Development Status of the SIRIAM Platform

Current Development Phase

At the time of publication of this handbook, the SIRIAM topical platform is in an active research and development phase.

The current magistral formulations represent the latest prototypes resulting from multiple iterative development cycles. These formulations are intended for further technical refinement and clinical evaluation before being considered final master formulations.

Iterative Development

The SIRIAM platform has been developed through successive formulation cycles.

Each new generation incorporates observations from:

technical formulation optimization.

The present formulation set represents approximately the sixth regional development generation of the neurodermal product platform.

Technical Validation

Before a formulation is considered final, it undergoes technical evaluation by the responsible pharmacist.

This includes, where appropriate:

practical manufacturing considerations.

The responsible pharmacist may recommend adjustments to ingredient concentrations or preparation procedures before a formulation is released as a Master Formula.

Clinical Evaluation

Following pharmaceutical optimization, formulations are evaluated in clinical practice.

The purpose of this phase is to assess:

patient-reported outcomes.

These observations may result in further refinement of the formulation.

The current handbook therefore distinguishes clearly between:

Development Formula

Validated Master Formula

Neurophysiological Evaluation

One of the research objectives of the SIRIAM platform is the evaluation of neurophysiological changes associated with standardized topical application.

Pilot work has already been initiated using surface electromyography (EMG) to assess changes in regional muscle activity before and after application of selected formulations, including OAA and TLO.

Future development aims to expand these evaluations using more comprehensive assessment protocols, including, where technically feasible, standardized whole-spine EMG measurements before and after topical application across different participants.

At present, this objective remains part of the ongoing research program and should not be interpreted as an established characteristic of the platform.

Continuous Platform Development

The SIRIAM platform is designed as a continuously evolving development system.

Adjustments may occur following:

future research findings.

All modifications are documented through the Development Record before incorporation into the official Master Formula

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Chapter 2A

SIRIAM Platform Standards (SPS)

SPS-001

Anatomy Before Ingredients

Every SIRIAM formulation originates from anatomical analysis.

Ingredient selection is always preceded by:

Clinical Assessment

Segment Prioritization

Metameric Foundation

Application Field definition

No formulation is developed by selecting ingredients first.

SPS-002

One Primary Application Field

Each SIRIAM formulation is linked to one primary standardized Application Field.

A formulation may contain multiple Neurodermal Application Zones, but always belongs to one principal Application Field.

SPS-003

Complete Neurodermal Coverage

The complete SIRIAM platform is designed to provide continuous neurodermal coverage from the cranio-cervical junction to the coccyx through overlapping regional Application Fields.

Regional overlap is intentional and represents a design feature rather than duplication.

SPS-004

Regional Overlap

Transition zones between neighbouring formulations are preserved to maintain continuity of neurodermal coverage.

Examples include:

Phrenic ↔ Plexus Brachialis

Plexus Brachialis ↔ CTO

TLO ↔ Plexus Lumbalis

Plexus Lumbalis ↔ Plexus Lumbosacralis

Plexus Lumbosacralis ↔ SX

SPS-005

Segmental Runner

KORR Integralis serves as the standardized segmental formulation for isolated facilitated dermatomes or spinal segments.

It is not considered a regional Application Field.

SPS-006

Symptom Support Line

InflammaSacra is a symptom- and phase-oriented support line.

It complements, but does not replace, the metameric recovery system.

SPS-007

DUO Architecture

Unless explicitly stated otherwise, every neurodermal formulation follows the standardized DUO architecture:

Release

↓

Integration

↓

Maintenance

Transition occurs after assessment of Biological Readiness.

SPS-008

Biological Readiness

Transition between Release and Integration is based upon Biological Readiness.

Biological Readiness combines:

Patient Reported Readiness

Clinical Readiness

Biological Readiness is assessed before changing formulation phase.

SPS-009

Vehicle Standard

The current SIRIAM Platform Vehicle is:

Lanette Cream FNA

Alternative vehicles may be investigated during research and development, but require separate validation before becoming platform standards.

SPS-010

Structural Matrix

Every formulation is built upon a Structural Matrix before regional signature ingredients are introduced.

