Improving the patient experience: Developing patient-centric dosage forms

Innovation brings new drugs to the market every month, from small molecules to biologics, and from off-the-shelf medications to personalised therapeutics. These medications, however, are only effective if the patients take them as they are prescribed: [1]

· In a US study, only 72% of new prescriptions were filled

· In a UK study, non-adherence in patients 75 and older was 25% at four weeks

· Ina global study, non-adherence of hypertension medication was 27-40%

Non-adherence has an impact on immediate symptoms, and on long-term disease management, for example potentially leading to increase rates of hospitalization and death. This affects patients and families, and increases costs for healthcare providers. [1]

How drugs are dosed, from ease of administration to packaging, plays an important role in adherence – if the packaging is hard to open, if the drug regimen is onerous and requires many pills or frequent trips to the hospital, or if the oral therapeutics taste unpleasant, patients are less likely to start and maintain their treatment.

Patient-centricity and dosage forms

Patient-centricity has been defined as: ‘Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.’ [2, 3]

There are a variety of factors that can improve the patient-centricity of pharmaceutical drug product design, and the process needs to begin with engaging with patients and carers to find out what they actually need, and involving them in the drug design and development process, from clinical trials, through formulation to packaging design. This will differ according to the issues faced by each population, for example, both older people and paediatric patients may have issues with swallowing medications. Older patients can have declines in motor function, cognition and visual acuity, and younger patients may need different doses according to body weight and age. [4]

There are many factors involved in adherence failures: [1, 5]

· Patient-related factors

o Age, gender, symptoms (or lack of), beliefs, engagement

· Treatment-related factors

o Pill burden, treatment complexity, tolerability profile of drugs, dosing frequency, portability and discretion of dosing

· Condition-related factors

o Comorbidities, type and severity of the disease, disabilities

· Socio-economic environment

o Education, affordability of treatment

· Health care system

o Access to care or drug reimbursement

o Relationship and communication with healthcare professionals

In a study based at a community pharmacy, oral once-daily medications were preferred by respondents, and high numbers of drugs or frequency of administration were associated with medication discontinuation. [6] The benefits of packaging improvements have also been shown in studies and meta-analyses. [4]

Reducing dose complexity

People, especially those with two or more conditions, may need to take a number of drugs at different times. This particularly affects younger people in at risk populations, and older people, and can lead to issues with adherence.

Sustained- and extended-release oral formulations, including gastroretentive formulations, allow oral drugs to be taken less frequently. Long-acting parenteral forms can be injected or implanted, releasing drugs over days, weeks or even months. [5, 7]

Fixed dose combinations of drugs that are commonly used together make it easier to take the right drug at the right time, particularly for conditions such as cardiovascular disease that commonly require more than one medication. Other examples include antiviral drugs for hepatitis C and HIV. Bright colours, colour combinations and shapes make tablets and capsules easier to identify and to remember. [4, 5, 7, 8]

Making drugs easier to take

Older people and children may have issues swallowing medications. Easy to swallow formulations include liquids, dispersible tablets, granules, multiparticulates, orodispersable tablets or lingual films that can be swallowed easily, sprinkled onto or mixed into soft food, or allowed to dissolve on or under the tongue. The volume of the drug should be as small as possible to make administration easier. [4, 5] Changing the size or shape of tablets can also make swallowing easier. [7]

Some drugs are bitter or have an unpleasant taste, and formulating for improved palatability can improve adherence, particularly for younger patients. Approaches to taste masking include lipid-based matrices, microencapsulation or ion-exchange resins. Drugs for children, however, need to have an appearance and taste that encourages the child to take the dose, but not be so attractive that they perceive it as a sweet and overuse it. [4, 5]

For some patients, drugs need to be available in a range of doses. As well as being easy to administer, oral liquids can support dosing flexibility, particularly important in infants and children who need doses based on body weight, and in people who may metabolise drugs differently because of concomitant conditions. [5]

