PART IV — FORMULATION SCIENCE
Vehicle Architecture
Chapter 11
11.1 Introduction
Within the SIRIAM Platform, the vehicle is regarded as the pharmaceutical carrier that enables the structural and functional integration of the formulation.
The vehicle is not considered an inert excipient but an essential component of the formulation architecture, as it determines the physical characteristics of the product, its reproducibility, its stability and its practical applicability.
For this reason, vehicle selection precedes the incorporation of regional signature ingredients.
11.2 Design Objectives
The platform vehicle shall provide:
practical applicability within clinical practice.
- homogeneous distribution of ingredients;
- reproducible pharmaceutical preparation;
- compatibility with hydrophilic and lipophilic compounds;
- adequate skin feel;
- controlled viscosity;
- compatibility with airless dispensing systems;
- acceptable storage stability;
11.3 Current Platform Vehicle
The current SIRIAM Platform is based on:
Lanette Cream FNA
At the present stage of platform development, Lanette Cream FNA serves as the standardized pharmaceutical vehicle for all regional neurodermal formulations.
This standardization aims to reduce unnecessary variability between formulations and facilitates pharmaceutical reproducibility.
11.4 Platform Standardization
Using one common vehicle throughout the platform provides several advantages.
Pharmaceutical consistency
Preparation procedures remain largely identical across the product range.
Platform identity
Regional formulations differ primarily through their Functional Matrix and Regional Signature Matrix rather than through changes in the vehicle.
Simplified quality control
Standardized vehicles facilitate:
batch reproducibility.
- viscosity assessment;
- pH control;
- homogenization;
- stability evaluation;
11.5 Vehicle Selection Criteria
A vehicle is considered suitable when it demonstrates:
Pharmaceutical criteria
compatibility with intended packaging.
Practical criteria
compatibility with repeated use.
Manufacturing criteria
compatibility with standard pharmacy equipment.
- homogeneous incorporation of ingredients;
- acceptable emulsion stability;
- reproducible preparation;
- appropriate preservation;
- pleasant application;
- adequate spreading;
- rapid absorption without excessive residue;
- reproducibility between batches;
- availability of pharmaceutical-grade raw materials;
- straightforward magistral preparation;
11.6 Future Vehicle Development
Although Lanette Cream FNA currently serves as the platform standard, future vehicle systems may be investigated.
Potential future developments may include:
other pharmaceutical carrier technologies.
Any alternative vehicle requires separate technical and pharmaceutical validation before integration into the SIRIAM Platform.
- hydrogel systems;
- oleogels;
- lamellar emulsions;
- liposomal systems;
- nanoparticle-based delivery systems;
11.7 Vehicle Independence of Clinical Architecture
The clinical architecture of a formulation remains independent of the selected pharmaceutical vehicle.
Changing the vehicle does not alter:
DUO Strategy.
Only the pharmaceutical implementation changes.
- Clinical Purpose;
- Segment Prioritization;
- Metameric Foundation;
- Application Field;
- Neurodermal Application Zones;
11.8 Vehicle Validation
Before becoming a platform standard, a vehicle should be evaluated for:
user experience.
- ingredient compatibility;
- emulsion stability;
- pH stability;
- viscosity profile;
- airless compatibility;
- storage stability;
- reproducibility;
11.9 Current Development Status
At the time of publication, the SIRIAM Platform uses Lanette Cream FNA as the current standardized vehicle.
This choice is based on accumulated internal formulation experience and practical development within the platform.
Future comparative pharmaceutical evaluations may result in adjustments to the platform vehicle if justified by technical or pharmaceutical advantages.
🔬 Professional Review Notes (werkversie)
Review 11.1 – Lanette Cream FNA
☐ Bevestigen of Lanette Cream FNA voor alle producten de voorkeursbasis blijft.
☐ Evalueren of uitzonderingen noodzakelijk zijn (bijv. lippen, slijmvliezen of sterk behaarde huid).
Review 11.2 – Waterfase
☐ Optimale verhouding aqua/Lanette bepalen per formulering.
☐ Effect van waterfase op viscositeit documenteren.
Review 11.3 – Mengvolgorde
☐ Kritische volgorde van oplossen (MSM, magnesiumchloride, hydrofiele en lipofiele componenten) vastleggen.
☐ Temperatuurvensters voor toevoeging van warmtegevoelige ingrediënten definiëren.
Review 11.4 – Airless-validatie
☐ Elke formule testen in de definitieve 15 ml-airless verpakking.
☐ Pompkracht, doseervolume en consistentie evalueren.
Review 11.5 – Stabiliteit
☐ Visuele beoordeling na 24 uur, 48 uur, 1 week en 1 maand.
☐ Eventueel aanvullende temperatuur- of centrifugetesten bespreken indien relevant voor magistrale bereiding.