Amoxicillin 125 mg or 250 mg capsules from 1 g dispersible tablets · TECH-FR-AMOX-001 (TECH-FR-AMOX-001)

REFERENCE FORMULA

Reference formula

Reference basis: Ncapsules of selected strength 125 or 250 mg amoxicillin per capsule

Ingredient	Source quantity	Scaled quantity
Homogeneous powder of authorised amoxicillin 1 g dispersible tablets, same product/lot	q.s. for 125 or 250 mg αμοξικιλλίνης/καψάκιο / mg amoxicillin per capsule	—
Empty gelatin capsule: size 4 for 125 mg orsize 1 for 250 mg	1 τεμάχιο/καψάκιο / unit per capsule	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Capsules containing white/off-white powder from dispersible tablets. Amoxicillin remains in trihydrate form together with the tablet excipients. One monograph covers two strengths, not two independent formulas. ^[1]

Action and use

Patient-specific oral antibiotic preparation where the prescribed strength/form is clinically needed. Technique originated during 2022 paediatric shortages; the French automatic-substitution exception ended 7 April 2025. Infection, weight and renal function guide clinical dose/duration. ^{[1], [2], [3]}

Specifications

Source content criterion: 90–120% of nominal strength. Test mass uniformity on 20 capsules and content on 10 pilot-batch units. Powder should be white/off-white; capsules properly closed and externally clean. Mass compliance alone does not prove active-content uniformity. ^[1]

Light

This monograph supplies no quantitative photostability limit. Use the specified suitable container and avoid unnecessary exposure; check any source-tablet requirement in its SmPC without transferring industrial shelf life. ^{[1], [3]}

Air and oxidation

Prompt closure of powder/capsule containers limits beta-lactam dispersion and environmental exposure. No inert gas or oxidative-exposure limit is specified. ^[1]

Water and solubility

No water is added in manufacture. A dispersible source tablet is not dissolved before encapsulation. Trihydrate waters do not establish the finished powder’s aw. ^[1]

Humidity

Limit moisture exposure and ensure equipment is fully dry after cleaning. Monitor humidity relevant to powder flow and shell performance. The technical monograph supplies no numeric RH or aw limit for these capsules. ^[1]

Temperature

Manufacture without thermal processing; store 15–25 °C. Proposed dating applies to those conditions, not refrigeration, freezing or elevated temperatures. ^[1]

pH and compatibility

No finished pH is defined for dry capsules. Any test-solution pH must belong to a specified analytical method and is not standalone stability evidence. ^[1]

Other interactions

Do not mix brands/lots with different excipients in one powder blend. Tablet sweeteners/flavours affect suitability in infants or metabolic disease and are not removed by crushing. ^{[1], [3]}

Ingredient-specific information

Check strength basis: 1 g amoxicillin per tablet, not 1 g total tablet mass. Trihydrate CAS 61336-70-7. As an example, Sandoz 1 g contains 4.8 mg aspartame/tablet: calculated 0.6 mg per 125 mg capsule or 1.2 mg per 250 mg capsule, only for that formulation and homogeneous distribution. Record all other actual-brand excipients. ^{[1], [3]}

Staff protection

Unpack/crush under a chemical hood or equivalent containment. Source identifies H334 respiratory and H317 skin sensitisation: use risk-selected FFP2/gloves, coat, hair/shoe protection. Dedicated equipment or validated campaign segregation/cleaning is required. ^[1]

Risk assessment

Priorities: beta-lactam sensitisation/cross-contamination, confusing powder mass with active mass and nonuniform filling. Review severe penicillin/beta-lactam allergy and excipient suitability. Renal function affects dose. Visually full capsules alone are insufficient for release. ^{[1], [3]}

Compounding conditions

Choose one strength S = 125 or 250 mg and total N including test units. Nominal requirement=N×S/1000 one-gram-tablet equivalents. Whole-tablet batches favour multiples of 8 capsules at 125 mg or 4 at 250 mg. Capsule powder mass derives from actual mean tablet mass×S/1000 with validated homogeneity/loss control, not 125 or 250 mg total powder. ^[1]

