Ispaghula husk with fructose/maltodextrin — powder for oral suspension · CGR-ES-109 (CGR-ES-109)

REFERENCE FORMULA

Reference formula

Reference basis: Official formula input quantities:100.1 g solids plus 4 drops essential oil; record actual final yield

Ingredient	Source quantity	Scaled quantity
Ispaghula seed husk (Plantago ovata), powdered	60 g	—
Fructose	20 g	—
Maltodextrin	20 g	—
Tartaric acid	100 mg	—
Ceylon cinnamon essential oil	4 drops	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Dry fine light-beige mixture containing Plantago ovata seed husk, fructose, maltodextrin, tartaric acid and cinnamon oil. The 60 g quantity is documented in the official 2019 edition and current leaflet composition. Inputs do not define exactly 100 g finished product; record actual yield. ^{[1], [8]}

Action and use

HMPC recognises well-established use of Plantago ovata husk for habitual constipation and conditions requiring soft stool, and adjunctive increased fibre intake in selected supervised settings. For constipation:7–11 g husk/day in adults/adolescents and 3–8 g in children 6–12, with verified delivered husk mass. Do not transfer P.afra/P.indica seed doses. A blend containing excipients does not automatically have the same gram dose as pure husk.

Adjunctive increased-fibre, irritable-bowel or hypercholesterolaemia use is not recommended below 12 years. Hypercholesterolaemia requires medical supervision; the 6–12-year dose concerns constipation/easier passage of soft stool. ^{[2], [3]}

Specifications

Husk against RFE/Ph.Eur.1334; fructose 0188, maltodextrin 1542, tartaric acid 0460 and Ceylon cinnamon oil 1501. The historical official source documents these identities. Specify authenticity, dryness, homogeneity, actual yield and appropriate swelling index. Obtain numerical limits from the current pharmacopoeia; do not invent aw or pH. ^{[1], [2], [3], [4], [8]}

Light

Protect dry powder from light, using opaque secondary packaging when necessary. Assess the whole mixture, including the small flavouring fraction; no quantitative photostability study of this exact formula was found. ^{[1], [4]}

Air and oxidation

Tight closure limits moisture transfer, dust and volatile-oil odour loss. Avoid prolonged open handling after adding flavour. No oxygen limit or inert atmosphere is specified. ^{[1], [4]}

Water and solubility

Swelling mucilage requires fluid at administration; no water is added to the stored powder. HMPC requires at least 30 mL fluid per 1 g husk and adequate daily hydration. Adding water to the entire batch creates a different preparation with no established BUD. ^{[1], [3]}

Humidity

Prepare at not above 60% relative humidity; protect from moisture and reclose promptly. Fructose, maltodextrin and mucilage can affect clumping/flow after moisture exposure. Ambient RH is not a product aw measurement. ^{[1], [6]}

Temperature

Prepare at 25±5 °C and store below 30 °C. No heating is required; added heating or wet drying is outside this formula. Do not freeze/refrigerate the dry powder without container/condensation assessment. ^{[1], [6]}

pH and compatibility

No dry-powder pH is specified. The 100 mg tartaric acid does not establish suspension pH without a defined water quantity and measurement. Do not classify tartaric acid as an antimicrobial preservative. ^{[1], [4]}

Other interactions

Ispaghula may delay intestinal drug absorption: separate ½–1 hour from other oral medicines. Thyroid hormones, antidiabetic therapy and medicines inhibiting peristalsis require specific review. P.ovata husk and whole P.afra/P.indica seed are not dose-equivalent. ^[3]

Ingredient-specific information

Husk comprises episperm and adjacent layers removed from Plantago ovata Forssk. seeds, rich in arabinoxylans; it is not whole seed. Fructose 20 g and maltodextrin 20 g are substantial blend fractions, requiring carbohydrate-exposure/HFI review. Tartaric acid 100 mg and 4 oil drops require uniform distribution and defined raw material. ^{[1], [2], [3], [4], [7], [8]}

