Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
Tranexamic Acid Nasal Gel   5% (w/w)
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    tranexamic acid  500 mg  TAB   
    Water, sterile       to wet tablets 
    SecarisŪ     GEL   
Recipe Total Quantity:
Final Quantity Desired: g

Directions: Use gloves and mask when preparing.

1. In a mortar, crush tablets and triturate to a fine powder.
2. Levigate powder with sterile water for injection to make a smooth paste.
3. Gradually add the SecarisŪ gel to the paste.
4. Pull the plunger out of a 60 mL syringe and fill the barrel with gel. Replace the plunger and transfer 1 mL of gel to a 3 mL syringe using a syringe tip connector. Cap with syringe tip cap.

Notes a) Actual concentration is about 4.5%.
b) Isopropyl alcohol was used as a wetting agent in the past.
c) Wetting agent can be omitted altogether.
d) Can be packaged in ointment jars.

Previous formulation listed Intrasite gel. Either Secaris or Intrasite gel can be used to prepare recipe.

Since no stability data available, assign beyond use date using principles of NAPRA Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations: Use the most conservative approach when there is conflicting information. As such, use the more conservative historical BUD of 7 days refrigerated rather than the arbitrary NAPRA BUD.

THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use or physician/pharmacy experience.

Packaging: 3 mL Syringe

Auxiliary Labels: Refrigerate

Storage/Expiry:Refrigerator: 7 days

Last Date Revised: 26-Aug-21

References:AHS Drug Information Service. Previous Question #20707. What should the BUD be for Tranexamic Acid Nasal Gel 5% (w/w)? 2020 Aug 26. Available at:
https://webappsint.albertahealthservices.ca/Pharmacy/PS_DI/admin_user/view_request.aspx?id=20707
 
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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