Essai de stérilité des préparations ophtalmiques sur milieu Reasoner's agar no 2 (R2A) : une solution pour diminuer le temps d’incubation

Thibert, E.; Saliege, M.; Chapelle, F.A.; Jouannet, Mireille; Traoré, Ousmane; Sautou, V.

doi:10.1016/j.phclin.2013.08.004

Cited by 3 publications

(2 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Sterility test method was validated (i.e. growth promotion test, validation of the sterility assay and elimination of the inhibitory effect) by Thibert et al (2014) , using a method adapted from the European Pharmacopoeia sterility assay (2.6.1). Multidose eyedroppers were opened under the laminar air flow of an ISO 4.8 microbiological safety cabinet, and the contents filtered under vacuum using a Nalgene analytical test filter funnel onto a 47 mm diameter cellulose nitrate membrane with a pore size of 0.45 μm (ref 147-0045, Thermo Electron SAS; ThermoFisher Scientific, Courtaboeuf Cedex, France).…”

Section: Methodsmentioning

confidence: 99%

Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers

Bouattour

Chennell

Wasiak

et al. 2018

PeerJ

View full text Add to dashboard Cite

BackgroundPolyhexamethylene biguanide (PHMB) eye drops are a frequently used medication to treat Acanthamoeba keratitis. In the absence of marketed PHMB eye drops, pharmacy-compounding units are needed to prepare this much needed treatment, but the lack of validated PHMB stability data severely limits their conservation by imposing short expiration dates after preparation. In this study we aim to assess the physicochemical and microbiological stability of a 0.2 mg/mL PHMB eye drop formulation stored in two kinds of polyethylene bottles at two different temperatures.MethodsA liquid chromatography coupled with diode array detector stability-indicating method was validated to quantify PHMB, using a cyanopropyl bonded phase (Agilent Zorbax Eclipse XDB-CN column 4.6 × 75 mm with particle size of 3.5 μm) and isocratic elution consisting of acetonitrile/deionized water (3/97 v/v) at a flow rate of 1.3 mL/min. PHMB eye drops stability was assessed for 90 days of storage at 5 and 25 °C in ethylene oxide sterilized low density polyethylene (EOS-LDPE) and gamma sterilized low density polyethylene (GS-LDPE) bottles. The following analyses were performed: visual inspection, PHMB quantification and breakdown products (BPs) screening, osmolality and pH measurements, and sterility assessment. PHMB quantification and BP screening was also performed on the drops emitted from the multidose eyedroppers to simulate in-use condition.ResultsThe analytical method developed meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity, and is stability indicating. During 90 days of storage, no significant decrease of PHMB concentration was found compared to initial concentration in all stored PHMB eye drops. However, BP were found at day 30 and at day 90 of monitoring in both kind of bottles, stored at 5 and 25 °C, respectively. Although no significant variation of osmolality was found and sterility was maintained during 90 days of monitoring, a significant decrease of pH in GS-LDPE PHMB eye drops was noticed reaching 4 and 4.6 at 25 °C and 5 °C respectively, compared to initial pH of 6.16.DiscussionAlthough no significant decrease in PHMB concentration was found during 90 days of monitoring in all conditions, the appearance of BPs and their unknown toxicities let us believe that 0.2 mg/mL PHMB solution should be conserved for no longer than 60 days in EOS-LDPE bottles at 25 °C.

show abstract

Section: Methodsmentioning

confidence: 99%

Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers

Bouattour

Chennell

Wasiak

et al. 2018

PeerJ

View full text Add to dashboard Cite

show abstract

“…Osmolality was measured for each solution using an osmometer Model 2020 Osmometer® (Advanced instruments Inc, Radiometer, SAS, Neuilly Plaisance).o Sterility assay Sterility test method was validated (i.e. growth promotion test, validation of the sterility assay and elimination of the inhibitory effect) byThibert et al (Thibert et al, 2014), using a method adapted from the European Pharmacopoeia sterility assay (2.6.1). Multidose eyedroppers were opened under the laminar air flow of an ISO 4.8 microbiological safety cabinet, and the contents filtered under vacuum using a Nalgene analytical test filter funnel onto a 47mm diameter cellulose nitrate membrane with a pore size of 0.45µm Thermo Scientific, Thermo Electron SAS, Courtaboeuf Cedex, France).…”

mentioning

confidence: 99%

Peer Review #1 of "Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers (v0.1)"

