DOI: https://doi.org/10.15587/2519-4852.2018.124449

Study of influence of primary packaging on the stability of the original veterinary preparation

Zhanna Polova, Lyudmyla Almakayeva

Abstract


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


Keywords


veterinary drug; primary packaging; stability; silver citrate

Full Text:

PDF

References


ISO 15378:2011. Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (2011). International Organization for Standardization.

Nastanova 42-3.2:2004. Nastanovy z yakosti. Likarski zasoby. Spetsyfikatsiyi: kontrolni vyprobuvannia ta kryteriyi pryiniatnosti (2004). Kyiv: MOZ Ukrainy, 38.

Swarbick, J. (Ed.) (2007). Encyclopedia of pharmaceutical technology. New York, London: Informa healthcare, 1171.

Nastanova 42-3.16:2014. Nastanovy z yakosti: Likarski zasoby. Plastykovi materialy dlia pervynnoi upakovky likarskykh zasobiv (2014). Kyiv: MOZ Ukrainy, 22.

Gudz', N. I. (2016). Osobye trebovaniya k upakovke dlya zhidkih parenteral'nyh i glaznyh lekarstvennyh form. Tovaroznavchyi analiz tovariv obmezhenoho aptechnoho asortymentu: materialy III naukovo-praktychnoi internet-konferentsiyi z mizhnarodnoiu uchastiu. Kharkiv: Vyd-vo NFaU, 90–91.

European pharmacopoeia 8th ed (2013). Strasbourg: European Directorate for the Quality of Medicines & Health Care, 3655.

Chuieshov, V. I., Hladukh, Ye. V., Saiko, I. V. et. al. (2013). Tekhnolohiya likiv promyslovoho vyrobnytstva. Ch. 2. Kharkiv: NFaU: Oryhinal, 638.

Campbell, G. A., Vallejo, E. (2015). Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during the heating for sterilization. Journal of Pharmaceutical Sciences, 104 (1), 52–62.

Hussong, D. (2010). Sterile Products: Advances and Challenges in Formulation, Manufacturing and Regulatory Aspects – A Regulatory Review Perspective. AAPS PharmSciTech, 11 (3), 1482–1484. doi: 10.1208/s12249-010-9503-z

Akala Emmanuel, O. (2010). Effect of Packaging on Stability of Drugs and Drug Products. Pharmaceutical Manufacturing: Regulations and Quality. John Wiley & Sons. doi: 10.1002/9780470571224.pse392

Hroncich, C. (2016). Examining Blow-Fill-Seal Technology for Aseptic Processes Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology. Pharmaceutical Technology, 40 (6), 49–51.

Amin, A., Dare, M., Sangamwar, A., Bansal, A. K. (2011). Interaction of antimicrobial preservatives with blow-fill-seal packs: correlating sorption with solubility parameters. Pharmaceutical Development and Technology, 17 (5), 614–624. doi: 10.3109/10837450.2011.557733

Feutry, F., Simon, N., Genay, S., Lannoy, D., Barthélémy, C., Décaudin, B. et. al. (2015). Stability of 10 mg/mL cefuroxime solution for intracameral injection in commonly used polypropylene syringes and new ready-to-use cyclic olefin copolymer sterile vials using the LC-UV stability-indicating method. Drug Development and Industrial Pharmacy, 42 (1), 166–174. doi: 10.3109/03639045.2015.1038273

Markarian, J. (2014). Blow-fill-seal Technology Advances in Aseptic Filling Applications. New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics. Equipment and Processing Report. Available at: http://www.pharmtech.com/blow-fill-seal-technology-advances-aseptic-filling-applications

Simmchen, J., Ventura, R., Segura, J. (2012). Progress in the Removal of Di-[2-Ethylhexyl]-Phthalate as Plasticizer in Blood Bags. Transfusion Medicine Reviews, 26 (1), 27–37. doi: 10.1016/j.tmrv.2011.06.001

Polova, Z., Almakayeva, L., Nehoda, T. (2017). Development of the composition of intramammary combined preparation based on silver citrate for veterinary. Ceska a Slovenska Farmacie, 66 (5), 227–233.

Polova, Zh. N., Almakaeva, L. G. (2017). Issledovanie stabil'nosti obrazcov protivomastitnogo preparata «Argocid». Respublikanskiy nauchnyy zhurnal «VESTNIK» Yuzhno-Kazahstanskoy gosudarstvennoy farmacevticheskoy akademii, 4 (81), 154–159.

Sayt TzOV «Brovafarma». Available at: http://brovafarma.com.ua/uk/news/evropejs-ki-tehnologii-virobnictva-za-gmp.html

Derzhavna farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi ekspertnyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.


