Lipid Nano Particles, (LNPs), are being used and investigated for a wide variety of medical treatments. Vaccines, gene therapy, and anti-cancer drugs are among the candidates for this delivery method. They can also be used to deliver large molecule payloads such as mRNA. LNPs as carriers avoid issues of toxicity, solubility, allergic and immunogenic reactions. LNPs can also stabilize chemically labile formulations. To date there has not been an effective way to assess the dissolution of drug from LNPs. Traditional dissolution apparatus assumes the dose is free to dissolve in the test medium, but with LNPs the active ingredient is sequestered in a lipid bubble. On analysis the lipid and active ingredient are analyzed together.
Logan Instrument Corporation has developed a method to separate the lipid from the active using a novel apparatus that can be utilized within a USP Apparatus 3 reciprocating rack system.
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