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Greek Pharmacist License study materials
Greek Pharmacist License study resources

Greek Pharmacist License: Pharmaceutical Technology and Compounding

Greek Pharmacist License · Work through your exam, one topic at a time.

All guide sections

Pharmaceutical Technology and Compounding

This domain covers industrial manufacture and extemporaneous compounding: unit operations, tablet and capsule technology, sterilisation, cleanroom classification, validation, and the rules and calculations used when a preparation is made in the pharmacy.

Sterilisation and cleanrooms

  • Moist-heat sterilisation in an autoclave: 121 °C for 15 minutes at about 1 bar overpressure (15 psi); the cycle is validated by F₀ and biological indicators (Geobacillus stearothermophilus).
  • Dry heat: 160 °C for 2 hours or 180 °C for 30 minutes - for glassware and thermostable powders.
  • Terminal sterilisation by moist heat is preferred; aseptic processing is reserved for thermolabile products.
  • Filtration through a 0.22 µm membrane gives sterilisation by removal; radiation at 25 kGy is used for single-use devices and some thermolabile materials.
  • EU GMP Annex 1 grades: Grade A (ISO 5) for the critical filling zone, Grade B as background, Grades C and D for less critical stages.

Tablets, capsules and coating

  • Wet granulation improves flow and compressibility; direct compression is cheaper but demands free-flowing, compressible excipients; roller compaction is a dry route.
  • Excipient roles: diluent (lactose, microcrystalline cellulose), binder (PVP, starch paste), disintegrant (croscarmellose sodium, sodium starch glycolate), lubricant (magnesium stearate), glidant (colloidal silica).
  • Defects: capping and lamination (air entrapment, over-compression), picking and sticking (moisture, engraving), mottling (dye migration).
  • Film coating with HPMC; enteric coating with polymers dissolving above about pH 5.5 (cellulose acetate phthalate, methacrylate copolymers).

Compounding in Greek practice

  • Magistral preparations follow a prescriber's formula for a named patient; officinal preparations follow a pharmacopoeial formula and may be stock preparations. Both must be recorded with formula, batch, date, expiry, storage and operator.
  • Potent drugs are weighed by aliquot or trituration because of the balance's minimum weighable quantity; mixing is by geometric dilution.
  • Capsule filling is calculated from the powder density and the capsule size volume; suppositories require displacement-value correction.

Worked example

Prepare 60 g of 2% w/w hydrocortisone ointment from 10% and 1% bases. Alligation: parts of the 10% base = 2 − 1 = 1; parts of the 1% base = 10 − 2 = 8; total 9 parts. Each part = 60/9 = 6.67 g. Use 6.67 g of the 10% base and 53.33 g of the 1% base. Check: 0.667 g + 0.533 g = 1.20 g in 60 g = 2% w/w, confirming the calculation.

Traps that cost marks

Using alligation with% w/v when the bases are% w/w; forgetting the drug's displacement volume in suppository moulds; assuming autoclave tape proves sterility (only biological and physical indicators validate the cycle); ignoring that a compounded product still needs a defined beyond-use date.