FAQ: Key Innovations in Drug Delivery and Formulation in 2025

1. How are drug developers using specialized, non-invasive delivery systems to improve patient adherence?

Non-invasive delivery, such as needle-free adrenaline nasal spray (EURneffy/Neffy), addresses psychological barriers like needle anxiety, preventing delays in administering life-saving treatment during anaphylaxis. Clinical data confirm its rapid absorption is comparable to intramuscular injection, even with nasal congestion (1,2). Logistically, the formulation offers an extended shelf life of up to 30 months and temperature stability, reducing cold chain reliance and waste (3). Separately, oral liquid suspensions are preferred by pediatric, geriatric, and dysphagic patients struggling with swallowing tablets. Liquids enhance compliance through flexible dosing, taste masking, and safer administration for dysphagia via thickened, slower-flowing alternatives that reduce aspiration risk (4).

2. What technologies are advancing sustained and targeted delivery, particularly for complex anatomical sites?

Sustained delivery systems are critical for complex sites like the posterior eye, reducing dosing frequency and increasing therapeutic durability. Innovations include bioerodable implants and FDA-approved intracameral implants (Durysta, iDoseTR) for glaucoma. Bioresorbable hydrogel technology enables long-term posterior delivery of small molecules, dissolving safely into neutral pH, cleared molecules. Nanoscale systems (liposomes, nanomicelles) also achieve sustained delivery and enhance bioavailability for ocular conditions like dry eye disorder (5). For large systemic volumes, facilitated subcutaneous immunoglobulin therapies, such as HYQVIA, utilize recombinant human hyaluronidase to increase subcutaneous dispersion (6). This allows for larger infusion volumes, decreasing dosing frequency to once every three or four weeks, a significant convenience over weekly or bi-weekly regimens.

3. How are formulation innovations attempting to overcome limitations of injectable biologics?

Because biologics are largely restricted to parenteral administration due to size, fragility, and degradation issues, intense R&D targets non-parenteral routes (oral, inhaled) (7). Lonza and Iconovo, for example, are using spray-drying to formulate an intranasal biologic candidate for obesity (8). An alternative is the development of next-generation oral macrocycle drugs, or "nCycles," by companies like Orbis Medicines, optimized via the nGen platform for oral bioavailability (9). These nCycles aim to replace injectable biologics by targeting the same validated pathways in a patient-preferred oral format. Finally, smart capsules integrate mechanical or electronic components to achieve site-specific release in the stomach or intestine, enabling tailored release profiles for complex oral drugs (7,8).

4. How is advanced manufacturing enabling personalized medicine and changing production models?

3D printing enables patient-centric care by allowing precise construction and customization of dosage forms, tailoring dose strength or drug combinations to individual needs, vital for pediatric and geriatric patients (10). This technology reduces drug variability and facilitates precise, targeted release profiles verified in vivo. Regulatory frameworks are evolving; the United Kingdom officially recognizes this shift as ‘modular manufacture,’ supporting decentralized production schemes. Although 3D printing automates compounding workflows and reduces pharmacist intervention time in hospital settings, challenges remain in manufacturing scalability, as the layer-by-layer method is currently too slow and costly for large-scale deployment.

5. Have recent regulatory decisions impacted stability or safety of existing drug formulations?

The European Commission decided to maintain the use of titanium dioxide (TiO2) in medicinal products. TiO2 is used in approximately 91,000 human drug products for color, uniformity, and stability. This decision followed the European Medicines Agency’s conclusion that substituting TiO2 in most medicines was not technically feasible without negatively impacting their quality, safety, and efficacy, which would threaten drug availability (11).

6. Has recent public health policy on vaccines sparked debate about patient adherence versus safety risk?

The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) voted to recommend separating the combined MMRV vaccine (measles, mumps, rubella, and varicella) into individual MMR and varicella shots for children four years old and younger. This was based on data showing the combined shot carries approximately double the rate of febrile seizures compared to the separate doses. Concerns were raised that increasing the number of required injections could threaten patient adherence to the immunization schedule. The situation became complex when the ACIP subsequently voted to retain coverage for the combined MMRV shot within the Vaccines for Children program (12).

References

1. ALK. EURneffy Needle-Free Nasal Adrenaline Spray for Emergency Anaphylaxis Treatment Now Available for Prescription in the UK. Press Release. Oct. 20, 2025.
2. FDA, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine,” Notice of Public Workshop—Request for Comments, Federal Register, 90 FR 52958, 52958–52960.
3. ALK. EURneffy Approved as the First Needle-free Anaphylaxis Treatment of Adults and Children in the UK. Press Release. July 18, 2025.
4. Owens, L.; Zhang, Y. Enhancing Patient-Centric Care Through Oral Liquid Drug Delivery Formulations. BioPharm International®/ Pharmaceutical Technology®/ Pharmaceutical Technology® Europe Trends in Formulation eBook 2025 October.
5. Challener, C. A. Advanced Solutions for Sustained Delivery of Ocular Therapies. Pharmaceutical Technology 2025, 49 (6) 12–15.
6. Takeda. Takeda Announces Approval of HYQVIA 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia. Press Release. Dec. 27, 2024.
7. Mirasol, F. Challenges, Innovations, and Future Outlook of Biologics Formulations. BioPharm International®/ Pharmaceutical Technology®/ Pharmaceutical Technology® Europe Trends in Formulation eBook 2025 October.
8. Lonza. Iconovo and Lonza to Collaborate on the Formulation Development of an Intranasal Biologic. Press Release. Jan. 13, 2025.
9. Orbis Medicines. Orbis Medicines Raises EUR 90 Million Series A Funding Round to Develop Pipeline of Oral Macrocycles. Press Release. Jan. 6, 2025.
10. Challener, C. A. Personalized and Patient-Centric Administration of Oral Medicines. Pharmaceutical Technology 2025, 49 (7) 14–17.
11. EC. Commission Staff Working Document on the Use of Titanium Dioxide in Medicinal Products. Health.ec.europa.eu, Aug. 4, 2025.
12. Sherman, C. CDC Panel Recommends Multiple Shots for Measles, Mumps, Rubella and Chickenpox Instead of Single Vaccine. theguardian.com, Sept. 18, 2025 (accessed Sept. 19, 2025).