Case Study Of Nano Precision Medical
The mission of Nano Precision Medical is to improve chronic diseases treatment by providing prolonged medication levels (for up to a year) without the need for continual injections. NanoPortal “it is the only one of its kind made entirely from titanium and titanium-oxide, biocompatible materials extensively used in FDA-approved implants” …show more content…
The short half-life of exenatide requires twice-daily injections. Nonetheless, with the combination of device/drug medication of NanoPortal this drug is delivered at an even rate over an extended period of time, which eliminates concentration variability, minimizes side effects, and maximizes treatment efficacy.
Nano Precision Medical technology allows for “independent tuning of size, duration, delivery rate, and molecule size, enabling optimization of a variety of treatments” . Currently, for the only drug candidate, Exenatide, NanoPortal it is designed to incorporate more than 300 mg of the medication and could last for 3 months to 1 year (it comes in different presentations).
The NanoPortal capsule is in preclinical development and is currently not used in any human studies . There are publications on the diffusion kinetics test in vitro, and in vivo test release where assembled capsules were implanted subcutaneously in rats . Nano Precision Medical is using a 505(b)(2) strategy for FDA approval. Which is a new drug application for “changes in dosage form, strength, formulation, dosing regimen or route of administration” . This approach offers differentiated benefits, reducing time and cost of the approval