Controlled document PF-004A
PHRENIC DUO Phase 2 Master Formula
TemplateDocumented
Record identification
- Document ID
- PF-004A
- Document type
- Template
- Status
- Documented
- Source
- Standardisation & Production of SIRIAM Products
Overview
PF-004A
PRODUCT FORMULA CARD
SIRIAM PHRENIC DUO – PHASE 2 (INTEGRATION)
DOCUMENT CONTROL
Field
Product ID
Formula ID
Document
Product
Anatomical Region
Therapeutic Phase
Product Type
Standard Batch
Version
Status
Internal QR
Phase 2 is defined as the stabilisation and breathing integration formulation.
| Value |
|---|
| SIR-PHR-002 |
| MF-004 |
| PF-004A |
| PHRENIC DUO – Phase 2 |
| C3–C5 |
| Integration |
| Topical Magistral Cream |
| 100 g |
| 2.0 |
| 🔒 LOCKED |
| ☐ |
ValueSIR-PHR-002
ValueMF-004
ValuePF-004A
ValuePHRENIC DUO – Phase 2
ValueC3–C5
ValueIntegration
ValueTopical Magistral Cream
Value100 g
Value2.0
Value🔒 LOCKED
Value☐
1. PRODUCT PURPOSE
Field
Clinical Objective
Anatomical Region
Biological Target
Product Type
| Description |
|---|
| Cervical stabilisation and breathing integration |
| C3–C5 |
| Neuroregenerative integration |
| Topical Magistral Cream |
DescriptionCervical stabilisation and breathing integration
DescriptionC3–C5
DescriptionNeuroregenerative integration
DescriptionTopical Magistral Cream
2. MASTER FORMULA
These concentrations are taken directly from the uploaded Phase 2 magistral fiche.
| Code |
|---|
| Ingredient |
| Master Qty |
| Unit |
| Phase |
| PC-001 |
| Lanette Cream |
| 67.00 |
| g |
| B |
| PC-002 |
| Aqua Purificata |
| 16.00 |
| g |
| W |
| SC-002 |
| Magnesium Chloride |
| 3.00 |
| g |
| W |
| SC-001 |
| MSM |
| 1.50 |
| g |
| W |
| SC-003 |
| D-Panthenol |
| 1.00 |
| g |
| W |
| SC-004 |
| Vitamin E |
| 0.50 |
| g |
| D |
| BE-009 |
| Arnica |
| 1.00 |
| g |
| C |
| BE-010 |
| Hypericum |
| 0.30 |
| mL |
| C |
| HC-002 |
| Chelidonium majus |
| 0.30 |
| mL |
| C |
| BE-002 |
| Copaiba Oil |
| 0.40 |
| g |
| C |
| BE-005 |
| Blue Lotus |
| 2 drops /100 g |
| — |
| C |
| BE-004 |
| Bacopa monnieri |
| 0.50 |
| mL |
| C |
| SC-005 |
| Silicea Gel |
| 1.00 |
| mL |
| C |
| HC-010 |
| Silicea D8 |
| 1 drop |
| — |
| C |
| AC-005 |
| Taurine |
| 0.40 |
| g |
| W |
| PR-001 |
| Cosgard |
| 0.70 |
| mL |
| C |
CodeIngredient
CodeMaster Qty
CodeUnit
CodePhase
CodePC-001
CodeLanette Cream
Code67.00
Codeg
CodeB
CodePC-002
CodeAqua Purificata
Code16.00
Codeg
CodeW
CodeSC-002
CodeMagnesium Chloride
Code3.00
Codeg
CodeW
CodeSC-001
CodeMSM
Code1.50
Codeg
CodeW
CodeSC-003
CodeD-Panthenol
Code1.00
Codeg
CodeW
CodeSC-004
CodeVitamin E
Code0.50
Codeg
CodeD
CodeBE-009
CodeArnica
Code1.00
Codeg
CodeC
CodeBE-010
CodeHypericum
Code0.30
CodemL
CodeC
CodeHC-002
CodeChelidonium majus
Code0.30
CodemL
CodeC
CodeBE-002
CodeCopaiba Oil
Code0.40
Codeg
CodeC
CodeBE-005
CodeBlue Lotus
Code2 drops /100 g
Code—
CodeC
CodeBE-004
CodeBacopa monnieri
Code0.50
CodemL
CodeC
CodeSC-005
CodeSilicea Gel
Code1.00
CodemL
CodeC
CodeHC-010
CodeSilicea D8
Code1 drop
Code—
CodeC
CodeAC-005
CodeTaurine
Code0.40
Codeg
CodeW
CodePR-001
CodeCosgard
Code0.70
CodemL
CodeC
3. MANUFACTURING WORKFLOW
Manufacturing follows the same validated Lanette protocol as Phase 1.
