A Method for Removal of Endotoxin from Pharmaceutical Formulation - The authors describe a simple method to remove endotoxins from highly viscous formulations. - BioPharm International

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A Method for Removal of Endotoxin from Pharmaceutical Formulation
The authors describe a simple method to remove endotoxins from highly viscous formulations.


BioPharm International
Volume 25, Issue 9, pp. 26-29

RESULTS


Table II: Values of endotoxin, Ca2+ and Na+ before treatment with Sartobind 100. EU is European units.
Table I shows the measured values of E. Coli endotoxin before and after a single passage through Sartobind Q15. By plotting the data in a diagram, it can be inferred that a safe capacity of Sartobind Q15 membranes for E. coli LPS can be set to 450–460 EU (see Figure 1). Within this range, the filtrate has concentrations < 0.5 EU/mL, which is considered acceptable for injection into experimental animals. The process had no effect on the iodine and Gd concentration and a negligible effect on pH.


Table III: Values of endotoxin, Ca2+ and Na+ after treatment with Sartobind 100. EU is European units.
The method was successfully applied to formulations containing Ca2+ and Na+ without affecting the ratio between them (see Tables II and III).

DISCUSSION

The method was ideal for preparing experimental formulations in exploratory phase where sterility of the starting materials is not an absolute requirement. As such, the method gave us an opportunity to increase the throughput for screening of new compounds.

ACKNOWLEDGMENTS

The authors would like to thank Dr. Ivar Martinsen, GE Healthcare, for the analysis of iodine and gadolinium of the samples and Dr. Jann Vestby and Dr. Signe Marie Jensen for determination of endotoxin concentrations.

Gunnar Hagelin, D. Philos.*, is a senior research scientist and Lars Gøran Wistrand, PhD, is department manager, both in Analytical and Bioanalytical Chemistry, Research, Medical Diagnostics at GE Healthcare, Oslo, Norway. *To whom correspondence should be addressed,
.

PEER-REVIEWED

Article submitted: Oct. 04, 2011. Article accepted: Jan. 31, 2012.

REFERENCES

1. F.C. Pearson, "Pyrogens—Endotoxins, LAL Testing and Depyrogenation," in Advances in Parenteral Sciences/2, J.R. Robinson, Ed. (Marcel Dekker Inc., New York and Basel, 1985).

2. Le Greneur Soizic et al., "Procede de Depyrogenisation De Solutions De Produits de Contraste Pour Imagerie Medicale," Demande De Brevet D'Invention, Fr. Demande, 8 pp. No. publ. 2 794 996; National Reg. No. 99 07844 (2000).

3. Ervino Morandi and Angelo Gallotti, "Process for the Depyrogenation of Injectable Pharmaceutical Solutions," PCT Int. Appl. 23 pp, European Patent Organization (EPO) No. 825 879 B1 (1996).

4. S. Brown and A.C. Fuller, J. Parent. Sci. Technol. 47 (6), 285 (1993).

5. G. Hagelin and L.G. Wistrand, "Endotoxin Removal in Contrast Media," GE Healthcare, PN0971 (2010) and EP 2286887 (2012).

6. J.W. Mitchell, "Prolonged Release of Biologically Active Polypeptides," US Patent 4,985,404, Jan. 15, 1991.


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