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CGR-ES-106 / EDITION 10.0

Barbados aloes dried leaf juice 50 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 dried leaf juice of Aloe barbadensis Mill.50 mg—
Capsule diluent no.1 FN/2003/EX/013q.s. to fill one capsule—
Hard capsule shell1 capsule—

Prerequisite formulations

Documentation

Preparation description
Hard capsule for oral use containing 50 mg of the specified herbal starting material. The source recommends size 2, with capacity verified against the actual batch bulk density. PAF/002 defines concentrated, dried leaf juice with at least 28.0% hydroxyanthracene derivatives as barbaloin on the dried-drug basis. It is a brown powder, not inner-leaf gel or decolourised juice. The 50 mg strength denotes the herbal material, not 50 mg aloin. [1], [3], [7]
Action and use
Stimulant laxative for short-term occasional constipation. HMPC specifies the smallest effective single evening dose within 10–30 mg of hydroxyanthracene derivatives as aloin / barbaloin for adults and adolescents over 12 years; no more than one week, usually only 2–3 doses during that week. HMPC describes a standardised aqueous dry extract, DER 1–3: 1, containing 28.6–36.6% derivatives as aloin. Botanical identity alone does not establish equivalence of every commercial aloe powder to that preparation. Confirm dried-juice identity, manufacturing process, assay and assay basis. This is not a protocol for chronic constipation or bowel preparation. [1], [2], [7]
Specifications
Pharmaceutical material meeting the applicable current RFE/Ph.Eur. specification 0257, 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. Investigate altered odour or colour alongside assay and chromatographic profile; appearance alone does not measure potency. [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. The pH-dependent urine colour reported for anthranoids is not a product-pH or stability specification. [1], [2], [4]
Ingredient-specific information
PAF/002 defines concentrated, dried leaf juice with at least 28.0% hydroxyanthracene derivatives as barbaloin on the dried-drug basis. It is a brown powder, not inner-leaf gel or decolourised juice. The 50 mg strength denotes the herbal material, not 50 mg aloin. HMPC describes a standardised aqueous dry extract, DER 1–3: 1, containing 28.6–36.6% derivatives as aloin. Botanical identity alone does not establish equivalence of every commercial aloe powder to that preparation. Confirm dried-juice identity, manufacturing process, assay and assay basis. [1], [2], [4], [7]
Other interactions
Hypokalaemia from laxative misuse can potentiate cardiac glycosides and affect antiarrhythmics. Diuretics, corticosteroids and liquorice may increase potassium loss. Assess coadministration with QT-prolonging medicines medically. These are clinical interactions, not demonstrated chemical incompatibilities inside the capsule. Do not empirically combine with other anthranoid laxatives. [2]
Risk assessment
Key risks are herb/extract substitution, incorrect assay basis, excessive daily derivatives as aloin / barbaloin, uneven capsule filling and microbial/chemical contaminants in botanical material. Exclude pregnancy, breastfeeding, age below 12 years, intestinal obstruction/stenosis/atony, appendicitis, inflammatory bowel disease, unexplained abdominal pain and severe dehydration. Renal disease and medicines affecting potassium require particular clinical assessment. HMPC reports preclinical genotoxicity findings for some anthranoids; this does not itself establish a particular occupational hazardous-drug classification for the entire herbal material. Document powder exposure, cross-contamination controls and review of the actual material safety data. [2], [4], [5], [6]
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 5 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
Use exact FN/2003/EX/013, register CGR-ES-049: microcrystalline cellulose 98.05 g plus colloidal anhydrous silica 1.95 g per 100 g. Determine the q.s. amount from actual fill volume and record its weighed mass. Do not silently substitute lactose, starch or another diluent. Apply PN/L/FF/001/00, PN/L/OF/002/00 and the applicable deagglomeration/weighing procedures. [1], [3], [5], [9]
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 50 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. Calculate total shell fill volume and make up the difference using deagglomerated EX/013; record actual diluent mass.
5. Mix to demonstrated homogeneity; the POF gives 15–30 minutes according to quantity. Use staged dilution for a low active proportion without adding an unlisted colour marker.
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], [9]
Observations
Reference calculation: derivatives per capsule=50 mg×A/100, where A is the documented percentage as aloin / barbaloin in material as weighed. Convert a dry-basis assay using the appropriate documented moisture/loss-on-drying basis before this calculation. A pharmacopoeial minimum assay is not the measured batch value. The pharmacist selects a whole-capsule count giving the smallest effective permitted dose; if this strength cannot provide a lower dose, another documented formulation is needed. Numerical batch scaling does not establish new stability. [1], [2], [4], [7]
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 Aloe barbadensis Mill., folii succus siccatus, 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
Before supply verify derivative potency, suitability of strength, age, pregnancy/breastfeeding, bowel symptoms, hydration and concomitant medicines. Swallow with water. Do not use beyond 7 days or increase dose by capsule count alone. Stop and seek medical assessment for severe/persistent pain, vomiting, bleeding, severe diarrhoea, worsening or failure to defecate. Explain that product storage period is not treatment duration. [1], [2], [7]
Labelling
Sample:‘Barbados aloes dried leaf juice 50 mg — hard capsules—oral use. Quantity:[…]capsules. Directions:[approved for the actual patient and potency]. Do not use in pregnancy/breastfeeding or below 12 years. Maximum treatment duration 7 days. 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]
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 — ÁLOE DE BARBADOS, CAPSULAS DURAS DEFN/2003/POF/001; 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 — Aloe barbadensis Mill., folii succus siccatusEMA/HMPC/625788/2015; final, 22 November 2016§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-14
  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 Aloe barbadensis Mill., folii succus siccatusFN/2003/PAF/002PDF 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. AEMPS — Excipiente n.º1 para cápsulasFN/2003/EX/013PDF p.2, §§3–7Microcrystalline cellulose 98.05% +colloidal anhydrous silica 1.95% powder blend; exact dependency CGR-ES-0492026-10-13
  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