Photo showing different forms of medication: why are medicines still standardized?

Blog

Blog

Personalized medicine: why are treatments still standardized?

Photo showing different forms of medication: why are medicines still standardized?

Every patient is different, yet medications are predominantly available in pre-defined dosages and forms. This standardization enables large-scale production, quality control, and guarantees the reproducibility of medicines.

And yet, needs vary according to age, weight, clinical status, or administration constraints. How can the demands of industrial production be reconciled with the need to better tailor medications to patients?

Why are medicines mass-produced?

Developing a medicine requires significant investment: research, clinical trials, formulation development, process validation, and regulatory assessment. Once the medicine is authorized, its production must comply with strict requirements to guarantee its quality and safety. Mass production allows these costs to be spread across many products and establishes an efficient supply chain.

Mass production ensures that medications meet defined specifications, particularly regarding composition, dosage, and quality. Standardization is therefore essential to the current industrial model. However, it relies on a limited number of presentations, which do not always correspond precisely to individual needs.

When available presentations are no longer enough

Tailoring a treatment does not necessarily mean creating a custom-made medicine. A healthcare professional can adjust a prescription based on the patient, but an appropriate form and dosage must still be available. For example, a child may require a dose that does not match commercially available strengths. Similarly, a person with swallowing difficulties may need a dosage form better suited to their constraints.

Solutions already exist, notably compounded preparations made within a defined framework. However, scaling them up faces challenges related to cost, organization, and quality control. In particular, each preparation must have a controlled dosage, adequate stability, and reproducible quality. The challenge is to make production more flexible when needs justify it.

Pharmaceutical 3D printing: beyond dosage

Pharmaceutical 3D printing makes it possible to manufacture dosage forms by progressively building their structure from a digital model. Its value is not limited to the ability to explore different dosages. By varying the geometry and internal architecture of a form, it becomes possible to study how its structure influences its behavior, particularly its disintegration or the release of the active ingredient.

This approach opens up avenues for designing pharmaceutical forms that meet specific needs. However, their feasibility depends on the formulation, the technology used, and the demonstration of their quality and reproducibility. 3D printing thus represents a complementary path of exploration to conventional processes, with one goal: expanding production possibilities without compromising pharmaceutical standards.

The pharmaceutical cartridge: combining standardization and personalization

One approach consists of separating the preparation of the formulation from the manufacturing of the final dosage form. This is the principle behind the pharmaceutical cartridge concept: a standardized formulation would be prepared upstream, then used to produce, via 3D printing, a pharmaceutical form tailored to a prescription.

This setup could combine the benefits of controlled upstream production with greater flexibility at the time of final manufacturing. In particular, it would allow for exploring a wider variety of dosages or forms without necessarily having to produce and store each presentation in large quantities. This model remains subject to several requirements: formulation stability, dosage accuracy, process reproducibility, traceability, and the applicable regulatory framework. Personalization cannot be envisioned independently of these constraints.

Toward more flexible pharmaceutical production

Mass production has ensured the availability and quality of medicines on a large scale. The challenge today is to explore how new technologies can complement this model to better meet certain individual needs. Pharmaceutical 3D printing and the cartridge concept are part of this vision: combining the rigor of industrial production with greater flexibility in medicine manufacturing.

The goal is not to systematically personalize every treatment, but to enable new production options when pharmaceutical needs and quality requirements allow.