| Literature DB >> 35202067 |
Amy E Barton1, Gerrit Borchard2, Matthias G Wacker3, Giorgia Pastorin3, Imran Y Saleem4, Shaqil Chaudary4, Tamer Elbayoumi5, Zhigang Zhao6,7, Beat Flühmann1.
Abstract
The emerging landscape of nanomedicine includes a wide variety of active pharmaceutical ingredients and drug formulations. Their design provides nanomedicines with unique features leading to improved pharmacokinetics and pharmacodynamics. They are manufactured using conventional or biotechnological manufacturing processes. Their physical characteristics are vastly different from traditional small-molecule drugs. Pharmacists are important members of the multi-disciplinary team of scientists involved in their development and clinical application. Consequently, their training should lead to an understanding of the complexities associated with the production and evaluation of nanomedicines. Therefore, student pharmacists, post-doctoral researchers, and trainees should be given more exposure to this rapidly evolving class of therapeutics. This commentary will provide an overview of nanomedicine education within the selection of pharmacy programs globally, discuss the current regulatory challenges, and describe different approaches to incorporate nanomedicine science in pharmacy programs around the world.Entities:
Keywords: liposomes; nanomedicine; nanoparticles; pharmacist; pharmacy
Year: 2022 PMID: 35202067 PMCID: PMC8878512 DOI: 10.3390/pharmacy10010017
Source DB: PubMed Journal: Pharmacy (Basel) ISSN: 2226-4787
Figure 1Human drug product submissions to the FDA containing nanomaterials, 1970–2019, Adapted from [2]. ANDA, abbreviated new drug application; NDA, new drug application; IND, investigational new drug application.
Figure 2Common classes of nanomedicines [1].
Factors crucial to the risk-based evaluation of drug products containing nanomaterials, adapted from [6,16].
| Adequacy of Characterization of the Material Structure and Its Function |
|---|
| Complexity of the material structure |
| Understanding the mechanism by which the physicochemical properties of the material impact its biological effects (e.g., effect of particle size on pharmacokinetic parameters) |
| Understanding the in vivo release mechanism based on the material physicochemical properties |
| Predictability of in vivo release based on established in vitro release methods |
| Physical and chemical stability |
| Maturity of the nanotechnology (including manufacturing and analytical methods) |
| Potential impact of manufacturing changes, including in-process controls and the robustness of the control strategy on critical quality attributes * of the drug product |
| Physical state of the material upon administration |
| Route of administration |
| Dissolution, bioavailability, distribution, biodegradation, accumulation, and their predictability based on physicochemical parameters and animal studies |
* Critical quality attributes have not been fully defined for all drug products containing nanomaterials.