Drug Nanocrystals

    Lipid Nanoparticles




    Intellectual Property

PharmaSol's SBA

Application areas:
Particulate adjuvant that can be added to vaccines to increase the immune response. The stable, biocompatible adjuvant (SBA) consists of a lipid particle suspension. Special features are that the particle suspension can be sterilised (e.g. autoclaving or sterile filtration) and it possesses long-term physical stability of up to 3 years when formulated as an aqueous suspension.

Technology description:

The lipid particle suspensions are produced in an identical way to the pharmaceutical NLC dispersions i.e. by high pressure homogenisation of melted lipids dispersed in hot surfactant solution. The particles can be made of only solid lipids or a blend of a solid lipid with a liquid lipid. Typical particle sizes are between 100 nm and 200 nm. Autoclaving is possible, the particles melt during the sterilisation but recrystallise again during the cooling process.
To achieve an adjuvant effect, the particle suspension can be added to the vaccine prior to lyophilisation or alternatively, the particle suspension can be admixed to the reconstituted vaccine.

Advantages over competing technologies:

Compared to aluminum oxide (alumen) particles, lipid nanoparticles possess a higher tissue tolerability at similar efficiency.
Products similar to the solid lipid particle suspensions (SBA) are o/w emulsions based on compounds, such as squalen and squalan. It is believed that a prolonged residence time of particles at the injection site is often beneficial to the immune response. The degradation velocity of solid lipid particles is slower than liquid oil droplets. In addition, the suspensions represent a physically stable system (especially when compared to highly unstable emulsion systems, such as Freund's adjuvant).

Large scale production/costs:

The particle suspensions are produced in an identical way to the pharmaceutical NLC i.e. by high pressure homogenisation and thus the production process itself is cost-effective. The excipients used need to be of parenteral quality e.g. parenterally accepted stabilisers such as Tween 80, lecithin or Span 85 and Poloxamer 188. The lipids used need to be composed of physiological fatty acids.

IP position:

For an overview of patents and patent applications please click "Intellectual property".

Further Information regarding this topic can be obtained by reading:

Olbrich, C., Müller, R. H., Tabatt, K., Kayser, O., Schulze, C., Schade, R., Stable biocompatible adjuvants - a new type of adjuvant based on solid lipid nanoparticles: A Study on cytotoxicity, compatibility and efficacy in chicken, Atla 30, 443.458, 2002

Olbrich, C., Kayser, O., Müller, R. H., Stability and biocompatibility optimized vaccine adjuvant (SBA) - based on solid lipid nanoparticles (SLN), Intern. Symp. Control. Rel. Bioact. Mater. 28, 1063-1064, 2001

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