BUD rationale

Source proposes 1 month at 15–25 °C and expressly requires stability-study confirmation. No verified study matching the selected tablet brand, capsule shell and container was retrieved. Therefore 28 days/1 calendar month is a provisional reference ceiling only, not a completed operational BUD. Approved evidence is required before final assignment. Neither bulk-API extensions nor source-blister expiry transfers. The 28-day value is only the conservative editorial conversion of one calendar month; it is not a completed local BUD. ^{[1], [2]}

Prerequisites

Requires the exact authorised 1 g dispersible-tablet product, current SmPC and size 4 or 1 shells. Not a dependency on CGR-FR-029, which uses bulk API and different excipients. ^{[1], [3]}

Equipment

Hood/equivalent containment, dedicated mortar/pestle/vessels, suitable balance, size 4/1 capsule filler and validated cleaning materials. Access to suitable HPLC is needed for pilot content/stability work and equipment for 20-unit mass testing. ^[1]

Compounding method

1. Approve product, lot, strength, count and filling calculation; confirm clean dry equipment. 2. Unpack under extraction, triturate and homogenise to fine powder. 3. Record yield/losses and confirm filling capacity for the actual brand. 4. Fill correct shells evenly by levelling without unplanned diluent. 5. Close, externally clean, count and test uniformity/content. 6. Package and label. Complete within 2 consecutive days, preferably using the same preparer. ^[1]

Observations

Do not reapply the 1.148 trihydrate factor to labelled tablet strength: marketed strength already expresses amoxicillin equivalent. Dividing a tablet into eighths/quarters does not replace validated powder homogenisation; its score may not ensure equal doses. ^{[1], [3]}

Container and packaging

Source proposes pharmaceutical 75 mL PETG container with tamper-evident closure or a qualified equivalent. Select for actual count/volume and moisture protection; a different blister or added desiccant needs separate assessment. ^[1]

Quality control

Assess net content mass on 20 capsules. Source limits are ±10% when mean mass < 300 mg or ±7.5% when ≥ 300 mg, with at most 2 outside these limits and none outside twice the range; apply the current lawfully accessible compendial method. Pilot: assay 10 units and retain 1 capsule-equivalent per campaign. Annex LC uses C 18, 150 × 4.6 mm, 2.6 µm; water/acetonitrile 90:10; 1 mL/min; 25 °C; 273 nm; 10 µL injection. Local suitability/reference-standard potency correction remains necessary; these are methods, not results from this project. ^[1]

Storage

Store 15–25 °C in a suitable closed container. A final period for every commercial tablet after crushing/repacking is not established. Enter discard date only after approved BUD assignment. ^[1]

Dispensing

State selected strength, count and exact prescribed dose/duration. Assess capsule swallowing; opening/dispersal requires specific written immediate-administration instructions, not a stored liquid stock. Counsel about allergy symptoms and correct antibiotic use. ^{[1], [3]}

Labelling

RESEARCH OUTLINE — NOT FOR DISPENSING before supporting evidence and approved BUD assignment. AMOXICILLIN [125 or 250] mg/capsule · ORAL USE. Made from [tablet product/lot]. Excipients of concern: [actual ones]. Count__/Directions__. Store 15–25 °C, closed, away from children. Batch__/Prepared__/Use by [after approved BUD]__. ^[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

ANSM — Amoxicilline 125 mg et 250 mg, gélules réalisées à partir d’Amoxicilline 1 g, comprimés dispersiblesDecember 2022, version 1pp 1–7 formulation, process, safety, QC/BUD;pp 8–9 assay annexExact source method and explicitly provisional 1 month shelf life; independent factual adaptation, not an official translation.2026-10-14
ANSM — Amoxicilline: recommendations and 7 April 2025 abrogation updateUpdated 7 April 2025; checked 13 October 2026Opening update paragraphTemporary automatic substitution recommendation withdrawn; technical monograph publication is not general current substitution permission.2026-10-13
French public medicines database — AMOXICILLINE SANDOZ 1 g dispersible tablet SmPCSmPC 21 August 2026; database 29 September 2026§§2,4.3–4.5,6.1Example of current source-product strength, excipients and clinical precautions. Other brands require their own SmPC; marketed-tablet shelf life does not transfer.2026-10-13
ANSM — Bonnes pratiques de préparationCurrent index retrieved 13 October 2026CurrentBPP and amoxicillin preparation linksFrench professional preparation framework and source location; not a statement of Greek compounding law.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