Sterile filtration of a multi‐serotype glycoconjugate vaccine drug product
Sign Up to like & getrecommendations! Published in 2023 at "Biotechnology and Bioengineering"
DOI: 10.1002/bit.28342
Abstract: Glycoconjugate vaccines consisting of multiple serotypes of the bacterial capsular polysaccharide can provide strong protection against infection by significant pathogens. Previous studies of the sterile filtration behavior of these glycoconjugates have been limited to experiments… read more here.
Keywords: sterile filtration; drug; drug product; glycoconjugate ... See more keywords
Biopharmaceutical aspects and implications of excipient variability in drug product performance
Sign Up to like & getrecommendations! Published in 2017 at "European Journal of Pharmaceutics and Biopharmaceutics"
DOI: 10.1016/j.ejpb.2016.11.004
Abstract: Graphical abstract Figure. No Caption available. ABSTRACT Implementation of Quality by Design approaches in pharmaceutical industry requires a sound understanding of the parameters triggering final product variability. Excipients, although generally regarded as inert components, are… read more here.
Keywords: product performance; product; drug; excipient variability ... See more keywords
Critical process parameters in manufacturing of liposomal formulations of amphotericin B.
Sign Up to like & getrecommendations! Published in 2019 at "International journal of pharmaceutics"
DOI: 10.1016/j.ijpharm.2019.04.052
Abstract: Identifying the critical process parameters (CPPs) of a complex drug product manufacture and the associated impact on critical quality attributes (CQAs) is essential to the development and quality control of both new and generic drugs.… read more here.
Keywords: critical process; drug; process; process parameters ... See more keywords
Spectral Markers for T Cell Death and Apoptosis-A Pilot Study on Cell Therapy Drug Product Characterization Using Raman Spectroscopy.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2021.08.005
Abstract: Application of Raman spectroscopy as a T cell characterization tool supporting cell therapy drug product development has been evaluated. Statistically significant correlations between a set of Raman signals and established flow cytometry markers associated with… read more here.
Keywords: cell therapy; spectroscopy; drug product; raman spectroscopy ... See more keywords
Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities
Sign Up to like & getrecommendations! Published in 2022 at "Chemical Research in Toxicology"
DOI: 10.1021/acs.chemrestox.1c00369
Abstract: The potential for N-nitrosamine impurities in pharmaceutical products presents a challenge for the quality management of medicinal products. N-Nitrosamines are considered cohort-of-concern compounds due to the potent carcinogenicity of many of the structurally simple chemicals… read more here.
Keywords: nitrosamine; drug product; practical science; nitrosamine impurities ... See more keywords
Surfactant Impact on Interfacial Protein Aggregation and Utilization of Surface Tension to Predict Surfactant Requirements for Biological Formulations.
Sign Up to like & getrecommendations! Published in 2020 at "Molecular pharmaceutics"
DOI: 10.1021/acs.molpharmaceut.0c00743
Abstract: Biological drug products are formulated with excipients to maintain stability over the shelf life of the product. Surfactants are added to the drug product to stabilize air-water interfaces known to induce protein aggregation. Early formulation… read more here.
Keywords: protein; aggregation; product; formulation ... See more keywords
Quantification and In Silico Toxicity Assessment of Tazarotene and its Impurities for a Quality and Safe Drug Product Development.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of chromatographic science"
DOI: 10.1093/chromsci/bmz037
Abstract: Tazarotene is internationally accepted common name for ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. It is a synthetic retinoid used for the topical treatment of mild to moderate plaque psoriasis, acne vulgaris and photo aging. To ensure the quality of… read more here.
Keywords: tazarotene; product; method; drug ... See more keywords
Comparing the variability of ingredient, strength, and dose form information from electronic prescriptions with RxNorm drug product descriptions
Sign Up to like & getrecommendations! Published in 2022 at "Journal of the American Medical Informatics Association : JAMIA"
DOI: 10.1093/jamia/ocac096
Abstract: OBJECTIVE To determine the variability of ingredient, strength, and dose form information from drug product descriptions in real-world electronic prescription (e-prescription) data. MATERIALS AND METHODS A sample of 10 399 324 e-prescriptions from 2019 to 2021 were… read more here.
Keywords: strength; drug product; variability ingredient; drug ... See more keywords
Physiologically Based Biopharmaceutics Model of Vildagliptin Modified Release (MR) Tablets to Predict In Vivo Performance and Establish Clinically Relevant Dissolution Specifications
Sign Up to like & getrecommendations! Published in 2022 at "AAPS PharmSciTech"
DOI: 10.1208/s12249-022-02264-2
Abstract: The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix-based modified release (MR) drug product of vildagliptin. Physiologically based biopharmaceutics modeling (PBBM) was developed using GastroPlus™ based on the… read more here.
Keywords: vildagliptin; dissolution specifications; drug product; modified release ... See more keywords
Oxidation of Drugs during Drug Product Development: Problems and Solutions
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DOI: 10.3390/pharmaceutics14020325
Abstract: Oxidation is the second most common degradation pathway for pharmaceuticals, after hydrolysis. However, in contrast to hydrolysis, oxidation is mechanistically more complex and produces a wider range of degradation products; oxidation is thus harder to… read more here.
Keywords: degradation; oxidation drugs; drug; drug product ... See more keywords
Application of Arrhenius Kinetics to Acceleration of Controlled Extraction Studies
Sign Up to like & getrecommendations! Published in 2018 at "PDA Journal of Pharmaceutical Science and Technology"
DOI: 10.5731/pdajpst.2018.009050
Abstract: Pharmaceutical drug products are packaged in containers so that they can be manufactured, distributed, and stored. During these events in a drug product's life cycle, the drug product and its packaging could interact, resulting in… read more here.
Keywords: drug products; acceleration; drug; practice ... See more keywords