Influence of pH on the dissolution of folic acid supplements (original) (raw)
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International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Objectives: Folic acid is a water-soluble B vitamin that is naturally present in some foods such as dark green leafy vegetables and dairy products, added to others such as fortified breads, and available as a dietary supplement. In a study performed in the United States, out of nine multivitamin products, only three products met US Pharmacopeia (USP) standard for folic acid dissolution. The aim of this study is to evaluate the dissolution profile of folic acid supplements in the United Arab Emirates according to the USP standards. Methods: Two commercial brands were collected from the market that are commonly prescribed. Water and citrate buffer (pH 6.0) were used as dissolution media. Results: Both products passed the dissolution testing of releasing the required amount of drug substance (75%) within 60 minutes. Also, both products contain an over age of up to 150% of the labeled amount to ensure the availability of the claimed amount. Conclusion: The study indicates that dissolution test is well established, reproducible, reliable and valuable tool for characterizing a drug product at different stages in its lifecycle. The use of citrate buffer showed a significant change in the release of folic acid from the tablets.
In Vitro Evaluation of Dissolution Profile of Two Commercially Available Folic Acid Preparations
International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Objectives: Folic acid is a water-soluble B vitamin that is naturally present in some foods such as dark green leafy vegetables and dairy products, added to others such as fortified breads, and available as a dietary supplement. In a study performed in the United States, out of nine multivitamin products, only three products met US Pharmacopeia (USP) standard for folic acid dissolution. The aim of this study is to evaluate the dissolution profile of folic acid supplements in the United Arab Emirates according to the USP standards. Methods : Two commercial brands were collected from the market that are commonly prescribed. Water and citrate buffer (pH 6.0) were used as dissolution media. Results : Both products passed the dissolution testing of releasing the required amount of drug substance (75%) within 60 minutes. Also, both products contain an over age of up to 150% of the labeled amount to ensure the availability of the claimed amount. Conclusion : The study indicates that dissol...
Folic acid tablets: dissolution – method development and validation
2010
Method for dissolving folic acid tablets is described in the United Stated Pharmacopoeia (USP). Water is used as a dissolution medium, although the folic acid is practically insoluble in it. Another disadvantage in using water is poor stability of its pH. For these reasons, other mediums have been researched. As a result another simple and rapid method for determination of dissolved folic acid in tablets has been developed and validated. A volume of 900 ml of phosphate buffer, pH 6.0, was used as the medium for a time of analysis of 45 minutes. As dissolution apparatus, Varian VK 7010 ; paddle (USP Apparatus 2) and Erweka DT6 ; paddle (USP Apparatus 2) were used. Rotational speed was set to 50 RPM and the temperature to 37°C ± 0, 5°C. HPLC analysis of dissolution samples was carried out on a Hypersil ODS column (250mm x 4.6mm i.d., 5 m particle size, guard column 4x4 mm). The UV detector was set to a wavelength of 282 nm. The dissolution method has been validated with satisfactory...
Macedonian Pharmaceutical Bulletin
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.
Physicochemical, Pharmacological and Analytical Profile of Folic Acid: A Comprehensive Review
International Research Journal Of Pharmacy
The importance of folic acid can be felt from the fact that it is required by a female since she plans for pregnancy. It is requiring 1 to 1.5 fold by a pregnant lady that is required by an adult person. Folic acid is needed by a person daily to undergo vital body function like hindrance in cycle, synthesis of DNA, RBC production etc. Deficiency of folic acid may lead to a severe complication like neural tube defects, megaloblastic anemia, malignancy and pregnancy complications. The present review summaries the physicochemical properties, biological action, pharmacological effect, therapeutic potential and analytical methods of folic acid. The recent researches on folic acid in the pharmaceutical field have also been discussed.
