Recipe - Compounding Worksheet
Unauthorized distribution, copying or disclosure prohibited.
These recipes are intended for use by the pharmacy manufacturing departments only.
Amiodarone Oral Suspension   20 mg/mL *Note Strength*
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    amiodarone  200 mg  TAB   
    Methylcellulose 1% (preserved with parabens) / Simple Syrup   1:1    qs to 
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: 1. In a mortar, crush tablets and triturate to a fine powder.
2. Mix methylcellulose 1% and simple syrup together (1:1) to make vehicle.
3. Gradually levigate powder with vehicle until a liquid is formed.
4. Pour into a graduated cylinder.
5. Rinse mortar and qs to final volume with vehicle.
6. Transfer to final container and label.

Notes See recipe for Methylcellulose 1% solution (preserved with parabens).

Since no stability data available, assign beyond use date using NAPRA Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations:
For Water Containing Oral Formulations: The BUD is not later than 14 days when stored at controlled cold temperatures.

This formulation is extrapolated from the Amiodarone 5 mg/mL oral suspension recipe (see Reference Section).

THIS FORMULATION IS NOT BASED ON LITERATURE, but is extrapolated from information found in the references and is a modified version of the amiodarone 5 mg/mL oral suspension recipe.

Packaging:  Amber Plastic Bottle

Auxiliary Labels: Note Strength
  Refrigerate
  Shake Well

Storage/Expiry:Refrigerator: 14 days

Last Date Revised: 25-Aug-21

References:Nahata MC. Stability of amiodarone in an oral suspension stored under refrigeration and at room temperature. Annals of Pharmacotherapy 1997 (Jul/Aug); 31:851-852.
Reference provides a recipe for Amiodarone 5 mg/mL oral suspension.

Alexander KS. Thyagarajapuram N. Formulation and accelerated stability studies for an extemporaneous suspension of amiodarone hydrochloride. International Journal of Pharmaceutical Compounding 2003; (7)5:389-393.
Reference provides a recipe for Amiodarone 20 mg/mL oral suspension prepared with carboxymethylcellulose vehicle.

Nahata MC. Morosco RS. Hipple TF. Stability of amiodarone in extemporaneously oral suspension prepared from commonly available vehicles. J Pediatr Pharm Pract 1999; 4:186-189.
Reference provides a recipe for Amiodarone 5 mg/mL oral suspension.
  For Water Containing Oral Formulations - The BUD is not later than 14 days when stored at controlled cold temperatures.
National Association of Pharmacy Regulatory Authorities (NAPRA). Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations. Ottawa, ON: National Association of Pharmacy Regulatory Authorities (NAPRA); 2018.
Available at: https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_Preparations_Guidance_June2018_FINAL.pdf

Completed Compound Check
Lot NoDate Prepared Expiry DateTechnicianPharmacist
   6-Dec-2021         


This content is provided for general information purposes only. It is not intended to replace consultations with a health care professional or to provide medical advice, diagnosis or treatment. Always seek the advice of a physician or other qualified health care provider with any medical or health questions. Alberta Health Services accepts no responsibility for any modification or redistribution of this document and is not liable for any actions taken by individuals based on the information provided, or for any inaccuracies, errors, or omissions in the information in this document. These recipes are to be used as a reference and are not intended to be master formulation records. Not all recipes may be compliant with NAPRA or other standards.