Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations DOI
Gur Jai Pal Singh,

S. Prasad Peri

Journal of Aerosol Medicine and Pulmonary Drug Delivery, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 9, 2024

Approved drug products may be subject to change(s) for a variety of reasons. The changes include, but are not limited to, increase in batch size, alteration the product constituent(s), improvement manufacturing process, and shift sites. extent pharmaceutical testing regulatory pathway timely implementation any change approved and/or process depends upon nature change. U.S. Food Drug Administration (FDA) has published guidelines that outline its expectations Scale-Up Postapproval Changes (SUPAC) solid oral immediate modified release (MR) products, semisolid formulations. However, date, no such have been issued address SUPAC orally inhaled (OIDPs), this article represents seminal contribution direction. It is hoped it will inspire contributions from relevant multidisciplinary experts industry agency accomplishing formal OIDP SUPAC. OIDPs complex drug-device combination products. Therefore, conceptualization these warrants consideration effect individual components (drug substance, formulation, device) as well compound single or multiple on performance, safety efficacy. This provides discussion scientific aspects bases development OIDPs, attempts considerations applicable addressing issues related context human drugs. authors' statements should viewed recommendations agency, would determined case-by-case evaluation by authorities.

Language: Английский

Pulmonary inhalation for disease treatment: Basic research and clinical translations DOI Creative Commons
Bin Wang, Lin Wang,

Qian Yang

et al.

Materials Today Bio, Journal Year: 2024, Volume and Issue: 25, P. 100966 - 100966

Published: Jan. 22, 2024

Pulmonary drug delivery has the advantages of being rapid, efficient, and well-targeted, with few systemic side effects. In addition, it is non-invasive good patient compliance, making a highly promising mode. However, there have been limited studies on via pulmonary inhalation compared oral intravenous modes. This paper summarizes basic research clinical translation for treatment diseases provides insights into latest advances in delivery. The discusses processing methods delivery, carriers (with focus various types nanoparticles), devices, applications (e.g., COVID-19, inhaled vaccines, diagnosis diseases, diabetes mellitus) an updated summary recent advances. Furthermore, this describes progress lung expands use drugs other diseases.

Language: Английский

Citations

21

Bacteria-based drug delivery for treating non-oncological diseases DOI
Zhenping Cao, Yan Pang,

Jun Pu

et al.

Journal of Controlled Release, Journal Year: 2024, Volume and Issue: 366, P. 668 - 683

Published: Jan. 18, 2024

Language: Английский

Citations

9

Excipient-free inhalable combination shell-core microparticles with clofazimine shell for extended pulmonary retention of isoniazid in core DOI
Kolimi Prashanth Reddy,

Lakshmi Tulasi Naraharisetti,

Vani Sai Prasanna

et al.

International Journal of Pharmaceutics, Journal Year: 2025, Volume and Issue: 672, P. 125310 - 125310

Published: Feb. 8, 2025

Language: Английский

Citations

1

Supercritical Fluids: An Innovative Strategy for Drug Development DOI Creative Commons
Hui Liu,

Xiaoliu Liang,

Yisheng Peng

et al.

Bioengineering, Journal Year: 2024, Volume and Issue: 11(8), P. 788 - 788

Published: Aug. 4, 2024

Nanotechnology plays a pivotal role in the biomedical field, especially synthesis and regulation of drug particle size. Reducing particles to micron or nanometer scale can enhance bioavailability. Supercritical fluid technology, as green development strategy, is expected resolve challenges thermal degradation, uneven size, organic solvent residue faced by traditional methods such milling crystallization. This paper provides an insight into application super-stable homogeneous intermix formulating technology (SHIFT) super-table pure-nanomedicine formulation (SPFT) developed based on supercritical fluids for dispersion micronization. These technologies significantly solubility permeability hydrophobic drugs controlling size morphology, modified show excellent therapeutic efficacy treatment hepatocellular carcinoma, pathological scarring, corneal neovascularization, their performance are highlighted when administered through multiple routes administration. Overall, have opened efficient pathway clinical development, which reduce side effects efficacy.

Language: Английский

Citations

6

Biocompatible biodegradable polymeric nanocarriers in dry powder inhalers (DPIs) for pulmonary inhalation delivery DOI
David Encinas-Basurto, Basanth Babu Eedara, Heidi M. Mansour

et al.

Journal of Pharmaceutical Investigation, Journal Year: 2024, Volume and Issue: 54(2), P. 145 - 160

Published: Feb. 8, 2024

Language: Английский

Citations

5

Dry powder inhaler design and particle technology in enhancing Pulmonary drug deposition: challenges and future strategies DOI
Nazrul Islam, Tan Suwandecha, Teerapol Srichana

et al.

DARU Journal of Pharmaceutical Sciences, Journal Year: 2024, Volume and Issue: unknown

Published: June 11, 2024

Language: Английский

Citations

5

Clinical application of nano-silver spray in patients with bacterial respiratory tract infections under CT examination DOI
Jingwen Wu, Jianwu Wu

Journal of Radiation Research and Applied Sciences, Journal Year: 2025, Volume and Issue: 18(1), P. 101284 - 101284

Published: Jan. 13, 2025

Language: Английский

Citations

0

Numerical analysis of collision mechanism that causes particle tribocharging in dry powder inhaler DOI Creative Commons
Ryosuke Mitani,

Muhammad Aiman bin Mohd Nor,

Takeshi Iinuma

et al.

Asian Journal of Atmospheric Environment, Journal Year: 2025, Volume and Issue: 19(1)

Published: Jan. 22, 2025

Abstract Chronic obstructive pulmonary disease (COPD) is induced by inhalation of toxic substances such as cigarettes and air pollution. Dry powder inhalers (DPIs) are the primary treatment for these diseases. However, they have some problems, residuals in a capsule caused electrostatic force before reaching human lungs. This study investigated particle tribocharging mechanism DPI using tandem differential mobility analyzer (TDMA) combined discrete element method computational fluid dynamics (DEM-CFD) approach. In TDMA experiment, charging state particles changed from negative to positive charge device fabricated 3D printer. because particle–particle collisions particle–wall collisions. numerical simulation, occurred more frequently than Therefore, change device. These results suggest that between walls cause become charged, leading decrease their deposition deeper regions Moreover, large turbulence kinetic energy airflow were widely dispersed optimum necessary reduce aggregation improve delivery efficiency DPIs Graphical

Language: Английский

Citations

0

Inhaled Dry Powder of Antiviral Agents: A Promising Approach to Treating Respiratory Viral Pathogens DOI Creative Commons
Tushar Saha,

Zia Uddin Masum,

Anik Naha Biswas

et al.

Viruses, Journal Year: 2025, Volume and Issue: 17(2), P. 252 - 252

Published: Feb. 12, 2025

Inhaled dry powder formulations of antiviral agents represent a novel and potentially transformative approach to managing respiratory viral infections. Traditional therapies in the form tablets or capsules often face limitations terms therapeutic activity, systemic side effects, delayed onset action. Dry inhalers (DPIs) provide targeted delivery system, ensuring direct administration antivirals infection site, tract, which enhance efficacy minimize exposure. This review explores current state inhaled agents, their advantages over traditional routes, specific under development. We discuss benefits delivery, such as improved drug deposition lungs reduced alongside considerations related formulation preparation. In addition, we summarize developed (published marketed) powders agents.

Language: Английский

Citations

0

A Technological Update on Inhalation Drug Delivery Devices DOI
Ankaj Kumar,

Ishwar Chandra,

V. Rajesh

et al.

Published: Jan. 1, 2025

Language: Английский

Citations

0