NanoCelle® D3

Delivery Platform
ANZCTR: ACTRN12616001027404
Date Started: 2013-10-09
Progress - Regulatory Submission - Approved

test

Study Site:

Medlab, Alexandria NSW Australia

Formulation:

NanoCelle® D3 is a sub-micron spray applied to the oro-buccal membrane delivering 5000 I.U. in 2 actuation of the pump. The absorption characteristics of the formulation were compared to 5 other Australian Vitamin D3 formulations in a Phase 0, absorption study.

About Trial:

This study is a Vitamin D3 hormone blood level absorption study, performed in healthy adult volunteers.

Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is obtained from sun exposure, food, and supplements are biologically inert and must undergo two hydroxylations in the body for activation. 

Source: Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Calcium and Vitamin D. 2010.Washington, DC: National Academy Press.

Vitamin D promotes calcium absorption in the gut and maintains adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and to prevent hypocalcemic tetany. It is also needed for bone growth and bone remodelling by osteoblasts and osteoclasts

Source: Cranney C, Horsely T, O’Donnell S, Weiler H, Ooi D, Atkinson S, et al. Effectiveness and safety of vitamin D. Evidence Report/Technology Assessment No. 158 prepared by the University of Ottawa Evidence-based Practice Center under Contract No. 290-02.0021. AHRQ Publication

HREC Date:

2013-10-09

HREC Date:

2013-10-09

HREC ID:

001/072013

PUBLICATIONS OR CONFERENCES ASSOCIATED WITH THE PROGRAM

Scientific Application for Innovative Delivery Systems: Bacteria and Nanotechnology Platforms

The 5th Annual Symposium of Drug Delivery Systems Oct 20-22, 2015. Beijing, China.

Date:          2015-10-20

Authors:   Coulson S

Invitation to Chair session on Nanotechnologies for Drug Delivery Systems: Redefining the Curve - Sustainable Compound Delivery Through Nanoparticles.

BIT’s 14th Annual Congress of IDDST June 16-18, 2016. South Korea

Date:          2016-06-16

Authors:   Hall S