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# CDER Research Helping Generic Inhaler Development
- URL: https://www.fdaweb.com/cder-research-helping-generic-inhaler-development/
- Published: 2022-05-23T12:00:00.000Z
- Updated: 2026-09-14T17:45:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151876

CDER says its researchers are helping to develop more realistic laboratory models of the mouth-throat region that allow the generic drug industry to efficiently test their metered-dose inhaler (MDI) products and speed access to generic products. A Center *Impact Story* [says](https://www.fda.gov/drugs/regulatory-science-action/effects-realistic-in-vitro-test-factors-aerosol-properties-metered-dose-inhalers?ref=fdaweb.com) experiments in a recent study measured the effect of *in vitro* test variables on the particle size distribution of aerosols exiting an anatomical mouth-throat model and may improve the predictability of *in vivo* lung disposition that could accelerate the development of generic as well as branded drug inhalers.

Five factors were examined in the study, the post says, including different geometry and sized mouth-throat models; inhalation profiles representing strong, medium, and weak inhalation; two commonly used mouth-throat model coatings; MDI insertion angles; and two MDI firing points after the start of inhalation profiles.

The researchers concluded that during the development of inhalers, applicants who use more realistic *in vitro* studies should consider how the experimental conditions, particularly the mouth-throat model type and inhalation profiles, affect the amount and particle size distribution of aerosols exiting an anatomical mouth-throat model when designing their studies.