2018

View full text Add to dashboard Cite

Background: Polyhexamethylene biguanide (PHMB) eye drops are a frequently used medication to treat Acanthamoeba keratitis. In the absence of marketed PHMB eye drops, pharmacy compounding units are needed to prepare this much needed treatment, but the lack of validated PHMB stability data severely limits their conservation by imposing short expiration dates after preparation. In this study we aim to assess the physicochemical and microbiological stability of a 0.2 mg/mL PHMB eye drop formulation stored in two kinds of polyethylene bottles at two different temperatures. Methods: A liquid chromatography coupled with diode array detector (LC-DAD) stability-indicating method was validated to quantify PHMB, using a cyanopropyl bonded phase (Agilent Zorbax Eclipse XDB-CN column 4.6 mm×75 mm with particle size of 3.5 μm) and isocratic elution consisting of acetonitrile/deionized water (3/97 v/v) at a flow rate of 1.3 mL/min. PHMB eye drops stability was assessed for 90 days of storage at 5 and 25°C in ethylene oxide sterilized low density polyethylene (EOS-LDPE) and gamma sterilized low density polyethylene (GS-LDPE) bottles. The following analyses: visual inspection, PHMB quantification and breakdown products (BP) screening, osmolality and pH measurements, and sterility assessment. PHMB quantification and BP screening was also performed on the drops emitted from the multidose eyedroppers to simulate in-use condition. Results: The analytical method developed meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity, and is stability-indicating. During 90 days of storage, no significant decrease of PHMB concentration was found compared to initial concentration in all stored PHMB eye drops. However, BP were found at day 30 and at day 90 of monitoring in both kind of bottles, stored at 5 ° and 25 °, respectively. Although no significant variation of osmolality was found and sterility was maintained during 90 days of monitoring, a significant decrease of pH in GS-LDPE PHMB eye drops was noticed reaching 4 and 4.6 at 25°C and 5 °C respectively, ompared to initial pH of 6.16. Discussion: Although no significant decrease in PHMB concentration was found during 90 days of monitoring in all conditions, the appearance of breakdown products and their unknown toxicities let us believe that 0.2 mg/mL PHMB solution should be conserved for no longer than 60 days in EOS-LDPE bottles at 25°C.

show abstract

Long term physicochemical stability study of novel ophthalmic formulations combining ceftazidime and vancomycin with and without cyclodextrins

Plaidy,

Bouattour,

Yessaad

et al. 2023

Pharmaceutical Technology in Hospital Pharmacy

View full text Add to dashboard Cite

Objectives Ceftazidime (CZ) and Vancomycin (VM) are used to treat bacterial keratitis; however, their physicochemical incompatibility does not allow their co-administration. This incompatibility can be managed by buffering the mixture at an alkaline pH or by using cage molecules such as cyclodextrins (CD). The objective of this work was to compare the stability during 168 days of frozen storage of two formulations combining VA and CZ at a final concentration of 25 mg/mL: a CD-free formulation, at a pH=8.5 and a formulation with CD. Methods Beforehand, a stability indicating method (SIM) was developed. Samples were analysed after 1, 3 and 6 months, and after 12, 24 and 72 h after defrosting. Analyses performed were the following: visual inspection, chromaticity, turbidity, osmolality and pH measurements, particles counting, CZ and VM quantification, breakdown product research, and sterility assay. Results The developed SIM allowed the simultaneous quantification and breakdown products research of both VM and CZ, without interference of the breakdown products. The analyses showed the presence of a visually detectable precipitate and increased turbidity as early as the first day after thawing for CD-free formulation and on the third day for the formulation with CD. CZ concentrations systematically decreased after thawing for both formulations whilst VM concentrations remained stable. Osmolality and pH remained unchanged, and no microbial growth was detected throughout the study. Conclusions CD delayed precipitation by 48 h compared to the CD-free formulation but did not permanently eliminate it. Both formulations showed very limited physicochemical stability after thawing.

show abstract

Essai de stérilité des préparations ophtalmiques sur milieu Reasoner's agar no 2 (R2A) : une solution pour diminuer le temps d’incubation

Cited by 3 publications

References 4 publications

Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers

Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers

Peer Review #1 of "Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers (v0.1)"

Long term physicochemical stability study of novel ophthalmic formulations combining ceftazidime and vancomycin with and without cyclodextrins

Contact Info

Product

Resources

About