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CGR-ES-112 / EDITION 10.0

Fennel fruit 250 mg — hard capsules

Hard capsules for oral use · Spain · AEMPS

2026-10-14Reference document · Local adoption required

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 10.0Record editorial review date: 2026-10-14

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REFERENCE FORMULA

Reference formula

Reference basis: Ανά 1 καψάκιο / Per 1 capsule

IngredientSource quantityScaled quantity
Powdered fennel fruit, specified variety250 mg—
Hard capsule shell1 capsule—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description
Hard capsule for oral use containing 250 mg of the specified herbal starting material. The source recommends size 00, with capacity verified against the actual batch bulk density. AEMPS permits bitter or sweet fennel fruit complying with RFE 0824 or 0825 respectively. Specify one variety and actual batch identity; do not silently blend them. Whole-fruit powder contains volatile oil with anethole, fenchone and variable estragole. It is not essential oil, an extract or aniseed. [1], [3], [7]
Action and use
AEMPS records capsule use for dyspeptic symptoms and flatulence. The adopted HMPC monographs for sweet and bitter fennel concern fruit infusion as herbal tea, not swallowed powder capsules. Tea dosing and exposure assessment cannot be transferred to 250 mg of powder. This capsule entry requires a separate clinical assessment. This is a documented formulation reference, not confirmation of efficacy or safety of a particular capsule dose. [1], [2], [9]
Specifications
Pharmaceutical material meeting the applicable current RFE/Ph.Eur. specification 0824 / 0825, according to variety, with traceable identity and batch. Numerical PAF descriptions are facts from the retrieved source, not a claim that the current licensed pharmacopoeial text was checked. Capsules must be closed and intact, without surface powder, agglomeration or leakage. The POF does not specify final-shell colour, numerical pH or aw. Establish identity, assay/marker, uniformity and microbial-quality acceptance criteria before manufacture. [1], [3], [4], [7]
Light
Protect the finished capsules and starting material from light. Select packaging with documented light protection or a suitable outer carton. No formulation-specific photodegradation rate is established by these sources. [1], [7]
Air and oxidation
Keep containers closed between weighing and sampling operations. The source requires neither nitrogen nor an antioxidant and establishes no separate allowable air-exposure period. For fennel, minimise unnecessary exposure to preserve the fruit volatile fraction. [1], [4], [7]
Water and solubility
No water is added to this composition. Retain the powder dosage form; it is not an oral suspension. Equipment must be fully dry after wet cleaning before contact with the herbal powder or capsule shell. Assess any wetted or leaking batch before use. [1], [3], [5]
Humidity
Manufacturing relative humidity:≤60%. Protect from moisture during storage. Monitor powder caking, brittle/soft shells and packaging moisture-barrier performance. Room relative humidity and loss on drying are not measurements of finished-capsule water activity. [1], [3], [4]
Temperature
Prepare at 25±5 °C under the general capsule procedure, subject to stricter material/shell requirements. Source storage is below 30 °C. Capsule manufacture uses no heat treatment; heating the herbal material is not a substitute for microbial-quality control. [1], [3], [4]
pH and compatibility
No pH is assigned to this dry finished dosage form, and no buffer is specified. If an aqueous-dispersion pH method is developed for raw-material testing, define ratio, solvent and method; the result is not the pH of the capsule. Do not adjust pH as a means of reducing estragole. [1], [2], [4]
Ingredient-specific information
AEMPS permits bitter or sweet fennel fruit complying with RFE 0824 or 0825 respectively. Specify one variety and actual batch identity; do not silently blend them. Whole-fruit powder contains volatile oil with anethole, fenchone and variable estragole. It is not essential oil, an extract or aniseed. The adopted HMPC monographs for sweet and bitter fennel concern fruit infusion as herbal tea, not swallowed powder capsules. Tea dosing and exposure assessment cannot be transferred to 250 mg of powder. This capsule entry requires a separate clinical assessment. [1], [2], [4], [7], [9]
Other interactions
Screen for allergy to fennel, anethole and Apiaceae such as celery, aniseed, caraway, coriander and dill, and cross-reactivity with mugwort pollen. HMPC reports no interactions; this is not proof that every capsule combination has been assessed. Do not replace fruit with essential oil. [2], [9]
Risk assessment
Key risks are botanical/variety substitution, unquantified estragole exposure, skin or respiratory allergy, sieving dust and botanical contaminants. HMPC treats estragole as a genotoxic carcinogen in rodents and calls for exposure as low as practically achievable. Estragole content has not been established for this capsule. Current precautions do not support pregnancy/breastfeeding use or transfer of paediatric tea doses to capsules. Clinical adoption requires variety identity, estragole assay, intended daily amount and a documented capsule-specific risk assessment. [2], [4], [7], [9]
Staff protection
During weighing, sieving, mixing and removal of surface powder, use enclosed/contained handling with appropriate local dust control, sleeved gown, hair cover, gloves and eye/respiratory protection selected from the exposure assessment. The source procedure requires a mask and goggles for powder-producing operations. A respirator class or exposure limit is not invented without the actual SDS. Clean between different herbal materials and verify complete drying of equipment. [3], [5], [6]
Compounding conditions
