Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
Doxepin Oral Mouthrinse   10 mg/mL
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    doxepin  50 mg  CAP   
    Methylparaben     PWD   
    Propylparaben    PWD   
    Water, sterile        
    peppermint oil    OIL   
    glycerin  100%  PO SOLN  qs to 
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: 1. Add methylparaben and propylparaben in glycerin and place on low heat. Stir until dissolved. Use an amount of glycerin that is approximately 75% of the final volume.
2. Empty contents of doxepin capsules into a mortar and triturate to a fine powder.
3. Gradually add sterile water in small amounts to doxepin powder and stir until dissolved.
4. Add together doxepin solution and methylparaben/ propylparaben solution.
5. Add peppermint oil.
6. QS to final volume with glycerin.
7. Transfer to final container and label.

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THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use, or physician/pharmacy experience.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

Storage/Expiry:Refrigerator: 14 days

Last Date Revised: 25-Aug-21

References:Professional Compounding Centers of America (PCCA) London, Ontario; Houston, Texas. Faxed recipe received March 23, 2009.
  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
   29-Nov-2021         


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