Recipe - Compounding Worksheet
Unauthorized distribution, copying or disclosure prohibited.
These recipes are intended for use by the pharmacy manufacturing departments only.
Akabutu's Mouthwash (For Batching)   .
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    hydrocortisone  20 mg  TAB   
    glycerin  100%  PO SOLN  30 to 50 mL as needed 
    nystatin  100,000 units/mL  SUSP   
    lidocaine HCL, viscous solution  2%     
    sodium chloride  0.9%  INJ  qs to 
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: 1. Triturate the hydrocortisone tablets into a fine powder and levigate with glycerin to form a paste.
2. Add a portion of the normal saline, and transfer into appropriate size container.
3. Add viscous lidocaine 2%, nystatin suspension, and QS with remaining normal saline.
4. Shake until mixed well.
5. Transfer to final container(s) and label. Refrigerate final product.

Notes Each standard 30 mL dose contains approximately 625,000 units of Nystatin.

Sodium chloride 0.9% for irrigation can be used instead of injection.

Use a glycerin product as close to 100% glycerin as available.

Use a 4L jug to mix when making batches of 2400mL.

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.

Per DI Question # 20572, a mouthwash will be considered an oral formulation.

THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use, or physician/pharmacy experience.

Packaging:  Amber Plastic Bottle

Auxiliary Labels: Protect From Light
  Refrigerate
  Shake Well

Storage/Expiry:Refrigerator: 14 days

Last Date Revised: 8-Sep-21

References:Das Gupta, V. Effects of Vehicles and Other Active Ingredients on Stability of Hydrocortisone, Journal of Pharmaceutical Sciences, 1978;67; 299-302.

McCrea, J Extemporaneous Oral Liquids - formulation guidelines, Pharmacy Practice 1997; vol 7 (Nov/Dec) No. 9 17-23.

Dr. Akabutu, UAH; Dr. Yanofsky; Cross Cancer Institute Edmonton Alberta
  Water-containing oral formulations The BUD is not later than 14 days with storage 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.