Characterization of Tetracycline Hydrochloride Compounded in a Miracle Mouthwash Formulation

Younis, Usir S.; Fazel, Mahdieh; Myrdal, Paul B.

doi:10.1208/s12249-019-1388-x

Cited by 7 publications

(6 citation statements)

References 10 publications

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“…[ 55 ] It should be noted that the pH of TTC-HCl varies from 1.8 to 2.2, depending on whether it is diluted in water, an anesthetic, or saline solution, although fluctuations in pH in the oral cavity range between 5.5 and 7.0. [ 56 ] pH values of >6.0 or <4.5 increase the solubility of TTC significantly. [ 57 ] It can be suggested that pH affects the microorganisms used here in addition to the effect of TTC-HCl.…”

Section: Discussionmentioning

confidence: 99%

In vitro assessment of the antimicrobial activity of tetracycline hydrochloride diluted in three different vehicles against Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum

Escalante-Herrera

Cháves

Villamil

et al. 2022

J Indian Soc Periodontol

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Background: The development and progression of periodontal diseases is a result of the dynamic interaction of microorganisms within their habitat, and changes in this habitat generate a dysbiotic state. Fusobacterium nucleatum and Prevotella intermedia are bridging microorganisms between the pioneer communities and other microorganisms responsible for periodontitis such as Porphyromonas gingivalis . Tetracycline hydrochloride (TTC-HCl) is commonly used as a coadjutant in periodontal treatment in the form of an antiseptic. However, there are no clear dilution or concentration protocols. Objective: This study aimed to evaluate the in vitro antimicrobial activity of TTC-HCl diluted in sterile water, saline solution, and 2% lidocaine with epinephrine 1:80,000 at concentration of 125, 250, and 500 mg, at three time points– 30, 60, and 120 s – on P. intermedia , F. nucleatum , and P. gingivalis using the Kelsey–Maurer technique. Materials and Methods: The antimicrobial activity of TTC-HCl was evaluated at the proposed concentrations and times, dissolved in the different vehicles at pH 1.9 and 7.0, on F. nucleatum , P. intermedia , and P. gingivalis . The Kelsey–Maurer test was used to verify the presence or absence of colony-forming units. Each test was performed in triplicates with its respective viability controls. Results: Inhibition of F. nucleatum , P. intermedia , and P. gingivalis was achieved with TTC-HCl at all concentrations, dissolved in distilled water, saline solution, and 2% lidocaine with epinephrine 1:80,000 for all times. Conclusions: The results show that TTC-HCl is a good antimicrobial alternative against F. nucleatum , P. intermedia , and P. gingivalis regardless of the vehicle in which it was dissolved, concentration, pH, or time used in this investigation.

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Section: Discussionmentioning

confidence: 99%

In vitro assessment of the antimicrobial activity of tetracycline hydrochloride diluted in three different vehicles against Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum

Escalante-Herrera

Cháves

Villamil

et al. 2022

J Indian Soc Periodontol

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“…Tetracycline antibiotics are unstable and degrade easily under unfavourable conditions. High humidity and temperature, extreme pH values, the presence of metals and exposure to light accelerate the processes of TC decomposition, and depending on the above conditions, various decomposition products are formed, e.g., 4-ETC, ATC and its toxic epimer, lumitetracycline and other derivatives [ 7 , 8 , 9 , 10 , 11 , 12 , 23 , 25 , 26 ]. The degradation of the TC molecule very often proceeds with a colour change.…”

Section: Discussionmentioning

confidence: 99%

“…The reason for such changes may be the precipitation of a crystalline, yellow precipitate only in the A1 solution already in the first days of observation, and the reason for crystallization may be the fact that the solubility of TC in water decreases with a decrease in temperature, which Varanda et al presented in their research [ 30 ]. Additionally, Younis et al showed that in an aqueous solution of TC, a crystalline precipitate of tetracycline hexahydrate occurs, which is less soluble in water than TC [ 25 ]. Moreover, Caira with the team analysed the crystalline precipitate from the hot solution of TC, confirming the structure of tetracycline hexahydrate [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

“…TC is an antibiotic with a broad spectrum of antibacterial activity, thanks to which it is widely used in dermatology, both in oral and topical preparations, as well as in urology, infections of the gastrointestinal tract, respiratory tract and others [ 1 , 25 , 35 , 40 , 41 ]. It also has a non-antibacterial effect and can be used in sub-antimicrobial doses in periodontitis, inflammatory diseases, rheumatoid arthritis, cancers and others [ 2 , 3 ].…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of the Influence of a Hydrogel Containing AMPD on the Stability of Tetracycline Hydrochloride

2021

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Tetracyclines, as beneficial antimicrobial factors in both local and systemic therapy, are characterized by high instability. The aim of the study was the development of the influence of hydrogel formulation on the tetracycline hydrochloride (TC) level under varying storage conditions. The HPLC, XPRD as well as SEM and macroscopic observations were involved in the study. The TC concentration decreased within ca. two months from 9.37 µg/mL to 4.41 µg/mL in the case of the photoprotected TC solution stored at 23 °C, whereas the decrease in storage temperature did not improve the final level of TC. In the presence of AMPD, the TC level in aqueous solution decreased drastically to ca. 1 µg/mL. Application of a polyacrylic acid derivative enabled conservation of the TC level through the ca. two months. Thus, the use of alcoholamine in the preparation of the TC hydrogel may result in the development of a therapeutic product with a dual action against acne, including antimicrobial activity and saponification of free fatty acids deposited in the follicles.

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“…Refractory neuropathic pain may benefit from compounded analgesic topical creams containing multiple medications not commercially available in combination; examples include ketamine, baclofen, gabapentin, amitriptyline, bupivacaine, and clonidine [ 14 ]. Painful oral lesions can be treated with “magic mouthwash” and dyspepsia can be treated with a “gastrointestinal (GI) cocktail”; these are terms that actually encompass a range of compounded preparations [ 15 ]. Total parenteral nutrition (TPN) is needed for patients unable to take in sufficient oral nutrition, and numerous chemotherapy regimens must be compounded for cancer treatment [ 16 , 17 ].…”

Section: Compounding: What It Is and Why It Is Essentialmentioning

confidence: 99%

Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors

et al. 2020

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Introduction Medications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature. Methods We gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration “Drug Alerts and Statements” repository. We categorized reports into errors of “contamination,” suprapotency,” and “subpotency.” Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available. Results We screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm. Discussion Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors. Conclusion In the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.

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Characterization of Tetracycline Hydrochloride Compounded in a Miracle Mouthwash Formulation

Cited by 7 publications

References 10 publications

In vitro assessment of the antimicrobial activity of tetracycline hydrochloride diluted in three different vehicles against Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum

In vitro assessment of the antimicrobial activity of tetracycline hydrochloride diluted in three different vehicles against Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum

Evaluation of the Influence of a Hydrogel Containing AMPD on the Stability of Tetracycline Hydrochloride

Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors

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