GOST Style Citations


ISO 15378:2011. Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). International Organization for Standardization, 2011.

Nastanova 42-3.2:2004. Nastanovy z yakosti. Likarski zasoby. Spetsyfikatsiyi: kontrolni vyprobuvannia ta kryteriyi pryiniatnosti. Kyiv: MOZ Ukrainy, 2004. 38 p.

Encyclopedia of pharmaceutical technology / J. Swarbick (Ed.). 3rd ed. New York, London: Informa healthcare, 2007. 1171 р.

Nastanova 42-3.16:2014. Nastanovy z yakosti: Likarski zasoby. Plastykovi materialy dlia pervynnoi upakovky likarskykh zasobiv. Kyiv: MOZ Ukrainy, 2014. 22 p.

Gudz' N. I. Osobye trebovaniya k upakovke dlya zhidkih parenteral'nyh i glaznyh lekarstvennyh form // Tovaroznavchyi analiz tovariv obmezhenoho aptechnoho asortymentu: materialy III naukovo-praktychnoi internet-konferentsiyi z mizhnarodnoiu uchastiu. Kharkiv: Vyd-vo NFaU, 2016. P. 90–91.

European pharmacopoeia 8th ed. Strasbourg: European Directorate for the Quality of Medicines & Health Care, 2013. 3655 p.

Tekhnolohiya likiv promyslovoho vyrobnytstva. Ch. 2: pidruchnyk / Chuieshov V. I., Hladukh Ye. V., Saiko I. V. et. al. Kharkiv: NFaU: Oryhinal, 2013. 638 p.

Campbell G. A., Vallejo E. Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during the heating for sterilization // Journal of Pharmaceutical Sciences. 2015. Issue 104 (1). P. 52–62.

Hussong D. Sterile Products: Advances and Challenges in Formulation, Manufacturing and Regulatory Aspects – A Regulatory Review Perspective // AAPS PharmSciTech. 2010. Vol. 11, Issue 3. P. 1482–1484. doi: 10.1208/s12249-010-9503-z 

Akala Emmanuel O. Effect of Packaging on Stability of Drugs and Drug Products. Pharmaceutical Manufacturing: Regulations and Quality. John Wiley & Sons, 2010. doi: 10.1002/9780470571224.pse392 

Hroncich C. Examining Blow-Fill-Seal Technology for Aseptic Processes Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology // Pharmaceutical Technology. 2016. Vol. 40, Issue 6. P. 49–51.

Interaction of antimicrobial preservatives with blow-fill-seal packs: correlating sorption with solubility parameters / Amin A., Dare M., Sangamwar A., Bansal A. K. // Pharmaceutical Development and Technology. 2011. Vol. 17, Issue 5. P. 614–624. doi: 10.3109/10837450.2011.557733 

Stability of 10 mg/mL cefuroxime solution for intracameral injection in commonly used polypropylene syringes and new ready-to-use cyclic olefin copolymer sterile vials using the LC-UV stability-indicating method / Feutry F., Simon N., Genay S., Lannoy D., Barthélémy C., Décaudin B. et. al. // Drug Development and Industrial Pharmacy. 2015. Vol. 42, Issue 1. P. 166–174. doi: 10.3109/03639045.2015.1038273 

Markarian J. Blow-fill-seal Technology Advances in Aseptic Filling Applications. New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics // Equipment and Processing Report. 2014. URL: http://www.pharmtech.com/blow-fill-seal-technology-advances-aseptic-filling-applications

Simmchen J., Ventura R., Segura J. Progress in the Removal of Di-[2-Ethylhexyl]-Phthalate as Plasticizer in Blood Bags // Transfusion Medicine Reviews. 2012. Vol. 26, Issue 1. P. 27–37. doi: 10.1016/j.tmrv.2011.06.001 

Polova Z., Almakayeva L., Nehoda T. Development of the composition of intramammary combined preparation based on silver citrate for veterinary // Ceska a Slovenska Farmacie. 2017. Issue 66 (5). P. 227–233.

Polova Zh. N., Almakaeva L. G. Issledovanie stabil'nosti obrazcov protivomastitnogo preparata «Argocid» // Respublikanskiy nauchnyy zhurnal «VESTNIK» Yuzhno-Kazahstanskoy gosudarstvennoy farmacevticheskoy akademii. 2017. Issue 4 (81). P. 154–159.

Sayt TzOV «Brovafarma». URL: http://brovafarma.com.ua/uk/news/evropejs-ki-tehnologii-virobnictva-za-gmp.html

Derzhavna farmakopeia Ukrainy. Vol. 1. 2-e vyd. Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi ekspertnyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 2015. 1128 p.







Copyright (c) 2018

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

ISSN 2519-4852 (Online), ISSN 2519-4844 (Print)