SikaliasCOMPOUNDING.GRGreek Formulary Sikalias
Stasinos Chr. Sikalias · The science of compounding

Aprepitant 20 mg/mL from 80 mg capsules — source discrepancy

CGR-FR-030 · ANSM — Monographie de préparation magistrale (outside Formulaire national)

Use on holdCGR-FR-030France

DO NOT COMPOUND — unresolved source inconsistency.

COMPOUNDING ON HOLD: an unresolved critical discrepancy exists. This record is for study and investigation; do not execute until a documented resolution is available.

Aprepitant: monograph uses 4 × 80 mg; the 80 mg technical note (18/05/2026, p.2) method says 4 × 125 mg. Do not compound pending publisher clarification. The 16 mL is added vehicle, not q.s. ad.

Aprepitant: monograph uses 4 × 80 mg; the 80 mg technical note (18/05/2026, p.2) method says 4 × 125 mg. Do not compound pending publisher clarification. The 16 mL is added vehicle, not q.s. ad.

Monograph PDF · GR/ENBlank batch worksheet
Dosage formOral suspension
Reference batch4 καψάκια 80 mg + 16 mL οχήματος / 4 × 80 mg capsules + 16 mL vehicle
Monograph version4.0
Source packagev4

Source formula

IngredientSource quantity
Aprepitant 80 mg capsules4 καψάκια / capsules
Ora-Blend OR Ora-Blend SF16 mL ΠΡΟΣΘΗΚΗ / ADDED

Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.

Description

Documented in source

White, homogeneous suspension. Net mass excluding cap/adapter: 18.1–20.1 g with Ora-Blend or 16.6–18.4 g with Ora-Blend SF.

References: [1]

Use and action

Documented in source

Antiemetic, NK1 antagonist.

References: [1]

Specifications

Documented in source

White, homogeneous suspension. Net mass excluding cap/adapter: 18.1–20.1 g with Ora-Blend or 16.6–18.4 g with Ora-Blend SF.

References: [1]

Light

Partial evidence

For the finished product the source specifies:
Amber type II glass or PET, suitable closure/EnFIT adapter. 2–8 °C, protected from light.

References: [1]

Air

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Water and solubility

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Humidity

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Temperature

Partial evidence

For the finished product the source specifies:
Amber type II glass or PET, suitable closure/EnFIT adapter. 2–8 °C, protected from light.

References: [1]

pH and related incompatibilities

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Other incompatibilities

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Ingredient-specific information

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Personal protective equipment

Partial evidence

Complete formula-specific PPE is not specified. Select gloves, eye protection and exposure controls using the exact materials’ SDS and the local risk assessment.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.

References: [1] · [3]

Risks and precautions

Partial evidence

A complete formula-specific hazard classification is not established. Assess potency, dust/aerosol, allergens, solvents, microbial risk and cross-contamination using the actual materials and process. Absence of a flag does not establish absence of hazard.

References: [1]

Compounding conditions

Partial evidence

Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

References: [1]

BUD rationale

Documented in source

Monograph reports 1 month. This is not an approved BUD while the record is on HOLD.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.

References: [1]

Bases and dependencies

Partial evidence

No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

References: [1]

Equipment

Editorial checklist

Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Mortar and pestle, Capsule-filling equipment, Calibrated pH meter. Selection/qualification is defined locally.

References: [1]

Preparation procedure

Documented in source

DOCUMENTARY ONLY; DO NOT COMPOUND. The 80 mg monograph wets four capsule contents with 2–3 mL of the measured 16 mL vehicle, waits 2–3 min, triturates 10–15 min, dilutes progressively and transfers quantitatively using the remaining vehicle. It does not specify q.s. ad 16 mL.

References: [1]

Observations

Documented in source

DISCREPANCY: the supplementary 80 mg note, v2 dated 18/05/2026, states four 125 mg capsules in its method, conflicting with the monograph’s 4 × 80 mg. Publisher clarification is required. Do not substitute bulk aprepitant: this source concerns the specified capsule contents.

References: [1] · [2]

Packaging

Documented in source

Amber type II glass or PET, suitable closure/EnFIT adapter. 2–8 °C, protected from light.

References: [1]

Quality control

Partial evidence

White, homogeneous suspension. Net mass excluding cap/adapter: 18.1–20.1 g with Ora-Blend or 16.6–18.4 g with Ora-Blend SF.

References: [1]

Storage

Documented in source

Amber type II glass or PET, suitable closure/EnFIT adapter. 2–8 °C, protected from light.

References: [1]

Dispensing and directions

Partial evidence

No additional special directions are established beyond the source route, storage and notes. Complete patient details, dose and directions from the prescription.

References: [1]

Labelling

editorial_specimen

Aprepitant 20 mg/mL from 80 mg capsules — source discrepancy
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: Amber type II glass or PET, suitable closure/EnFIT adapter. 2–8 °C, protected from light.
Shake before use.
DRAFT — not a release label.

References: [1]

Sources and traceability

  1. ANSM — Monographie de préparation magistrale (outside Formulaire national)

    v1 • 13/04/2026; note v2 • 18/05/2026 · PDF pp. 1–8; note σελ. / p. 2 · A1

    Review date reported in supplied metadata: 2026-09-10

  2. fr_aprepitant

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–4 · A1

    Review date reported in supplied metadata: 2026-09-10

  3. PN/L/PG/002/00 INDUMENTARIA

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1

    Review date reported in supplied metadata: 2026-09-10

Provenance and reuse

This record comes from the supplied v4 collection. Primary-source rights and licences remain separate. No new comprehensive licence review has been performed for the earlier 239 records.

SHA-256 of the supplied PDF: fe3a26c4d2775b6b111d3592b19271094331a2eae10ea834a77c5b85698c708a

Monograph PDF · GR/ENBlank batch worksheet