• P-ISSN 0973-7200 E-ISSN 2454-8405
  • Follow us

Journal of Pharmaceutical Research

Article

Formulation and Evaluation of Multivitamin Soft Gelatin Capsules: Development, Optimization, and Stability Analysis
  • VIEWS 21
  • PDF 16

Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v18.3.bhagyashree

Year: 2019, Volume: 18, Issue: 3, Pages: 19-24

Original Article

Formulation and Evaluation of Multivitamin Soft Gelatin Capsules: Development, Optimization, and Stability Analysis

K Bhagyashree1, A Saritha1

1Department of Pharmaceutical Technology, Krupanidhi College of Pharmacy, Bangalore, Karnataka, India

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

This study aimed to develop a soft gelatin capsule dosage form containing multivitamin and mineral suspensions to address dietary deficiencies and meet varying nutritional requirements. Multivitamin and mineral supplements in soft gelatin capsules are popular due to convenience, stability, and improved absorption rates. Objective of the study is to formulate and test a soft gelatin capsule with suspended multivitamins and minerals to guarantee stability, content uniformity, and conformity to official standards. Preformulation studies on active pharmaceutical ingredients (APIs) included visual observation, solubility determination, loss on drying, and sulphated ash. Multivitamin soft gelatin capsules were prepared by encapsulating a stable dispersion of the active drug in a gelatin shell made from glycerin, purified water, and gelatin powder. The fill consisted of soybean oil, hydrogenated vegetable oil, and soy lecithin. After encapsulation, the capsules were inspected for viscosity, bloom strength, weight uniformity, disintegration, and assays. Formulation F5 proved to be stable under accelerated storage conditions, with assay values falling within acceptable limits. The soft gelatin capsules exhibited uniform appearance, fill weight, hardness, and disintegration time. The physical characteristics and content uniformity complied with the official specifications. The stability study showed that the formulation did not undergo any degradation after storage for two months. We developed high-quality multivitamin soft gelatin capsules with good content uniformity, stability, and physical characteristics. The formulation effectively protects against degradation and ensures the stable delivery of multivitamins and minerals. Further bioavailability studies and clinical trials are needed to assess its therapeutic effects.

Keywords: Soft Gelatin Capsules, Multivitamins, Stability Testing

References

  1. Singh BN, Kim KH. Floating drug delivery systems: an approach to oral controlled drug delivery via gastric retention. Journal of Controlled Release. 2000;63(3):235–259. Available from: https://doi.org/10.1016/S0168-3659(99)00204-7
  2. Villiers MMD. Oral Conventional Solid Dosage Forms: Powders and Granules, Tablets, Lozenges, and Capsules. In: TKG, Jasti BR., eds. Theory and Practice of Contemporary Pharmaceutics (1). (pp. 273-326) New York. CRC Press. 2004.
  4. Tabibi SE, Gupta SL. Soft Gelatin Capsules Development. In: Water-Insoluble Drug Formulation (2). (pp. 603-622) CRC press. 2008.
  5. Marques MR, Cole E, Kruep D, Gray V, Murachanian D, Brown WE, et al. Liquid-filled gelatin capsules. Pharmacopeial forum. 2009;35(4):1029–1041. Available from: https://www.researchgate.net/publication/237388385_Liquid-filled_Gelatin_Capsules
  6. Reich G. Formulation and physical properties of soft capsules. Pharmaceutical Capsules. (pp. 201-212) London. Pharmaceutical Press. 2004.
  7. Augsburger LL. Hard and soft gelatin capsules. Drugs and the pharmaceutical sciences. 1990;40:441–490. Available from: http://dx.doi.org/10.1201/9780824744694.ch11
  8. Podczeck F, Jones BE. Pharmaceutical Capsules (2). (pp. 1-272) Pharmaceutical press. 2004.
  9. Murphy SP, White KK, Park SY, Sharma S. Multivitamin-multimineral supplements' effect on total nutrient intake. The American Journal of Clinical Nutrition. 2007;85(1):280S–284S. Available from: https://doi.org/10.1093/ajcn/85.1.280s
  10. Radimer KL, Subar AF, Thompson FE. Nonvitamin, nonmineral dietary supplements: issues and findings from NHANES III. Journal of the American Dietetic Association. 2000;100(4):447–454. Available from: https://doi.org/10.1016/s0002-8223(00)00137-1
  11. Park SY, Murphy SP, Wilkens LR, Yamamoto JF, Kolonel LN. Allowing for variations in multivitamin supplement composition improves nutrient intake estimates for epidemiologic studies. Journal of nutrition. 2006;136(5):1359–1364. Available from: https://doi.org/10.1093/jn/136.5.1359
  12. Bajaj S, Singla D, Sakhuja N. Stability testing of pharmaceutical products. Journal of applied pharmaceutical science. 2012;2(3):129–138. Available from: https://dx.doi.org/10.7324/JAPS.2012.2322
  13. Kim MS, Kim JS, You YH, Park HJ, Lee S, Park JS, et al. Development and optimization of a novel oral controlled delivery system for tamsulosin hydrochloride using response surface methodology. International Journal of Pharmaceutics. 2007;341(1-2):97–104. Available from: https://doi.org/10.1016/j.ijpharm.2007.03.051
  14. Rao RN, Talluri MK, Raju AN, Shinde DD, Ramanjaneyulu GS. Development of a validated RP-LC/ESI-MS–MS method for separation, identification and determination of related substances of tamsulosin in bulk drugs and formulations. Journal of Pharmaceutical and Biomedical Analysis. 2008;46(1):94–103. Available from: https://doi.org/10.1016/j.jpba.2007.09.009
  15. Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Current Medical Research and Opinion . 2010;26(10):2375–2384 . Available from: https://doi.org/10.1185/03007995.2010.515478
  17. Reddy G, Muthukumaran M, Krishnamoorthy B. Soft Gelatin Capsules-Present and Future Prospective as a Pharmaceutical Dosage Forms -A Review. International Journal of Advance Pharmaceutical Genuine Research. 2013;1(1):20–29.

Copyright

© 2019 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 

  • 18 April 2025

Year: 2019, Volume: 18, Issue: 3


More articles

DON'T MISS OUT!

Subscribe now for latest articles and news.