Abstract
The vitamin folic acid has received considerable attention because of it′s role in decreasing risk of neural tube birth defects, and it′s potential role in reducing risks of cardiovascular and psychiatric diseases. We evaluated compositions of 5 different formulations in terms of meeting the USP standard for dissolution and disintegration .However all the examined formulations had met the disintegration test but only 3 formulations had met the dissolution requirements to release 75 % of the active ingredient in 45 minutes. The maximum value of dissolution of 97.52 % in S5 composition was achieved by combination of certain excipients (combination of hydrophilic and hydrophobic filler and suitable wetting agent) and wet high shear mixing granulation technique, resulting with optimize release of the active substance.
Highlights
Folic acid is a B complex vitamin, used for prevention and treatment of vitamin B deficiency, and it can be isolated from green leafy vegetables, liver, yeast and fruits
We evaluated compositions of 5 different formulations in terms of meeting the USP standard for dissolution and disintegration . all the examined formulations had met the disintegration test but only 3 formulations had met the dissolution requirements to release 75 % of the active ingredient in 45 minutes
The maximum value of dissolution of 97.52 % in S5 composition was achieved by combination of certain excipients and wet high shear mixing granulation technique, resulting with optimize release of the active substance
Summary
Folic acid is a B complex vitamin, used for prevention and treatment of vitamin B deficiency, and it can be isolated from green leafy vegetables, liver, yeast and fruits. According to the European Pharmacopoeia, the substance is characterized as yellowish or orange crystalline powder, practically insoluble in water and in most organic solvents, but it dissolves in dilute acids and in alkaline solutions. Folic acid obtained from preparations is more bioavailable than dietary folate, since up to half of dietary folate is lost in the cooking process and requires hydrolysis for absorption (Suitor and Bailey, 2000). The failure of folic acid supplements to meet several pharmacopoeial requirements for disintegration has been reported earlier (Stout et al, 1996). Monograph for folic acid tablets in the current edition of US Pharmacopoeia
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