FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Peanut suspension

ALG-002 / v2.0

Peanut suspension

The existing technical example is assessed as a suspension under development. Clinical immunotherapy literature does not establish quality or dating of this local product.

Download this document · PDF
Development dossier · No validated formula, clinical dosing schedule or established finished-preparation BUD.

Material and strength basis

Record Arachis hypogaea, form/milling, roasting or defatting, lot and allergenic contaminants. Distinguish food mass from total protein and individual-analyte content. A well-characterised material does not automatically establish suspension uniformity.

Redispersibility and syringe

Study particle distribution, settling, compact sediment and recovery after the intended shaking. Check clogging, dead volume, adsorption and actual withdrawal with the exact syringe/adapter. Assess delivery during the last container withdrawals too.

What PALFORZIA evidence covers

The FDA label covers a specific standardised powder with controlled doses. It directs emptying the dose into semisolid food and consuming promptly, and excludes liquid mixing for that administration. It does not establish dating for a premade oral suspension. Anaphylaxis, uncontrolled-asthma and eosinophilic-oesophagitis warnings concern the actual product and clinical assessment.

Dating and release

Require protein/analyte retention, uniformity, microbiology and in-use data for the exact matrix. Refrigeration does not replace a study. This dossier assigns no numerical BUD. Release requires technical and clinical agreement with results, not only a completed form.

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
  3. FDA — PALFORZIA prescribing informationUS prescribing information, July 2024 revision, accessed 2026-09-12Sections 1, 2.3, 4, 5 and 16Specific authorised product only; no equivalence with pharmacy-made peanut preparations2026-09-12
  4. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12