[PMID]: | 21428703 |
[Au] Autor: | Amin A; Dare M; Sangamwar A; Bansal AK |
[Ad] Endereço: | National Institute of Pharmaceutical Education and Research (NIPER), Punjab, India. |
[Ti] Título: | Interaction of antimicrobial preservatives with blow-fill-seal packs: correlating sorption with solubility parameters. |
[So] Source: | Pharm Dev Technol;17(5):614-24, 2012 Sep-Oct. |
[Is] ISSN: | 1097-9867 |
[Cp] País de publicação: | England |
[La] Idioma: | eng |
[Ab] Resumo: | The aim of this work was to study the interaction of four commonly used ophthalmic antimicrobial preservatives [benzyl alcohol (BA), chlorbutol (CBL), benzalkonium chloride (BKC), and chlorhexidine gluconate (CG)] with Blow-Fill-Seal (BFS) packs. Effect of packaging material [low-density polyethylene (LDPE), polypropylene (PP)], humidity (25% RH, 75% RH) and concentration (0.5, 1.0, 2.0 mM BA/CBL in LDPE) was studied. BKC and CG gave negligible loss (<4%) in BFS packs over a period of 3 months. BA and CBL, however, gave marked losses in LDPE (ca. 70-90%) and PP (ca. 7-25%) packs. Humidity did not have any effect on the sorption loss of any preservative. Loss of BA switched from Case II to anomalous behavior with increasing initial concentration. A two-stage sorption behavior was inherent at all concentrations. Loss of CBL followed anomalous behavior with biphasic kinetics of loss. It was concluded that all the four preservatives were appropriate for use in PP BFS packs. However, only BKC and CG were amenable to be used in LDPE BFS packs. Lastly, an empirical expression consisting of the "solubility parameter distance" and "molar volume" of preservatives was developed to correlate the preservative loss in LDPE with the physicochemical properties of the preservatives. |
[Mh] Termos MeSH primário: |
Anti-Infecciosos/química Compostos de Benzalcônio/química Álcool Benzílico/química Clorexidina/análogos & derivados Clorobutanol/química Embalagem de Medicamentos Conservantes Farmacêuticos/química
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[Mh] Termos MeSH secundário: |
Adsorção Clorexidina/química Embalagem de Medicamentos/métodos Umidade Polietileno/química Polipropilenos/química Solubilidade
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[Pt] Tipo de publicação: | JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T |
[Nm] Nome de substância:
| 0 (Anti-Infective Agents); 0 (Benzalkonium Compounds); 0 (Polypropylenes); 0 (Preservatives, Pharmaceutical); 9002-88-4 (Polyethylene); HM4YQM8WRC (Chlorobutanol); LKG8494WBH (Benzyl Alcohol); MOR84MUD8E (chlorhexidine gluconate); R4KO0DY52L (Chlorhexidine) |
[Em] Mês de entrada: | 1301 |
[Cu] Atualização por classe: | 131121 |
[Lr] Data última revisão:
| 131121 |
[Sb] Subgrupo de revista: | IM |
[Da] Data de entrada para processamento: | 110325 |
[St] Status: | MEDLINE |
[do] DOI: | 10.3109/10837450.2011.557733 |
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