Novel Approach for the Bioequivalence Assessment of Topical Cream Formulations: Model-Based Analysis of Tape Stripping Data Correctly Concludes BE and BIE
| العنوان: | Novel Approach for the Bioequivalence Assessment of Topical Cream Formulations: Model-Based Analysis of Tape Stripping Data Correctly Concludes BE and BIE |
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| المؤلفون: | Murray P. Ducharme, Isadore Kanfer, Deniz Ozdin |
| المصدر: | Pharmaceutical Research. 37 |
| بيانات النشر: | Springer Science and Business Media LLC, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, Stripping (chemistry), Chemistry, Pharmaceutical, Skin Absorption, Pharmacology toxicology, Biological Availability, Pharmaceutical Science, 02 engineering and technology, Bioequivalence, Administration, Cutaneous, 030226 pharmacology & pharmacy, Ointments, 03 medical and health sciences, 0302 clinical medicine, Humans, Applied mathematics, Pharmacology (medical), Skin, Mathematics, Pharmacology, Organic Chemistry, 021001 nanoscience & nanotechnology, Drug content, Reference product, Topical cream, Therapeutic Equivalency, Mixed effects, Molecular Medicine, Female, Epidermis, 0210 nano-technology, Biotechnology |
| الوصف: | The purpose of this study was (a) to suggest a novel dermatopharmacokinetic (DPK) approach from which pharmacokinetic parameters relevant to the bioequivalence (BE) assessment of a topical formulation can be deduced while circumventing the need for numerous measurements and assumptions, and (b) to investigate whether this approach enables the correct conclusion of BE and bioinequivalence (BIE). Bioequivalent and bioinequivalent formulations of acyclovir were compared versus a reference product (Zovirax®). Tape Stripping was conducted at only one dose duration during the uptake phase to generate drug content in stratum corneum versus time profiles, each time point corresponding to one stripped layer. Nonlinear mixed effect modeling (ADAPT5®) (MLEM algorithm) was used to fit the DPK data and to estimate the rate (Kin) and extent (FS) of drug absorption/input into the skin. Results were evaluated using the average BE approach. Estimated exposure metrics were within the usual BE limits for the bioequivalent formulation (FS: 102.4 [90%CI: 97.5–107.7]; Kin: 94.2 [90%CI: 83.7–106.0]), but outside those limits for the bioinequivalent formulation (FS: 43.4 [90%CI: 27.9–67.6]; Kin: 54.5 [90%CI: 36.6–81.1]). The proposed novel DPK approach was shown to be successful, robust and applicable to assess BE and BIE correctly between topical formulations. |
| تدمد: | 1573-904X 0724-8741 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e16a47f2962298a1ae02b6a02a0bfd07Test https://doi.org/10.1007/s11095-019-2724-2Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....e16a47f2962298a1ae02b6a02a0bfd07 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1573904X 07248741 |
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