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Veronica Ruz, Yolanda Ruiz, Carlos Astrain, Carlos Segura, Noelia Miguel, Carlos millan, Victoria Gonzalez, Maria D Company; Stability study of SYL1001 eye drops (a siRNA compound) for Dry Eye Disease in different containers. Invest. Ophthalmol. Vis. Sci. 2017;58(8):476.
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© ARVO (1962-2015); The Authors (2016-present)
To study the stability of SYL1001 ophthalmic solution (a new chemical entity based on siRNA technology) as eye drops in different containers.SYL1001 eye drops are a siRNA investigational new drug developed by Sylentis. SYL1001 has been developed to treat patients with Dry Eye Disease (DED). Currently the compound has completed Phase 2 of clinical development. The drug product has been formulated as an eye drops solution, in phosphate buffer saline, free of preservatives.
During the clinical trials corresponding to phases 1 and 2, and in order to select the best dose for the treatment of sign and symptoms of DED with SYL1001 eye drops, the solution was formulated in unit glass vials free of preservatives. Once the best dose was chosen, SYL1001 has been formulated in plastic ampoules in strips inside a foil to carry out phase 3 clinical trials and reach the market. Both types of primary pharmaceutical packaging have been compared in order to study the stability of the same formulation of SYL1001 drug product: unit-dose plastic containers (in strips inside a sachet) and in unit glass vials. These presentations have been tested under controlled stability conditions during 1 year with the aim to assess the stability of the medication and comply with the regulatory requirements.The samples were placed in qualified chambers protected from light at the following conditions: 5(±3) C, 25 (±2) C, and 40 C for plastic unit dose strips. Glass vials containers were placed at 5(±3) C condition. All samples were analyzed at different time-points. Physicochemical and microbiological tests were performed in order to assess that the product is within specifications.Impurities of both investigational new products were also compared with the time zero analysis of the drug substance.
All formulations showed good stability at the studied conditions during the time-points studied.
SYL1001 drug product shows good stability properties during the time of the study and is able to be packed in both type of containers and complies with the specifications that guarantee the integrity of the medication.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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