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PharmTech.com Trends in Formulatio eBook September 2024 Pharmaceutical Technology ® 33 INHAL ATION Delivery device selection When formulating an inhaled drug, the device used to deliver the medicine to the lungs is very import- ant, according to Gupta. Because these dr ugs are drug/device combination products, the drug is not usef ul without the correct device. "If you're look- ing for a generic device to use, which is already out there on the market with your formulation or drug product, you have to make sure that it is compati- ble with the excipients that you that you are using," Gupta said. "[Once you put the drug in] the inhaler/ nebulizer device, [and] either you star t seeing de- vice or dosage form degradation, or the device does not per for m wel l w it h t he dosage for m, t hen we [have] to go back to the drawing board and think about other excipients which have been shown to be compatible with that particular device, and redo the formulation." "As t he i n ha ler is t he engi ne used to d isperse t he med ici ne for onwa rd del iver y to t he lu ngs, t he for mu lat ion needs to be developed i n close i nteg rat ion w it h t he t a rget dev ice," says Cost a. "In t he context of DPI, each specif ic in ha ler has a unique dispersion performance and resistance depending on the target patient population. The for mu lat ion composit ion need s to accou nt for these specif icities so as to ensure a robust f ina l deliver y performance, dose by dose throughout the medication use." Excipient choice for inhaled drugs is dependent on the type of device that will be used to deliver the drug, according to Brennan. "The deliver y device also has evolved to be more patient centric," says Brennan. "In the case of DPI, the patient's breath controls the actuation where in a metered dose in- haler, a synchronization of the actuating and the patient's breath are required." The future of inhalation New delivery forms, or new uses for existing deliv- ery methods, are part of bio/pharmaceutical research. The biopharmaceutical industry is actively looking for new ways of delivering biologics, including devel- oping biologics formulations that can be inhaled (2). "If you're looking for delivering right into the lungs, for something, for a disease that happens into the lungs, I think inhaled product makes perfect sense," said Gupta. "And I think there is a there is a lot of interest in [these] products, especially after COVID, because COVID affected mostly respiratory systems." Gupta pointed out that while inhalation delivery of biologics makes sense, this type of delivery can be difficult because biologics degrade easily. "But people have developed technologies like lipid nanoparticles, … which has come across as very promising for deliv- ering biologics, RNA therapeutics, etc. [to the lungs]." "Ac t ive prog ra ms for s ystem ic del iver y v ia t he lungs of small and macro-molecules is also trend- ing positively, whereby a better understanding of the challenges to be overcome in this area is grow- i ng," says Costa. "T he pipel i ne of d r ugs i n devel- opment has ver y much diversif ied over t he years with an increasing fraction of biomolecules, where tailor-made deliver y platforms at the formulation a nd dev ice levels a re a requi rement to f i rst ma x- im ize deliver y ef f icienc y and t hen ensuring t hat the biologic, either a protein or an oligonucleotide, reaches the right target in the right cell and tissue," she concludes. References 1. Haigney, S. AAPS PharmSci 360 2024: Developing Inhalation Drugs. PharmTech.com. Aug. 21, 2024. 2. Mirasol, F. Exploring Innovative Means for Biologics Delivery. BioPharm International 2024 37 (9). ■ Developing Inhalation Drugs For a preview of what's to come at the AAPS PharmSci 360 show in October, Pharmaceutical Technology ® spoke with Vivek Gupta, PhD, associate dean for Graduate Education and Research, associate professor, Pharmaceutical Sciences, St. John's University, Queens, New York, about the formulation of inhalation dosage forms. Scan the QR code to watch or visit pharmtech.com/view/aaps- pharmsci-360-2024- developing-inhalation-drugs