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Liposomal drug delivery for ivermectin and vaccines
Interview and article by Christine Clark.
Liposomal drug delivery holds out the prospect of oral drug administration without the need for water and more economical use of oral vaccines, according to Dennis Hancock, President and CEO of Mountain Valley MD.
IvectosolTM, the solubilised form of ivermectin produced by Mountain Valley MD has been tested against three variants of SARS-CoV2 and has proved effective at interfering with viral replication and driving viral clearance in each case. The study was conducted in a biosafety level 4 (BSL-4) laboratory.
“What’s really exciting – in a mouse model we tested [the drug] against the original variant and were able to prove the effectiveness of Ivectosol in completely clearing and preventing covid-19. Further in vitro studies then established the drug’s efficacy against the original variant, the South African variant, and the Brazil variant. This laid the foundations for the next steps which will be human trials and then full scale production inside both Bangladesh and on the continent of Africa.
Liposomal drug delivery
Mountain Valley MD has developed two types of liposomal delivery system. One is a solubilised form that relies on the company’s patented QuicksolTM technology. This is used in the injectable form. The other is a desiccated liposome technology – QuicksomeTM that is used in a sublingual dosage form.
Mr Hancock explains that many of the drug molecules that they use are heat-sensitive and so a low-temperature process was required to encapsulate the drugs into liposomes. The desiccated liposomes are completely dry and are used to make the sublingual dosage form which is presented as a soluble oral film. The company has also made a rapid-dissolve wafer and thin, ‘sugar-sip’ presentations that are poured under the tongue. “So depending on load we would take the molecule, protect it in a liposome format and then as it hydrates the liposome simply adheres to the skin cells and transfers the contents into the body across the mucosa”, explains Mr Hancock. “So our oral rapid-dissolve format is in a packed powder format – it’s a tablet you can hold with your hand but it requires no water [for administration] you let it dissolve. And so – the saliva actually rehydrates the molecules in the liposome format”, he adds.
This technology could offer important benefits for third world countries where it is difficult to maintain a cold chain during transport. Moreover, a product that can be administered sublingually, without the need for water, and uses one fifth of the active pharmaceutical ingredient (API) has a double benefit, says Mr Hancock.
Liposomal vaccine delivery
Mountain Valley MD has also explored the use of its liposome technology for vaccine delivery. This arose from the personal interest of one of the principal scientists whose father had suffered from polio. “He started – almost on a personal mission – doing some very advanced work suspending the polio vaccine inside our liposome format and then testing its ability to be preserved in that format. So, we could imagine sublingual vaccines, needle-free vaccines and then also distribution outside of cold chain. So we’ve done some really amazing work with Dr Chumakov at the FDA Polio laboratory and his team”, explains Mr Hancock.
The company has also undertaken advanced cold chain testing to find out whether the vaccine could be packed in vials, transported without refrigeration and then rehydrated locally. “What’s amazing when you learn about third world electricity infrastructure [is that] 90% of third world countries don’t have the electricity infrastructure needed. The resulting problem is we see over $17 billion spent in cold chain logistics which is keeping vaccines between 2.0 and 8:0 degrees Celsius. Then you have the problem of wastage as things come outside of that cold chain infrastructure. People would be shocked to learn over $35 billion a year worth of vaccines are spoiled and literally disposed of – which is almost half that [which is] even produced”, he says. Reducing the logistics costs and ensuring that more of the vaccines reach the intended users is very much in keeping with the Mountain Valley MD business model. “You know that’s a $50 billion problem that could be poured into schools and infrastructure and business and true drivers of economy …… so we’re really excited about the work and what this breakthrough will inform, which could transform how a lot of that vaccine work is done in the future”, he concludes.
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