Early drug design, also known as a Proof of Concept formulation, has completed the application of NanoCelle™ technology to develop a nanoparticle Chloroquine (CQ) spray delivered by the oro-buccal membrane.
CQ, a known anti-malaria drug under investigation for the treatment of patients infected with the COVID-19 virus, is registered in the Australia Register of Therapeutic Goods and marketed under the brand name Chlorquin.
Notably, CQ is not approved for COVID-19 use outside investigative trials.
“CQ primed for delivery”
Medlab’s director of medical research Professor Louis Vitetta said: “Presently our findings for applying Medlab’s NanoCelle™ technology to formulate CQ has been initially validated by the University of Sydney’s, NanoScale Unit confirming the submicron particle size and concentration below the medicine in a water-soluble formulation.
“This result makes CQ primed for delivery by the buccal membrane, like other MDC NanoCelle™ products such as NanaBis™.”
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Early studies have reported some positive coronavirus outcome treatments from the use of high oral dosing (500mg tablets once to twice daily for up to 10 consecutive days) that resulted in small levels of the drug detected in plasma.
This became of interest to MDC specifically potentiating the use of the NanoCelle™ delivery platform to provide for a more efficient (and potentially safer) means of delivering CQ.
The Therapeutic Goods Administration (TGA) cites the following contraindications/side effects for CQ4 as it relates to the approved use for the treatment of malaria:
- Retinal damage or impaired visual field; and
- Allergy to chloroquine/hydroxychloroquine.
Adverse effects –
- Skin eruptions/itch;
- GI disturbance;
- May worsen psoriasis; and
- Rare - psychotic episodes, anxiety, personality change, seizures, blood dyscrasias.
As research evolves, the literature (non-peer reviewed) also shows serious contraindication concerns, such as with the concomitant use of Metformin5, a common drug used to manage type 2 diabetes.
Adding to concerns, a recent Brazilian Safety study of 440 COVID-19 patients terminated early due to lethality concerns using doses as high as 600 mg CQ twice per day.
“Lesser side effects”
Vietta continued: “Considering the clinical literature with regards to CQ, our focus is about the efficient and effective delivery of CQ that accesses the bloodstream.
“Hopefully, this would translate to lesser side effects as cited in current literature.
“This is especially important considering literature regarding pharmacokinetic and pharmacodynamic data reports that up to 77% of oral ingested (600 mg tablet) CQ is excreted in urine.”
NanoCelle™ is a patent-protected, proprietary delivery platform used in both nutraceuticals and pharmaceuticals, which allows for the creation of water solubilised nanoparticles of an API for fast and efficient utilisation by the human body and
It is most known for its use in the cancer pain program, NanaBis™.