Formula basis: one capsule. For 100 capsules use 25 g of the specified starting material for the source composition; do not change herbal mass to a target marker dose without a documented new formulation, and do not add arbitrary overage. Environment 25±5 °C,RH≤60%. Verify balance suitability, starting-material identity, capsule count and actual fill volume. Weigh recovery after sieving/deagglomeration. The master manufacturing record fixes shell supplier/type and blending method. [1], [3], [5]
BUD rationale
This POF gives 3 calendar months under optimal preservation, below 30 °C and protected from light/moisture. The selected reference ceiling is 89 days and never later than 3 calendar months, conditional on matching the starting material/composition, shell, process, suitable packaging and source quality controls. No published stability study was identified in this search supporting a longer period for the exact finished capsule/container. This is adoption of an official formulary period, not independent laboratory certification. Shorten for ingredient expiry, failed QC, storage excursions or other evidenced limits. No aw was measured. USP<795> alternative requires aw-category justification. Capsule aw was not established in this work. A different composition/packaging requires fresh justification and, where needed, marker/degradant, disintegration and microbial-quality studies. Editorial convention: calendar-month source periods are retained as calendar periods; the calendar-period conversion ceiling is 28 days for one month or 89 days for three months; a separately selected shorter ceiling still governs. It is a conservative conversion, not a source quotation. [1], [3], [4], [10]
Prerequisites
The listed formula contains only the specified herbal powder and capsule shell. Do not add CGR-ES-049 without a documented formula revision. Apply PN/L/FF/001/00 and weighing, with sieving/deagglomeration and mixing where necessary. A cited RFE monograph identifies required raw-material compliance; it does not replace the actual batch certificate. [1], [3], [5], [7]
Equipment
Suitable calibrated balance, graduated cylinder for apparent volume, clean mortar/pestle or mixer, spatula and capsule filler compatible with the shells. The POF specifies sieve(355) or an oscillating sieving device. Provide temperature/RH recording and facilities for mass, integrity and, under the QC programme, disintegration and microbial-quality testing. [1], [3], [5]
Compounding method
1. Verify raw-material identity/quality, shells, calculations and a clean dry work area.
2. Weigh 250 mg per intended capsule multiplied by batch count. Sieve/deagglomerate where necessary and verify recovered mass.
3. Measure apparent volume using the source standardised method; never assume 1 g=1 mL.
4. Quantitatively distribute the specified powder into shells. The recommended size must be verified against apparent volume/mass. If the target mass cannot be filled uniformly, reassess size/process without an undeclared excipient.
5. Maintain powder homogeneity and minimise segregation during filling.
6. Fill, close and gently remove exterior powder under dust control.
7. Check yield, integrity, mass uniformity and specified additional QC. Package and label only after the responsible pharmacist reviews the batch. [1], [3], [5]
Observations
Neither volatile-oil yield nor anethole percentage substitutes for estragole assay. Exposure calculation: daily estragole(μg)=daily powder(mg)×[estragole(μg/g powder)]/1000. Concentration must be measured for the actual batch using a valid method. Tea doses or extraction factors are not inserted into this swallowed-powder calculation. [2], [4], [7], [9]
Container and packaging
The POF allows a blister or capped bottle. Select a pack protecting against light/moisture and compatible with the specific shell; the source does not identify polymer, glass type or blister laminate. Record supplier, pack code/barrier, closure integrity and capsule count. Do not automatically add desiccant, which may affect the shell; document compatibility. [1], [3], [4]
Quality control
Starting material: identify Foeniculum vulgare Mill. subsp. vulgare var. vulgare OR var. dulce, fructus, verify specifications and quantitatively determine relevant constituents/markers. Assess microbial burden, mycotoxins, pesticides, elemental impurities and adulteration under the applicable specification and risk assessment. Finished product: organoleptic/visual examination, closure integrity, yield/count and mass uniformity using the method referenced by the source procedure(RFE 2.9.5). For batches, that procedure adds disintegration(RFE 2.9.1), microbial quality(RFE 5.1.4) and active-specific controls. Mass uniformity alone does not demonstrate activity uniformity. Extending the period requires suitable degradation-discriminating methods, actual-container studies and justified limits, not visual inspection alone. [1], [3], [4], [7]
Storage
Below 30 °C, protected from light and moisture in the qualified closed pack. Refrigeration/freezing has not been established as an alternative for this formula. Keep temperature records and investigate excursions, moisture or shell changes before supply. Calculate the actual batch beyond-use date separately. [1], [3], [4]
Dispensing
Supply only after separate swallowed-powder assessment, estragole documentation and an approved individual instruction. Do not derive a paediatric capsule dose from tea dosing. Screen Apiaceae/mugwort allergy and pregnancy/breastfeeding. Swallow with water; do not substitute essential oil; seek assessment for persistent or worsening symptoms. Botanical origin is not evidence of safety. [1], [2], [9]
Labelling
Sample:‘Fennel fruit 250 mg — hard capsules—oral use. Quantity:[…]capsules. Directions:[approved for the actual patient and potency]. Contains fennel(Apiaceae). Capsule directions require a specific clinical assessment. Store below 30 °C, protected from light/moisture. Keep out of reach of children. Batch:[…]. Prepared:[…]. Use by:[…]. Pharmacy/contact:[…].’ State the specific herbal material, actual potency where required, and declarable excipients/shell components. Dates and batch fields remain blank until actual manufacture. [1], [2], [8], [9]
v9_controls
The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.

