Effects of Folic Acid Consumption on Newborn Defects and Miscarriage, and Content Uniformity Analysis of Three Different Brands of Folic Acid Tablets Dosage Forms

• Adel B Mohamed

  Department of Pathology, faculty of Veterinary Medicine, Omar Al-Mukhtar University. Al-Bayda. Libya

  Author

• Azza M Ali

  Department of Pharmaceutics and industrial pharmacy, faculty of pharmacy, Omar Al-Mukhtar University. Al-Bayda. Libya

  Author

• Samia A Magid

  Department of Pharmaceutics and industrial pharmacy, faculty of pharmacy, Omar Al-Mukhtar University. Al-Bayda. Libya

  Author

There is a recent rise in the number of birth defects. This could be related to folic acid deficiency. Folic acid, as an antioxidant, is an important factor in preventing birth defects during embryonic development. This study, via content uniformity measurements and medical history, aimed to investigate the role of folic acid before and during pregnancy and to measure the content uniformity of different brands of folic acid tablets. The statistical study aimed to determine the relationship between folic acid consumption, miscarriage, and anomalies in newborn babies. The study studied a sample of 300 women based on their medical records. There was no significant effect (p-value = 0.143) of folic acid consumption on the frequency of anomalies. On the other hand, there was a high significant relation (p-value = 0.003) between folic acid consumption and miscarriage. The correlation, principally with miscarriage, coincides with previous studies and highlights the importance of folic acid supplementation before and during gestation. Content uniformity measurements were made on three famous folic acid brands (Folic Acid-Nile, Folicum-Julphar and Wockhardt-UK) available at local pharmacies. Measurements on the three folic acid brands were conducted in compliance with the British Pharmacopoeia (BP) (2010) test for content uniformity. Ten tablets from each brand were tested using the UV spectrophotometric method. The results showed that only the first brand name passed the content uniformity test, while the other two brands did not comply with the standards. This result highlights the problem of under-dosing in commercially available folic acid dosage forms, and identifies the need for taking action towards the implementation of quality control on all medical drugs.  

Ahn, E., Nava-Ocampo, A. A., & Koren, G. (2004). Multivitamin supplements for pregnant women. New insights. Canadian family physician, 50(5), 705-706.

Al-Mashhadane, F. A., Al-Mashhadane, A. A., & Taqa, A. A. R. (2018). Folic Acid Supplementation: A Review of the Known Advantages and Risks.

Andres, J., Evans, J., & Royle, C. (2008). Prevalence of congenital anomalies. Canadian Perinatal Health Report, 158-163.

Bower, C., & Stanley, F. J. (1989). Dietary folate as a risk factor for neural‐tube defects: evidence from a case‐control study in Western Australia. Medical Journal of Australia, 150(11), 613-619.

Brown, J. E., Jacobs, D. R., Hartman, T. J., Barosso, G. M., Stang, J. S., Gross, M. D., & Zeuske, M. A. (1997). Predictors of red cell folate level in women attempting pregnancy. Jama, 277(7), 548-552.

Czeizel, A., Dudás, I., Vereczkey, A., & Bánhidy, F. (2013). Folate deficiency and folic acid supplementation: the prevention of neural-tube defects and congenital heart defects. Nutrients, 5(11), 4760-4775.

Đuriš, J., Čalija, B., Vidović, B., Dobričić, V., Milić, J., & Ibrić, S. (2017). Comparative analysis of mechanical and dissolution properties of single-and multicomponent folic acid supplements. Journal of Food Composition and Analysis, 60, 17-24.

French, A. E., Grant, R., Weitzman, S., Ray, J. G., Vermeulen, M. J., Sung, L., Greenberg, M., & Koren, G. (2003). Folic acid food fortification is associated with a decline in neuroblastoma. Clinical Pharmacology & Therapeutics, 74(3), 288-294.

Goh, Y. I., Bollano, E., Einarson, T. R., & Koren, G. (2006). Prenatal multivitamin supplementation and rates of congenital anomalies: a meta-analysis. Journal of obstetrics and gynaecology Canada, 28(8), 680-689.

Green, N. S. (2002). Folic acid supplementation and prevention of birth defects. The Journal of nutrition, 132(8), 2356S-2360S.

Hibbard, B. M. (1965). The role of folic acid in pregnancy with particular reference to anaemia, abruption and abortion. Obstetrical & Gynecological Survey, 20(1), 35-39.

Matias, R., Ribeiro, P., Sarraguça, M., & Lopes, J. (2014). A UV spectrophotometric method for the determination of folic acid in pharmaceutical tablets and dissolution tests. Analytical Methods, 6(9), 3065-3071.

McStay, C., Prescott, S., Bower, C., & Palmer, D. (2017). Maternal folic acid supplementation during pregnancy and childhood allergic disease outcomes: a question of timing? Nutrients, 9(2), 123.

Pharmacopoeia, B. (2010). Vol. 1, The Department of Health. British Pharmacopoeia Commission, London, 1, 219-222.

Pulikkunnel, S. T., & Thomas, S. (2005). Neural tube defects: pathogenesis and folate metabolism. JAPI, 53, 127-135.

Ribeiro, M. V. d. M., Melo, I. d. S., Lopes, F. d. C. d. C., & Moita, G. C. (2016). Development and validation of a method for the determination of folic acid in different pharmaceutical formulations using derivative spectrophotometry. Brazilian Journal of Pharmaceutical Sciences, 52(4), 741-750.

Smithells, R., Sheppard, S., & Schorah, C. (1976). Vitamin dificiencies and neural tube defects. Archives of disease in childhood, 51(12), 944-950.

Smithells, R., Sheppard, S., Schorah, C., Seller, M., Nevin, N., Harris, R., Read, A., & Fielding, D. (1980). Possible prevention of neural-tube defects by periconceptional vitamin supplementation. The Lancet, 315(8164), 339-340.

Wald, N., Law, M., Morris, J., & Wald, D. (2001). Quantifying the effect of folic acid. The Lancet, 358(9298), 2069-2073

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