AIMC Topic: Drug Stability

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Deconvoluting Biophysical Factors that Influence Long-Term Aggregation Rates of High-Concentration Monoclonal Antibody Formulations.

Molecular pharmaceutics
Efficient determination of developable protein drug candidates and stable solution conditions is a key challenge in industrial drug development. Protein aggregation is difficult to predict and can lead to challenges in manufacturing, storage, and pat...

A quantitative size stability metrics for long-acting suspensions and its prediction with machine learning.

International journal of pharmaceutics
Defining suspension stability can be extremely complex, but beyond critical during the formulation development of nano- and microsuspensions intended for long-acting injectables. As of now, the current practice is based on the trial-and-error approac...

Machine learning strengthened formulation design of pharmaceutical suspensions.

International journal of pharmaceutics
Many different formulation strategies have been investigated to oppose suboptimal treatment of long-term or chronic conditions, one of which are the nano- and microsuspensions prepared as long-acting injectables to prolong the release of an active ph...

Particle formation in response to different protein formulations and containers: Insights from machine learning analysis of particle images.

Journal of pharmaceutical sciences
Subvisible particle count is a biotherapeutics stability indicator widely used by pharmaceutical industries. A variety of stresses that biotherapeutics are exposed to during development can impact particle morphology. By classifying particle morpholo...

Reliable stability prediction to manage research or marketed vaccines and pharmaceutical products. "Avoid any doubt for the end-user of vaccine compliance at time of administration".

International journal of pharmaceutics
A major challenge for the pharmaceutical/vaccine industry is to anticipate and test/control product stability, regardless of the time/temperature profile of the product, from release to administration. Current empirical stability protocols performed ...

Development of LC-MS/MS determination method and backpropagation artificial neural networks pharmacokinetic model of febuxostat in healthy subjects.

Journal of clinical pharmacy and therapeutics
WHAT IS KNOWN AND OBJECTIVE: Febuxostat is a well-known drug for treating hyperuricemia and gout. The published methods for determination of febuxostat in human plasma might be unsuitable for high-throughput determination and widespread application. ...

Application of machine learning to predict monomer retention of therapeutic proteins after long term storage.

International journal of pharmaceutics
An important aspect of initial developability assessments as well formulation development and selection of therapeutic proteins is the evaluation of data obtained under accelerated stress condition, i.e. at elevated temperatures. We propose the appli...

Ceftolozane-tazobactam in an elastomeric infusion device for ambulatory care: an in vitro stability study.

European journal of hospital pharmacy : science and practice
OBJECTIVES: Published in vitro stability data for ceftolozane-tazobactam supports intermittent short duration infusions. This method of delivery is not feasible for many outpatient antimicrobial therapy services that provide only one or two visits pe...

Physicochemical stability of an admixture of lidocaine and ketamine in polypropylene syringe used in opioid-free anaesthesia.

European journal of hospital pharmacy : science and practice
OBJECTIVES: Opioid-free anaesthesia is a treatment strategy of pain management based on the use of drugs such as lidocaine, ketamine and dexmedetomidine that do not interact significantly with opioid receptors. In particular, these drugs are used by ...

DeepChemStable: Chemical Stability Prediction with an Attention-Based Graph Convolution Network.

Journal of chemical information and modeling
In the drug discovery process, unstable compounds in storage can lead to false positive or false negative bioassay conclusions. Prediction of the chemical stability of a compound by de novo methods is complex. Chemical instability prediction is commo...