دورية أكاديمية
Silicone elastomer formulations for improved performance of a multipurpose vaginal ring releasing dapivirine and levonorgestrel.
| العنوان: | Silicone elastomer formulations for improved performance of a multipurpose vaginal ring releasing dapivirine and levonorgestrel. |
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| المؤلفون: | Dallal Bashi YH; School of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK., Murphy DJ; School of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK., McCoy CF; School of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK., Boyd P; School of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK., Brown L; Elkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA., Kihara M; Elkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA., Martin F; Elkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA., McMullen N; Elkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA., Kleinbeck K; International Partnership for Microbicides, Silver Spring, MD 2910, USA., Dangi B; International Partnership for Microbicides, Silver Spring, MD 2910, USA., Spence P; International Partnership for Microbicides, Silver Spring, MD 2910, USA., Hansraj B; International Partnership for Microbicides, Silver Spring, MD 2910, USA., Devlin B; International Partnership for Microbicides, Silver Spring, MD 2910, USA., Malcolm RK; School of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK. |
| المصدر: | International journal of pharmaceutics: X [Int J Pharm X] 2021 Jul 14; Vol. 3, pp. 100091. Date of Electronic Publication: 2021 Jul 14 (Print Publication: 2021). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101753452 Publication Model: eCollection Cited Medium: Internet ISSN: 2590-1567 (Electronic) Linking ISSN: 25901567 NLM ISO Abbreviation: Int J Pharm X Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: [Amsterdam] : Elsevier B.V., [2019]- |
| مستخلص: | A dapivirine-releasing silicone elastomer vaginal ring for reducing women's risk of HIV acquisition has recently been approved. A next-generation multipurpose vaginal ring releasing dapivirine and levonorgestrel is currently in development, offering hormonal contraception and HIV prevention from a single device. Previously, we reported challenges with incorporating levonorgestrel into rings manufactured from addition-cure silicone elastomers due to an irreversible chemical reaction between the levonorgestrel molecule and the hydride-functionalised crosslinker component of the silicone elastomer formulation, leading to low drug content assay, cure inhibition, and reduced ring mechanical properties (which may account for the increased incidence of ring expulsion in vivo). Here, we report on the development and testing of various custom silicone elastomer materials specifically formulated to circumvent these issues. After extensive testing of the custom silicones and subsequent manufacture and testing (Shore M hardness, pot life, content assay, oscillatory rheology, mechanical testing) of rings containing both dapivirine and levonorgestrel, a lead candidate formulation was selected that was amenable to practical ring manufacture via injection molding, exhibited no substantial levonorgestrel binding, and offered suitable mechanical properties. Competing Interests: Leeanne Brown, Matthew Kihara, François Martin and Nicole McMullen are employees of Elkem Silicones. The other authors declare no competing financial or personal interest. (© 2021 The Author(s).) |
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| فهرسة مساهمة: | Keywords: HIV microbicide; Hormonal contraception; Mechanical properties; Multipurpose prevention technology (MPT); Rheology; Silicone elastomer; Vaginal rings |
| تواريخ الأحداث: | Date Created: 20220103 Latest Revision: 20220104 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC8683669 |
| DOI: | 10.1016/j.ijpx.2021.100091 |
| PMID: | 34977558 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2590-1567 |
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| DOI: | 10.1016/j.ijpx.2021.100091 |