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BackgroundA paediatric patient in our hospital suffers from a rare, hereditary transcobalamin II deficiency resulting in an intracellular vitamin B12 deficiency. Treatment consists of massive parenteral intake of vitamin B12. Parenteral vitamin B12 solution, suitable for children under 3 years of age, is not commercially available in our country.PurposeThe aim was to produce a preservative-free, sterile hydroxocobalamin (vitamin B12) solution at a concentration of 10 mg/2 ml for intramuscular use and to develop an analytical method of indicating the stability in order to determine the shelf life of the solution.Material and methodsThe entire manufacturing process took place under aseptic conditions. Hydroxocobalamin hydrochloride was dissolved in NaCl 0.9% to give a concentration of 10 mg/2ml. The pH value was adjusted to 4.3–4.5 using hydrochloric acid. The solution was 0.2 µm filtered and finally, 2.4 ml of solution was aseptically filled into sterilised brown glass vials. The filter integrity was tested using the bubble point method. The vials were kept in the refrigerator. Alternatively, the solution was autoclaved at 121°C for 15 min and assessed by high performance liquid chromatography (HPLC) for degradation products.ResultsThe autoclaved solution contained degradation products and the hydroxocobalamin content had decreased by 20%. In contrast, the sterile filtered solution showed no degradation products and no loss in the hydroxocobalamin content was observed after storage for 24 months at 2–8°C. The solution was stable when stored for one month at room temperature and even exposure to 56°C for 2 days did not cause the product to degrade.ConclusionWe produced a hydroxocobalamin solution for intramuscular use with a shelf life of at least 24 months if refrigerated. The treatment of our patient with this solution, administered as an intramuscular injection once a week, has been extremely successful for more than 3 years.References and/or acknowledgementsNo conflict of interest.

Background Indomethacin 1 mg is used in premature infants to close the patent ductus arteriosus. The commercial product Indocid PDA is no longer available in Switzerland. Nevertheless, on our paediatric ward there is a great need for an intravenous indomethacin solution that can be used at a dose of 0.1–0.2 mg/kg body weight. Purpose To produce a parenteral ready-to-use solution containing 0.2 mg/ml indomethacin and to determine the long-term stability using a stability indicating high-pressure liquid chromatography (HPLC) method. Materials and Methods Liometacen, containing 50 mg sterile indomethacin (as meglumine salt), was reconstituted with 2 ml water for injection and then diluted with 250 ml NaCl 0.9% to a final indomethacin concentration of 0.2 mg/ml. Finally, a 5 ml indomethacin solution was filled into 10 ml sterilised brown glass vials. The entire process took place under aseptic conditions. Sterility testing was performed before final batch release. The vials were stored for up to 18 months frozen at −20°C, at 2–8°C or at room temperature, and the solutions were assessed by HPLC for indomethacin and its degradation products. Results Indomethacin solutions were submitted to conditions of oxidative or heat degradation, and the HPLC method was found to indicate stability. The stability testing revealed that the solutions retained at least 95% of their initial indomethacin concentration when they were stored at room temperature for 12 days or at 2–8°C for 23 days. In contrast, when the solutions were stored in a deep-freezer, they were stable for at least 18 months. During this time, no degradation of indomethacin occurred and the indomethacin concentration remained stable. Conclusions Indomethacin solutions may be prepared in advance and stocked for at least 18 months at −20°C. After thawing they can be kept at room temperature for 7 days or alternatively at 2–8°C for 14 days. This procedure is used successfully in our hospital for the treatment of the patent ductus arteriosus. No conflict of interest.