The need for increased convenience and compliance is shining a spotlight on patient centricity when designing dosage forms.
These medicines are developed specifically for a target patient population, tailoring the properties of the drug product to better meet patient needs.
This can range from improving the stability and shelf-life of existing formulations to producing a combination product that reduces pill burden and, ultimately, improves patient outcomes.
Properties of patient-centric dosage forms
Patient-centric drug design focuses on enhancing patient adherence and convenience to improve health outcomes. How developers achieve this differs depending on the patient population, drug product and disease target.
For paediatric or geriatric patient populations, for example, several key properties must be considered when developing treatments, including shape, size, taste and palatability.
Formulating tablets that are quick to dissolve, smaller in size or can be formulated as a liquid — such as solutions or suspensions — significantly reduces the risk of choking. With the rising prevalence of chronic disease, there is also an increase in dysphagia.
Therefore, producing drug products that are easy to swallow is critical.
Pill burden can significantly reduce treatment adherence. By opting for long-acting formulations such as extended-release tablets or depot injections to provide sustained drug release, the required frequency of dosing is minimised.
Combination products can also reduce pill burden by combining two or more active substances in a single dose.
Development strategies to meet patient needs
Considering the needs of the patient from the earliest point of the drug development process ensures that the dosage form is designed with the patient in mind throughout each stage.
This requires a comprehensive understanding of the target patient population, including demographics, medical history or preferences. Effectively obtaining this information requires input from patients.
With this information on hand, formulation scientists can optimise the composition, utilising the necessary excipients to promote patient centricity while maintaining quality, safety and efficacy.
In addition, healthcare professionals with access to patient information can offer valuable insights into market gaps, opportunities for innovation, alternative dosage forms and subpopulations that might benefit from a new product.
When developing a novel therapeutic, engaging in early discussions with regulators is paramount to assessing its compliance with relevant legislation. This proactive approach minimises the risk of wasting time and resources on developing a non-compliant product.
By seeking agency input at an early stage, potential issues can be identified and addressed promptly, ensuring a smoother and more efficient product development process and aligning with regulatory requirements while meeting patient needs.
Even after a drug product has been introduced to the market, strategies to gain a deeper understanding of patient needs remain important.
Post-market surveillance helps to identify areas for improvement, such as enhancing the formulation, packaging or labelling of materials to provide a better experience for patients.
Importance of the disease target
Even with a thorough understanding of the target population, the disease target can influence the dosage form and limit the strategies that can be used to address the patient population’s needs.
For example, the route of administration may be limited, which in turn influences the formulation. Localised diseases may require oral administration whereas respiratory diseases often rely on inhalation devices.
The severity and progression of the disease can also play a role; whereas chronic conditions might require long-acting formulations, acute ones may need immediate-release formulations. The formulation scientist must consider all these factors when designing a drug product.
Looking ahead with patient-centric dosage forms
Patient-centric dosage forms are rising in prevalence throughout the pharmaceutical industry and their future lies in continuous innovation. The rise of 3D printing and artificial intelligence (AI) is facilitating the production of medicines that are tailored for specific patient subpopulations.
Using 3D printers allows flexibility in terms of dosing and design. AI assists in drug design, reducing development time and enabling the provision of patient-centric formulations.
These advancements hold the potential to revolutionise healthcare by offering more effective and efficient treatments that are aligned with individual patient needs.
