Near-patient stability studies

Barnes, Allan J.

doi:10.1046/j.1365-2710.1996.89675896.x

Cited by 2 publications

(3 citation statements)

References 26 publications

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“…The stabilities of vancomycin 50 mg/ml in all vehicles were examined by absorbance and calculated with standard vancomycin to percent of the labeled amount. It was found that more than 90% of the initial vancomycin concentration remained after 30 days at 2-8 o C, as shown in Fig 1a [10]. The MIC from broth dilution of vancomycin 50 mg/ml of all vehicles were in an acceptable range of 0.5-2.0 µg/ml after 30 days at 2-8 o C in accordance with CLSI 2011 guidelines [7].…”

Section: Resultssupporting

confidence: 73%

Comparison of Vehicles for Vancomycin Drug Delivery in Extemporaneously Prepared Ophthalmic Solutions

Khangtragool

2012

AMR

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This work compares the ophthalmic delivery of vancomycin 50 mg/ml eye drops using 5 different vehicles, namely: 0.3% w/v chitosan, 0.3% and 0.4% w/v HPMC (Methocel E4M), Tears NaturaleTMII and 0.9% w/v sodium chloride solution.In vitroandin vivostudies were carried out and the results evaluated in terms of viscosity, compatibility, stability, clarity, minimum inhibitory concentration (MIC) and pharmacokinetics. The viscosity of Tears NaturaleTMII was comparable with that of HPMC (0.3% pH 7.1) but was higher than 0.3% w/v chitosan. The percent labeled amounts and MIC of vancomycin 50 mg/ml in all of the vehicles were stable for 30 days at 2-8°C, while the clarity in 0.3% w/v chitosan, 0.3% and 0.4% HPMC (pH 7.1), Tears NaturaleTMII and 0.9% sodium chloride solution was stable for 30, 14, 1 and 3 days respectively at 2-8°C.In vivopharmacokinetic determinations of the AUC of tear film reciprocal of minimum inhibitory titer showed that vancomycin 50 mg/ml in 0.3% w/v chitosan, 0.3% and 0.4% w/v HPMC pH 7.1 and Tears NaturaleTMII were significantly different from 0.9% sodium chloride solution. At the present time, chitosan is undergoing clinical trials in Thailand with a view to its use in ophthalmology, while HPMC (0.3% w/v) in pH 7.1 has already been approved for use as a vehicle in ophthalmology for the delivery of vancomycin 50 mg/ml in extemporaneous eye drops.

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Section: Resultssupporting

confidence: 73%

Comparison of Vehicles for Vancomycin Drug Delivery in Extemporaneously Prepared Ophthalmic Solutions

Khangtragool

2012

AMR

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“…A decrease of no more than 10% is typically accepted as a stability limit for extemporaneously formulated ophthalmic solutions and has been used by previous studies addressing the stability of voriconazole in solution. 9,15,16…”

Section: Discussionmentioning

confidence: 99%

“…9,16,17 Although there was a statistically significant drop in voriconazole concentration at the 40°C storage temperature between day 0 and day 30, no solution fell below 94% of the original concentration, which is well above the 90% limit for extemporaneously prepared ophthalmic solutions. 9,15,16 Although voriconazole appears to remain stable at the studied temperatures, efficacy of the solutions was not evaluated. In addition, all solutions were maintained at a constant temperature for 30 days, only being briefly removed from the incubators for sample collection.…”

Section: Discussionmentioning

confidence: 99%