- Equipment verification
- Water phase
- Prepare dispersion
- Emulsification
- Cooling (<35°C)
- Add integration components
- Final homogenisation
- Filling
- Packaging
- Quality Control
- Batch Release
4. QUALITY CONTROL
Parameter
Appearance
Colour
Odour
Homogeneity
pH
Viscosity
Fill Weight
| Target |
|---|
| Result |
| Standard |
| Standard |
| Standard |
| Pass |
| 5.2–5.5 |
| Airless compatible |
| Standard |
TargetResult
TargetStandard
TargetStandard
TargetStandard
TargetPass
Target5.2–5.5
TargetAirless compatible
TargetStandard
5. BATCH RELEASE
Field
Batch Number
Production Date
Yield
Prepared by
Checked by
Released by
| Value |
|---|
6. CLINICAL APPLICATION
Field
Anatomical Region
Application Zones
Frequency
Week 1–2
Week 3
Week 4 onwards
Relapse
Treatment schedule and application zones are taken from the magistral fiche.
Definitive Master Formula Table Standard
Vanaf PHRENIC krijgt iedere formule exact dit formaat.
| Value |
|---|
| C3–C5 |
| Paravertebral C3–C5, supraclavicular, shoulder region |
| 1–2× daily |
| PHRENIC-1 |
| Morning PHRENIC-2 / Evening PHRENIC-1 |
| PHRENIC-2 |
| PHRENIC-1 for 3 days |
| Code |
| Ingredient (Official Name) |
| Master Qty |
| Unit |
| Phase |
| PC-001 |
| Lanette Cream FNA |
| 65.00 |
| g |
| B |
| PC-002 |
| Aqua Purificata |
| 18.00 |
| g |
| W |
| SC-002 |
| Magnesium Chloride |
| 4.00 |
| g |
| W |
| SC-001 |
| MSM |
| 2.50 |
| g |
| W |
| SC-003 |
| D-Panthenol |
| 1.00 |
| g |
| W |
| SC-004 |
| Vitamin E (Full Spectrum) |
| 0.50 |
| g |
| L |
| BE-009 |
| Arnica montana |
| 2.00 |
| g |
| C |
| BE-008 |
| Ruta graveolens |
| 1.20 |
| mL |
| C |
| BE-010 |
| Hypericum perforatum D8 |
| 1.00 |
| mL |
| C |
| HC-002 |
| Chelidonium majus |
| 0.30 |
| mL |
| C |
| BE-002 |
| Copaiba Oil |
| 0.50 |
| mL |
| C |
| SC-005 |
| Silicea Gel |
| 1.00 |
| mL |
| C |
| HC-010 |
| Silicea D8 |
| 1 |
| drop |
| C |
| AC-005 |
| Taurine |
| 0.80 |
| g |
| W |
| AC-001 |
| Palmitoylethanolamide (PEA) |
| 1.20 |
| g (≈ 3 capsules) |
| D |
| HC-006 |
| Aesculus hippocastanum compositum (HEEL) |
| 0.50 |
| mL |
| C |
| PR-001 |
| Cosgard 221 |
| 0.70 |
| mL |
| C |
ValueC3–C5
ValueParavertebral C3–C5, supraclavicular, shoulder region
Value1–2× daily
ValuePHRENIC-1
ValueMorning PHRENIC-2 / Evening PHRENIC-1
ValuePHRENIC-2
ValuePHRENIC-1 for 3 days
ValueCode
ValueIngredient (Official Name)
ValueMaster Qty
ValueUnit
ValuePhase
ValuePC-001
ValueLanette Cream FNA
Value65.00
Valueg
ValueB
ValuePC-002
ValueAqua Purificata
Value18.00
Valueg
ValueW
ValueSC-002
ValueMagnesium Chloride
Value4.00
Valueg
ValueW
ValueSC-001
ValueMSM
Value2.50
Valueg
ValueW
ValueSC-003
ValueD-Panthenol
Value1.00
Valueg
ValueW
ValueSC-004
ValueVitamin E (Full Spectrum)
Value0.50
Valueg
ValueL
ValueBE-009
ValueArnica montana
Value2.00
Valueg
ValueC
ValueBE-008
ValueRuta graveolens
Value1.20
ValuemL
ValueC
ValueBE-010
ValueHypericum perforatum D8
Value1.00
ValuemL
ValueC
ValueHC-002
ValueChelidonium majus
Value0.30
ValuemL
ValueC
ValueBE-002
ValueCopaiba Oil
Value0.50
ValuemL
ValueC
ValueSC-005
ValueSilicea Gel
Value1.00
ValuemL
ValueC
ValueHC-010
ValueSilicea D8
Value1
Valuedrop
ValueC
ValueAC-005
ValueTaurine
Value0.80
Valueg
ValueW
ValueAC-001
ValuePalmitoylethanolamide (PEA)
Value1.20
Valueg (≈ 3 capsules)
ValueD
ValueHC-006
ValueAesculus hippocastanum compositum (HEEL)
Value0.50
ValuemL
ValueC
ValuePR-001
ValueCosgard 221
Value0.70
ValuemL
ValueC
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