Personalized and Patient-Centric Administration of Oral Medicines

Patient adherence to medication is a challenge. Patients prefer the use of oral medicines over injectable ones for obvious reasons. Therefore, there is an ongoing need to develop personalized and patient-centric delivery solutions, including devices, for the administration of oral medicines that fit patient lifestyles and optimize the safe and effective use of oral medicines. Key attributes include improved taste and ease of swallowing, patient-friendly administration, flexible dosing, and reduced dosing frequencies.

More sophisticated and tailored solutions are emerging, including modified-, sustained-, extended, and controlled-release formulations; smart pills incorporating digital technologies for sensing and reporting; transdermal patches; and subcutaneous implants. New manufacturing methods are also being explored to enable more personalized and patient-centric dosage forms, such as 3D printing of oral solid dosage (OSD) drugs.

Tailoring medicines to improve outcomes

Personalized OSD forms aim to improve outcomes and adherence by tailoring medicines to each patient’s needs. “Standard tablets are easy to mass-produce but do not account for differences in age, weight, genetics, or disease progression,” says Bing Xun Tan, pharmaceutical application laboratory manager, Roquette Health & Pharma Solutions. “Customizing dose strength or form maximizes therapeutic efficacy while minimizing side effects, which is crucial for pediatric and geriatric patients,” he notes.

Personalized formulations support drug titration—such as loading and maintenance dosing—as well as body surface area- or weight-based adjustments, which are particularly important in oncology and pediatric care, according to Thierry Jomini, CEO and founder of AbbatiaLabs. In addition, he observes that personalized dosing facilitates safe medication tapering, giving patients a better chance to discontinue treatment optimally, and helps combat issues like antibiotic resistance and drug habituation. Finally, comments Jomini, solid oral forms offer superior stability compared to liquids, enabling global accessibility even in regions without refrigeration, thus ensuring reliable treatment delivery across diverse environments.

Advances like 3D printing, multiparticulate systems, and improved excipients such as pregelatinized starch or mannitol now enable bespoke formulations, according to Tan. Regulators, he adds, are also starting to play a role. FDA’s pediatric exclusivity provision (1), for instance, provides a financial incentive for pharmaceutical manufacturers to conduct and submit pediatric studies supporting the development of age-appropriate dosage forms that could also allow for dose titration. Similarly, in Europe, the Pediatric Use Marketing Authorization (PUMA) (2) incentivizes medicines developed exclusively for use in the pediatric population with data and market protection for product authorization.

“These drivers support the shift from ‘one-size-fits-all’ medicines towards precision approaches that make drug therapy safer, more effective, and better adapted to the patient,” Tan concludes.

Enhancing treatment efficacy through better adherence

The drivers for patient-centric formulation development are similar to those for personalized OSD drugs because both approaches focus on enhancing treatment efficacy and patient adherence by emphasizing individual preferences and needs, says Lydia Marinou, technical sales manager with Adragos Pharma.

As examples, Marinou points out that flexible dosing schedules and dosage forms that align with patients' lifestyles can significantly improve adherence rates, and the use of mobile health applications that gather patient feedback further supports this trajectory. “Successful case studies, such as patient-centric inhalers collecting real-time data, illustrate how understanding patient profiles and medication adherence can lead to more effective and satisfactory treatment outcomes,” she adds.

John van den Anker, chief scientific officer of AbbatiaLabs, agrees that the primary motivation for both personalized and patient-centric products is improved adherence to therapy. “Medications that are easier to administer—whether by patients themselves or by caregivers—significantly increase the likelihood of consistent treatment,” he notes. “Moreover,” he continues, “patient-centric products help reduce dosing errors, which are a leading cause of medication-related issues, particularly in settings requiring precise, bodyweight-based dosing such as pediatric care.”

Patient-centric design, according to Tan, focuses on making medicines easier to use—like easier-to-swallow tablets or chewables, taste-masked forms for children or older adults, or fast-melt options including orally disintegrating tablets (ODTs) for those with dysphagia. “By reducing behavioral and sensory barriers, these designs encourage correct use. Commercially, they appeal to patients, caregivers, and providers seeking better compliance,” he says.

In addition, Tan comments that as lifestyle medicines (like those for weight loss) grow in popularity, there is also a market-driven demand for more lifestyle-friendly, personalized formats. This trend, he observes, mirrors similar trends in nutraceuticals and cosmetics, where personalization is already a significant consumer demand.

Significant overlap between personalized and patient-centric OSD drugs

Consequently, there is a clear overlap between personalized and patient-centric oral solid dosage drugs, as both concepts prioritize ease of use and accuracy in drug administration, according to Jomini.

