Morphine hydrochloride 10 mg/mL (1% w/v) oral solution with simple syrup · CGR-ES-084 (CGR-ES-084)

REFERENCE FORMULA

Reference formula

Reference basis: 100 mL τελικού διαλύματος / 100 mL final solution

Ingredient	Source quantity	Scaled quantity
Morphine hydrochloride, RFE 0097 specification	1 g	—
Simple syrup, CGR-ES-022	30 g	—
Purified water	q.s. ad 100 mL	—

Prerequisite formulations

CGR-ES-022 · Simple Syrup 84% w/v EX022

Documentation

Preparation description

Nonsterile clear oral solution of morphine hydrochloride. The 10 mg/mL strength refers to the hydrochloride salt of the pharmacopoeial raw material. It includes 30 g simple syrup per final 100 mL; it is neither undiluted simple syrup nor a commercial morphine solution. ^[1]

Action and use

Intended for individually prescribed opioid treatment of severe pain after medical assessment. The source includes persistent cancer pain and rescue treatment in appropriately managed patients [1]. Dose, interval and any opioid conversion are clinical decisions, not derived from this preparation sheet [2]. ^{[1], [2]}

Specifications

The source specifies a clear liquid and nominal 1 g/100 mL strength; it gives no numerical pH, water activity, assay acceptance range or microbiology results [1]. Locally record appearance, final volume, pH as a monitoring parameter and checks according to an approved control plan [3]. ^{[1], [3]}

Light

Package in amber glass [1] and retain light protection during storage and supply. Stability in a clear bottle is not established by the monograph; changing the container requires separate assessment. ^[1]

Air and oxidation

Keep the bottle tightly closed [1]. Limited opening and clean withdrawal reduce contamination and evaporation [3]. The source specifies neither oxygen removal, inert gas nor antioxidant addition. Do not introduce such an ingredient without new supporting evidence. ^{[1], [3]}

Water and solubility

Use purified water for initial dissolution and then final-volume adjustment. The 30 g syrup portion is substantially diluted; sucrose presence does not establish self-preservation or aw < 0.60. Avoid tap water, bottle topping-up and returning withdrawn doses. ^{[1], [3]}

Humidity

No numerical humidity sensitivity is supplied for the finished solution. Closure protects composition against volume/environmental changes [1,3]. Calculate API mass from the exact material form and assay certificate; do not apply a speculative correction for water of crystallisation or absorbed moisture. ^{[1], [3]}

Temperature

AEMPS requires refrigeration; the operating target is 2–8 °C. Dissolution does not require heating. Do not transfer another formulation’s room-temperature period. Crystals or turbidity require investigation, not merely warming and resupply. ^{[1], [3]}

pH and compatibility

This monograph supplies no numerical pH specification. Measure and record initial pH for local documentation and batch comparison. Do not invent an acceptance limit or acid/base adjustment; investigate meaningful deviations before release. ^{[1], [3]}

Other interactions

Substitution of sulfate for hydrochloride, use of tablets or addition of a preservative creates a different preparation. Oramorph information supports morphine hazards, not salt equivalence, excipients or this solution’s BUD [2]. Do not mix other treatments into the stock bottle. ^{[1], [2]}

Ingredient-specific information

For the RFE 0097 API, verify hydrochloride identity, hydration state and assay basis on the CoA before approving weighing. No free-base equivalence is asserted. Simple syrup is weighed as 30 g, not measured as 30 mL, and supplies sucrose; assess diabetes/hereditary sugar intolerance using the actual content. ^{[1], [3]}

Staff protection

The active material handled here is morphine hydrochloride. Use dust containment, closed transfers, powder-free gloves and protective clothing for weighing; protect eyes during pouring. A local assessment and the exact SDS determine extraction or respiratory protection. Do not taste-test or handle with bare hands. ^{[2], [3]}

Risk assessment

Potent opioid: respiratory/CNS depression, dependence, constipation and urinary retention [1,2]. Renal/hepatic dysfunction and concurrent benzodiazepines, gabapentinoids or other depressants require clinical review [2]. Critical compounding points are salt/hydrate identity, 30 g syrup, final volume and 10-versus-1 mg/mL confusion. Use independent double checking and restricted access/accountability [3]. ^{[1], [2], [3]}

Compounding conditions

For final volume V mL: 0.010×V g API on the specified material basis, 0.30×V g simple syrup and water to V mL. Water is not automatically 70 mL: syrup is specified by mass and volumes are not assumed additive. Do not add an arbitrary API excess to compensate for losses. ^{[1], [3]}

