STUDIES OF QUALITY OF LIPOSHELL® TECHNOLOGY PRODUCTS

LIPOSHELL® technology products are manufactured in compliance with the highest quality standards, using innovative manufacturing processes which give them globally unique qualities.

Quality of our products is subjected to regular controls both during the manufacturing process and in independent microbiology laboratories.

ASCOLIP® meets both PN-EN 7218:2008/A1:2013-10 standards and the Polish Pharmacopoeia, edition X, as appropriate for oral formulations. Meeting the above requirements ensures proper quality of pharmaceutical raw materials, foodstuffs and medicinal products, which in turn guarantees quality and safety of their use.

THE HIGHEST QUALITY OF LIPOSHELL® LIPOSOMES SUPPORTED BY RESEARCH STUDIES

LIPOSHELL® liposomes are the effect of many years of research by a multidisciplinary team of Polish scientists.

LIPOSHELL® liposomes are characterised by the highest quality, optimum and homogeneous size and high stability, which have been confirmed in studies.

LIPOSHELL® liposomes are characterised by an optimum size

Test by laser dynamic light scattering (DLS) technique.

Liposomes manufactured in the LIPOSHELL® technology are tested with the use of the dynamic light scattering technique on the Malvern ZetaSizer NanoZS device that determines the hydrodynamic diameter of liposomes. Measurements were performed at Lipid Systems Ltd. and confirmed at the Department of Biomedical Engineering, Wrocław University of Science and Technology.

Each manufactured batch of ASCOLIP® is characterised by the size of liposomes whose mean size is 170 nm +/- 15%.

LIPOSHELL® liposomes are homogeneous in size

Test by laser dynamic light scattering (DLS) technique.

In addition to size distribution, testing by the dynamic light scattering (DLS) technique assesses ASCOLIP® also for homogeneity of the liposome population. Correlation function (orange points on the chart) is calculated on the basis of light scattering measurements. The model function is fitted to the measurement points obtained. If the function overlaps well with the measured points, this demonstrates that liposomes are homogeneous and well characterised. The polydispersity index for ASCOLIP® is less than 0.15. The index value ranges from 0 to 1. The higher its value, the less homogeneous are the liposomes.

ASCOLIP® has the most homogeneous liposome population among the tested products available in the market. The studies were performed at Lipid Systems Ltd. and confirmed at the Department of Biomedical Engineering, Wrocław University of Science and Technology.

LIPOSHELL® liposomes are characterised by high quality

Comparative studies conducted in parallel at Lipid Systems and at the Department of Biomedical Engineering, Wrocław University of Science and Technology, in 2017. *Products A, B, C and D are well recognized brands, products B and D are available globally.

Comparative studies on commercial, best-selling products available globally, conducted in parallel at Lipid Systems and at the Department of Biomedical Engineering, Wrocław University of Science and Technology indicate that LIPOSHELL® technology makes it possible to obtain liposomes that are smallest in size and most homogeneous. Competitive products, manufactured by recognised international companies (including companies from USA), have liposomes at least twice their size.

ASCOLIP® provides higher blood levels of vitamin C, maintained longer than with the conventional oral form

Results of a study conducted at the Regional Specialist Hospital, Research and Development Centre in Wrocław. Investigator: Prof. Wojciech Witkiewicz, Ethics Committee approval No.:KB/5/2016.

ASCOLIP® – high-performance, liposomal vitamin C in the patented LIPOSHELL® technology makes it possible to obtain higher absorption of vitamin C and a prolonged half-life in the bloodstream. The study was conducted in healthy volunteers in the Regional Specialist Hospital, Research and Development Centre in Wrocław. Concentrations were analysed by HPLC and UV-VIS detection on the basis of literature methods of proper collection of blood samples for vitamin C analyses. European Journal of Clinical Nutrition (2007) 61, 1233–1236; doi:10.1038/sj.ejcn.1602655; published online 7 February 2007.

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