Issue link: https://www.e-digitaleditions.com/i/1481708
12 Pharmaceutical Technology ® Trends in Formulation 2022 eBook PharmTech.com Development perspective in pharma. A combination of improved transparenc y and access to medica l information, along with the establishment of patient groups, has allowed patients to become more informed regarding their medication. Empowered with this newfound confidence and knowledge, patients have now entered into discus- sions with pharma companies through all stages of the drug development process. For example, phar- m aceut ica l compa ny Der m i ra gat hered a foc u s group to draw upon patient preferences when de- termining the formulation and packaging for their new skin medicine product (1). Supplied with these crucial insights from the end-user, pharmaceutical manufacturers are able to understand patient needs and enhance lifecycle management strategies from the outset. Pharma companies are no longer waiting until the product has been released before under- standing patient needs, resulting in a method that benefits both parties. Furthermore, digital platforms have been crucial in providing a way for the industr y to talk directly to the patient in real time (2). Previously, only doc- tors or pharmacists had direct contact with patients, meaning patients could only provide guidance on drugs already on the market. This digital revolution ha s been a pa r t ic u la r ga me-cha nger to t hose pa- tients who may be less able to go to face-to-face dis- cussions due to mobility issues and health problems. It opens the opportunity for all types of patients to have their input, providing pharma companies with a more well-rounded and inclusive platform to de- velop future drugs. Equipped with this plethora of information, it is unsurprising that pharma companies now have the capabilities to adapt drugs to meet specific age and condition requirements, moving away from the one- size-fits-all formulation system that has previously been applied. FDA Listening Sessions have started to look at specific requirements for patient groups that exhibit a specific profile, or those that are suffering from a rare disease (3). Taking this concept one step further is the emer- gence of personalized medicines and devices that t a rget t he i nd iv idua l beyond age a nd cond it ion. Offering these tailor-made therapeutics improves ad herence a nd appropr iate use, a s ca n be exem- pl i f ied by selec t i ng t he cor rec t i n h a ler de v ices for asthmatic patients. Age, dexterit y, inspirator y c apac it y, cog n it ive abi l it y, hea lt h l iter ac y, a nd ethnicit y all have an impact on a patient's inhaler technique and intention to use their device, as well as t he si mple, yet of ten forgot ten, considerat ion of a patient's preference (4). Aligning the patient's re qu i rement s w it h a n i n h a ler t h at h a s t he cor- rect characteristics is cr ucia l. This is why for the same molecule or molecule combinations, as seen in chronic obstr uctive pulmonar y disease (COPD) treatment, doctors can choose from a nebulizer, a pressurized metered-dose inhaler (pMDI), and var- ious dr y powder inhalers (DPIs). However, it is also key that physicians educate and train the patient on the appropriate usage of the device, as well as frequently checking in to make sure it remains the right choice (4). Patient-centric innovations for small molecules Wit h medica l ad herence at t he top of t he agenda, pat ient-cent r icit y is d r iv i ng for mu lat ion i n nova- tion to tackle three key challenges: drug size, drug adm in istration, and adverse side ef fects. Patient compliance plummets when medicines are uncom- fortable to swallow, require hospital visits, or cause unpleasa nt side ef fec ts (5). Yet, how do ma nufac- turers tackle these issues while maintaining drug efficacy and qualit y? Tec h nolog y-d r iven solut ion s a re sh api ng t he pharmaceutical landscape, both for small-molecule drugs and biologics. Nanoparticle engineering has emerged in t he pha r maceut ica l sphere as a st rat- egy for enhancing patient-centricity by generating smaller drug particles that have improved pharma- cokinetic properties. The generation of smaller APIs increases the drug particle's surface area and subse- quently improves solubility and bioavailability, en- hancing the drug's performance. With smaller drug particles, oral pills can be smaller while remaining as effective and, therefore, are accessible to patients who suf fer from dif f icult y swallowing, k nown as dysphagia; can offer alternative, less invasive drug administration routes, such as pulmonary or nasal deliveries; and are also opened up by the small size, a l low i ng d r ug for mu lat ions to become more ta r- geted and localized, minimizing side effects (6). There are several nanoparticle technologies avail- able, including controlled expansion of supercritical solutions (CESS) technolog y. With this technique, par ticles are dissolved in supercritica l carbon di- ox ide (scCO 2 ) a nd cr yst a l l i zed u nder cont rol led temperature and pressure, without excipients. The process creates uniform par ticles of t unable size, shape, and polymorphic form that can be as small as 10 nm (7). Together with the appropriate formu- lation approach, nanoparticle engineering technol- ogies such as CESS can build unique release profiles for small molecules that will meet specific patient needs. This could be useful in a variety of situations, for example, with controlled- and sustained-release formulations to simplif y drug regimens. T h ree-dimensiona l printing (3DP) is a lso accel- erating the shif t to patient-centric medicines. 3DP technologies can construct unique structures that