Sensitivity of Different In Vitro Performance Tests and Their In Vivo Relevance for Calcipotriol/Betamethasone Ointment
| Autor: | Nina Habjanič, Katja Kristan, Mojca Kerec Kos |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Pharmaceutical Science 02 engineering and technology Pharmacology In Vitro Techniques 030226 pharmacology & pharmacy Betamethasone Clinical study Discriminatory power Ointments 03 medical and health sciences chemistry.chemical_compound Random Allocation 0302 clinical medicine Calcitriol In vivo Psoriasis medicine Humans Pharmacology (medical) Calcipotriol Therapeutic equivalence business.industry Organic Chemistry 021001 nanoscience & nanotechnology medicine.disease In vitro Drug Liberation chemistry Therapeutic Equivalency Molecular Medicine Drug Evaluation Female Dermatologic Agents 0210 nano-technology business Biotechnology medicine.drug |
| Zdroj: | Pharmaceutical research. 37(3) |
| ISSN: | 1573-904X |
| Popis: | We compared results of in vitro performance testing with results of therapeutic equivalence study for calcipotriol/betamethasone ointment, to evaluate their sensitivity and in vivo relevance. Different in vitro methods were used to evaluate drug release and permeation from the test and reference ointment. Moreover, 444 psoriasis patients were randomized in the therapeutic equivalence study and the parameters of efficacy and safety were compared with in vitro results. In vitro release and permeation rate of calcipotriol and betamethasone from the test formulation was higher than from the reference product for all methods used (p ≤ 0.05 for calcipotriol and p |
| Databáze: | OpenAIRE |
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