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Investigations in ConComp®, are concerned with two types of compatibility phenomena:
A. Interaction of physico/chemical nature between the components of the infusion solution and
the IV-drug:
- The IV-drug is added to the infusion solution prior to the start of the infusion. The mixing
ratio relationship is defined and constant. The contact time for the components in the mixture
can be several hours, in case of aseptic preparation up to 24 hours.
Determination: physico/chemical compatibility.
Investigation time points: 0; 24 hours
- The IV drug flows into the ongoing infusion solution (Y- connector, 3-way valve). The mixing
ratio is not defined and is dependent on the infusion speed of both components. The contact
time in the infusion line between the connection and catheter tip adds up to only a few
minutes.
Determination: physico/chemical compatibility.
Investigation time points: 0; 1 hour
B. Interaction between the IV-drug and the container of the infusion solution:
- The drug is added to the infusion solution. Active pharmaceutical ingredient losses caused by
the adsorption of the drug at the container wall can be significant,depending on the structure
of the active ingredient, the container material and the active ingredient concentration.
Contact time can be several hours, in aseptic preparation up to 24 hours. Determination: the content of the remaining active ingredient in the infusion solution.
Investigation time points: 0, 24; (48; 72) hours
Determination of physical / chemical compatibility by means of::
- pH value
- Visual inspection
- Particle filtration (> 10µm, > 25µm)
- Turbidity, opalescence (Nephelometer)
- UV absorption (UV-VIS-Photometer)
Determination of drug loss because of the adsorption phenomena:
- Quantitative UV absorption
- HPLC
ConComp includes studies from the literature as well as from our own laboratories.
In our own investigations the infusion solution is usually a proprietary product of B. Braun. |