Release of copper and indomethacin from intrauterine devices immersed in simulated uterine fluid

Zhou, Xiaowen; Liu, Ying; Jiang, Xian; Qiu, Lirong; Liu, Jianping

doi:10.3109/13625181003782860

Cited by 14 publications

(5 citation statements)

References 8 publications

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“…They were paired for comparison according to the device properties and the release of cupric ion was determined by flame atomic absorption spectrometer for about 160 days. Consistent with the in vivo studies, copper release was higher during the first month, followed by a slower steady rate (Zhou et al., 2010 ; Zhang et al., 2015 ). Another recent study reporting on copper IUD corrosion (Cu 2 O), measured by X‐ray diffraction was focused on the benefit of intended use but neither copper release nor systemic exposure was considered (Wildemeersch et al., 2014 ).…”

Section: Assessmentsupporting

confidence: 79%

Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources

More¹,

Bampidis²,

Benford³

et al. 2023

EFS2

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Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health‐based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non‐dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow‐on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non‐oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth.

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Section: Assessmentsupporting

confidence: 79%

Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources

More¹,

Bampidis²,

Benford³

et al. 2023

EFS2

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“…The simulated uterine cavity fluid (g L −1 ) was prepared according to the ratio in Table 1 and stored for later use at 2–8 °C. 22…”

Section: Methodsmentioning

confidence: 99%

A mechanically robust and stable estradiol-loaded PHEMA-based hydrogel barrier for intrauterine adhesion treatment

Xie

Ouyang

et al. 2022

J. Mater. Chem. B

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“…A number of additional authors reported the use of SUFs in studying copper, zinc, or indometacin release from IUDs (40)(41)(42)(43)(44)(45)(46)(47). However, in all of these studies, the media designed by Zhang et al (35) or the slightly modified version reported by Mora et al (39) were applied.…”

Section: Media Simulating Human Uterine Fluidmentioning

confidence: 99%

Simulated Genital Tract Fluids and Their Applicability in Drug Release/Dissolution Testing of Vaginal Dosage Forms

Tietz¹,

Klein²

2018

Dissolution Technol.

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There has been a trend towards the development of novel vaginal dosage forms both for local therapy and systemic absorption. The growing number of vaginal dosage forms, however, presents with an increasing demand for appropriate in vitro test methods for ensuring a safe and reliable in vivo performance of each of the formulations. Application of biorelevant in vitro parameters, i.e., addressing in vivo parameters that significantly affect drug release from a vaginal dosage form in an in vitro test setup, could ensure that the results of the dissolution/drug release test are clinically meaningful and also predictive for detection of changes in the post-approval drug product. Thus, the development of predictive in vitro test methods for vaginal dosage forms is of great interest. A number of simulated vaginal fluids have been introduced in the recent past. In addition, several other genital fluids that could affect the intravaginal fluid composition, such as simulated cervical fluid/mucus, simulated intrauterine fluid, and simulated semen have been described in the literature. More frequent use of these media can be assumed, and future experiments will show if the current media will require more fine-tuning to even better reflect all physiological parameters that can affect drug release/dissolution in the vagina or if there is also a chance to simplify these media without losing their biorelevance.

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Release of copper and indomethacin from intrauterine devices immersed in simulated uterine fluid

Abstract: The surface area of the copper and the pH of the test medium modulate the in vitro release of cupric ions from Cu-IUDs.

Cited by 14 publications

References 8 publications

Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources

Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources

A mechanically robust and stable estradiol-loaded PHEMA-based hydrogel barrier for intrauterine adhesion treatment

Simulated Genital Tract Fluids and Their Applicability in Drug Release/Dissolution Testing of Vaginal Dosage Forms

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