Product Concept
NanoMedex Pharmaceuticals, Inc. Product Technology
NanoMedex has developed technology that enables the direct dispersion or emulsification of oils or water-insoluble liquids in aqueous media.
NanoMedex(NMDX) accomplishes this through the use of both a nonionic surfactant and an ionic surfactant to stabilize the nanoparticles of the active oil/liquid as they are formed by dispersing in water under shear. Current technologies for making macro-dispersions of active pharmaceuticals involve using an inert carrier such as soybean oil to form the dispersion.
Microfol™:
Propofol is both fast acting and has a rapid recovery or re-awakening time following administration. Propofol is used to both induce anesthesia in patients and to maintain a state of anesthesia when used in combination with other drugs. It is also becoming increasingly popular in emergency room sedations, intensive care sedations, and in diagnostic imaging procedures requiring sedation. Problems with Diprivan® include severe discomfort and pain at the site of intravenous injection, a propensity for rapid bacterial growth because of the presence of the soy bean oil carrier, the inability to use propofol with patients who are allergic to egg products or choose not to consume egg products for various reasons, and problems with continued use in patients requiring sedation. NMDX’s nano-dispersion of propofol is predicted to be devoid of these problems and to have a lower cost of materials used in its manufacture.
The components of the Reference Listed Drug(RLD) Diprivan® (AstraZeneca and Abraxis BioSciences) and the available generics macroemulsions are compared in the table below to NanoMedex’s microemulsion.
| Propofol Formulation Components (Macroemulsion vs. Microemulsion) | |||||
|---|---|---|---|---|---|
| Diprivan |
Bedford | Teva | Hospira | NanoMedex | |
| Propofol | 1% | 1% | 1% | 1% | 1% |
| Soybean Oil | Yes | Yes | Yes | Yes | None |
| Glycerol | Yes | Yes | Yes | Yes | None |
| Anti-microbial | EDTA | Benzyl alcohol | Metabisulfite | Benzyl alcohol | None |
| Egg lecithin | Yes | Yes | Yes | Yes | None |
The product profiles of these propofol formulations differ similarly and substantially from NMDX’s microemulsion Microfol™. The differences can be attributed to the commonality of properties shared by propofol formulations made by formulating a macroemulsion versus NMDX’s microemulsion approach. The properties of propofol macroemulsions and microemulsions are show in the following table.
| Property Comparison Macroemulsions vs. Microemulsion | ||
|---|---|---|
| Property | Macroemulsion Diprivan® Generics |
Microemulsion NanoMedex Microfol™ |
| Bacterial Growth | Supported | Not supported |
| Antimicrobial | Added excipient, which has some biological activity | Not needed |
| Appearance | Opaque and milky | Clear and colorless |
| Stability | 2 years | 4 years |
| Price | More expensive excipients | Less expensive excipients |
| Lipid load | High (pancreatic effects) | None |
| Vegetarian Patients | Animal products present | No animal products use |
| Sepsis Cascade | Precursors present | No precursors present |
| Intellectual Property | Generic available | Protected until 2023 |
