FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Monographs / Lidocaine HCl 1% compound buccal suspension · CGR-ES-085

CGR-ES-085 / EDITION 10.0

Lidocaine HCl 1% compound buccal suspension

Buccal/oropharyngeal suspension · 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

Download bilingual PDFJSON

REFERENCE FORMULA

Reference formula

Reference basis: 100 mL finished suspension

IngredientSource quantityScaled quantity
Lidocaine hydrochloride1 g—
Aluminium hydroxide, pharmaceutical raw material7 g—
Diphenhydramine hydrochloride0.25 g—
Glycerol10 g—
Carmellose sodium1 g—
Sodium methyl parahydroxybenzoate0.1 g—
Saccharin sodium0.1 g—
Peppermint essential oil0.20 mL—
Purified waterq.s. ad 100 mL—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description
Whitish suspension containing lidocaine HCl 10 mg/mL, diphenhydramine HCl 2.5 mg/mL and nominal aluminium hydroxide 70 mg/mL. Redisperse the solid before each dose and filling operation. [1]
Action and use
FN describes local analgesia/anaesthesia for mucositis and oral ulcers. It does not validate every “magic mouthwash”. Prescriber must specify expectoration versus swallowing; it is not routinely supplied for teething. [1], [4]
Specifications
Source: whitish suspension, pH 6–7. Local checks include 100 mL final volume, uniform redispersion, no persistent cake and no free oil droplets. Numeric particle-size and API-assay limits are not supplied. [1]
Light
Use amber glass and protect from light as specified. An acceptable exposure-time threshold is not established. [1]
Air and oxidation
Close tightly and limit aeration to avoid foam and volatile-oil loss. Do not judge uniformity while the sample remains foamy. [1]
Water and solubility
Aqueous preparation: purified water to final 100 mL after incorporation of solids, not 100 mL water added on top. Glycerol 10 g does not establish low aw. [1], [5]
Humidity
Keep carmellose/salts closed before weighing to limit moisture-related caking and inconsistent hydration/dispersion. FN supplies no numeric relative-humidity limit. [1]
Temperature
Heat the carmellose/glycerol/partial-water dispersion to 50 °C. Prolonged heating of actives or peppermint oil is not required. Source storage below 30 °C; selected practice 20–25 °C. [1]
pH and compatibility
Source release target pH 6–7. Measure a homogenised sample with a calibrated meter; do not add acid/base without an approved revision because solubility/particles and preservation may change. [1]
Other interactions
Other local anaesthetics increase cumulative exposure. Swallowing adds systemic diphenhydramine: review other sedatives/diphenhydramine products. Substituting magnesium, sucralfate or a marketed antacid does not preserve the same BUD automatically. [1], [2], [3]
Ingredient-specific information
Carmellose 1% suspends the solid; sodium methyl parahydroxybenzoate 0.1% is the specified preservative salt. Qualify aluminium hydroxide pharmaceutical grade, physical form and CoA assay;7 g of a commercial aqueous gel is not automatically equivalent to 7 g raw material. [1]
Staff protection
Use gloves, coat and eye protection for anaesthetic/antihistamine weighing and heated dispersion. Contain powder/splashes and independently verify strengths before making up to volume. [1]
Risk assessment
Risks include swallowed diphenhydramine sedation/anticholinergic effects, lidocaine toxicity from volume error and aspiration during numbness. Review liver disease, traumatised mucosa and cumulative anaesthetic exposure. Do not derive paediatric doses from the old sheet’s large adult volumes. [1], [2], [3]
Compounding conditions
Conversions: 1 mL supplies 10 mg lidocaine HCl and 2.5 mg diphenhydramine HCl. For V mL multiply fixed amounts by V/100 and make up to final volume. Confirm aluminium hydroxide form and the dose-measuring device volume. [1]
BUD rationale
FN assigns 3 months below 30 °C/light-protected. Select a conservative 35-day reference ceiling at 20–25 °C for the exact preserved aqueous composition at pH 6–7; this default is not demonstrated chemical/microbial stability. No study matching all 9 components, final-mixture AET or aw was retrieved. A different antacid or doubled diphenhydramine requires reassessment. 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], [5]
Prerequisites
No marketed antacid or premade mouthwash is required. Introduce actives/aluminium as qualified pharmaceutical raw materials specified by this formula. [1]
Equipment
Balance, vessels, suspension mixer, water bath/thermometer, volumetric equipment and pH meter. Maintain adequate agitation during filling to prevent aluminium settling. [1]
Compounding method
Premix carmellose with glycerol; add approximately half the planned water and disperse at 50 °C with stirring. Separately dissolve lidocaine HCl/diphenhydramine HCl in part of remaining water and incorporate. Add preservative salt, disperse aluminium hydroxide, then add saccharin/peppermint oil. After cooling make up to 100 mL, homogenise, check pH 6–7 and fill under agitation. [1]
Observations
Maintain diphenhydramine 0.25 g/100 mL. Alternative antacids or 0.5% diphenhydramine, although mentioned by the source, are different formulations. [1]
Container and packaging
Amber glass bottle, tight closure and sufficient shaking space. Supply an appropriate measure for the prescribed volume rather than a household spoon. [1], [2]
Quality control
Check pH 6–7, final volume, uniform redispersion/sediment behaviour and filling under agitation. Where dose-uniformity evidence is needed, use a validated sampling/assay method; visual uniformity alone does not prove active content. [1]
Storage
Store 20–25 °C, closed and light-protected, always below 30 °C. Do not freeze without redispersion data. [1], [5]
Dispensing
Shake before use. Specify exact volume, frequency and clinician-selected “spit out” or “swallow”. Avoid food for 60 minutes and chewing while numb. Stop and obtain urgent help for marked drowsiness, breathing difficulty or seizures. [1], [2]
Labelling
Lidocaine HCl 10 mg/mL + diphenhydramine HCl 2.5 mg/mL · BUCCAL USE · SHAKE. Volume__/Spit-or-swallow instruction__.20–25 °C, protected from light/children. Batch__/Prepared__/Use by__. [1], [5]
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

  1. AEMPS — Formulario Nacional — FN/2003/FMT/015 LIDOCAÍNA COMPUESTA, SUSPENSIÓN BUCAL DECurrent AEMPS standalone PDF; code FN/2003/FMT/015PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
  2. DailyMed — Lidocaine viscous 2% label, RemedyRepackUpdated 3 September 2026Boxed warning; warnings; precautions/information for patientsMucosal lidocaine systemic toxicity and 60-minute post-use food restriction; different 2% product, no direct efficacy orBUD equivalence.2026-10-13
  3. DailyMed — Diphenhydramine HCl oral solution 12.5 mg/5 mLCurrent label retrieved 13 October 2026Warnings: drowsiness, alcohol/sedatives and other diphenhydramine productsSwallowed diphenhydramine safety; not clinical validation of this buccal mixture.2026-10-13
  4. FDA — Do not use oral viscous lidocaine for teething painSafety communication 26 June 2014; retrieved 13 October 2026Safety announcement and information for health professionalsPaediatric teething hazard;2% marketed oral viscous product. No dosing orBUD transfer.2026-10-13
  5. USP — Compounding Standards and Beyond-Use DatesNovember 2022 USP publication, public copy hosted by Mississippi Boardp 2 nonsterile comparison tableGeneral category limits only; not product-specific stability, antimicrobial effectiveness or Greek law.2026-10-13
  6. 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