The formulation and how it is swallowed can change exposure even when the nominal dose is unchanged.
Twelve healthy volunteers received printed orodispersible midazolam films, oral solution and intravenous comparators. Immediately swallowed films produced exposure close to oral solution at the examined doses. Holding the film in the mouth for two minutes before swallowing increased absolute bioavailability.
The small healthy-adult experiment does not establish equivalent results in children or older patients. Bioequivalence conclusions differed by endpoint: overall exposure and peak concentration were not interchangeable. The work did not validate a concentration threshold for impairment.
For an exposure reconstruction, record whether a film was swallowed promptly or retained against the oral mucosa. Product strength alone may not explain systemic delivery. Separate nominal dose, route behavior, absorption and observed effect rather than assuming every oral formulation behaves like a swallowed solution.
Source reviewed: Oral bioavailability of microdoses and therapeutic doses of midazolam as a 2 dimensionally printed o (PMC9649511). Forensic applications above are interpretive analysis of the supplied publication.
Related reading: Laser Versus Laser Plus Clonazepam: Reading the Burning-Mouth Comparison.