Structural Matrix

The Structural Matrix forms the pharmaceutical backbone of every SIRIAM topical formulation.

It consists of ingredients that provide the physicochemical framework required for reproducible preparation, formulation stability and practical application.

The Structural Matrix is intentionally standardized across the platform wherever possible.

Regional differentiation is introduced only after the Structural Matrix has been established.

The Structural Matrix is designed to provide:

consistent user experience.

The Structural Matrix is independent of the regional anatomical identity of the formulation.

• pharmaceutical consistency;
• formulation stability;
• reproducible preparation;
• compatibility between ingredients;
• appropriate texture;
• standardized dispensing;

Within the SIRIAM Platform, the Structural Matrix is organized into complementary functional layers.

Layer 1 — Vehicle

The pharmaceutical base responsible for the physical structure of the formulation.

(Currently standardized as Lanette Cream FNA.)

Layer 2 — Aqueous Phase

The aqueous phase supports dissolution and homogeneous distribution of hydrophilic ingredients.

Its composition may vary slightly according to formulation requirements while maintaining platform consistency.

Layer 3 — Lipid Phase

The lipid phase contributes to:

incorporation of lipophilic compounds.

Layer 4 — Structural Support Components

Structural support components contribute to the overall physical characteristics of the formulation.

Depending on the formulation, these may include ingredients that support:

packaging compatibility.

Layer 5 — Preservation System

Every formulation containing an aqueous phase requires an appropriate preservation strategy.

The preservation system is selected according to pharmaceutical compatibility and stability requirements.

• spreadability;
• skin feel;
• emulsion stability;
• viscosity;
• texture;
• emulsion stability;
• ingredient dispersion;

The current SIRIAM Platform utilizes a group of recurring structural ingredients that are shared across most formulations.

These ingredients constitute the Platform Components.

Their role is primarily pharmaceutical and structural rather than regional.

The exact composition may evolve as the platform develops.

Standardization of the Structural Matrix offers several advantages.

It:

allows regional differences to arise from the Regional Signature Matrix rather than from changes in the formulation backbone.

• minimizes unnecessary variability;
• facilitates pharmaceutical preparation;
• improves reproducibility;
• simplifies quality control;

Within the SIRIAM Platform, a clear distinction is maintained between:

Structural Matrix

and

Functional Matrix

The Structural Matrix provides the pharmaceutical framework.

The Functional Matrix defines the intended biological role of the formulation.

This separation improves consistency and facilitates future optimization.

The Structural Matrix is regarded as an evolving platform component.

Adjustments may occur following:

future technological developments.

Such modifications do not alter the clinical architecture of the formulation.

• pharmaceutical review;
• stability evaluation;
• preparation experience;
• manufacturing optimization;

Future modifications should preferentially preserve the Structural Matrix unless a clear pharmaceutical advantage has been demonstrated.

This principle ensures long-term platform consistency while allowing controlled innovation.

Every regional formulation originates from the same Structural Matrix.

Regional identity is created by adding a Regional Signature Matrix on top of this common foundation.

This modular architecture enables the development of new formulations without redesigning the entire pharmaceutical platform.

Professional Review Notes (Anouck Van Aerschot)

Review 12.1 – Platform Components

☐ Definitieve lijst van platformcomponenten bevestigen.

☐ Controleren of elk onderdeel een structurele of een functionele rol heeft.

Review 12.2 – Oplosbaarheid

☐ Maximale oplosbaarheid van hydrofiele componenten in de waterfase bepalen.

☐ Risico op kristallisatie tijdens bewaring evalueren.

Review 12.3 – Emulsiestabiliteit

☐ Homogeniteit van de emulsie na bereiding beoordelen.

☐ Eventuele fasescheiding opvolgen.

Review 12.4 – Viscositeit

☐ Invloed van platformcomponenten op de eindviscositeit documenteren.

☐ Indien nodig concentraties aanpassen voor optimale 15 ml-airless compatibiliteit.

Review 12.5 – Platformharmonisatie

☐ Beoordelen of structurele componenten verder kunnen worden gestandaardiseerd tussen de verschillende regionale formuleringen.

☐ Eventuele wijzigingen documenteren in de Development Record vóór opname in de Master Formula.