In Vitro Stability of Fortified Ophthalmic Antibiotics Stored at −20°C for 6 Months

Objective This study investigates the effectiveness of self-nanoemulsifying drug delivery system (SNEDDS) in improving voriconazole transcorneal permeability. Methods Voriconazole-SNEDDS was prepared with isopropyl myristate, PEG 400, Tween 80 â and Span 80 â and was subjected for physicochemical characterization after reconstitution with NaCl 0.9% (1/9; v/v). In-vitro antifungal activity was assessed and compared with the marketed formulation. In-vivo studies, namely ocular irritation test via modified Draize test and pharmacokinetic study, were investigated using rabbit as animal model. Key findings Voriconazole-SNEDDS presented a droplet size of 21.353 AE 0.065 nm, a polydispersity index of 0.123 AE 0.003, a pH of 7.205 AE 0.006 and an osmolarity of 342.667 AE 2.517 mOsmol/l after reconstitution with NaCl 0.9%. Voriconazole-SNEDDS minimum inhibitory concentration (MIC 90 ) was similar to the one of marketed formulation for Candida species while it was significantly lower (P < 0.001) for Aspergillus fumigatus. Draize test revealed that Voriconazole-SNEDDS was safe for ocular administration. Voriconazole maximum concentration (5.577 AE 0.852 µg/ml) from SNEDDS was higher than marketed formulation (C max = 4.307 AE 0.623 µg/ml), and the T max was delayed to 2 h. The area under the concentration-time curve value of Voriconazole-SNEDDS was improved by 2.419-fold. Conclusion Our results suggest that SNEDDS is a promising carrier for voriconazole ocular delivery and this encourages further clinical studies.

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“…Moreover, the eye supports an osmotic pressure from 240 to 550 mOsm/l without pain or cell damage. [ 27 ]…”

Section: Resultsmentioning

confidence: 99%

Self-nanoemulsifying drug delivery system to improve transcorneal permeability of voriconazole: in-vivo studies

Rasoanirina

Lassoued

Miladi

et al. 2020

Journal of Pharmacy and Pharmacology

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“…Furthermore, it is necessary to provide efficient and timely drug provision in order to avoid practical problems such as delays in treatment [4]. Access to existing bodies of clinical knowledge is an important factor and is reflected in the sheer volume of formulation studies which have been published since the 1960s [5,6] Such studies are typically long-term, analyze drug content and drug degradation, and consider a variety of environmental factors (such as temperature, light and pH).…”

Section: Introductionmentioning

confidence: 99%

Medical Formulation Recognition (MFR) using Deep Feature Learning and One Class SVM

Kawi

Clawson

Paul³

et al. 2020

2020 International Joint Conference on Neural Networks (IJCNN)

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Specials medications are personalized formulations manufactured on demand for patients with unique prescription requirements and constitute an essential component of patient treatment. Specials are becoming increasingly in demand due to the need for personalized and precision medicine. The timely provision of optimal personalized medicine, however, is challenging, subject to strict regulatory processes, and is expert intensive. In this paper, we propose a new medical formulation engine (MFE) that performs semantic search across multiple disparate formulations archives to enable data driven formulation intelligence. We develop a new platform for medical formulations recognition (MFR) that curates a new dataset comprising formulations and non-formulations (clinical) text and uses a novel pipeline encompassing deep feature extraction and one-class support vector machine learning. The proposed MFR framework demonstrates promising performance and can be used as a benchmark for future research in formulations recognition.

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“…In similar regard to the IV fluids, the balanced salt solutions lack preservatives, making them suboptimal for the multi-dose ophthalmic solutions. 20-22…”

Section: Introductionmentioning

confidence: 99%

“…In similar regard to the IV fluids, the balanced salt solutions lack preservatives, making them suboptimal for the multi-dose ophthalmic solutions. [20][21][22] Aside from the complexity of vehicle selection, chemical stability of vancomycin should be carefully evaluated in compounded ophthalmic solutions. As shown in Figure 1, vancomycin contains various chemically labile or reactive functional groups, such as phenols and acetals.…”

Section: Introductionmentioning

confidence: 99%

An Exploratory Study of a New Vancomycin Eye Drops Formulation for Extemporaneous Compounding

et al. 2020

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Purpose: Compounded eye drop solutions of vancomycin hydrochloride have important clinical applications, such as postoperative antimicrobial prophylaxis and bacterial keratitis. There exists a plethora of data to support the use of various liquid vehicles to compound vancomycin hydrochloride eye drops. However, there are a number of limitations for implementation, especially the frequent shortage or discontinuation of the vehicle products. This study was designed to investigate the use of an OTC eye wash product as the evergreen vehicle and to evaluate the physical and chemical stability of the new formulation. Methods: The Advance Eye Relief® eye wash and vancomycin hydrochloride for injection vials were used to prepare 10 and 50 mg/mL vancomycin eye drop solutions. The solutions were packaged in Steri-Droppers® bottles and stored in a freezer for 14 days followed by 28 days in refrigeration. The 14-day period of freezing was included to allow time for sterility testing. At pre-determined stability time points, samples were taken for visual inspection, pH and osmolality measurement, and analysis by a stability-indicating high performance liquid chromatography (HPLC) method. Results: Freshly prepared vancomycin eye drops were clear, colorless, and free of particulates. The pH readings were 7.03 and 6.28 for the 10 and 50 mg/mL solutions, respectively. The osmolality of both solutions were within the range of 300-330 mOsmol/kg and considered isotonic. Initial drug concentrations of all samples were confirmed by HPLC to be within 100%-103% of the label claims. Throughout the stability study period, there were no significant changes in the appearance, pH, or osmolality of any samples. The HPLC results also confirmed that the drug concentrations in all stability samples were within 98%-101% of the initial time zero values and no significant degradation product peaks were observed. Conclusion: A new compounded vancomycin eye drop formulation was developed to mitigate vehicle sourcing issues. This eye drop formulation was easy to prepare, exhibited satisfactory properties for ophthalmic applications, and remained stable chemically and physically when stored for 14 days in freezer followed by 28 days in refrigerator.

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In Vitro Stability of Fortified Ophthalmic Antibiotics Stored at −20°C for 6 Months

Abstract: Fortified ophthalmic antibiotic solutions prepared and supplied by a pharmacy can be stored in freezers at -20 degrees C for later use.

Cited by 13 publications

References 9 publications

Self-nanoemulsifying drug delivery system to improve transcorneal permeability of voriconazole: in-vivo studies

Self-nanoemulsifying drug delivery system to improve transcorneal permeability of voriconazole: in-vivo studies

Medical Formulation Recognition (MFR) using Deep Feature Learning and One Class SVM

An Exploratory Study of a New Vancomycin Eye Drops Formulation for Extemporaneous Compounding

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