||The strength (potency) of each bottle of bulk nystatin USP is different, therefore a new calculation for dilution is required with each batch prepared. Add amount required to make 100,000 units/gram concentration.
1. Weigh out nystatin powder and magnesium carbonate powder required.
2. Blend powders together in mortar and pestle.
3. Dispense in plastic squeeze bottle.
||The BUD should be EITHER 180 days OR the time remaining until the earliest expiry date of any ingredient, whichever is shorter.
180 day room temperature stability is for Galenova brand nystatin ONLY.
This recipe may be used as an alternative to nystatin topical powder in sterile talc if sterile talc is not readily available.
THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use, or physician/pharmacy experience.
|| Plastic Bottle
||For External Use Only|
||Store at Room Temperature
|Storage/Expiry:||Room Temperature: 180 days |
|Last Date Revised:
|References:||Boies, Philippe (Galenova Inc.). RE: Nystatin Powder Stability [Email]. Message to: Kristina Haagsma (Alberta Health Services, Edmonton, AB). 2021 Sept 2. cited 2021 Sept 2.|
For stability data.
Magnesium Carbonate. In: Martindale: The Complete Drug Reference [database on the Internet]. Hudson (OH): Lexicomp Inc.: 2016 [updated 4 April 2019; cited 27 June 2019]. Available from: http://online.lexi.com. Subscription required to view.
Shrewsbury, Robert. Applied Pharmaceutics in Contemporary Compounding Third Edition 2015.
Rowe, R.C, Sheskey, P. J, and M.E Quinn. Handbook of pharmaceutical excipients 6th edition, August 2009.
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