<1664.1> ORALLY INHALED AND NASAL DRUG PRODUCTS  

INTRODUCTION

This section addresses specific considerations for leachables in orally inhaled and nasal drug products (OINDP), including metered dose inhalers (MDIs); nasal sprays; inhalation solutions, suspensions, and sprays; and dry powder inhalers (DPIs). Although OINDP can be a combination of products that are comprised of drug and device constituent parts, the primary mode of action is typically through the drug. For this reason OINDP are treated as drugs from a regulatory perspective. Regulatory guidance documents and detailed best practice recommendations specific to OINDP are available (1–5). Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic (i.e., elemental) leachables, see Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems <1664>.