Abstract

JUBERIAS SANCHEZ, A. et al. Development of a new liquid pharmaceutical form needed in a situation of a nuclear accident. Sanid. Mil. [online]. 2011, vol.67, n.3, pp.273-283. ISSN 1887-8571.  https://dx.doi.org/10.4321/S1887-85712011000400004.

Introduction: The administration of stable iodine in the form of iodide, is used as a buffer against the harmful effects of radiation, this prophylactic regimen is also assumed by NATO STANAG 2461 in NBC / MED. The difficult delivery to specific population groups with difficulties in swallowing solid oral forms of stable iodine, requires the availability of certain preparations that would circumvent the disadvantages of these formulations and facilitate the management of this asset. Place: Center Pharmacy Military Defense. Objective: Design and to evaluate a stable preparation of potassium iodide in solution for oral administration to complete the gap in the Spanish and European therapeutic arsenal. Production and validation of industrialscale process of an oral solution of potassium iodide. Defining the parameters which determine the quality of the product. Evaluation of the stability of the preparation. Statistical treatment of results. Material and methods: Components manufactured product. Process and control equipment used in industrial pharmaceutical manufacturing solutions. Definition of limits applied to product specifications. Stability study according to protocol 1QE ICH climatic zones III and IV on manufactured industrial lots. SPSS version 15. Results: The results corroborate the quality and stability of three industrial lots under study (18-22 ml packed volume, density :1,100-1, 300 g / ml, pH :5,5-6, 5; iodide content: 90%-110%, molecular iodine <2% total aerobes at 37^o C and 25^o C <100 col / g; no pathogens). The level of significance obtained from analysis of variance in the uniformity of size, density, pH, content of iodine and free iodine value is greater than 0.05. The values set for lots meet all specifications for 2 years. Third and fourth year there is damage to the packaging and elevated concentration of the solution, without any alteration. Discussion: The absence of significance in the comparison of the means in the variables studied in the three lots, shows that the process is robust and repetitive. The results of stability allow to assign a validity period of at least 2 years. The upkeep specifications product, despite the deterioration observed in the package, ensures a high degree of stability of the scheme drawn up. Conclusions: A stable solution of potassium iodide has been designed and manufactured on an industrial scale. The data obtained concerning the quality of the manufactured product helps to ensure the absence of significant variations between different batches studied, confirming that process design is the proper. The data obtained allow us to ensure, also a stable behavior of the solution, both from the standpoint of chemical and biological.

Keywords : Nuclear accident; Potassium iodide; Oral solution; Special populations.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )