Protocol for aseptic preparation of amphotericin B paste for instillation into pulmonary cavity to treat inoperable aspergilloma

According to the cavity size, one to five vials of the following are required:

  • Fungizone IV 50 mg
  • Lipiodol Ultra fluid 2.4 ml (comes in 20 ml amps)
  • Suppocire C 7.6 ml (made by Gattefosse, France, Melting pt. 38-40°C)

This makes up 10 ml of sterile paste. Because of the complexity of the procedure, and the need for microbial investigation, at least 4 to 5 days notice of preparation is required.

Method

Formula

  • Fungizone IV 50 mg
  • Lipiodol Ultra fluid 2.4 ml (optional)
  • Suppocire C 7.6 ml

Materials

  • One porcelain dish (to melt Suppocire)
  • Heated ring (to melt Suppocire)
  • Sterile bung/stopper (teflon)
  • Sterile aluminium disk
  • Sterile aluminium seal
  • Forceps/pliers (to crimp seal on stopper)
  • 15ml empty sterile vial
  • 5 and 10 ml sterile syringes
  • 40/11 size needles (needle size probably important due to viscous wax)
  • Forceps
  • Gauze
  • Elastic bands
  • Thermometer (0-25°C range)

To be sterilised in HSSD or obtained sterile

  • 15 ml empty sterile vial or DIN bottle
  • Teflon bung/stopper
  • Aluminium disk
  • Aluminium seal

Non-Aseptic part of Method

In the porcelain dish, melt the Suppocire C (suppository wax) at 50C. Using the 10 ml syringe and needle, remove 7.6 ml of melted wax and inject into the sterile 15 ml vial or DIN bottle. Put on the disk and the seal and crimp seal. Leave to cool.

Sterilisation

Using autoclave on liquid cycle, sterilise the vial containing the wax for 3 to 4 hours at 121°C.

Under Aseptic Conditions

Put the following in the laminar flow cabinet/isolator: Fungizone dry powder vial, Lipiodol ampoule, vial containing Suppocire C and equipment - forceps, 5 ml syringes, 10/11 needles, swabs, gauze and elastic band.

Technique

Uncork the vial containing Suppocire. Remove cap from vial of Fungizone using forceps. Pour the amphotericin B powder onto paper (the sterile wrap from the gauz), and use as a funnel to pour the powder into the Suppocire C. Draw up 2.4 ml of Lipiodol and inject into the Suppocire/amphotericin mixture (omit if desired). Put the teflon stopper on the vial, then put seal and disk on top, then fold gauze in half, place on top of vial and attach with elastic band.

Remove from isolator/laminar flow cabinet
Seal. Carefully remove elastic band and compress.  Send a small sample of the mixture and the Suppocire to microbiology for bacterial and fungal culture. Cultures should be done after heating to 50°C to melt the mixture.

Stability

Protect from light. Store at 4°C for seven days, commencing 24 hours after heating. Stable for 7 days only.

Availability of ingredients

Lipiodol Ultra Fluid available in boxes of 5 x 20ml amps from Gaten.

Suppocire C is only available in France - manufactured by:

Gattefosse
36 Chemin de Genas
69800 St Priest
France
Tel: 72 22 9800
Fax: 78 90 4567

UK Contact: (Andrew Mitchell - Alpha Chemicals - 0344 861800)

Formula provided by Dr Ane (Pharmacist Centre Hospitalier Regional de Toulouse (010 33 6177 2533).
This protocol has been translated from the French original with grateful thanks to Dr Marianne Parry. 

Prepared by:
Jeanette Bond
Pharmacy 
North Manchester General Hospital
Manchester, UK

June 1998

Year prepared: 

1998