دورية أكاديمية
أعرض في EDS

Refining the in vitro release test method for a dapivirine-releasing vaginal ring to match in vivo performance.

التفاصيل البيبلوغرافية
العنوان: Refining the in vitro release test method for a dapivirine-releasing vaginal ring to match in vivo performance.
المؤلفون: Murphy DJ; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK., Lim D; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK., Armstrong R; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK., McCoy CF; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK., Bashi YHD; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK., Boyd P; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK., Derrick T; International Partnership for Microbicides, Silver Spring, MD, USA., Spence P; International Partnership for Microbicides, Silver Spring, MD, USA., Devlin B; International Partnership for Microbicides, Silver Spring, MD, USA., Malcolm RK; School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK. k.malcolm@qub.ac.uk.
المصدر: Drug delivery and translational research [Drug Deliv Transl Res] 2023 Aug; Vol. 13 (8), pp. 2072-2082. Date of Electronic Publication: 2021 Oct 21.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Springer Country of Publication: United States NLM ID: 101540061 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2190-3948 (Electronic) Linking ISSN: 2190393X NLM ISO Abbreviation: Drug Deliv Transl Res Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York : Springer
مواضيع طبية MeSH: Anti-HIV Agents*/chemistry , Contraceptive Devices, Female* , HIV Infections*/prevention & control, Humans ; Female ; 2-Propanol/analysis ; Vagina
مستخلص: Previously reported in vitro release test methods for drug-releasing vaginal rings containing poorly water-soluble drugs have described use of water-alcohol systems or surfactant solutions in efforts to maintain sink conditions. Here, as part of efforts to more closely match in vitro and in vivo release for the 25 mg dapivirine matrix-type silicone elastomer vaginal ring for HIV prevention, we have investigated alternatives to the 1:1 v/v water/isopropanol medium described previously. Specifically, we evaluated dapivirine release from rings into (i) monophasic water/isopropanol mixtures of varying compositions and (ii) biphasic buffer/octanol systems using pH 4.2 and pH 7.0 buffers. The rate and mechanism of dapivirine release were dependent upon the isopropanol concentration in the release medium, in accordance with the observed trend in drug solubility. At 0 and 10% v/v isopropanol concentrations, dapivirine release followed a partition-controlled mechansim. For media containing ≥ 20% v/v isopropanol, in vitro release of dapivirine was significantly increased and obeyed permeation-controlled kinetics. Cumulative release of ~3.5 mg dapivirine over 28 days was obtained using a water isopropanol mixture containing 20% v/v isopropanol, similar to the ~4 mg dapivirine released in vivo. Dapivirine release into the biphasic buffer/octanol system (intended to mimic the fluid/tissue environment in vivo) was constrained by the limited solubility of dapivirine in the buffer component in which the ring resided, such that cumulative dapivirine release was consistently lower than that observed with the 20% v/v isopropanol in water medium. Release into the biphasic system was also pH dependent, in line with dapivirine's pK a and with potential implications for in vivo release and absorption in women with elevated vaginal pH.
(© 2021. The Author(s).)
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فهرسة مساهمة: Keywords: Biorelevant; Dapivirine; Drug release; In vitro release testing; Vaginal ring
المشرفين على المادة: 0 (Anti-HIV Agents)
TCN4MG2VXS (Dapivirine)
ND2M416302 (2-Propanol)
تواريخ الأحداث: Date Created: 20211021 Date Completed: 20230704 Latest Revision: 20230705
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC10315348
DOI: 10.1007/s13346-021-01081-7
PMID: 34674162
قاعدة البيانات: MEDLINE
الوصف
تدمد:2190-3948
DOI:10.1007/s13346-021-01081-7