JULY 2022
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JULY 2022
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 Considerations for developing dry powder inhalation (DPI) products
 The majority of commercialized dry powder inhalation (DPI) products available today are multi-dose (mDPI) devices used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). However, the DPI pipeline has grown to include indications such as idiopathic pulmonary fibrosis (IPF), pulmonary arterial hypertension (PAH), rare lung disorders, infectious diseases and neurological conditions. Capsule-based DPIs can offer an alternative approach for treatment of these diseases and there are several reasons to consider pursuing them in development programs. Capsule-based DPIs may accommodate higher doses of medication than multi-dose devices, especially if the inhaled powder is produced by spray drying and, therefore, may provide significantly more active pharmaceutical ingredient (API) than blended, lactose-carrier DPIs. Development of capsule-based DPIs may reduce clinical and regulatory complexities that can be associated with mDPIs. For instance, during dose-ranging studies, capsules offer flexibility, as different doses can be evaluated by altering fill weights or by taking multiple capsules. From a regulatory standpoint, using an off-the-shelf, pre-approved device may reduce risk. Further considerations include manufacturing cost efficiencies, as capsule filling may be more economical than blister filling. In summary, pursuing a capsule-based development approach may decrease regulatory and clinical complexities and reduce development timelines. Catalent Inhalation US: +1 888 SOLUTION (765-8846) solutions@catalent.com catalent.com/inhalation |
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 In silico studies of spray droplet transport and deposition in nasal airway models using computational fluid dynamics (CFD) simulations can provide detailed, and sometimes enhanced, information on device performance and nasal deposition. Additionally, CFD simulations validated with in vitro experimental measurements can be used as a research tool to analyze the effect of product and usage variability while limiting time and cost associated with extensive in vitro testing and/or in vivo human subject testing. This article illustrates some recommended modeling practices that could be followed in setting up and running CFD simulations of nasal spray transport and deposition in the nasal airways. In addition, two case studies illustrate how CFD simulations can potentially be applied, including use of CFD for spray metric sensitivity analysis/bioequivalence evaluation and use of CFD for improving nasal spray designs and optimizing drug delivery.
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 A dry powder inhalation (DPI) formulation, which contains active pharmaceutical ingredient(s) (APIs) micronized to inhalable particle size and a few excipients may, at first glance, appear simple. However, a large number of factors are critical to the performance of these formulations. Furthermore, many of these factors interact in complex ways. Dry powder formulation development is therefore a complex and challenging task, typically involving a range of experimental design campaigns. The articles in this two-part series will focus on adhesive mixtures for inhalation. The first article, discusses considerations relating to the four parts that together define a dry powder formulation: the active pharmaceutical ingredient (API), excipient(s), composition and processing. The author's vision is that in-depth knowledge of these four parts and the ways they interact can lead to improved formulation development in the future.
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