Some drugs that require IV infusion, such as biologics, can be switched to subcutaneous formats that can be administered at home. This frees patients up from regular and time-consuming visits to hospitals or clinics. There are also research programs under way to create oral formulations of biologics. [5]

Transdermal delivery can also make dosing simpler and more acceptable, with formulations including patches, gels and foams. [4]

Designing better packaging

Packaging, especially for older people and people with limited manual dexterity, should be easy to open and the drugs or devices should be easy to handle. Improving the readability of packaging, using larger and clearer fonts, choosing the colours of the packaging for better contrast, and including Braille has potential to reduce medication errors. [4]

Incorporating calendar packaging, such as medication intake reminders, multidose dispensing systems (MDDS), dose dispensing devices, multi-compartment containers (pill boxes), blister packaging and bubble packages can help people remember when to take their medication. Dose dispensing devices or applicators for topical treatments can make the administration process easier and more accurate. [4, 7]

Approaches for the future

Fully personalised 3D-printed forms of combination drugs, allowing bespoke drug release of a number of drugs in a single tablet, are being developed, using inkjet printing technology. Personalised 3D printed therapeutics could be tailor-made to individual patient characteristics, such as physiology, concurrent therapy, drug response, genetic makeup, disease state, sex, weight and age, and to patient preferences, for example shape, size, texture and flavour. The drugs could be printed and dispensed in different healthcare settings, including pharmacies, hospital wards and clinics. [9-11]

Working with patients to understand what they need has potential to improve adherence by tackling patient- and treatment-related factors, and will make medications easier to use for the entire population, not just for individual groups.

References

1. Burnier, M., The role of adherence in patients with chronic diseases. Eur J Intern Med, 2024. 119: p. 1-5.

2. Yeoman, G., et al., Defining patient centricity with patients for patients and caregivers: a collaborative endeavour. BMJ Innov, 2017. 3(2): p. 76-83.

3. Elvidge, S., The Importance of Patient-Centricity in Drug Development. Pharma Sources: An eye on the biopharma industry, 29 August 2024. Available from: https://www.pharmasources.com/industryinsights/the-importance-of-patient-centricity-in-76733.html.

4. Menditto, E., et al., Patient Centric Pharmaceutical Drug Product Design-The Impact on Medication Adherence. Pharmaceutics, 2020. 12(1).

5. Page, S., et al., Patient Centricity Driving Formulation Innovation: Improvements in Patient Care Facilitated by Novel Therapeutics and Drug Delivery Technologies. Annu Rev Pharmacol Toxicol, 2022. 62: p. 341-363.

6. Limenh, L.W., et al., Patients' Preference for Pharmaceutical Dosage Forms: Does It Affect Medication Adherence? A Cross-Sectional Study in Community Pharmacies. Patient Prefer Adherence, 2024. 18: p. 753-766.

7. Auerbach, M., Drug Delivery Challenges: Issues and Opportunities for Solid Dosage Products. Tablets & Capsules, 2024. 22(2): p. 46-47.

8. Varghese, D., et al., Polypharmacy, in StatPearls. 2025: Treasure Island (FL).

9. Rivers, G., et al., Enabling high-fidelity personalised pharmaceutical tablets through multimaterial inkjet 3D printing with a water-soluble excipient. MaterialsToday Advances, 2024. 22: p. 100493.

10. Icke, J., An easy pill to swallow – new 3D printing research paves way for personalised medication. University of Nottingham. 14 May 2024. Available from: https://www.nottingham.ac.uk/news/an-easy-pill-to-swallow-new-3d-printing-research-paves-way-for-personalised-medication.

11. Basit, A.W. and S.J. Trenfield, 3D printing of pharmaceuticals and the role of pharmacy. The Pharmaceutical Journal, 30 March 2022. Available from: https://pharmaceutical-journal.com/article/research/3d-printing-of-pharmaceuticals-and-the-role-of-pharmacy.