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1.
J Pharm Sci ; 109(11): 3292-3299, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32679217

RESUMO

Prefilled syringes (PFSs) are commonly used for parenteral delivery of protein therapeutics. In PFSs, the inner surface of the syringe barrel is typically coated with silicone oil for lubrication. The total amount of silicone oil as well as its distribution can impact syringe functionality and particle formation. However, methods to non-destructively characterize the silicone oil distribution are limited. In this paper, we developed a method to visualize and quantify the relative distribution of silicone oil in unfilled syringes using a custom-built multi-color interferometric imaging system. We then applied the system in a preliminary study to investigate the impact of the silicone oil distribution on the number of particles formed in solution after filling and extrusion for two different types of syringes. The syringe type with significantly lower particle counts also exhibited significantly more homogeneous silicone oil distributions. Within syringe types, no significant association was found between silicone oil distribution and particle formation. Our method can be used in further studies that investigate the impact of syringe siliconization on PFS functionality and particle formation.


Assuntos
Óleos de Silicone , Seringas , Lubrificação
2.
J Pharm Sci ; 101(4): 1378-84, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22234873

RESUMO

Glass particles generated by glass dissolution and delamination of the glass container for pharmaceutical products have become a major issue in the pharmaceutical industry. The observation of glass particles in certain injectable drugs, including several protein therapeutics, has recently resulted in a number of product recalls. Glass vial surface properties have been suggested to play a critical role in glass dissolution and delamination. Surface characterization of glass container, therefore, is important to evaluate the quality of the glass container. In this work, we demonstrate that differential interference contrast (DIC) microscopy is a powerful, effective, and convenient technique to examine the inner surface morphology of glass vials nondestructively. DIC microscopy does not require the cutting of the glass vial for scanning the inner surface and has sufficient spatial resolution to reveal glass pitting, phase separation, delamination scars, and other defects. Typical surface morphology of pharmaceutical glass vials with different alkalinity are compared and discussed.


Assuntos
Embalagem de Medicamentos , Microscopia de Interferência/métodos , Vidro , Solubilidade , Propriedades de Superfície
3.
PDA J Pharm Sci Technol ; 64(1): 11-9, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-21501999

RESUMO

Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and tungsten. The origin of the tungsten was traced to the tungsten pins used in the supplier's syringe barrel forming process. A tungsten recovery study showed that the vacuum stopper placement process has a significant impact on the total amount of tungsten in solutions. The air gap formed in the syringe funnel area (rich in residual tungsten) becomes accessible to solutions when the vacuum is pulled. Leachable tungsten deposits that were not removed by the supplier's wash process are concentrated in this small area. Extraction procedures used to measure residual tungsten in empty syringes would under-report the tungsten quantity unless the funnel area is wetted during the extraction. Improved syringe barrel forming and washing processes at the supplier have lowered the residual tungsten content and significantly reduced the risk of protein aggregate formation. This experience demonstrates that packaging component manufacturing processes, which are outside the direct control of drug manufacturers, can have an impact on the drug product quality. Thus close technical communication with suppliers of product contact components plays an important role in making a successful biotherapeutic.


Assuntos
Seringas , Tungstênio , Humanos , Soluções Farmacêuticas , Embalagem de Produtos , Proteínas , Análise de Causa Fundamental , Soluções , Vácuo
4.
PDA J Pharm Sci Technol ; 64(3): 242-8, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-21502024

RESUMO

An unexpected, black particle (∼300 microns) was visually observed adhering to the interior shoulder of a prefilled glass syringe containing a biological drug product. The goal of this study was to determine the source, identity, and leachables of the black particle. The particle originated from a polymeric pin used during the syringe manufacturing process. Fourier transform infrared (FTIR) spectra comparison of the black particle and polymeric pin correlated to a database match of Nylon-MXD6 with glass fibers. Liquid chromatography/mass spectroscopy analyses identified Nylon-MXD6 and Nylon-6 photo-oxidized-related compounds in both the pin extract and syringe solution. The black particle originated from the pin and contained glass fibers, Nylon-MXD6, and Nylon-6. All nylon-related compounds were observed at <260 ng/mL (ppb) in the syringe solution. Syringes without black particles contained no detectable levels of nylon-related compounds, suggesting that routine contact between a pin and syringe barrel may not lead to syringe contamination or leachables originating from the pin. Abnormal heat exposure and/or extensive pin usage may have led to pin wear and tear.


Assuntos
Embalagem de Medicamentos , Seringas , Contaminação de Medicamentos , Contaminação de Alimentos , Cromatografia Gasosa-Espectrometria de Massas , Soluções Farmacêuticas , Espectroscopia de Infravermelho com Transformada de Fourier
5.
J Pharm Sci ; 98(12): 4695-710, 2009 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19645002

RESUMO

Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different model proteins with tungsten species obtained from the extraction of tungsten pins typically used in syringe manufacturing processes. These results were compared to those obtained with various soluble tungsten species from commercial sources. Although visible protein particles and aggregates were induced by tungsten from both sources, the extract from tungsten pins was more effective at inducing the formation of the soluble protein aggregates than the tungsten from other sources. Furthermore, our studies showed that the effect of tungsten on protein aggregation is dependent on the pH of the buffer used, the tungsten species, and the tungsten concentration present. The lower pH and increased tungsten concentration induced more protein aggregation. The protein molecules in the tungsten-induced aggregates had mostly nativelike structure, and aggregation was at least partly reversible. The aggregation was dependent on tungsten and protein concentration, and the ratio of these two and appears to arise through electrostatic interaction between protein and tungsten molecules. The level of tungsten required from the various sources was different, but in all cases it was at least an order of magnitude greater than the typical soluble tungsten levels measured in commercial PFS.


Assuntos
Proteínas/química , Tungstênio/química , Soluções Tampão , Cromatografia em Gel , Dicroísmo Circular , Concentração de Íons de Hidrogênio , Luz , Espectrometria de Massas , Tamanho da Partícula , Conformação Proteica , Espalhamento de Radiação , Soluções , Espectrofotometria Infravermelho , Espectrofotometria Ultravioleta , Análise Espectral Raman
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