Document Detail


Sorption of antimicrobial agents in blow-fill-seal packs.
MedLine Citation:
PMID:  20887236     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
The present work studies the interaction of methyl paraben (MPB) and propyl paraben (PPB), two widely used antimicrobial agents in multi-dose ophthalmic formulations, with 5 mL, low density polyethylene (LDPE) and polypropylene (PP) blow-fill-seal (BFS) packs, by subjecting the systems to accelerated stability conditions of 40°C/25% RH. The effect of pH, paraben concentration, and relative humidity (RH) on the sorption loss of both the parabens was studied. Additionally, the effects of buffer species and buffer strength on MPB sorption were studied. LDPE packs showed significantly higher loss compared to PP packs which showed < 5% loss in all cases. PPB showed a significantly higher loss (40-50%) than MPB (9-16%) in LDPE. pH (3.0, 5.0, 7.0) did not have a statistically significant effect on sorption. However, concentration, humidity and buffer at pH 7 affected paraben sorption. The application of the power law suggested that the MPB followed non-Fickian diffusion while PPB showed non-Fickian to Case II diffusion in LDPE packs. In conclusion, caution should be exercised while using parabens in LDPE BFS packs because substantial losses of the antimicrobial agent during the shelf-life can compromise the preservative effectiveness against 'in-use' contamination.
Authors:
Aeshna Amin; Sateesh Chauhan; Manish Dare; Arvind Kumar Bansal
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Publication Detail:
Type:  Journal Article     Date:  2010-10-04
Journal Detail:
Title:  Pharmaceutical development and technology     Volume:  17     ISSN:  1097-9867     ISO Abbreviation:  Pharm Dev Technol     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9610932     Medline TA:  Pharm Dev Technol     Country:  England    
Other Details:
Languages:  eng     Pagination:  84-93     Citation Subset:  IM    
Affiliation:
National Institute of Pharmaceutical Education and Research (NIPER) , Sector 67, S.A.S. Nagar (Mohali), Punjab.
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