An industrial approach towards solid dosage development for first-in-human studies: Application of predictive science and lean principles

Kalaria, Dhaval R.; Parker, Keith D.; Reynolds, Gavin K.; Laru, Johanna

doi:10.1016/j.drudis.2019.12.012

Cited by 26 publications

(7 citation statements)

References 71 publications

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“…In the pharmaceutical industry, solid dosage forms are most commonly prescribed and preferred by most medical practitioners, due to their accurate dosing, superior stability, and high precision [ 22 , 23 ]. For instance, the Therapeutic Goods Administration (TGA), Australia approved 59 solid dosage form products in October 2015 containing A. paniculata [ 24 ].…”

Section: Conventional Dosage Formsmentioning

confidence: 99%

Andrographis paniculata Dosage Forms and Advances in Nanoparticulate Delivery Systems: An Overview

2022

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Andrographis paniculata is a well-known Asian medicinal plant with a major phytoconstituent of diterpene lactones, such as andrographolide, 14-deoxyandrographolide, and neoandrographolide. A World Health Organization (WHO) monograph on selected medicinal plants showed that A. paniculata extracts and its major diterpene lactones have promising anti-inflammatory, antidiabetic, antimalarial, anticancer, antifungal, antibacterial, antioxidant, and hypoglycemic activities. However, these active phytochemicals have poor water solubility and bioavailability when delivered in a conventional dosage form. These biological barriers can be mitigated if the extract or isolated compound are delivered as nanoparticles. This review discusses existing studies and marketed products of A. paniculata in solid, liquid, semi-solid, and gaseous dosage forms, either as an extract or isolated pure compounds, as well as their deficits in reaching maximum bioavailability. The pharmaceutics and pharmacological activity of A. paniculata as a nano-delivery system are also discussed.

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Section: Conventional Dosage Formsmentioning

confidence: 99%

Andrographis paniculata Dosage Forms and Advances in Nanoparticulate Delivery Systems: An Overview

2022

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“…17 Sin embargo, hasta el momento no existe una cura efectiva para la infección por SARS-CoV-2, aunque múltiples medicamentos antivirales, incluyendo remdesivir y lopinavir más ritonavir, se han utilizado en la práctica clínica, si bien la seguridad y eficacia de éstos aún no están claros y están bajo evaluación clínica. 26 En un estudio se analizaron características específicas de pacientes con mal pronóstico en donde se identificó disminución progresiva de linfocitos y un aumento progresivo de la interleucina 6. 17…”

Section: Wwwmedigraphicorgmxunclassified

Índice de desregulación inmunológica como predictor de evolución hacia síndrome de insuficiencia respiratoria progresiva del adulto en pacientes con neumonía por SARS-CoV-2

Granillo¹,

Aguirre²,

Chavarría³

et al. 2020

Medicina Crítica

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Índice de desregulación inmunológica como predictor de evolución hacia síndrome de insuficiencia respiratoria progresiva del adulto en pacientes con neumonía por SARS-CoV-2** Immune dysregulation index as a predictor of evolution to acute respiratory distress syndrome in patients with SARS-CoV-2 pneumonia Índice de disregulação imunológica como preditor da evolução da síndrome de insuficiência respiratória progressiva do adultos em pacientes com pneumonia por SARS-CoV-2

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“…Polymorphism of APIs is the ability of API molecules to feature differences in molecular conformation, overall packing, or a combination of both in crystal structures. , Simple polymorphic systems, in contrast to multicomponent system like salts and cocrystals, generally advocate a simpler development approach as typically required in early phase drug development where the pace of the project is higher . Apart from a polymorphic system of anhydrous compounds, hydrate forms of APIs are also a still viable alternative of solid forms in early phase drug development owing that incorporation of water into the crystal structure may result in better physicochemical properties such as stability, especially of interest for liquid formulations including suspensions that are typically used in preclinical studies.…”

Section: Introductionmentioning

confidence: 99%

Understanding Crystal Structures to Guide Form Selection of Active Pharmaceutical Ingredients: A Case Study of AZD9567

Putra

Ottosson

Lill

et al. 2021

Crystal Growth & Design

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AZD9567 is a novel oral selective glucocorticoid receptor modulator drug candidate in AstraZeneca's pipeline. Three distinctive solid forms of AZD9567 were identified during early development where Form A was found to be a hydrate, and both Forms B and C are anhydrous. In this study, we present the significance of applying crystal structure assessments along with typical solid-state experimental characterizations in early stage drug development to guide solid form selection. The Form A hydrate, which is usually regarded as the preferred form in liquid formulation, is found not stable, narrowing the form selection toward Forms B and C. Anhydrous Form C has disorder depending on the temperature and is more stable than anhydrous Form B, and this is supported by a higher melting point and experimental density as well as a series of density functional theory calculations. This eventually results in the recommendation of selecting anhydrous AZD9567 Form C as the solid form to move forward for further development.

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An industrial approach towards solid dosage development for first-in-human studies: Application of predictive science and lean principles

Cited by 26 publications

References 71 publications

Andrographis paniculata Dosage Forms and Advances in Nanoparticulate Delivery Systems: An Overview

Andrographis paniculata Dosage Forms and Advances in Nanoparticulate Delivery Systems: An Overview

Índice de desregulación inmunológica como predictor de evolución hacia síndrome de insuficiencia respiratoria progresiva del adulto en pacientes con neumonía por SARS-CoV-2

Understanding Crystal Structures to Guide Form Selection of Active Pharmaceutical Ingredients: A Case Study of AZD9567

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