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Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
UNASSIGNED：盐酸万古霉素复合滴眼液具有重要的临床应用，如术后抗菌预防和细菌性角膜炎。存在大量数据来支持将各种液体载体用于复方盐酸万古霉素滴眼液。然而,实施有许多限制，特别是车辆产品的频繁短缺或停产。这项研究旨在研究使用OTC洗眼产品作为常绿载体，并评估新配方的物理和化学稳定性。
UNASSIGNED:使用AdvanceEyeRelief®洗眼剂和盐酸万古霉素注射小瓶制备10和50mg/mL万古霉素滴眼液。将溶液包装在Steri-Droppers®瓶中并在冰箱中储存14天,随后冷藏28天。包括14天的冷冻期以留出时间进行无菌测试。在预定的稳定时间点，取样进行目视检查，pH和渗透压测量，并通过稳定性指示的高效液相色谱（HPLC）方法进行分析。
UNASHSIGNED：新鲜配制的万古霉素滴眼液清晰，无色,而且没有微粒.10和50mg/mL溶液的pH值分别为7.03和6.28，分别。两种溶液的渗透压在300-330mOsmol/kg的范围内并且认为是等渗的。通过HPLC确认所有样品的初始药物浓度在标签要求的100%-103%内。在整个稳定性研究期间，外观没有明显变化,pH值,或任何样品的渗透压。HPLC结果还证实,所有稳定性样品中的药物浓度在初始时间零值的98%-101%内,并且没有观察到显著的降解产物峰。
UNASSIGNED：开发了一种新的复合万古霉素滴眼液，以缓解车辆采购问题。这种滴眼液配方易于制备，表现出令人满意的眼科应用性能，在冰箱中储存14天，然后在冰箱中储存28天时，在化学和物理上保持稳定。
UNASSIGNED:使用AdvanceEyeRelief®洗眼剂和盐酸万古霉素注射小瓶制备10和50mg/mL万古霉素滴眼液。将溶液包装在Steri-Droppers®瓶中并在冰箱中储存14天,随后冷藏28天。包括14天的冷冻期以留出时间进行无菌测试。在预定的稳定时间点，取样进行目视检查，pH和渗透压测量，并通过稳定性指示的高效液相色谱（HPLC）方法进行分析。
UNASHSIGNED：新鲜配制的万古霉素滴眼液清晰，无色,而且没有微粒.10和50mg/mL溶液的pH值分别为7.03和6.28，分别。两种溶液的渗透压在300-330mOsmol/kg的范围内并且认为是等渗的。通过HPLC确认所有样品的初始药物浓度在标签要求的100%-103%内。在整个稳定性研究期间，外观没有明显变化,pH值,或任何样品的渗透压。HPLC结果还证实,所有稳定性样品中的药物浓度在初始时间零值的98%-101%内,并且没有观察到显著的降解产物峰。
UNASSIGNED：开发了一种新的复合万古霉素滴眼液，以缓解车辆采购问题。这种滴眼液配方易于制备，表现出令人满意的眼科应用性能，在冰箱中储存14天，然后在冰箱中储存28天时，在化学和物理上保持稳定。
