet granulation method increased the rate of degradation. The acidic medium increased the cleavage of the structure of folic acid in addition to the illumination.