Issue link: https://www.e-digitaleditions.com/i/1481708
PharmTech.com Trends in Formulation 2022 eBook Pharmaceutical Technology ® 13 Development stray from those made by traditional manufactur- ing techniques. For example, Aprecia's ZipDose for- mulations enable dose loading of up to and beyond 1000 mg that disintegrate in the mouth in seconds when taken with a small sip of liquid (8). Combining CESS-nanoformed fast dissolution par ticles w it h this ZipDose technology platform for rapid disinte- gration could enable high performance buccal and oral deliver y of medicines to patients where rapid absorption is essential (9). Additional benefits may include lower dosage products, less excipient con- tent, and reduced pill burden. Championing patient-friendly biological formulations Biologics is an emerging field in the pharmaceuti- cal industr y. However, formulation of biologics is considerably more complex than small molecules given their size, sensitivity to pH, enzyme degrada- tion, and temperature, and low permeability, mean- ing that biologics remain challenging to adminis- trate outside t he injectable routes (10). Current ly, t he biolog ic a l f ie ld i s u n d e r goi n g r e s e a r c h on long-acting injectables to minimize the number of injections. There is hope that this can be achieved by developi ng cont rol led- a nd sust a i ned-relea se for mu lat ions. Na nopa r t icle engineer ing tech nol- og y can also be of use to enhance the patient-cen- t r icit y of biolog ics for mu lat ions. Biolog ics, such a s pept ides, a l ready of fer t he pat ient benef it s of greater specificity, fewer off-target side effects, and a reduced risk of drug–drug interactions compared to small-molecule drugs (11). For instance, nanoparticle technologies can be used to create biological nanoparticles as small as 50 nm (e.g., under gentle conditions). This ability can help develop biological formulations for novel drug deliv- ery routes, creating new possibilities for patients (12). Reformulation and enhanced medical devices A growing number of pharmaceutical manufacturers are choosing the 505(b)(2) drug development route. The 505(b)(2) pathway enables manufacturers to find opportunities for new products by exploring mole- cules already on the market that can be made better. By choosing the reformulation path, manufacturers may face fewer regulatory hurdles, accelerating their drug to market. Beyond dr ug development, the pharmaceutical industr y is also seeing a surge in enhanced medi- cal devices that are manufactured to help patients to adhere to their medical regimens. Whether it is digital-based solutions, such as patient-monitoring apps that prompt patients to take their medication, or even Bluetooth-enabled smart inhalers that contain sensors that record when the medication is taken (13). Advancements in this sector are all geared towards the increased personalization of medication. Despite significant progress in the development of patient-centric innovations, the challenges of this route cannot be ignored. Every time a self-adminis- tration device is involved, the patient must learn how to use it. Therefore, it can only be deemed effective if it is simple to use. For example, issues with apply- ing novel insulin products have increased questions around variability and outcome, arguably hindering medical adherence further (14). A new era of patient-centric formulation strategies It is clear that the new focus on patients has driven technologica l and formulation innovation in the ph a r m a ce ut ic a l f ie ld , f r om n a nop a r t ic le e n g i- ne e r i n g to r e f or mu l at ion s t r ateg ie s. T he s e a d- va ncement s ca n be acc red ited to t he i nc rea sed understanding of patient needs from the patients t he m s e l ve s e a rl y on i n t he d r u g d e ve lopme nt process. Equ ipped w it h t h i s i n for m at ion , ph a r- m ace ut ic a l compa n ies h ave t he a bi l it y to a l so overcome existing challenges that still face the in- dustry today and create a truly patient-centric future. References 1. C o u n c i l f or I n t e r n a t i on a l O r g a n i z a t i on s o f Medical Sciences Working Group, Patient Involve- ment in The Development, Regulation and Safe Use of Medicines (2022). 2. S. Page, et al., Annual Review of Pharmacology and Toxicology. 62, 341–363 (2022). 3. A. Abernathy, "Patient Perspective Is Vital to FDA's Work," www.fda.gov. (2019). 4. A. Kaplan and D. Price, Canadian Respiratory Journal online, doi:10.1155/2018/9473051 (2018). 5. F. Kleinsinger, The Permanente Journal online. doi: 10.7812/TPP/18-033 (2018). 6. S.M. Dizag, et al., Research in Pharmaceutical Sci- ences. 10(2): 95–108 (2015). 7. S. Moore, "Nanoform Wins Award for Drug Devel- opment and Delivery," AzoNano. Nov. 12, 2019. 8. N . S a n d l e r a n d T. We s t , O N d r u g D e l i v e r y. 1 (122) 9–13 (2021). 9. J. S p i n n e r, " N a n o f o r m , A p r e c i a p a r t n e r o n 3D-printed nanomedicines," Outsourcing Pharma, April 27, 2021. 10. S. Mitragotri, P. Burke, and R. Langer, Nat Rev Drug Discov. online doi: 10.1038/nrd4363 (2014). 11. C. Oo and S.S. Ka lbag, Expert Re view of Clinical Pharmacology. 9 (6) 747–749, (2016). 12. M. Otmani, "Nanoform launches technology for biologics," Nordic Life Science News, Nov. 30, 2020. 13. A. Whittamore, "Smart Inhalers—Your Questions Answered," www.asthma.org.uk. (2017). 14. M.E . Pau le y, e t a l., M ed D e v ices ( A uckl). 1 4 , 3 39–354 (2021). ■