Nonclinical development program
Liber’s nonclinical development program comprises two phases:
- Characterising the interim product formulations and aerosol of the Nicovape® Q nicotine-containing liquid using chemistry, analytical, and desk-based approaches; and
- Working with the TGA to further assess the chemistry and toxicology of Nicovape® Q in cell-based (in vitro) assays, in vivo studies, or clinical studies, where necessary, for registration of the product as a pharmaceutical on the Australian Register of Therapeutic Goods (ARTG).
Liber’s nonclinical development program ensures that product formulations have been screened for critical human health hazards from inhalation exposure. The nonclinical program underway is designed to assess the toxicology and human health risk of the liquid formulation and the toxicology and human health risk of select constituents in the aerosol the device generates.
Nicovape® Q Liquid Formulation
The Nicovape® Q liquid formulation consists of the active ingredient nicotine in the form of a nicotine salt (with an acid as a pH adjuster), the humectants propylene glycol (PG) and glycerol (VG), and flavouring ingredients, which constitute less than 3% of the formulation by weight.
Liber formulates its Nicovape® Q liquids with nicotine salts that are:
- Sourced from pharmaceutical suppliers meeting GMP standards;
- Documented to meet purity standards for the presence of nicotine degradation compounds; and
- Evaluated for potential toxicological effects at anticipated levels of exposure.
Liber has formulated its Nicovape® Q liquids with PG and VG at ratios anticipated to reduce levels of compounds generated through thermal degradation in the aerosols. Liber has toxicologically evaluated and formulated its Nicovape® Q liquids with PG and VG at levels that would result in aerosol exposures below levels associated with toxicological concern.
All flavouring ingredients in Liber’s formulations are molecularly defined and, where available, sourced as food grade quality or higher (USP/EP).
Liber applies a screening toxicological risk assessment process to evaluate each ingredient for key toxicological hazards potentially associated with inhalation exposure. Liber has formulated ingredients at levels that would result in daily inhalation exposures below those associated with toxicological concern as defined by authoritative and regulatory agencies.
The Nicovape® Q Device and Aerosol
The Nicovape® Q device is designed to deliver nicotine in aerosol while minimising the generation of compounds through thermal degradation or other potentially harmful constituents, such as metals.
Device design considerations include:
- Temperature protection: Microelectronics prevent overheating conditions when generating the aerosol;
- Low power design: Low-power devices produce fewer emissions and are capable of delivering sufficient nicotine with the correct liquid formulation;
- Innovative cartridge: No non-coil metal components in contact with the liquid. A unique coil-liquid separation mechanism prevents metal leaching during shelf storage; and
- High-grade cartridge materials: resins and silicone compliant with U.S. FDA 21 CFR 177.1520 (human food grade).
Preliminary HPHC analysis indicates that HPHCs, such as carbonyls and metals, are in the aerosol at levels below toxicological concern.
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