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Stability of Oral Cholecalciferol (Vitamin D 3 ) Liquid Formulations in Olive Oil
Author(s) -
Joseph Pathma D,
Hemmens Violet J,
Munns Craig F
Publication year - 2012
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2012.tb00173.x
Subject(s) - cholecalciferol , medicine , vitamin d and neurology , olive oil , vitamin , chromatography , vitamin d deficiency , high performance liquid chromatography , zoology , chemistry , food science , biology
Background Vitamin D deficiency states in children are treated with extemporaneously prepared oral cholecalciferol liquid in olive oil at The Children's Hospital at Westmead. No formal stability data are available for these cholecalciferol dose forms. Aim To investigate the stability of extemporaneously prepared oral cholecalciferol liquid formulations in olive oil. Method Three different concentrations of cholecalciferol formulations were prepared extemporaneously. Cholecalciferol contents were assayed using ultra‐performance liquid chromatography. Determinations of the specific gravity and cholecalciferol concentrations were made over 9 months. Formulations were tested for microbial contamination at the beginning and end of the study. Results The initial concentrations of cholecalciferol in the formulations were assayed at 60 178 IU/mL, 5680 IU/mL and 400 IU/mL. Over the 9‐month study period, specific gravity determinations indicated that no major changes had occurred in the physical nature of the formulations. Linear regression analysis showed that all data points fell within the 95% confidence interval of the starting concentrations. The negative trend over time indicated that the cholecalciferol concentration decreased slowly, but remained within the British Pharmacopoeia limits for solid dose forms of 90% to 125%. The formulations passed microbial testing after 9 months. Conclusion These stability data support the current 3‐month expiry date for cholecalciferol liquid formulations in olive oil. The limitations of extemporaneous manufacture support the use of commercial products when possible.