Accelerated aging: Prediction of chemical stability of pharmaceuticals

Waterman, Kenneth C.; Adami, Roger C.

doi:10.1016/j.ijpharm.2004.12.013

Cited by 290 publications

(172 citation statements)

References 91 publications

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“…Lyophilized silk systems exhibited the lowest degradation rates and longest half-lives, while lyophilized vaccine powder degraded fastest at all storage temperatures. Humidity can also have a significant effect on vaccine products as the excess water introduced to the system can lead to increase in mobility and corresponding reactivity of the viral proteins (40). The residual moisture analysis of the films revealed increased residual moisture over the course of 6 mo in storage, especially in the high temperature ranges.…”

Section: Discussionmentioning

confidence: 99%

RETRACTED: Stabilization of vaccines and antibiotics in silk and eliminating the cold chain

Zhang

Pritchard

et al. 2012

Proc. Natl. Acad. Sci. U.S.A.

152

148

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Sensitive biological compounds, such as vaccines and antibiotics, traditionally require a time-dependent “cold chain” to maximize therapeutic activity. This flawed process results in billions of dollars worth of viable drug loss during shipping and storage, and severely limits distribution to developing nations with limited infrastructure. To address these major limitations, we demonstrate self-standing silk protein biomaterial matrices capable of stabilizing labile vaccines and antibiotics, even at temperatures up to 60 °C over more than 6 months. Initial insight into the mechanistic basis for these findings is provided. Importantly, these findings suggest a transformative approach to the cold chain to revolutionize the way many labile therapeutic drugs are stored and utilized throughout the world.

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Section: Discussionmentioning

confidence: 99%

RETRACTED: Stabilization of vaccines and antibiotics in silk and eliminating the cold chain

Zhang

Pritchard

et al. 2012

Proc. Natl. Acad. Sci. U.S.A.

152

148

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“…Cellulose-based paper is an effective medium for biological fluid collection and storage because a number of drugs have been found to be more stable in DBS samples than in refrigerated or frozen liquid blood [8,9]. Also, a small volume of blood (typically G50 μL) is sufficient for several replicate analyses by paper spray, compared with 0.5 mL or more used for typical plasma analysis.…”

mentioning

confidence: 99%

Quantitative Analysis of Therapeutic Drugs in Dried Blood Spot Samples by Paper Spray Mass Spectrometry: An Avenue to Therapeutic Drug Monitoring

Manicke

Abu-Rabie

Spooner

et al. 2011

J. Am. Soc. Mass Spectrom.

207

183

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A method is presented for the direct quantitative analysis of therapeutic drugs from dried blood spot samples by mass spectrometry. The method, paper spray mass spectrometry, generates gas phase ions directly from the blood card paper used to store dried blood samples without the need for complex sample preparation and separation; the entire time for preparation and analysis of blood samples is around 30 s. Limits of detection were investigated for a chemically diverse set of some 15 therapeutic drugs; hydrophobic and weakly basic drugs, such as sunitinib, citalopram, and verapamil, were found to be routinely detectable at approximately 1 ng/mL. Samples were prepared by addition of the drug to whole blood. Drug concentrations were measured quantitatively over several orders of magnitude, with accuracies within 10% of the expected value and relative standard deviation (RSD) of around 10% by prespotting an internal standard solution onto the paper prior to application of the blood sample. We have demonstrated that paper spray mass spectrometry can be used to quantitatively measure drug concentrations over the entire therapeutic range for a wide variety of drugs. The high quality analytical data obtained indicate that the technique may be a viable option for therapeutic drug monitoring.

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“…31 Here, a short-term (2-week) accelerated stability study was conducted at 40 C to evaluate the stability of the 0.1% PS80-containing formulation, specifically to assess the risk that PS80 (or impurities and degradation products) may adversely affect the stability of the mAb via oxidative degradation during long-term storage.…”

Section: Effect Of Ps80 On Otelixizumab Stability In Vials and Selectmentioning

confidence: 99%

Development of a stable low-dose aglycosylated antibody formulation to minimize protein loss during intravenous administration

Morar-Mitrica

Puri

Sassi

et al. 2015

mAbs

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The physical and chemical integrity of a biopharmaceutical must be maintained not only during long-term storage but also during administration. Specifically for the intravenous (i.v.) delivery of a protein drug, loss of stability can occur when the protein formulation is compounded with i.v. bag diluents, thus modifying the original composition of the drug product. Here we present the challenges associated with the delivery of a low-dose, highly potent monoclonal antibody (mAb) via the i.v. route. Through parallel in-use stability studies and conventional formulation development, a drug product was developed in which adsorptive losses and critical oxidative degradation pathways were effectively controlled. This development approach enabled the i.v. administration of clinical doses in the range of 0.1 to 0.5 mg total protein, while ensuring liquid drug product storage stability under refrigerated conditions.

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Accelerated aging: Prediction of chemical stability of pharmaceuticals

Cited by 290 publications

References 91 publications

RETRACTED: Stabilization of vaccines and antibiotics in silk and eliminating the cold chain

RETRACTED: Stabilization of vaccines and antibiotics in silk and eliminating the cold chain

Quantitative Analysis of Therapeutic Drugs in Dried Blood Spot Samples by Paper Spray Mass Spectrometry: An Avenue to Therapeutic Drug Monitoring

Development of a stable low-dose aglycosylated antibody formulation to minimize protein loss during intravenous administration

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