The impact of primary packaging on the quality of parenteral products

Solomun, Ljiljana; Ibrić, Svetlana; Boltić, Zorana; Djurić, Z.; Stupar, Biljana

doi:10.1016/j.jpba.2008.07.025

Cited by 6 publications

(5 citation statements)

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“…Stoppers of different composition immersed in 0.9% benzyl alcohol solutions can cause pH change of the solution upon storage. Maximum pH change from pH 6.5–9.1 was observed within 10 days of storage at 40°C for one type of bromobutyl stoppers, whereas no significant change in pH for chlorobutyl or ultralow extractables bromobutyl stoppers …”

Section: Evaluation and Selection Of A Product Container/closure Systemmentioning

confidence: 90%

“…Maximum pH change from pH 6.5-9.1 was observed within 10 days of storage at 40 • C for one type of bromobutyl stoppers, whereas no significant change in pH for chlorobutyl or ultralow extractables bromobutyl stoppers. 182 Other stopper leachables/extractables can potentially influence the stability of proteins. Thiuram disulfides, frequently used as accelerators in rubber stoppers, was found to leach or be extracted from stoppers to interact with captopril (a thiolcontaining drug) through thiol-disulfide exchange.…”

Section: Extractable and Leachablesmentioning

confidence: 99%

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Impact of Residual Impurities and Contaminants on Protein Stability

Wang

Arunkumar

Thakkar

2014

Journal of Pharmaceutical Sciences

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Section: Evaluation and Selection Of A Product Container/closure Systemmentioning

confidence: 90%

Section: Extractable and Leachablesmentioning

confidence: 99%

Impact of Residual Impurities and Contaminants on Protein Stability

Wang

Arunkumar

Thakkar

2014

Journal of Pharmaceutical Sciences

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“…Some researchers found that packaging material grossly affects product quality. For instance, glass vials and rubber closures could cause pH changes in parenteral products [28,29]. Another study reported that aluminum tube coating released substances into semisolid products that could interact with the medicine and affect quality of those medicines [30].…”

Section: Discussionmentioning

confidence: 99%

Factors Affecting Drug Quality Problems in Thailand

Ongoagchai

Harun-Or-Rashid

Sakamoto

2011

Quality Assurance Journal

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SummaryPoor drug quality is a global concern as it can cause treatment failure, adverse effects, increased morbidity, mortality and development of drug resistance. This study was aimed to identify factors affecting drug quality problems. Odds ratio (OR) and 95% confidence intervals (CIs) were used through a logistic regression model to determine association between 4 M factors (man, machine, materials and methods) and drug quality problems (physical appearance changes, labeling problems, packaging problems and packing problems). We found that two factors, man and material, were mainly associated with drug quality problems. Among other man factors, 'inspector checking the finished products' was the leading cause for labeling problems. Likewise, aluminum foil was responsible for packaging problems among other material factors. We conclude that drug manufacturers should consider using detector and barcode systems to reduce human errors and use good quality packaging materials to reduce drug quality problems.

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“…Glass vials (Type I, borosilicate) are typically used along with various rubber stoppers. Solomun et al (2008) reviews criteria for selecting parenteral packaging materials, where the type of rubber stoppers or glass materials can cause pH drifts of the reconstituted liquid formulation. Other packaging configurations involve sealed pouches made of foil, paper, or plastic materials for containing transdermal patches.…”

Section: Primary Packagingmentioning

confidence: 99%

Overview of Drug Product Development

Narayan

2011

CP Pharmacology

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The process for developing drug delivery systems has evolved over the past two decades with more scientific rigor, involving a collaboration of various fields, i.e., biology, chemistry, engineering, and pharmaceutics. Drug products, also commonly known in the pharmaceutical industry as formulations or "dosage forms," are used for administering the active pharmaceutical ingredient (API) for purposes of assessing safety in preclinical models, early- to late-phase human clinical trials, and for routine clinical/commercial use. This overview discusses approaches for creating small-molecule API dosage forms, from preformulation to commercial manufacturing.

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The impact of primary packaging on the quality of parenteral products

Cited by 6 publications

References 0 publications

Impact of Residual Impurities and Contaminants on Protein Stability

Impact of Residual Impurities and Contaminants on Protein Stability

Factors Affecting Drug Quality Problems in Thailand

Overview of Drug Product Development

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