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Stability of Tetracycline Hydrochloride in Miracle Mouthwash Formulations Containing Diphenhydramine and Dexamethasone Elixir

Class of 2015 Abstract / Objectives: To assess the solubility and stability of tetracycline in compounded miracle mouthwash solutions over time, and at different temperatures (room temperature versus refrigerated) and pH (unaltered versus pH 7).
Methods: Miracle mouthwash (MMW) solutions were compounded using tetracycline HCl capsules and 1:1 pseudo-dexamethasone elixir and diphenhydramine. High-performance liquid chromatography (HPLC) was used to measure the tetracycline concentrations in the MMW samples tested. Data on tetracycline crystal composition over time were also collected using powder x-ray diffraction, differential scanning calorimetry (DSC), and thermal gravimetric analysis (TGA).
Results: For the tetracycline MMW solutions stored at room temperature, only 16% of the original tetracycline remained in solution after 24 hours, stabilizing at 65-81 mcg/mL on day 5 then decreasing further down to 45 mcg/mL by day 15. Similar results were obtained for the refrigerated tetracycline MMW solution (11% of original concentration after 5 days, with a decrease from 31-54 mcg/mL on day 5 to 22 mcg/mL on day 15). Tetracycline concentrations appeared to undergo a steeper decline in MMW solutions of pH 7 than in unadjusted MMW solutions (pH 4.68). All MMW samples exhibited a conversion from tetracycline HCl to tetracycline hexahydrate.
Conclusions: Tetracycline solubility decreases rapidity in MMW within 24 hours of compounding regardless of temperature. MMW solutions at pH 7 may have further reduced solubility. Stability decreases at a stable rate from tetracycline HCl to tetracycline hexahydrate.

Identiferoai:union.ndltd.org:arizona.edu/oai:arizona.openrepository.com:10150/614108
Date January 2015
CreatorsFazel, Mahdieh, Goodlet, Kellie, Myrdal, Paul, Karlage, Kelly
ContributorsMyrdal, Paul, Karlage, Kelly, College of Pharmacy, The University of Arizona
PublisherThe University of Arizona.
Source SetsUniversity of Arizona
Languageen_US
Detected LanguageEnglish
Typetext, Electronic Report
RightsCopyright © is held by the author.

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