REFERENCE FORMULA
Reference formula
Reference basis: 100 mL τελικού παρασκευάσματος / 100 mL final preparation
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Chloral hydrate, pharmacopoeial quality | 5 g | — |
| Acacia mucilage 10% in sodium chloride 0.9% solution | q.s. ad 100 mL | — |
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Clear, viscous rectal solution containing 50 mg chloral hydrate per mL. The vehicle is acacia mucilage in saline; the oral syrup vehicle and flavour are absent. Strength expresses chloral hydrate mass per final volume. [1]
Action and use
AEMPS describes sedative/hypnotic use in children undergoing diagnostic procedures, with administration restricted to a healthcare service providing appropriate monitoring [1]. A patient-specific prescription must specify rectal administration. UK oral-product information supplies safety context and does not authorise this enema [2]. [1], [2]
Specifications
Theoretical content is 5 g/100 mL = 50 mg/mL. The source specifies a clear, viscous liquid, without numerical pH, viscosity, osmolality or assay limits. Sodium chloride 0.9% is the vehicle solvent; it does not establish isotonicity of the finished mixture. Clarity does not establish chemical or microbiological suitability. [1]
Light
Protect the finished preparation from light in an amber glass bottle, including any temporary storage before supply. No permissible light-exposure period is specified. [1]
Air and oxidation
Close raw-material and preparation containers promptly to limit moisture uptake by the starting material, water evaporation and transfer-related contamination. The monograph specifies no inert atmosphere or oxygen limit. [1]
Water and solubility
Use mucilage in sodium chloride 0.9%, not mucilage in plain water. Do not add water to dilute a dose or correct viscosity without a separate approved instruction. The source provides neither measured water activity nor an antimicrobial effectiveness test for this aqueous composition. [1]
Humidity
Chloral hydrate is strongly hygroscopic and is weighed immediately before use. The source sets room relative humidity at ≤ 60%. Record the reading and minimise open-container time during weighing. [1]
Temperature
Preparation environment: 25 ± 5 °C in the AEMPS method. Finished-product storage: room temperature no higher than 25 °C, protected from light. The upper preparation-room limit of 30 °C is not an allowable storage temperature. The method does not require heating the drug. [1]
pH and compatibility
There is no numerical pH specification for this vehicle. Recording initial pH with a calibrated instrument is proposed for trending, without inventing an acceptance range. A study of a simple 5% aqueous solution found pH decline during storage [5]; it supplies no mucilage pH target and does not justify adding a buffer. [1], [5]
Other interactions
Ingredient-specific information
Chloral hydrate is the sedative active ingredient and requires pharmacopoeial identity and batch certification. Acacia supplies viscosity; saline remains its specified preparation medium. No added preservative is listed. Check patient sensitivity to the drug and gum, and document each ingredient’s exact grade and lot. [1]
Staff protection
During weighing use local extraction, gloves and eye protection; avoid dust. ICSC records toxicity and carcinogenic/genotoxic hazards. Minimise exposure and apply the actual raw-material SDS [3]. [3]
Risk assessment
Critical errors include confusion with the 100 mg/mL oral preparation, wrong route and mg-to-mL conversion. A prescribed D mg corresponds to D/50 mL and requires independent checking. The source flags respiratory depression, arrhythmias and airway obstruction in susceptible children [1]. Renal/hepatic impairment and severe heart disease require contraindication review; other sedatives and coumarins require interaction review. Rectal administration does not remove the concern about neonatal metabolic immaturity [2]. [1], [2]
Compounding conditions
Execute under an approved master record, checked vehicle calculation and suitable equipment for a nonsterile rectal liquid. For V mL, drug mass is 0.05×V g and the specified vehicle makes up the final volume. Do not treat 100 mL vehicle as an amount to add on top of the drug. Record temperature, humidity and theoretical yield. [1]
BUD rationale
AEMPS assigns 15 days in a closed container at no more than 25 °C, protected from light [1]. Adopt this source-specific limit, shortened by any earlier material/vehicle expiry. Yoshida studied 5% in water for injection without gum or sodium chloride and proposed 30 days in glass at 4 °C in darkness; this does not support extending this mucilage [5]. No in-use period or measured aw is established. The present handling instruction is to use immediately after first opening and discard the remainder; this is a conservative local policy, not a study result. Application requires local adoption of the exact composition, method, container and controls; it is not a Greek legal rule or laboratory validation. [1], [5]
Prerequisites
Dependency: acacia mucilage 10% in sodium chloride 0.9%, prepared within this formula. Do not substitute plain-water mucilage or another thickener. AEMPS gives no separate vehicle code or full individual-charge table; the approved gum/saline calculation must document the basis of 10% and final yield. [1]
Equipment
Calibrated balance, mortar and pestle, stirring rod, beaker, suitable clarifying filter, final-volume measuring vessel and amber glass screw-cap bottle. Use a thermohygrometer for room limits and a pH meter if the proposed trending check is adopted. [1]
Compounding method
1. Verify the approved calculation for 10% acacia mucilage in sodium chloride 0.9%. Gradually incorporate three quarters of the calculated saline into the gum in a mortar with continuous mixing, then filter the intermediate as specified by the source.
