Formulation development

 

Comparison of bioavailability of liposomal and traditional formulation of vitamin D3.
(Commercial product Lipo4U™ Vit. D3)

  1. Bioethics Committee Approval Number: –
  2. NCT Number:
    clinicaltrials.gov
  3. Status:
    study completed

The aim of the study was to compare the bioavailability of vitamin D3 in its traditional and liposomal forms. Vitamin D3 influences the maintenance of calcium-phosphate homeostasis by affecting the intestines, kidneys, and bones. The active form of vitamin D—calcitriol—participates in numerous physiological processes, including supporting the proliferation and differentiation of cells in the immune system, inducing apoptosis in cancer cells, and slowing their proliferation. Hypervitaminosis D can contribute to an increased risk of skeletal fractures, decreased immunity, the onset of autoimmune diseases, hypertension, and diabetes [1]. In Poland, vitamin D deficiency of varying severity has been found in 90% of adults, children, and adolescents [2].

The application of liposome technology results in increased bioavailability compared to traditional forms, leading to higher concentrations of active substances and greater efficacy with the same dosage.

The study included the following groups:

  • receiving vitamin D3 in traditional formulation (powder),
  • receiving vitamin D3 in liposomal formulation (powder).

As part of the study, levels of 25-hydroxycholecalciferol (vitamin D), CRP protein, and albumin were measured. Additionally, the quality of the diet was assessed using a validated FFQ questionnaire.

[1] Pludowski P, Holick MF, Grant WB, Konstantynowicz J, Mascarenhas MR, Haq A, Povoroznyuk V, Balatska N, Barbosa AP, Karonova T, Rudenka E, Misiorowski W, Zakharova I, Rudenka A, Łukaszkiewicz J, Marcinowska-Suchowierska E, Łaszcz N, Abramowicz P, Bhattoa HP, Wimalawansa SJ. Vitamin D supplementation guidelines. J Steroid Biochem Mol Biol. 2018 Jan;175:125-135. doi: 10.1016/j.jsbmb.2017.01.021.

[2] Rusińska A. i wsp. „Zasady suplementacji i leczenia witaminą D –nowelizacja 2018 r.”, Postępy neonatologii 2018; 24(1)

 

Comparison of bioavailability of liposomal and traditional formulation of vitamin C. (Commercial product Lipo4U™ Vit. C)

  1. Bioethics Committee Approval Number: 121/2021
  2. NCT Number: clinicaltrials.gov / NCT05843617
  3. Status: study completed

Due to its strong antioxidant properties, vitamin C reduces DNA damage and protects cells from oxidative stress. It also plays a significant protective role in the context of heart disease and the vascular system [1]. Vitamin C contributes to immune defense, and its deficiency can result in impaired immunity and increased susceptibility to infections [2]. Additionally, vitamin C is involved in the synthesis of collagen, hormones, and neurotransmitters, and it enhances the absorption of iron and calcium [3].

The application of liposome technology results in increased bioavailability compared to traditional forms, leading to higher concentrations of active substances and greater efficacy with the same dosage.

The study included the following groups:

  • receiving vitamin C in traditional form (powder),
  • receiving vitamin C in liposomal form (powder).

As part of the study, serum ascorbic acid levels were measured at specific time intervals. Additionally, body composition analysis and diet quality assessment were conducted using the FFQ questionnaire.

[1] Zhang PY, Xu X, Li XC. Cardiovascular diseases: oxidative damage and antioxidant protection. Eur Rev Med Pharmacol Sci. 2014 Oct;18(20):3091-6.

[2] Carr AC, Maggini S. Vitamin C and Immune Function. Nutrients. 2017 Nov 3;9(11):1211. doi: 10.3390/nu9111211.

[3] Moszczyński P., Pyć R.: Biochemia witamin. Witaminy lipofilne i kwas askorbinowy. Część II. PWN, Warszawa 1999, 112–136.