Food Science and Biotechnology, 2019
Milk contains a certain amount of folate binding proteins. The binding capacity varies in acidic conditions and affects the bioavailability of folic acid. Folic acid is commonly added into baby foods to ensure adequate intake of infants. The aim of this study was to determine the bioaccessibility of added folic acid in baby foods formulated with milk and milk products under different gastric pH values by an in vitro digestive system. The bioaccessibility of folic acid ranged between 56-71 and 35-49% in infant formula samples, between 59-78 and 31-67% in cereal-based baby foods, and between 42-67 and 38-57% in follow-on baby milk at gastric pH 1.5 and pH 4, respectively. Our results demonstrate that the bioaccesibility of folic acid that is added to baby food is affected by gastric pH. Therefore, it was observed that the bioaccesibility of folic acid was lower in the higher gastric pH.
Veterinary Quarterly, 1994
After intravenous (1 mg/kg body weight), intramuscular (1 mg/kg body weight) and oral (1 and 50 mg/kg body weight) administration of folic acid (FA) to pigs, plasma levels of FA, tetrahydrofolic acid (THF), 5-methyltetrahydrofolic acid (5MF) were determined by using highperformance liquid chromatography. The pharmacokinetic profile of plasma FA after oral administration indicated an absorption rate-limited elimination, i.e., so called 'flip-flop' phenomenon. The bioavailability of FA was quite low after a high oral dose (F=0.01), in contrast to a high value after intramuscular administration (F=0.95). The plasma levels of biologically active, reduced forms of folates (THF and 5MF) were significantly increased over their basal levels after IV and IM administration to FA. The levels of these active folates were not increased after oral administration of a similair dose of FA. A 50 times higher dose was required to increase the active folates to the levels observed after IV and IM administration.
Estimation of the Folic Acid Using Zero Order, Area Under Curve and First Derivative Spectrophotometric Methods in Pure and Marketed Tablet Formulations, 2017
Three simple, inexpensive and nontoxic spectrophotometric methods have been used for determination folic acid in pure and market formulation tablets. Linearity was founded in the range 6- 20 mg.l-1 for the all three methods, the detection limits was found to be 0.261 for zero order method, 0.006 for AUC method and 3.800 for first derivative method. The RSD% was found to be less than 0.856 indicating a good accuracy and precision of three proposed methods. The results of zero order, AUC and first derivative methods were statistically compared with those obtained by the official standard method using the F-test and t-test and found to be a good agreement. [DOI: 10.22401/JUNS.20.3.07]
PHARMACOKINETIC STUDY OF HY-FOLIC® AND FOLIC ACID IN HEALTHY VOLUNTEERS
International Journal of Applied Pharmaceutics, 2024
Objective: HY-FOLIC® is the active form of Folic Acid (FA) produced by PT Simex Pharmaceutical Indonesia containing (6S)-5-Methyltetrahydrofolate (5-MTHF). We evaluated the pharmacokinetic profiles of HY-FOLIC® versus FA after single oral administration in healthy volunteers. Methods: A randomized, open-label, 2-way crossover, single-dose design was conducted on 12 healthy subjects with two steps. In the first step, 6 subjects were given 1100 mcg of HY-FOLIC®(1.3 μmol), and 6 subjects were given an equimolar dose of 600 mcg of FA (1.3 μmol) in a fasting condition. Blood samples were taken before, and at 1, 2, 3, 4, 5, 6, 7, and 8 h after administration of products for measurement of peak concentration (Cmax), the Area Under the Curve at t-time (AUCt) and infinite time (AUCinf). After a washout period of 14 d, the same procedure was repeated in which the first 6 subjects received FA, and the second 6 subjects received HY-FOLIC®. Pharmacokinetic data of 5-MTHF and Unmetabolized Folic Acid (UMFA) were compared with paired t-tests. Results: Cmax of 5-MTHF (mean±SD) following administration of HY-FOLIC®and FA were 46.91+28.16 vs 22.61+15.73 nmol/l, respectively (p=0.000); the AUCt were 214.47+183.46 vs 112.93+112.11 h. mmol/l (p=0.001). Conversely, Cmax of UMFA were 9.49+7.89 vs 21.97+14.79 nmol/l (p=0.003); AUCt 33.29+39.34 vs 78.16+58.93 h. nmol/l (p=0.001). Conclusion: HY-FOLIC®is much more bioavailable than FA as indicated by much higher Cmax and AUCt of the active form of 5-MTHF.