Ανεξάρτητη ελληνική/αγγλική επιστημονική προσαρμογή πηγών AEMPS και EMA από το compounding.gr — Στασινός Χρ.Σικαλιάς. Δεν αποτελεί επίσημη μετάφραση ή έγκριση των φορέων. / Independent Greek/English scientific adaptation of AEMPS and EMA sources by compounding.gr — Stasinos Chr.Sikalias; not an official translation or endorsement.

Sources and references

  1. AEMPS — Formulario Nacional — FRUTO DE HINOJO, CÁPSULAS DURAS DEFN/2003/POF/007; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
  2. EMA/HMPC — European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus, Revision 1EMEA/HMPC/372839/2016; final revision 1, 31 January 2024§§2–4; §5.3; fennel additionally §6Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
  3. AEMPS — Elaboración de cápsulas durasPN/L/FF/001/00; current official standalone PDFPDF pp.3–5, §§4.2–4.6Preparation environment, volume-based capsule selection, encapsulation and source QC requirements2026-10-13
  4. EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal productsEMA/HMPC/CHMP/CVMP/201116/2005 Rev.3; final 18 January 2022§§3,5,7,8; PDF pp.5–15Herbal-material identity, standardisation, contaminants, finished-product controls and stability principles; not a numerical BUD study for this capsule2026-10-13
  5. AEMPS — Mezclado de polvosPN/L/OF/002/00; current official standalone PDFPDF pp.3–5, §§4.2–4.4Powder mixing, dilution sequence, cross-contamination controls and drying after cleaning2026-10-13
  6. AEMPS — IndumentariaPN/L/PG/002/00; current official standalone PDFPDF p.3, §4Clothing, gloves and eye/respiratory protection during powder handling2026-10-13
  7. AEMPS — Herbal starting material Foeniculum vulgare Mill. subsp. vulgare var. vulgare OR var. dulce, fructusFN/2003/PAF/008PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
  8. AEMPS — EtiquetadoPN/L/PG/008/00; current official standalone PDFPDF pp.3–4, §4Label identifiers and patient instructions; Spanish procedural model adapted independently2026-10-13
  9. EMA/HMPC — Foeniculum vulgare subsp. vulgare var. vulgare, fructusEMA/HMPC/372841/2016; final revision 1,31 January 2024§§2–4,5.3,6Bitter-fennel tea scope, allergy, estragole and pregnancy/lactation precautions; not capsule efficacy or stability2026-10-13
  10. USP compounding update — public NABP webinar handout14 September 2023; presentation by USP expertsPDF pp.10–11, slides 19–22Public explanation of aw-dependent BUD categories; not the full licensed chapter, not a Greek legal requirement and not stability evidence for this capsule2026-10-13
  11. USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14