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Dissertacao - Simplificada - Corrigida (1) - SPGV Embalagem Primária Estabilidade
Dissertacao - Simplificada - Corrigida (1) - SPGV Embalagem Primária Estabilidade
Ribeirão Preto
2012
UNIVERSIDADE DE SÃO PAULO
FACULDADE DE CIÊNCIAS FARMACÊUTICAS DE RIBEIRÃO PRETO
Ribeirão Preto
2012
AUTORIZO A REPRODUÇÃO E DIVULGAÇÃO TOTAL OU PARCIAL DESTE TRABALHO,
POR QUALQUER MEIO CONVENCIONAL OU ELETRÔNICO, PARA FINS DE ESTUDO E
PESQUISA, DESDE QUE CITADA A FONTE.
The Large Volume Parenteral Solutions (LVP´s) are defined as an apyrogenic and
sterile solution used in a single dosage in parenteral application, in which the plastic
is the primary packaging material used. This study aimed to evaluate physical-
chemical and microbiological characteristics of physiological sodium chloride solution
0,0% m/v, as well as the chemical and physical properties of the primary packaging
material. In this work, samples of sodium chloride solution injection of 0,9% m/v of
500 mL in many different commercial primary packing (Groups A, B, C and D) were
used, after being stored in a climatic chamber. An evaluation of the physical-chemical
and microbiological characteristics of the solution was performed by storing the
different packages in a climatic chamber during the period of 0, 90 and 180 days,
under conditions of 40ºC of temperature and 75% of humidity, as established by the
International Conference on Harmonisation (ICH) and 25% RH, according to the
specific legislation of the Health Surveillance Agency (ANVISA). An assessment was
carried out to determine the chemical and physical tests for the primary packaging in
contact with the solution. In addition, was evaluated the conservation of care in
hospitals LVP's. The results confirmed the influence of relative humidity (RH) in the
rate of permeability to water vapor, which was statistically significant (p<0,05) for all
groups. In all comparisons, the weight loss performed at 25% RH was always higher
than 75% RH, and Group B showed the lowest weight loss compared to other
groups. Group D presented results for volume that are different from the specification
of United States Pharmacopoeia, at all storage times. Integrity failures and rupture of
the primary packages were observed in Groups C and D, which provide leakage of
the solution and allows entry of microorganisms. The tensile properties were
evaluated and Group A showed higher breakdown and lower elongation as
compared to Groups C and D. These Groups presented significant difference
between them related to maximum tensile strength and Group C showed the highest
values of this parameter. The evaluation results show the influence and particularity
of each packing type and also showed the importance of an adequate product
storage environment after manufacturing so the use and stability of the parenteral
solutions is not jeopardized.
1. INTRODUÇÃO
2. REVISÃO DE LITERATURA
Sim (com
PVC flexível Elevada Elevada Moderada Flexível
precaução)
PEBD = polietileno de baixa densidade, PEAD = polietileno de alta densidade, PVC = policloreto de vinila.
2.2.4 Polietileno
2.2.5 Polipropileno
7. CONCLUSÃO
8. REFERÊNCIAS
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