Tan, meanwhile, views personalized OSD drugs with doses and/or drug combinations customized for individuals as, effectively, a subset of the broader patient-centric approach. “While personalization focuses on pharmacological customization (right drug, right dose), patient-centric design ensures that the dosage form itself is acceptable, convenient, and adapted to the patient’s needs and preferences,” he explains. In practice, Tan notes that advances like 3D printing enable both at once: for example, a chewable, flavored tablet designed for a child that also delivers a precise weight-based dose.

Van den Anker contends that flexible dosing devices—such as POWDOSE from AbbatiaLabs—exemplify this convergence by enabling patients or caregivers to easily and reliably select the precise dose needed, typically in just a couple of simple steps. “These innovations support both individualized treatment regimens and user-friendly administration, making them essential tools for delivering truly tailored and accessible therapies,” van den Anker believes.

Overall, concludes Tan, “patient-centric design provides the usability framework, while personalization ensures pharmacological precision. Together, they represent a shift from viewing the patient as a passive recipient of standardized treatment to an active participant whose unique needs and circumstances shape the final product.”

Recent technology advances of note for van den Anker include flexible and user-friendly dosing solutions that allow precise, individualized dosing. He also highlights 3D printing as an emerging and powerful tool for creating customized drug formulations tailored to each patient’s needs; long-acting formulations, which contribute by reducing dosing frequency and improving adherence; and easy-to-swallow formats—such as multiparticulates and dissolvable tablets—that enhance patient comfort and usability, particularly for children and the elderly. “Together, these innovations are transforming the landscape of oral drug delivery toward more tailored and accessible care,” he states.

Manufacturing, scalability, and regulatory complexity challenges

Developing patient-centric and personalized OSD drugs is not a simple endeavor, however. There are several challenges along the way. The biggest hurdles, according to Tan, lie in manufacturing, scalability, and regulatory complexity.

One major barrier highlighted by Jomini is the need for the pharmaceutical industry to invest in new infrastructure, such as equipment for 3D printing individualized doses or systems for filling flexible dosing devices, which also require compatible multiparticulate formulations.

Technologies like 3D printing, adds Tan, are well suited to one-off or small-batch production, but because each tablet is printed layer-by-layer, this method is too slow and costly for large-scale deployment. In addition, he notes that supply chains must also adapt, particularly for excipients. “The sourcing of ready-to-use blends and functional excipients that streamline small-batch production has never been more important,” Tan states.

Furthermore, Tan emphasizes that highly individualized production demands new distribution models, specialized training, and flexible quality systems capable of ensuring consistency and safety for varied products. Regulations need updating as well. “Regulatory frameworks, while evolving, still generally assume mass production of standardized forms. Clear guidance on quality controls, validation, and data protection (especially when handling patient-specific data) is still developing,” Tan says.

Another challenge for van den Anker is the need for development of robust clinical evidence clearly demonstrating that precise dosing leads to better health outcomes. In addition, he observes that for many personalized and patient-centric OSD drugs, “payers must be willing to support potentially higher costs for these advanced therapies in recognition of their benefits in adherence and therapeutic effectiveness.”

Overall, according to Tan, “the crux is how to scale up personalization without compromising cost-effectiveness, safety, or regulatory compliance—challenges that will require not only technological solutions but also reimagined business and regulatory models.”

Highlighting regulatory considerations

Regulatory considerations significantly impact the development of personalized and patient-centric OSD drugs, and agencies are adapting their frameworks to better accommodate innovations, Marinou says. She points to incorporation of quality-by-design principles to ensure safety and efficacy as an example.

Regulatory frameworks must continue to evolve, however, to address novel challenges while maintaining safety and quality, according to Tan. “New production methods require robust validation (especially for on-demand and small-scale manufacturing environments), as well as solid quality controls and assured compliance with good manufacturing practices. Handling patient-specific data also demands stringent privacy protections,” he explains.

The approval of patient-customized 3D-printed medicines and devices exemplifies the evolving landscape for Marinou (3–5). She emphasizes, though, that addressing compliance complexities and establishing robust pharmacovigilance systems remain critical for companies aiming to introduce personalized treatments that align with regulatory standards. “Navigating the complexities of compliance is essential,” she says, “particularly as the inclusion of real-world evidence, which allows companies to leverage patient data for adaptive regulatory pathways, becomes increasingly important.”

If delivery is achieved using specialized devices, there are additional regulatory considerations. Products that include a device component—such as a flexible dosing system—may be classified as combination products, which can introduce added regulatory complexity, especially for developers more accustomed to small-molecule drugs, says Jomini. “While this pathway is more common in biologics and injectables, it poses a challenge in the OSD space. Moreover, any medical claims, such as improved outcomes, must be substantiated by robust clinical evidence,” he observes. Despite these hurdles, Jomini does note that specialized regulatory expertise is available to support developers through this process.

