Study of influence of primary packaging on the stability of the original veterinary preparation
DOI:
https://doi.org/10.15587/2519-4852.2018.124449Keywords:
veterinary drug, primary packaging, stability, silver citrateAbstract
A great importance during the design of veterinary drugs is given to the choice of primary package, the material which is directly contact with the dosage form. Stability of samples of veterinary medicines should be investigated in packages that will be used during serial production of drugs. It is also necessary to investigate the processes that can occur with active pharmaceutical ingredients under the influence of substances contained in the packaging material. On the basis of these data, determine the shelf life of the veterinary drugs in the appropriate package.
Aim. The influence of primary packaging on quality characteristics of solution based on silver citrate codenamed "Argocid", namely ampoules of 10 ml capacity and vials with a capacity of 50 ml made of light-protection glass; plastic containers (ampoules) in a capacity of 10 ml and 50 ml vials.
Methods. Methods of research were conducted in accordance with the requirements of the State Pharmacopoeia of Ukraine.
Results of the research. It was investigated that 10 ml plastic containers of Pharmalene®, 50 ml bottles of Riblene® FL 20 PH of low density polyethylene, do not cause changes in the quality of the veterinary solution regulated in the specification and allow the product to remain stable for a shelf life of 2 years. In the process of storing a silver-citrate solution of in a polymeric package of 10 ml Pharmalene® grade polyethylene occurred a volume reduction of up to 1.5 % over a period of 2 years. However, the evaporation rate of the solvent is too small for the concentration of active substances to exceed the acceptable values.
Conclusions. It was established that all investigated types of containers are suitable for use as an initial packaging for the veterinary drug "Argocid", a solution for intramammary administration on the basis of silver citrate, since they allow the drug to be stable for 2 years
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