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| Mouthwash BLM |
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Loyd V. Allen, Jr., PhD
Professor Emeritus
College of Pharmacy,
University of Oklahoma
Oklahoma City
Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each ingredient. Before compounding, tap the top and bottom of the lidocaine hydrochloride (HCl) bottle. Open the suspension bottle and empty the lidocaine HCl powder into the suspension. Likewise, tap the top and bottom of the diphenhydramine HCl bottle. Remove the cap. Because of the hygroscopic nature and small volume of the powder, use the enclosed spatula to empty the contents into the mouthwash suspension. Close the suspension bottle and vigorously shake it vertically for approximately 20 to 30 seconds. The appropriate quantities of diphenhydramine HCl powder and lidocaine HCl powder have been packaged in each bottle to deliver the required dose of each drug. Residual quantities remaining in the bottles after emptying need not be rinsed out. Package and label.
Use: This preparation is used to ease mucositis symptoms caused by some forms of chemotherapy and radiation therapy, as well as for aphthous ulcers, other oral ulcers, and other mouth pain.
Packaging: Package in the container in which it is provided and compounded.
Labeling: Keep out of reach of children. Avoid contact with the eyes. Keep container tightly closed. Keep refrigerated. Protect from light. Protect from freezing. Shake well before each use. Discard after ____ [time period].
Stability: Based on real-time controlled room temperature and humidity testing, the finished, compounded Mouthwash BLM Compounding product is stable for at least 180 days.
Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties, physical observation, and physical stability (discoloration, foreign materials, gas formation, and mold growth).
Discussion: This formula is equivalent to the active ingredients in compounded Magic Mouthwash [Benadryl Elixir:Lidocaine HCl 2% Viscous:Maalox Suspension (1:1:1 v/v/v)]. The Mouthwash BLM Compounding Kit contains premeasured diphenhydramine HCl powder, lidocaine HCl powder, and mouthwash suspension (aluminum hydroxide, magnesium hydroxide, and simethicone, plus inactive ingredients). The 119-mL size of the compounded preparation contains diphenhydramine HCl 0.1 g, lidocaine HCl 0.8 g, and FIRST Mouthwash Suspension 118 mL.
Diphenhydramine HCl (C17H21NO.HCl, MW 291.82), an H1-receptor antagonist used for the relief of hypersensitivity reactions, occurs as a white, odorless, crystalline powder. It slowly darkens on exposure to light, and its solutions are practically neutral. Diphenhydramine HCl is freely soluble in water and in alcohol. It elicits mild anesthetic properties when used topically. Read more.
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How Pharmacists Are Adapting to USP <795>
During COVID-19 |
Tyler A. Goins, PharmD, MSHA, BCPS
Assistant Manager of Inpatient Sterile Compounding and Childrens Hospital Clinical Operations
UVA Health System
Charlottesville, Virginia
Patient care is in a continual state of change, and pharmacy practice must reinvent itself to keep up with dynamic times. The coronavirus disease 2019 (COVID-19) pandemic has increased the rate of that change and has forced pharmacists and other healthcare professionals to adapt more quickly. Pharmaceutical compounding provides a prime example of the need to stay updated with new evidence and evolving requirements that keep patients and healthcare professionals safe. Compounding is the creation of customized medications for specific patients that should be prepared in an appropriate environment to maintain safety and effectiveness. Pharmacies across the country are looking for new ways to stay ahead of potential contamination, supply shortages, and uncertain times.
Pharmacists are relied on to have expertise in medication compounding and the guidelines that govern compounding practice. U.S. Pharmacopeia General Chapter <795> (USP <795>) addresses extemporaneous compounding of pharmaceuticals and defines what constitutes good compounding practices. The complexity of compounding guidance can be difficult for pharmacy staff to adhere to, especially those who do not perform extemporaneous compounding on a routine basis. Read more.
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