Also on the positive side, Tan notes that many pharmaceutical regulatory agencies are already encouraging patient-focused approaches. In addition to the aforementioned pediatric development incentives, he highlights FDA’s Patient-Focused Drug Development initiative (6), which emphasizes incorporating patient perspectives and needs. “Together, these regulatory drivers support safer, more tailored therapies that meet the multifaceted needs of a diverse, global patient body,” Tan says.

Progress through innovation

Despite the many challenges, developers of OSD drugs are pursuing innovative solutions that support the creation of personalized and patient-centric products designed to increase medication adherence and provide better outcomes.

Tan notes that the ability of 3D printing to enable on-demand, patient-specific tablets with tailored doses and flavors has been demonstrated for pediatric use in hospital trials (7). “Hospital pharmacies are beginning to adopt 3D printers and precise dosing devices to create tailored oral forms at the point of care—such as child-friendly, flavored tablets with exact doses,” he notes.

Fast-melt tablets and dissolvable oral films improve administration for those with swallowing difficulties, while multiparticulate systems, such as pellets and minitablets, enable flexible drug-dose combinations that can reduce pill burden, according to Tan. He points to the OraFID (Sensidose, part of Navamedic ASA) prefilled dose dispenser as simplifying minitablet administration by allowing patients and caregivers to accurately dispense the required dose. “Minitablets and multiparticulates promise superior accuracy and dosing flexibility, allowing complex regimens to be delivered in single capsules or even sprinkles with specific release profiles,” he says.

Other advances highlighted by Tan include improvements to excipient offerings such as plant-based mannitol and other starch derivatives, which ultimately support better taste-masking, compressibility, and customized release profiles. “The industry’s growing understanding of the importance of these factors is driving the development of excipients designed specifically for patient-centric forms and advanced manufacturing, laying the groundwork for truly personalized, user-friendly oral medicines,” he says.

Innovative drug delivery systems, meanwhile, are transforming personalized medicine, according to Marinou. “Nanoscale carriers, such as dendrimers and liposomes, enhance drug solubility and targeting, allowing for treatments such as personalized cancer therapies that deliver chemotherapeutics directly to tumor cells. Layered tablets provide controlled release of multiple drugs, which is particularly useful for the management of chronic conditions, as seen in combination therapies for diabetes. Additionally, smart delivery systems, such as implantable devices that can adjust dosages based on real-time physiological data, represent the future of medication adherence and effectiveness, allowing for tailored treatments that adapt to individual patient dynamics,” she comments.

In the near future, van den Anker believes the development of oral formulations for traditionally injectable therapies, such as oral insulins and GLP-1 drugs for obesity and type 2 diabetes, will have significant potential to advance personalized and patient-centric OSD drugs. “These innovations could greatly improve patient comfort and adherence,” he states.

Longer-term, Tan believes artificial intelligence (AI)-driven formulation design and fully decentralized manufacturing will revolutionize production of personalized and patient-centric OSD drugs. “AI models can help predict optimal doses and formulations based on individual patient data, while advanced manufacturing units in pharmacies or clinics produce these custom forms on demand,” he observes. Tan also expects smart ingestible devices and biosensors will eventually provide the added benefit of real-time monitoring and responsive drug release, enabling dynamic personalization (8). “Once the lingering technological and regulatory barriers have been addressed, these developments could create an interconnected, on-demand systems delivering personalized oral therapies at scale within the next decade.”

References

1. FDA. The Pediatric Exclusivity Provision: Status Report to Congress, January 2001. https://www.fda.gov/media/70272/download
2. EMA. Paediatric-use Marketing Authorisations. Ema.europa.eu. Updated July 31, 2025. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/paediatric-medicines-marketing-authorisation/paediatric-use-marketing-authorisations
3. Alqahtani; et al. 3D Printed Pharmaceutical Systems for Personalized Treatment in Metabolic Syndrome. Pharmaceutics, 2023 15 (4), 1152. DOI:10.3390/pharmaceutics15041152
4. Aprecia. FDA Approves the First 3D Printed Product. Press Release. Aug. 3, 2015, https://aprecia.com/resources/press/fda-approves-the-first-3d-printed-drug-product/
5. Triastek. Triastek's 3D-Printed Gastric Retention Product T20G Receives FDA IND Clearance. Press Release. March 17, 2025. https://www.triastek.com/detail/40.html
6. FDA. CDER Patient-Focused Drug Development. FDA.gov. March 21, 2025.https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development
7. Stoops; et al., Clinical Implementation of a Paediatric 3D-printed Combination of Sulfamethoxazole and Trimethoprim. International Journal of Pharmaceutics, 2025 Volume 676, 125581. DOI: 10.1016/j.ijpharm.2025.125581
8. Chai; et al., Utilizing an Ingestible Biosensor to Assess Real-Time Medication Adherence. J Med Toxicol. 2015 Dec;11(4):439-44. DOI: 10.1007/s13181-015-0494-8

About the author

Cynthia A. Challener, PhD is a contributing editor to Pharmaceutical Technology®.