Développement galénique et analytique d’un collyre à base de tacrolimus 0,06 %

Gauthier, Anne‐Sophie; Rival, B; Sahler, J.; Fagnoni-Legat, C.; Limat, Samuel; Guillaume, Yves Claude; Delbosc, B

doi:10.1016/j.jfo.2012.03.019

Cited by 4 publications

(2 citation statements)

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“…This is coherent with other previously published studies. In 2013, a 0.6 mg/mL tacrolimus eyedrop prepared in castor oil and stored at ambient temperature showed a decrease in tacrolimus concentrations after four months of storage [18]. In 2017, Ezquer-Garin et al published a stability study on a 0.3 mg/mL tacrolimus ophthalmic solution prepared by diluting I.V.…”

Section: Discussionmentioning

confidence: 99%

“…This has led to numerous formulations being developed and tested by the pharmaceutical and medical communities. Some ophthalmic formulations based on castor oil [18] or olive oil [19] have been reported in the literature, but numerous adverse effects such as redness, burning, itching have been identified due to the use of these oily excipients. Other formulations have been tested, but their long-term stability (more than three months) is either insufficient [20] or was not evaluated [21].…”

Section: Introductionmentioning

confidence: 99%

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Physicochemical Stability of a Novel Tacrolimus Ophthalmic Formulation for the Treatment of Ophthalmic Inflammatory Diseases

et al. 2022

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Tacrolimus is an immunosuppressant used to treat a large variety of inflammatory or immunity-mediated ophthalmic diseases. However, there are currently no commercial industrial forms available that can provide relief to patients. Various ophthalmic formulations have been reported in the literature, but their stability has only been tested over short periods. The objective of this study was to evaluate the physicochemical stability of a preservative-free tacrolimus formulation (0.2 and 1 mg/mL) at three storage temperatures (5 °C, 25 °C and 35 °C) for up to nine months in a multidose eyedropper. Analyses performed were the following: visual inspection and chromaticity, turbidity, viscosity, size of micelles, osmolality and pH measurements, tacrolimus quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. In an in-use study, tacrolimus quantification was also performed on the drops emitted from the eyedroppers. All tested parameters remained stable during the nine month period when the eyedrops were stored at 5 °C. However, during storage at 25 °C and 35 °C, several signs of chemical instability were detected. Furthermore, a leachable compound originating from a silicone part of the eyedropper was detected during the in-use assay. Overall, the 0.2 mg/mL and 1 mg/mL tacrolimus ophthalmic solutions were physicochemically stable for up to nine months when stored at 5 °C.

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Section: Discussionmentioning

confidence: 99%