Stability of frozen 1% voriconazole eye-drops in both glass and innovative containers

Roche, M; Lannoy, Damien; Bourdon, Françoise; Danel, Cécile; Labalette, Pierre; Berneron, C; Simon, Nicolas; Odou, Pascal

doi:10.1016/j.ejps.2019.105102

Cited by 9 publications

(16 citation statements)

References 32 publications

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“…Microbiological testing of the final product is an essential test to be able to assign a microbiological shelf-life (along with prerequisites such as controlled cleanroom environment, validated preparation conditions, and integrity testing of the container and closure [ 47 ]). Concerning the container and closure system, the gamma-sterilized eyedroppers were provided with a closure system (Novelia ® caps) which does not allow unfiltered air to penetrate the eyedropper, is commercially guaranteed to preserve sterility of the content more than a month [ 48 ], as well as has been tested for various hospital-prepared ophthalmic solutions either after one month of simulated use or after freezing and thawing [ 27 , 29 ].…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, few studies have been published concerning atropine eyedrops stability, but the analyses were either lacking several tests or suffered from shortcomings concerning breakdown product research [ 24 , 25 , 26 ]. As single-dose container technology is not readily available to compounding pharmacies, multidose eyedroppers (often in low dose polypropylene) are the most used container and therefore the most studied [ 27 , 28 , 29 , 30 ]. However, not all of those devices possess a system allowing their content to be preservative-free, and their contents must therefore be preserved.…”

Section: Introductionmentioning

confidence: 99%

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Stability of Ophthalmic Atropine Solutions for Child Myopia Control

et al. 2020

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Myopia is an ophthalmic condition affecting more than 1/5th of the world population, especially children. Low-dose atropine eyedrops have been shown to limit myopia evolution during treatment. However, there are currently no commercial industrial forms available and there is little data published concerning the stability of medications prepared by compounding pharmacies. The objective of this study was to evaluate the stability of two 0.1 mg/mL atropine formulations (with and without antimicrobiobial preservatives) for 6 months in two different low-density polyethylene (LDPE) multidose eyedroppers. Analyses used were the following: visual inspection, turbidity, chromaticity measurements, osmolality and pH measurements, atropine quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. In an in-use study, atropine quantification was also performed on the drops emitted from the multidose eyedroppers. All tested parameters remained stable during the 6 months period, with atropine concentrations above 94.7% of initial concentration. A breakdown product (tropic acid) did increase slowly over time but remained well below usually admitted concentrations. Atropine concentrations remained stable during the in-use study. Both formulations of 0.1 mg/mL of atropine (with and without antimicrobial preservative) were proved to be physicochemically stable for 6 months at 25 °C when stored in LDPE bottles, with an identical microbial shelf-life.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability of Ophthalmic Atropine Solutions for Child Myopia Control

et al. 2020

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“…Still, precaution should be taken as ataluren concentration decreased upon exposure when nanoparticles of titanium dioxide P25, a powerful photocatalyst, were added [23]. This points out that ataluren may degrade in the presence of a strong oxidizing agent, such as hydroxyl radical (•OH), which was detected in the context of nuclear cataract [24,25].…”

Section: Discussionmentioning

confidence: 99%

“…The sterility assay did not reveal any microbial contamination over the study time. The closure system eyedropper (Novelia ® ), which does not allow unfiltered air to penetrate the eyedropper, provided a further guarantee for sterility preservation of the content more than one month of simulated use [25]. Unlike a suspension, the sterilizing filtration process of removing microorganisms using a 0.22 µm filter can be performed with ataluren eye drops solution.…”

Section: Discussionmentioning

confidence: 99%

Formulation and Stability of Ataluren Eye Drop Oily Solution for Aniridia

et al. 2020

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Congenital aniridia is a rare and severe panocular disease characterized by a complete or partial iris defect clinically detectable at birth. The most common form of aniridia occurring in around 90% of cases is caused by PAX6 haploinsufficiency. The phenotype includes ptosis, nystagmus, corneal limbal insufficiency, glaucoma, cataract, optic nerve, and foveal hypoplasia. Ataluren eye drops aim to restore ocular surface PAX6 haploinsufficiency in aniridia-related keratopathy (ARK). However, there are currently no available forms of the ophthalmic solution. The objective of this study was to assess the physicochemical and microbiological stability of ataluren 1% eye drop in preservative-free low-density polyethylene (LDPE) bottle with an innovative insert that maintains sterility after opening. Because ataluren is a strongly lipophilic compound, the formulation is complex and involves a strategy based on co-solvents in an aqueous phase or an oily formulation capable of totally dissolving the active ingredient. The visual aspect, ataluren quantification by a stability-indicating chromatographic method, and microbiological sterility were analyzed. The oily formulation in castor oil and DMSO (10%) better protects ataluren hydrolysis and oxidative degradation and permits its complete solubilization. Throughout the 60 days period, the oily solution in the LDPE bottle remained clear without any precipitation or color modification, and no drug loss and no microbial development were detected. The demonstrated physical and microbiological stability of ataluren 1% eye drop formulation at 22–25 °C might facilitate clinical research in aniridia.

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“…Trauma is the most predominant cause of ocular fungal infections, whereas the most common isolated species are Fusarium, Aspergillus, and Candida. 18,82,83 Few eye drops are available for fungal infection treatment; thus, researchers aimed to develop voriconazoleloaded (O/W) type MEs for efficient drug delivery. For example, O/W MEs of voriconazole were produced based on oleic acid and isopropyl myristate as the oil phase and Tween 80 and propylene glycol as surfactant and cosurfactant.…”

Section: Novel Ocular Microemulsionsmentioning

confidence: 99%

Novel Ocular Drug Delivery Systems: An Update on Microemulsions

Okur

Çağlar

Sıafaka

2020

Journal of Ocular Pharmacology and Therapeutics

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Sufficient ophthalmic drug delivery is still challenging for pharmaceutical technologists, despite various scientific efforts. Several ocular drug carriers have been designed to enhance bioavailability by prolonging the drug retention time. One of the current encouraging approaches is the utilization of colloidal carriers with the characteristic submicron-nanometer size. Microemulsions (MEs) are such colloid systems that present sizes between 5 and 200 nm with significant thermodynamic stability and low surface tension. In addition, MEs as topical ocular carriers can lead to great ocular drug adsorption due to their enhanced retention time. Furthermore, considering that MEs are stable for long time and various temperatures, their ocular application is of great interest. The aim of this study is to cover basic physicochemical principals of ocular MEs such as their possible size, stability, and therapeutic efficacy against various eye disorders. Thus, a comprehensive review for ocular drug delivery systems in the form of MEs that show promising characteristics as their stability and therapeutic efficiency is performed.

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Stability of frozen 1% voriconazole eye-drops in both glass and innovative containers

Cited by 9 publications

References 32 publications

Stability of Ophthalmic Atropine Solutions for Child Myopia Control

Stability of Ophthalmic Atropine Solutions for Child Myopia Control

Formulation and Stability of Ataluren Eye Drop Oily Solution for Aniridia

Novel Ocular Drug Delivery Systems: An Update on Microemulsions

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