2. Weigh 5 g chloral hydrate immediately before use and dissolve in the mucilage.
3. Add the remaining calculated saline, ensuring the prescribed vehicle composition and 100 mL final preparation are achieved. Homogenise.
4. Check clarity, final volume and batch documentation; pack in amber glass with a screw cap. This filtration is not sterilisation. [1]
2. Weigh 5 g chloral hydrate immediately before use and dissolve in the mucilage.
3. Add the remaining calculated saline, ensuring the prescribed vehicle composition and 100 mL final preparation are achieved. Homogenise.
4. Check clarity, final volume and batch documentation; pack in amber glass with a screw cap. This filtration is not sterilisation. [1]
Observations
This is a reference preparation for specifically supervised sedation, not a substitute for a clinical protocol. The source professional section does not list gastric ulceration as a rectal contraindication, whereas its patient leaflet does; obtain clinical assessment when relevant to the patient. Its Spanish psychotropic classification does not establish Greek legal status. [1], [4]
Container and packaging
Quality control
Before release, independently check identity/lots, 50 mg/mL calculation, mucilage/saline composition, final volume, clarity, absence of visible foreign particles, viscous appearance, closure and rectal labelling. Record any measured pH as a baseline without inventing a pharmacopoeial limit. Assay and microbiological testing require suitable laboratory methods/specifications; no such testing was performed in this work. [1], [5]
Storage
Store closed in amber glass at room temperature no higher than 25 °C, protected from light, in a controlled area preventing unauthorised access. Refrigeration does not justify an extension. After first opening apply the immediate-use/discard instruction. [1]
Dispensing
Supply to the responsible clinical service against a patient-specific order stating drug, mg, mL and rectal route. Administration requires appropriate respiratory/circulatory monitoring and capacity to manage deterioration. It is not intended for unsupervised home sedation. Respiratory difficulty, unexpectedly prolonged sedation or suspected overdose requires urgent medical assessment. [1], [2]
Labelling
CHLORAL HYDRATE 50 mg/mL — ENEMA. FOR RECTAL USE ONLY. Volume: ___ mL. Patient/dose: ___ mg = ___ mL, only as ordered by the clinical team. Batch: ___. Prepared: ___. Use by: ___ (maximum 15 days, closed). Store at no more than 25 °C; protect from light. Use immediately after opening; discard remainder. Administration only in a monitored healthcare service. Keep out of reach of children. [1]
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.
Sources and references
- AEMPS — Formulario Nacional, FN/2003/FMT/037: Hidrato de cloral, enemaModificado 2022PDF pp. 2–4; §§3–12 and patient leafletExact master formula, source method, container, 15-day closed-container period and route-specific safety2026-10-14
- MHRA — Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication6 October 2021Advice for healthcare professionals; Off-label use for sedation in childrenCurrent clinical context; prolonged metabolite half-life in infants. UK oral-product authorisation is not a rectal authorisation.2026-10-13
- ILO/WHO — International Chemical Safety Card 0234: Chloral hydrateApril 2013 card; accessed 2026Prevention; Chemical dangers; Exposure and health effectsOccupational handling of chloral hydrate CAS 302-17-0; raw-material hazards, not a finished-mixture CLP classification.2026-10-13
- Marlborough Pharmaceuticals — Chloral Hydrate 500 mg/5 mL Oral Solution, SmPCSmPC revised 17 August 2026; emc update 24 August 2026Sections 4.1–4.6, 4.8, 5.2Authorised oral-product safety. Its excipients, dosing and shelf-life are not substituted for this compounded formulation.2026-10-13
- Yoshida N, Arai K, Kohda Y. Stability of Chloral Hydrate in Aqueous Solution for Rectal Use. Jpn J Hosp Pharm. 2000;26: 198–2012000; DOI 10.5649/jjphcs 1975.26.198Full text pp.198–201, especially preparation p.199 and Tables 1–25% chloral hydrate in distilled water for injection, without acacia or saline; nonmatching formulation. Chemical assay and pH, not preservation validation.2026-10-13
- 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