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In line final filters for removing particles from amphotericin B infusions
Abstract:
The feasibility of using membrane filters to remove particles from intravenous infusions of amphotericin B in dextrose 5% (a colloidal solution) was studied. Six types of commercial membrane filters, ranging in pore size from 0.45-1.0 mum, were used. Because of the effect of pH on the particle size of colloidal solutions, each filter was tested at solution pH 4.7, 5.6 and 6.5. Samples of filtrate were analyzed spectrophotometrically for amphotericin content. All filters of pore size 0.22 mum removed amphotericin B from solution and were inappropriate for use with this product. Solutions at pH 4.7 were turbid, filtered slowly and were generally unacceptable for clinical use. At pH 5.6, only filters with pore sizes of 1.0 mum or greater showed acceptable results. At pH 6.5, filters with pore sizes of 0.45 mum or greater gave acceptable results; the use of a filter with a pore size of not less than 1.0 mum would provide a margin for error to compensate for variations in the colloidal particle size of amphotericin B.
Insights
Membrane filters can remove particles from amphotericin B infusions. For safe intravenous use, select filters with pore sizes of 0.45-1.0 µm, considering pH effects on colloidal solutions.
Area of Science:
- Pharmaceutical Technology
- Colloid Science
- Filtration Technology
Background:
- Intravenous infusions require sterile, particle-free solutions.
- Amphotericin B in dextrose 5% is a colloidal solution susceptible to particle formation.
- Membrane filtration is a common method for sterilizing and clarifying pharmaceutical solutions.
Purpose of the Study:
- To evaluate the feasibility of using membrane filters for particle removal from amphotericin B infusions.
- To determine the optimal filter pore size and pH conditions for effective filtration.
- To assess the impact of filtration on amphotericin B content in the solution.
Main Methods:
- Six commercial membrane filters (0.45-1.0 µm pore size) were tested.
- Filtration was performed at three pH levels (4.7, 5.6, 6.5) to account for colloidal solution behavior.
- Filtrate analysis included spectrophotometry for amphotericin B content and visual inspection for turbidity.
Main Results:
- Filters with pore sizes ≤ 0.22 µm removed amphotericin B, rendering them unsuitable.
- At pH 4.7, solutions were turbid and filtered slowly, indicating clinical unsuitability.
- Acceptable filtration results were achieved at pH 5.6 with ≥ 1.0 µm filters and at pH 6.5 with ≥ 0.45 µm filters.
Conclusions:
- Membrane filter selection for amphotericin B infusions is critical and dependent on pH.
- Filters with pore sizes of 1.0 µm or greater are recommended for safe clinical use, providing a buffer for colloidal particle size variations.
- Optimizing filtration parameters ensures product quality and patient safety.