Scientific and regulatory activities initiated by the US food and drug administration to foster approvals of generic dry powder inhalers: bioequivalence perspective

B Newman, A Babiskin, E Bielski, S Boc… - Advanced Drug Delivery …, 2022 - Elsevier
Regulatory science for generic dry powder inhalers (DPIs) in the United States (US) has
evolved over the last decade. In 2013, the US Food and Drug Administration (FDA) …

Scientific and regulatory activities initiated by the US Food and Drug Administration to foster approvals of generic dry powder inhalers: quality perspective

N El-Gendy, CM Bertha, M Abd El-Shafy… - Advanced Drug Delivery …, 2022 - Elsevier
Regulatory science for generic dry powder inhalation products worldwide has evolved over
the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder …

[HTML][HTML] Advancements in the design and development of dry powder inhalers and potential implications for generic development

AR Mohan, Q Wang, S Dhapare, E Bielski, A Kaviratna… - Pharmaceutics, 2022 - mdpi.com
Dry powder inhalers (DPIs) are drug–device combination products where the complexity of
the formulation, its interaction with the device, and input from users play important roles in …

Bioequivalence evaluations of generic dry powder inhaler drug products: similarities and differences between Japan, USA, and the European Union

R Kuribayashi, T Yamaguchi, H Sako, T Takishita… - Clinical …, 2017 - Springer
In Japan, the development of generic oral dry powder inhaler (DPI) drug products for
marketing approval has recently increased. The Pharmaceuticals and Medical Devices …

In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases

SL Lee, WP Adams, BV Li, DP Conner, BA Chowdhury… - The AAPS journal, 2009 - Springer
Dry powder inhalers (DPIs) are used to deliver locally acting drugs (eg, bronchodilators and
corticosteroids) for treatment of lung diseases such as asthma and chronic obstructive …

[HTML][HTML] Inhalation dosage forms: a focus on dry powder inhalers and their advancements

S Magramane, K Vlahović, P Gordon, N Kállai-Szabó… - Pharmaceuticals, 2023 - mdpi.com
In this review, an extensive analysis of dry powder inhalers (DPIs) is offered, focusing on
their characteristics, formulation, stability, and manufacturing. The advantages of pulmonary …

[HTML][HTML] Dry powder inhalers in the digitalization era: current status and future perspectives

S Xiroudaki, A Schoubben, S Giovagnoli, DM Rekkas - Pharmaceutics, 2021 - mdpi.com
During the last decades, the term “drug delivery systems”(DDSs) has almost fully replaced
previously used terms, such as “dosage forms”, in an attempt to emphasize the importance …

Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two …

PT Daley-Yates, DA Parkins, MJ Thomas, B Gillett… - Clinical …, 2009 - Elsevier
Background: The use of dry-powder inhalers (DPIs) to administer respiratory medicines is
increasing, and new DPIs are likely to be developed because of expiring patents. However …

Improvements in and relating to carrier particles for use in dry powder inhalers

JN Staniforth - 1995 - Google Patents
First worldwide family litigation filed litigation Critical https://patents. darts-ip. com/? family=
10768844&utm_source= google_patent&utm_medium= platform_link&utm_campaign …

Recent developments in dry powder inhalation (DPI) formulations for lung-targeted drug delivery

MS Yang, JH Kang, DW Kim, CW Park - Journal of Pharmaceutical …, 2024 - Springer
Background Dry powder inhalation (DPI) formulations have been widely studied for the
treatment of respiratory diseases, including COVID-19, which have become common and …