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Do Ophthalmic Solutions of Amphotericin B Solubilised in 2-Hydroxypropyl-?-Cyclodextrins Possess an Extended Physicochemical Stability?

ABSTRACT: Fungal keratitis is a sight-threatening disease for which amphotericin B eye drops is one of the front-line treatments. Unfortunately, there are currently no commercial forms available, and there is little data concerning the long-term stability of compounded formulations based on intravenous dosages forms. New formulations of amphotericin B ophthalmic solutions solubilised with ?-cyclodextrins have shown promising in-vitro results, but stability data is also lacking. The objective of this study was therefore to investigate the stability of a formulation of ready-to-use amphotericin B solubilised in 2-hydroxypropyl-?-cyclodextrins (AB-HP-?-CD), for 350 days. An amphotericin B deoxycholate (ABDC) formulation was used as a comparator. Analyses used were the following: visual inspection, turbidity, osmolality and pH measurements, amphotericin B quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. AB-HP-?-CD formulation showed signs of chemical instability (loss of amphotericin B) after 28 and 56 days at 25 °C and 5 °C. Adding an antioxidant (ascorbic acid) to the formulation did not improve stability. ABDC formulation showed signs of physical instability (increased turbidy and amphotericin B precipitation) after 28 days and 168 days at 25 °C and 5 °C. As such, AB-HP-?-CD formulation does not provide long-term stability for ophthalmic amphotericin B solutions.

SUBMITTER: Chennell P

PROVIDER: S-EPMC7559369 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Do Ophthalmic Solutions of Amphotericin B Solubilised in 2-Hydroxypropyl-γ-Cyclodextrins Possess an Extended Physicochemical Stability?

Chennell Philip P Yessaad Mouloud M Abd El Kader Florence F Jouannet Mireille M Wasiak Mathieu M Bouattour Yassine Y Sautou Valérie V

Pharmaceutics 20200819 9

Fungal keratitis is a sight-threatening disease for which amphotericin B eye drops is one of the front-line treatments. Unfortunately, there are currently no commercial forms available, and there is little data concerning the long-term stability of compounded formulations based on intravenous dosages forms. New formulations of amphotericin B ophthalmic solutions solubilised with γ-cyclodextrins have shown promising in-vitro results, but stability data is also lacking. The objective of this study ...[more]

PMID: 32825121

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Dataset Information

Do Ophthalmic Solutions of Amphotericin B Solubilised in 2-Hydroxypropyl-?-Cyclodextrins Possess an Extended Physicochemical Stability?

Publications

Do Ophthalmic Solutions of Amphotericin B Solubilised in 2-Hydroxypropyl-γ-Cyclodextrins Possess an Extended Physicochemical Stability?

Similar Datasets

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