The Structural Matrix provides the physicochemical foundation of the formulation.

SPS-011

Functional Matrix

The Functional Matrix defines the biological objective of the formulation.

Ingredient selection follows the Functional Matrix rather than preceding it.

SPS-012

Regional Signature Matrix

Only after the Functional Matrix has been established are Regional Signature Ingredients selected.

These ingredients differentiate one neurodermal Application Field from another.

SPS-013

Standardized Application

Each formulation is applied according to a standardized Application Sequence.

Application order, frequency and treatment phase are predefined for every Application Field.

SPS-014

Neurodermal Application Zones

Each Application Field is subdivided into standardized Neurodermal Application Zones (NAZ).

Every NAZ has:

defined role within the Application Field.

SPS-015

One Formulation — One Design Logic

Each formulation follows one coherent design philosophy.

No ingredient is added without a defined anatomical, structural or functional rationale.

SPS-016

Platform Core Before Regional Diversity

The Platform Core remains as uniform as possible across formulations.

Regional diversity is introduced only where functionally justified.

SPS-017

Pharmaceutical Validation

Every formulation undergoes pharmaceutical review before release as a Master Formula.

The responsible pharmacist evaluates:

packaging suitability.

SPS-018

Development Status

Every formulation receives a documented development status.

Development versions remain separate from validated Master Formulas.

SPS-019

Continuous Improvement

The SIRIAM platform is considered a continuously evolving development platform.

New scientific evidence, pharmaceutical optimization and clinical observations may result in controlled updates of formulations.

All changes are documented.

SPS-020

Version Control

Every formulation receives:

Version number

Revision history

Development Record

Professional Review

Master Formula

Historical versions remain archived.

SPS-021

Batch Reproducibility

Master Formulas are written to ensure reproducible pharmaceutical preparation.

Ingredient quantities, preparation sequence and critical process parameters are standardized.

SPS-022

Quality Control

Each batch is evaluated for:

visual inspection.

SPS-023

Airless Compatibility

All current SIRIAM topical formulations are optimized for dispensing in 15 ml airless containers.

The final formulation is adjusted to achieve consistent dispensing, spreading characteristics and storage stability within this packaging system.

SPS-024

Standardized Units

Master Formulas are expressed as:

grams per 100.00 g finished product

Capsule counts and approximate measurements are excluded from validated Master Formulas.

SPS-025

Professional Collaboration

The development of SIRIAM formulations is performed through interdisciplinary collaboration.

The current platform combines:

Anatomical design (R&D)

Pharmaceutical formulation

Clinical evaluation

Each discipline contributes within its own field of expertise.

SPS-026

Evidence Development

The SIRIAM platform supports continuous technical and clinical evaluation.

Where appropriate, this may include assessments such as surface EMG, clinical observations, patient-reported outcomes and future validation studies. Findings from these evaluations may inform future iterations of the platform but do not automatically establish causal mechanisms or clinical efficacy.

Mijn enige toevoeging

Ik denk dat er nog één standaard ontbreekt, en die zou ik persoonlijk zelfs SPS-000 noemen:

SPS-000 — Clinical Purpose

Every SIRIAM formulation exists to support a clearly defined clinical purpose. The anatomical target, formulation architecture and ingredient selection are all derived from that purpose. No formulation is developed without a predefined therapeutic objective.

• anatomical design;
• practical pharmaceutical preparation;
• clinical experience;
• user feedback;
• pharmaceutical compatibility;
• dispersion and homogeneity;
• viscosity;
• stability;
• pumpability in 15 ml airless dispensers;
• reproducibility of preparation;
• tolerability;
• practical usability;
• consistency of application;
• clinician observations;
• pharmaceutical review;
• technical optimization;
• stability testing;
• manufacturing experience;
• clinical observations;
• anatomical boundaries;
• neurodermal relevance;
• standardized application method;
• compatibility;
• stability;
• homogeneity;
• viscosity;
• pH;
• reproducibility;
• homogeneity;
• pH;
• viscosity;
• phase stability;
• dispensing performance;