Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Stability of Amphotericin B in 5% Dextrose Ophthalmic Solution

Author(s):  Peyron Florence, Elias R, Ibrahim E, Amirat-Combralier V, Bues-Charbit M, Balansard G

Issue:  Jul/Aug 1999 - Compounding Parenteral Products
View All Articles in Issue

Abstract:  The stability of amphotericin B 5 mg/mL in 5% dextrose ophthalmic solution prepared by the Hospital Pharmacy Service was studied in different conditions of storage and use. Admixtures of amphotericin B were aseptically prepared in low-density polyethylene dropper bottles. The stability of amphotericin B was evaluated in ophthalmic dropper bottles stored in a refrigerator, at room temperature, protected from, or exposed to, light. To simulate the effect of exposure to air, some ophthalmic dropper bottles were opened twice daily and two drops were removed. Immediately after preparation, samples were collected to determine the initial drug concentration by high-performance liquid chromatography and to assess pH, osmolality and sterility. The same tests were conducted after four, eight and 15 days of storage in ophthalmic containers opened daily and unopened after eight, 15, 30, 60, 75 and 120 days of storage. Samples were visually inspected daily for signs of physical incompatibility. An additional study was conducted in four ophthalmic containers collected in the ophthalmology unit after eight or 15 days of current patient use testing the same parameters. Ophthalmic containers stored in the refrigerator (the closed and the opened daily set) showed no loss or deterioration of amphotericin B during the corresponding period of storage (120 and 15 days, respectively). We observed precipitation and degradation after 13 days of storage in ophthalmic containers exposed to normal lighting conditions at room temperature, and after 16 days in ophthalmic containers protected from light. There was no appreciable change in pH or osmolality in any of the samples. Microbiological investigation disclosed negative culture results for all samples. This study shows that aseptically prepared amphotericin B ophthalmic solution packaged in low-density polyethylene bottles can be stored safely for up to 120 days when unopened and stored at 4°C and protected from light, for 16 days when stored at 22°C and protected from light and for 13 days when stored at 22°C and exposed to light.

Related Keywords: amphotericin B, degradation, ophtalmic solution, osmolality, pH, precipitation


Printer-Friendly Version

Download in electronic PDF format for $65

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Stability of Amphotericin B in 5% Dextrose Ophthalmic Solution Peyron Florence, Elias R, Ibrahim E, Amirat-Combralier V, Bues-Charbit M, Balansard G Jul/Aug 1999 316-320 Buy
pH Stability of Injectable Fentanyl, Bupivacaine, or Clonidine Solution or a Ternary Mixture in 0.9% Sodium Chloride in Two Types of Polypropylene Syringes Jappinen Annaliisa L, Kokki H, Rasi A S, Naaranlahti Toivo J Nov/Dec 2002 471-474 Buy
Formulation and Stability of Solutions Akers Michael J Jan/Feb 2016 41-45 Buy
Basics of Compounding: Compounding Irrigation Solutions for Sterile and Nonsterile Preparations Allen Loyd V Jr Nov/Dec 2017 481-486 Buy
Basics of Compounding for Disorders of the External Ear Allen Loyd V Jr Jan/Feb 2004 46-48 Buy
Quality-Control Analytical Methods: Osmolality and Osmometry Allen Loyd V Jr Mar/Apr 2004 143-145 Buy
Basics of Compounding: Compounding Solutions Allen Loyd V Jr Mar/Apr 2000 122-125 Buy
pH and Osmolarity, A Review of Stranz Marc, Kastango Eric S May/Jun 2002 216-220 Buy
Quality Control Analytical Methods: Testing of Electrolytes Solutions Vu Nicole Jan/Feb 2009 53-55 Buy
Sterile Basics: Intravenous Admixture Preparation Considerations, Part 5: pH Considerations Allen Loyd V Jr Jul/Aug 2020 305-309 Buy
Particle Measuring Systems - USP <797> Environmental Monitoring Solutions