Publications, Pharmaceutical

Developing in vitro dissolution tests for orally inhaled drug products

The fate of inhaled drug substances, in vivo, is not well-understood but is believed to be dependent, to some extent, on dissolution characteristics.

This paper presents work to develop an in vitro apparatus and standardized methodology for quantifying the dissolution behavior of orally inhaled drug products. The developed solution incorporates an aerosol dose collection apparatus that collects the dose over a large area, and a modified USP Apparatus V Paddle Over Disc for dissolution testing. The discriminating ability of this solution was demonstrated via testing with a range of commercially available orally inhaled drug products (MDIs and DPIs). Good correlation was observed between in vivo mean absorption time and in vitro dissolution half-life. It is concluded that the developed solution has potential for compendial and QC testing and in the development of both branded and generic orally inhaled drug products.

Download Publication
10 Jun 2020

Learn more about Aptar Pharma Expertise
in Pulmonary Drug Delivery

Find Out More

This Might Also Be of Interest

3 Jul 2023

Leachables Assessment: New pMDI with Low-GWP Propellants

Publications, Pharmaceutical, Sustainability, Device Innovations, Brand Differentiation, Market Insights, Product Solutions

Read More
3 Jul 2023

Performance of Low-GWP Propellants in pMDIs: Filling and Dose Evaluation

Publications, Pharmaceutical, Product Solutions, Sustainability, Device Innovations, Market Insights

Read More
3 Jul 2023

Orally Inhaled Drug products; Bioequivalence Models

Publications, Pharmaceutical, Market Insights, Product Solutions, Device Innovations, Brand Differentiation

Read More
10 May 2023

Navigating the Development for Orally Inhaled and Nasal Drug Products

Publications, Pharmaceutical, Device Innovations, Market Insights, Product Solutions

Read More
1 2 3 17
Back To Top