Staff protection

Inhaled ispaghula powder can cause occupational sensitisation and serious reactions. Use controlled extraction/enclosed handling, gloves, clothing and appropriate respiratory protection based on exposure assessment. Avoid open sieve shaking, compressed air and dry sweeping. Sensitised staff must avoid exposure. ^{[1], [3], [6]}

Risk assessment

Critical risks are allergenic powder, anaphylaxis, choking and oesophageal/intestinal obstruction when taken with insufficient fluid. Contraindications include swallowing disorders, narrowing/obstruction, megacolon, unexplained bleeding or unexplained altered bowel habits. Diabetes and thyroid treatment require supervision. Additional risks are variable final yield, unspecified flavour drops, inaccurate scoop and fructose exposure. Because it contains fructose, patients with hereditary fructose intolerance should not take the product. ^{[1], [3], [4], [7]}

Compounding conditions

Use fully dry equipment. Separately weigh 60 g husk, 20 g fructose, 20 g maltodextrin and 0.100 g tartaric acid; add 4 drops of defined oil. Do not subtract 0.1 g excipient to force an artificial 100-g total. Record drop system, recovery, actual yield and calculation of husk content per administered unit.

Recovered mass alone does not establish the final husk fraction. Do not divide the initial 60 g by a lower recovered yield: nonselective homogeneous losses remove botanical material as well and preserve the initial mass fraction. Dose conversion requires exact total inputs including documented oil-drop mass, and an approved mass balance/representative quantitative confirmation of composition. ^{[1], [3], [6], [8]}

BUD rationale

The official source gives 3 months for dry powder below 30 °C, protected from light/moisture. Use a register ceiling of 89 days, not exceeding 3 calendar months or the earliest ingredient expiry. This is an official-formula period; no matching exact-formula/container study or measured aw was found. Do not automatically select 180 days merely because the product appears dry. Consume the individual reconstituted dose immediately and do not store it. Different oil, quantities, container or premixed liquid requires new evidence.

The 89 days are only a conditional source reference period for dry powder. No operational batch date is assigned before approval of actual composition, drop system, recovery mass balance and dose conversion. 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], [4], [5]}

Prerequisites

Local SOPs for botanical identity, weighing, sieving, powder blending, allergen control, cleaning and labelling. Add no prepared oral vehicle. The 4-drop operation needs an identified dispenser; automatic proportional scaling is unavailable without an acceptable volumetric/gravimetric basis. ^{[1], [3], [6]}

Equipment

Calibrated balances for bulk quantities and 100 mg acid, 355-µm sieve, dry enclosed small mixer or mortar, spatulas, defined dropper and appropriate container. Supply requires a dosing device with verified delivered mixture mass. ^{[1], [6]}

Compounding method

1. Identify husk material and sieve dry powder through 355 µm with dust controls. 2. Break fructose/maltodextrin agglomerates. 3. Predisperse the small acid/flavour fractions in part of the excipient, then combine all components in a dry system. 4. Source mixing time is 15–30 minutes according to batch size; verify uniformity. 5. Weigh recovery, test and package. Add no water or additional solvent to the stored blend; add only the specified four drops of identified cinnamon oil. ^{[1], [6], [8]}

Observations

Recovered mass alone does not establish the final husk fraction. Do not divide the initial 60 g by a lower recovered yield: nonselective homogeneous losses remove botanical material as well and preserve the initial mass fraction. Dose conversion requires exact total inputs including documented oil-drop mass, and an approved mass balance/representative quantitative confirmation of composition. ^{[1], [8]}

Container and packaging

Pharmaceutical wide-mouth bottle with tight closure and suitable moisture barrier. Source does not specify container material. Provide light protection and a separate dry dosing device; unit-dose sachets are a distinct implementation requiring filling documentation. ^{[1], [4]}

Quality control

Verify species/plant part and pharmacopoeial quality. Check appearance, clumping, actual mass, representative-sample homogeneity and mass delivered by the dosing device. Swelling/mucilage behaviour, moisture and microbiological quality are relevant controls. The source gives no pH, aw or numerical final-blend-uniformity limits; define them in an approved specification. ^{[1], [2], [3], [4], [6]}