BUD rationale

AEMPS gives 15 days in a tightly closed refrigerated container [1]. No fully appraisable study matching 10 mg/mL morphine hydrochloride and 30 g simple syrup/100 mL was identified. A different oral-morphine study was located, but its full text was not appraised and is not used to extend the period [4]. The source-specific reference ceiling is 15 days from preparation at 2–8 °C, only with documented local adoption of the exact formula, glass container and controls. Otherwise, the official conservative general fallback is up to 14 days at 2–8 °C [3]. No water-activity or preservative-effectiveness evidence is available. Earlier API/vehicle expiry prevails; opening does not restart the clock. ^{[1], [3], [4]}

Prerequisites

CGR-ES-022: simple syrup. Verify its exact version/composition, batch and expiry before weighing 30 g. Do not substitute preserved syrup, sugar-free syrup or a commercial suspending vehicle. Oral-solution, opioid-handling, cleaning and labelling SOPs are required. ^{[1], [3]}

Equipment

Balance suitable for 1 g API and 30 g viscous syrup, dissolving vessel, stirrer, apparatus for final 100 mL volume, pH meter for recording and amber bottle with oral adaptor. Plan quantitative transfer to account for syrup retained on vessel walls. ^{[1], [3]}

Compounding method

1. Verify and weigh the hydrochloride material. 2. Dissolve in part of the purified water. 3. Add 30 g simple syrup and mix uniformly. 4. Transfer quantitatively and make to a final 100 mL with water; mix. 5. Perform checks, package in amber glass, close and refrigerate. This is not a tablet-based suspension procedure. ^{[1], [3]}

Observations

For a prescription of D mg of the same hydrochloride salt, volume is D/10 mL. This is not a conversion from morphine sulfate, a parenteral route or another opioid. Sucrose per mL is calculated from the approved content of the actual simple syrup, not by assuming 30% sucrose. ^{[1], [2]}

Container and packaging

Amber-glass bottle with tamper-evident closure as specified by AEMPS. Provide a suitable oral-syringe adaptor and child-resistant closure where appropriate. Verify tightness and legibility of the 10 mg/mL strength. ^{[1], [3]}

Quality control

Verify salt identity, weighing reconciliation, final volume, clarity and absence of foreign particles; record pH without an invented limit. Reconcile label, prescription and device and independently check mg-to-mL conversion. Assay and microbiological tests are performed as required by the approved plan; visual inspection cannot replace them. ^{[1], [3]}

Storage

Store at 2–8 °C in a tightly closed amber bottle with secure access. Protect against access by children and unauthorised users. Withhold supply pending investigation if turbidity, crystals, leakage or unexpected deterioration occurs. ^{[1], [3]}

Dispensing

Verify the lawful prescription, exact salt, concentration and clinical plan. Supply an oral dosing syringe with the dose written in mg and mL, not a household spoon. Counsel about constipation, sedation, avoidance of unapproved depressants and urgent help for difficulty waking or breathing. ^{[1], [2], [3]}

Labelling

Morphine hydrochloride 10 mg/mL — ORAL SOLUTION. Contains sucrose. Patient: __. Dose: __ mg = __ mL, frequency: __. Oral use only. Refrigerate at 2–8 °C; tightly closed, protected from light, out of children’s reach. Batch: __. Prepared: __. Use by: __ [approved BUD]. Quantity: __. compounding.gr. ^{[1], [2], [3]}

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: HIDROCLORURO DE MORFINA, SOLUCIÓN ORAL DEFN/2003/FMT/012; current standalone PDF retrieved 2026-10-13PDF p. 2, sections 3–7; subsequent clinical and patient sectionsExact master formula, preparation, source specifications, container and source-specific period; independently adapted, not an official translation2026-10-14
AEMPS CIMA — Oramorph 20 mg/mL solución oral, SmPCCurrent CIMA version retrieved 2026-10-13Sections 4.3–4.9; substance/route scope onlyOral morphine hazards and interactions; commercial product is morphine sulfate with different excipients; no salt-equivalence, dose or stability transfer2026-10-13
Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp. 51–58; especially pp. 54–57Risk-based controls, nonsterile preparation, packaging, independent checks and conservative fallback; Spanish hospital guidance, not Greek legislation2026-10-13
Pourroy B et al. — Availability of Morphine Oral Solution for Childhood Cancer Patients in Low-Income Countries: Compounding and Stability Study in a Cote d’Ivoire University Teaching HospitalJ Pain Symptom Manage 2020;59: e 10–e 13. DOI 10.1016/j.jpainsymman.2019.10.005Bibliographic record retrieved; publisher search extract identifies 1 mg/mL; full text not available in this reviewStudy identified but not sufficiently matched or fully appraised; does not support extending this 10 mg/mL hydrochloride formula2026-10-13
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