TY  - JOUR
AU  - Solomun, Ljiljana
AU  - Ibrić, Svetlana
AU  - Boltić, Zorana
AU  - Đurić, Zorica
AU  - Stupar, Biljana
PY  - 2008
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1024
AB  - The unique approach in manufacturing of pharmaceutical dosage forms of active substances known to be unstable in aqueous solution is the introduction of lyophilization process. Nevertheless, these products must be reconstituted using the diluent from a separate container before application. The possible solution for this problem is the application of dual chamber vials comprising the freeze-dried product in a lower compartment of the vial and the solution for reconstitution in the upper chamber. The main issue in development of such product is the choice of contact packaging (rubber closures, glass vials and the container closure system as a whole). The most important parameter used for evaluation of the influence of contact material on product quality was the pH value. The results have shown that the type of vials (moulded or tubular glass) has no impact on pH shift of the solution for reconstitution (tested solution-TS), while significant differences in pH value of the TS were observed depending on the rubber closures formulation used (with some formulations, the pH shift during the test was 6.5-9.14). Benzyl alcohol assay during the tests remained unchanged. Integrity tests of the container closure system (CCS) have demonstrated the adequacy of the selected packaging system. The quality of the CCS of choice was confirmed in the course of stability studies, only parameters directly influenced by CCS being presented in this work: loss on drying and pH value. On the basis of these results, no changes in loss on drying were connected to CCS, and the pH value of the reconstituted solution remains unchanged in samples tested both ex-tempore and after in-use period of 48 h.
PB  - Pergamon-Elsevier Science Ltd, Oxford
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - The impact of primary packaging on the quality of parenteral products
VL  - 48
IS  - 3
SP  - 744
EP  - 748
DO  - 10.1016/j.jpba.2008.07.025
ER  - 

@article{
author = "Solomun, Ljiljana and Ibrić, Svetlana and Boltić, Zorana and Đurić, Zorica and Stupar, Biljana",
year = "2008",
abstract = "The unique approach in manufacturing of pharmaceutical dosage forms of active substances known to be unstable in aqueous solution is the introduction of lyophilization process. Nevertheless, these products must be reconstituted using the diluent from a separate container before application. The possible solution for this problem is the application of dual chamber vials comprising the freeze-dried product in a lower compartment of the vial and the solution for reconstitution in the upper chamber. The main issue in development of such product is the choice of contact packaging (rubber closures, glass vials and the container closure system as a whole). The most important parameter used for evaluation of the influence of contact material on product quality was the pH value. The results have shown that the type of vials (moulded or tubular glass) has no impact on pH shift of the solution for reconstitution (tested solution-TS), while significant differences in pH value of the TS were observed depending on the rubber closures formulation used (with some formulations, the pH shift during the test was 6.5-9.14). Benzyl alcohol assay during the tests remained unchanged. Integrity tests of the container closure system (CCS) have demonstrated the adequacy of the selected packaging system. The quality of the CCS of choice was confirmed in the course of stability studies, only parameters directly influenced by CCS being presented in this work: loss on drying and pH value. On the basis of these results, no changes in loss on drying were connected to CCS, and the pH value of the reconstituted solution remains unchanged in samples tested both ex-tempore and after in-use period of 48 h.",
publisher = "Pergamon-Elsevier Science Ltd, Oxford",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "The impact of primary packaging on the quality of parenteral products",
volume = "48",
number = "3",
pages = "744-748",
doi = "10.1016/j.jpba.2008.07.025"
}

Solomun, L., Ibrić, S., Boltić, Z., Đurić, Z.,& Stupar, B.. (2008). The impact of primary packaging on the quality of parenteral products. in Journal of Pharmaceutical and Biomedical Analysis
Pergamon-Elsevier Science Ltd, Oxford., 48(3), 744-748.
https://doi.org/10.1016/j.jpba.2008.07.025

Solomun L, Ibrić S, Boltić Z, Đurić Z, Stupar B. The impact of primary packaging on the quality of parenteral products. in Journal of Pharmaceutical and Biomedical Analysis. 2008;48(3):744-748.
doi:10.1016/j.jpba.2008.07.025 .

Solomun, Ljiljana, Ibrić, Svetlana, Boltić, Zorana, Đurić, Zorica, Stupar, Biljana, "The impact of primary packaging on the quality of parenteral products" in Journal of Pharmaceutical and Biomedical Analysis, 48, no. 3 (2008):744-748,
https://doi.org/10.1016/j.jpba.2008.07.025 . .