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White Papers / Tech Papers

In Vivo Testing of Nasal Dosage Forms

Released By Upperton

Interest in developing nasal dosage forms has increased significantly in the last two years, driven by a number of recent successful FDA approvals such as BAQSIMI® (dry-powder glucagon) NEFFY® (liquid epinephrine spray) and NARCAN® (liquid naloxone spray). 

In all of these cases, drugs that have previously been administered via the subcutaneous route have been re-developed as nasal dosage forms that offer a more patient-friendly and needle-free administration option.

These ground-breaking dosage forms have increased interest in nasal dosage forms as a potential route of administration of new and existing drugs that require:

  • Rapid, systemic uptake (e.g. pain management and emergency recovery drugs)
  • Local delivery of vaccines (mucosal immunity)
  • Delivery to the brain via the direct nose-to-brain delivery (avoiding blood-brain barrier)

However, developing a nasal dosage form that is capable of delivering the correct dose of drug (either as a liquid or a powder) is only part of the challenge. Further in vivo testing in animals is required and these tests include:

  • Pharmacological testing: can the drug being administered reach its target and subsequently provide an efficacious dose via the nasal route? 
  • Safety testing: can the drug be administered via the nasal route without any harmful toxicological effects?

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