Exploiting Pharma 4.0 Technologies in the Non-Biological Complex Drugs Manufacturing: Innovations and Implications
Abstract
:1. Introduction
2. Emerging Tools of Pharma 4.0
2.1. Additive Manufacturing: Three-Dimensional (3D) Printing
Advancements in the Pharmaceutical Industry Offered by 3D Printing Technology
2.2. In Silico Modeling
2.3. Machine Learning (ML)
2.4. Digital Twins
3. Non-Biological Complex Drugs (NBCDs)
3.1. Polymeric Micelles
3.2. Liposomes
3.2.1. Niosomes
3.2.2. Transfersomes
3.3. Glatiramoid/Glatiramer Acetate (GA)
3.4. Iron Carbohydrate Complexes Drugs
3.5. Nanocrystals
4. Applying Pharma 4.0 Tools in the Production of Non-Biological Complex Drugs
4.1. Additive Manufacturing: 3D Printing
4.1.1. Polymeric Micelles
4.1.2. Liposomes/Niosomes
4.1.3. Nanocrystals
4.2. In Silico Modeling
4.2.1. Polymeric Micelles
4.2.2. Liposomes/Transfersomes
4.2.3. Nanocrystals
4.3. Machine Learning
4.3.1. Polymeric Micelles
4.3.2. Liposomes/Niosomes
4.3.3. Nanocrystals
4.4. Digital Twins
5. Regulatory Issues
6. Future Prospects
7. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
ANN | Artificial neural network |
AI | Artificial intelligence |
API | Active pharmaceutical ingredient |
ASP | Antisolvent precipitation |
BWM | Ball wet milling |
CESS® | Controlled expansion of supercritical solution |
CMAs | Critical material attributes |
CNS | Central nervous system |
CPPs | Critical process parameters |
CQAs | Critical quality attributes |
3D | Three-dimensional |
Dexi | Dexibuprofen |
DMT | Disease-modifying treatment |
DRZ | Dorzolamide hydrochloride |
EAE | Experimental autoimmune encephalomyelitis |
EUD | Eudragit |
FD | Freeze-dried |
FDA | Food and Drug Administration |
GA | Glatiramer acetate |
GI | Gastrointestinal |
hERG | Human ether-a-go-go-related gene |
HME | Hot-melt extrusion |
HPH | High-pressure homogenization |
HPMC | Hydroxypropyl methylcellulose |
IOP | Intraocular pressure |
ISGS | In situ gelling system |
MD | Molecular dynamics |
MIMO | Multiple-input–multiple-output |
MISO | Multiple-input–single-output |
MF | Microfluidic technology |
ML | Machine learning |
MRE | Mean relative error |
MS | Multiple sclerosis |
NanoPRX | Nanoformed piroxicam |
NN | Neural network |
NAP | Naproxen |
NBCD | Non-biological complex drug |
PEO-PPO-PEO | Poly(ethylene oxide)-Poly(propylene oxide)-Poly(ethylene oxide) |
PAL | Palmatine HCL |
PAT | Process analytical technology |
PDI | Polydispersity index |
PVP | Polyvinyl pyrrolidone |
QbD | Quality by design |
RTD | Room temperature-dried |
SDS | Sodium dodecyl sulfate |
SVM | Support vector machines |
SSE | Semi-solid extrusion |
TEER | Transepithelial electrical resistance |
TIM | Timolol maleate |
TNF-α | Tumor necroses factor-α |
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Malheiro, V.; Duarte, J.; Veiga, F.; Mascarenhas-Melo, F. Exploiting Pharma 4.0 Technologies in the Non-Biological Complex Drugs Manufacturing: Innovations and Implications. Pharmaceutics 2023, 15, 2545. https://doi.org/10.3390/pharmaceutics15112545
Malheiro V, Duarte J, Veiga F, Mascarenhas-Melo F. Exploiting Pharma 4.0 Technologies in the Non-Biological Complex Drugs Manufacturing: Innovations and Implications. Pharmaceutics. 2023; 15(11):2545. https://doi.org/10.3390/pharmaceutics15112545
Chicago/Turabian StyleMalheiro, Vera, Joana Duarte, Francisco Veiga, and Filipa Mascarenhas-Melo. 2023. "Exploiting Pharma 4.0 Technologies in the Non-Biological Complex Drugs Manufacturing: Innovations and Implications" Pharmaceutics 15, no. 11: 2545. https://doi.org/10.3390/pharmaceutics15112545