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1.
AAPS PharmSciTech ; 22(5): 196, 2021 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-34184149

RESUMO

In a formulation, traces of peroxides in copovidone can impact the stability of drug substances that are prone to oxidation. The present study aimed to investigate the impact of peroxides in novel Plasdone™ S630 Ultra and compare it with regular Plasdone™ S630 on the oxidative degradation of quetiapine fumarate amorphous solid dispersions prepared via hot-melt extrusion technique. The miscibility of copovidones with drug was determined using the Hansen solubility parameter, and the results indicated a miscible drug-polymer system. Melt viscosity as a function of temperature was determined for the drug-polymer physical mixture to identify the suitable hot-melt extrusion processing temperature. The binary drug and polymer (30:70 weight ratio) amorphous solid dispersions were prepared at a processing temperature of 160°C. Differential scanning calorimetry and Fourier transform infrared spectroscopy studies of amorphous solid dispersions revealed the formation of a single-phase amorphous system with intermolecular hydrogen bonding between the drug and polymer. The milled extrudates were compressed into tablets by using extragranular components and evaluated for tabletability. Stability studies of the milled extrudates and tablet formulations were performed to monitor the oxidative degradation impurity (N-oxide). The N-oxide impurity levels in the quetiapine fumarate - Plasdone™ S630 Ultra milled extrudates and tablet formulations were reduced by 2- and 3-folds, respectively, compared to those in quetiapine fumarate - Plasdone™ S630. The reduced oxidative degradation and improved hot-melt extrusion processability of Plasdone™ S630 Ultra make it a better choice for oxidation-labile drugs over Plasdone™ S630 copovidone.


Assuntos
Tecnologia de Extrusão por Fusão a Quente/métodos , Excipientes Farmacêuticos/síntese química , Povidona/síntese química , Pirrolidinas/síntese química , Fumarato de Quetiapina/síntese química , Compostos de Vinila/síntese química , Varredura Diferencial de Calorimetria/métodos , Química Farmacêutica/métodos , Composição de Medicamentos/métodos , Temperatura Alta , Oxirredução , Excipientes Farmacêuticos/farmacocinética , Povidona/farmacocinética , Pirrolidinas/farmacocinética , Fumarato de Quetiapina/farmacocinética , Solubilidade , Espectroscopia de Infravermelho com Transformada de Fourier/métodos , Compostos de Vinila/farmacocinética
2.
BJGP Open ; 4(5)2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33051222

RESUMO

BACKGROUND: Irritable bowel syndrome (IBS) is common and often negatively affects quality of life. Patients frequently perceive medical interventions as inadequate and seek support from other sources, including online discussion forums. AIM: To explore online discussion forum topics posted by people with IBS. DESIGN & SETTING: A qualitative study exploring three UK-based online discussion forums. METHOD: A scoping review identified UK-based discussion forums with high activity and frequent use, which did not require a password/registration to view posts (two IBS-specific and one general health forum). Internal search functions were used to identify and export relevant discussion threads relating to managing IBS. Inductive thematic analysis of exported discussions was undertaken. RESULTS: Analysis identified two main overarching themes from 122 relevant discussion threads: 1) sharing information and practical advice about lifestyle changes; and 2) receiving emotional support. The most prevalent topics were lifestyle changes, including diet, using oral preparations (for example, supplements or probiotics), and physical activity. Dietary changes were usually considered positive, and most hopeful for potentially alleviating symptoms. Emotional support was also regularly offered with expressions of empathy, kindness, and gratitude, and a sense of users feeling less alone. Some discussions raised concern around potentially inappropriate symptomatic reassurance, and negative or conflicting advice. CONCLUSION: Online forums seem, generally, to be a positive experience for those posting, but include potential risks of misinformation. Most posts focus on symptomatic relief through lifestyle change and/or emotional support. Clinicians could gain a better understanding of patients' ideas, concerns, and expectations of IBS diagnosis and management by asking about patient-acquired online forum information.

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