Storage

Store dry blend below 30 °C, away from light/moisture, reclose immediately. Use a dry scoop/device. Do not store the reconstituted suspension. Investigate changed flow, clumping, moisture or unusual odour. ^{[1], [4]}

Dispensing

The professional specifies individual actual husk grams and corresponding mixture mass. Mix the dose in suitable fluid and drink immediately, with at least 30 mL fluid per g husk. Never swallow dry powder or take immediately before bed. Separate ½–1 hour from other medicines. HMPC does not recommend use under 6; verify swallowing ability and hydration. Seek advice if constipation persists 3 days or pain/vomiting occurs. ^[3]

Labelling

Ispaghula (P. ovata) — powder for oral suspension. Dose:____ g mixture, equivalent to____ g husk by approved calculation. Mix and drink immediately with at least 30 mL fluid per g husk. Do not swallow dry. Contains fructose/maltodextrin and cinnamon essential oil. Below 30 °C; protect from light/moisture. Batch____. Prepared____. Use by____. Keep out of children’s reach. Do not use in hereditary fructose intolerance. ^{[1], [3], [7], [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.

Independent Greek/English scientific synthesis crediting AEMPS with supporting evidence. This is not an official translation, marketing authorisation or publisher endorsement. Stasinos Chr.Sikalias — compounding.gr.

Sources and references

AEMPS Formulario Nacional — FN/2003/POF/004 Cutícula de ispágula, polvo para suspensión oral deSourceFN/2003; current standalone PDF reviewed 13 October 2026PDF pp.2–4; process/storage/validity; patient leaflet p.4 corroborates 60 gCurrent factual process and patient composition; current master-table quantity discrepancy is not adopted; reference 8 provides actual historical master quantity2026-10-14
AEMPS Formulario Nacional — FN/2003/PAF/009 Ispágula, cutícula seminal deFN/2003; current official standalone PDF reviewed 13 October 2026PDF pp.2–3; plant part, identity, RFE1334 and handlingPlantago ovata seed husk, rather than whole seed; older clinical doses independently reassessed2026-10-14
EMA/HMPC — Community herbal monograph on Plantago ovata Forssk., seminis tegumentum14 May 2013; EMA/HMPC/199774/2012PDF pp.3–8; indications, form, doses, contraindications and occupational allergyCurrent adopted husk-specific scientific reference; not authorisation or exact-blend stability evidence2026-10-13
EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal products, revision 318 January 2022; EMA/HMPC/CHMP/CVMP/201116/2005 Rev.3PDF pp.9–10 and 12–16; sections 5.1,7,8Identity, contaminants, justified specifications, chromatographic fingerprint and multi-component stability principles; numerical shelf life not supplied2026-10-13
USP Compounding Expert Committee — USP Compounding Webinar, NABP public handout14 September 2023; primary-author public educational handoutPDF pp.10–11, slides 19–22General aw-dependent BUD framework comparator; not full licensed USP795 text, Greek law, or measured stability/aw for this formulation2026-10-13
AEMPS — PN/L/OF/002/00 Mezclado de polvosPN/L/OF/002/00; current official PDF reviewed 2026-10-13PDF pp.3–5; environment, mixing and cleaningPowder blending, cross-contamination prevention, equipment and complete drying2026-10-13
EMA — Annex to European Commission excipient labelling guideline, Revision 5SANTE-2017-11668, Revision 5; published 5 December 2025English worksheet, rows 47–50: fructose declaration, exposure and hereditary fructose intoleranceCurrent fructose labelling/clinical precautions; not a product-specific BUD or efficacy approval2026-10-13
AEMPS/BOE — Formulario Nacional,2 nd edition, October 2019 official publicationSecond edition; October 2019 updatePrinted p.609; PDF p.623; FN/2003/POF/004§§3.1–3.2Historical quantitative facts:60 g husk and correct raw-material identities. No publisher erratum or permission to reproduce the bound book is claimed. No protected prose/layout is reproduced.2026-10-14
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