My lab has patented a technology (Indian patent 336184 granted) for effectively encapsulating Amphotericin B in systematically optimised (using QbD) solid lipid nanoparticles (AmB occurring as discrete monomeric form) with ~1500% increase in bioavailability; 3.2 times higher LD50, no repeat dose toxicity observed in rats (OECD guidelines); 20 times lower MIC against Candida albicans; better (~10 times) uptake into host macrophages and Candida albicans.
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1] Is there any human clinical trial data on its bioavailability level in the blood, half-life, and any significant improvement with its efficacy for this drug?
Response: I have all pre- clinical data on efficacy, safety, stability and in vitro cellular uptake and antifungal efficacy.
2] Wanted to understand and read more about the concept- Is it feasible as an end product for human application, namely the stability of the drug and treatment? If you have any publications on this topic can you please share them?
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3] Is it an oral formulation?
Response: No it is evaluated as an IV injection but we can do studies for oral bioavailability also.
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