CombiVacS study has demonstrated a strong immune response of the heterologous ChAdOx1-S/BNT162b2 vaccine combination. The primary outcomes of the study were to assess the humoral immune response against SARS-CoV-2, 28 days after a third dose of a mRNA vaccine, in subjects that received a previous prime-boost scheme with ChAdOx1-S/BNT162b2. Secondary outcomes extended the study to 3 and 6 months.
View Article and Find Full Text PDFPrimary Central Nervous System Lymphoma (PCNSL) is an aggressive brain tumour with a median survival rarely exceeding 3 months without treatment when seen in association with advanced HIV. High dose methotrexate (HD-MTX) in association with combination antiretroviral therapy (cART) is the recommended chemotherapy. However, HD-MTX may be not feasible due to poor performance status and concerns about toxicity.
View Article and Find Full Text PDFIn vitro dissolution experiments are becoming increasingly complex attempting to replicate in vivo behavior. The objective of these new methods is to explore the behavior of low-solubility drugs. This is more relevant for drugs classified in subclasses 2a, 2b and 2c of the BCS, considering their pH-dependent solubility and dissolution characteristics.
View Article and Find Full Text PDFItraconazole is a drug used in veterinary medicine for the treatment of different varieties of dermatophytosis at doses between 3-5 mg/kg/day in cats. Nevertheless, in Spain, it is only available in the market as a 52 mL suspension at 10 mg/mL. The lack of alternative formulations, which provide sufficient formulation to cover the treatment of large animals or allow the treatment of a group of them, can be overcome with compounding.
View Article and Find Full Text PDFPharmaceutics
March 2024
The purpose of this study was to predict the in vivo bioequivalence (BE) outcome of valsartan (VALS, BCS class IV) from three oral-fixed combination products with hydrochlorothiazide (HCTZ, BCS class III) ( as reference and two generic formulations in development) by conducting in vivo predictive dissolution with a gastrointestinal simulator (GIS) and a physiologically based biopharmaceutic model (PBBM). In the first BE study, the HCTZ failed, but the VALS 90% CI of Cmax and the AUC were within the acceptance limits, while, in the second BE study, the HCTZ 90% CI of Cmax and the AUC were within the acceptance limits, but the VALS failed. As both drugs belong to different BCS classes, their limiting factors for absorption are different.
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