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Veronica Ruz, Victoria Gonzalez, Ana Isabel Jimenez, Lola Company, Yolanda Ruiz, Carlos Astrain; Stability study of Bamosiran (a siRNA compound) in ophthalmic solution in different containers. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3040.
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© ARVO (1962-2015); The Authors (2016-present)
To study the stability of bamosiran (a new chemical entity based on siRNA technology) in ophthalmic solution to be administered as eye drops in different containers.Bamosiran eye drops is an RNAi drug developed by Sylentis. Bamosiran has been developed to treat patients with elevated intraocular pressure and/or open angle glaucoma. Currently the compound has completed Phase 2 of clinical development. The drug product has been formulated as a solution in phosphate buffer saline at physiological pH and isotonicity free of preservatives.
Do not include preservatives in the formulation is a handicap from the pharmaceutical point of view.Two types of primary pharmaceutical packaging have been selected in order to study the stability of the same formulation of bamosiran drug product: unit-dose containers (in strips) and preservative free multi-dose containers able to guarantee the sterility of the formulation without antimicrobial preservative for at least 28 days. These presentations have been tested under ICH stability conditions with the aim to assess the stability of the medication and comply with the regulatory requirements and compared with the same formulation packed in single glass vials and maintained in stability during 5 years.The samples were placed in qualified chambers protected from light at the following ICH conditions: 5(±3)C, 25 (±2)C/60% (±5%)RH, 30 (±2)C/35% (±5%)RH and 40(±2)C/NMT 25% RH for unit dose strips. Multidose containers were placed at 5(±3)C, 25(±2)C, and 40(±2)C conditions. Glass vials were placed at 5(±3)C, 25(±2)C/60% (±5%)RH, and 40(±2)C/75% RH. All samples were analysed at different time-points. Physicochemical and microbiological tests were performed in order to assess that the product is within specifications.
All formulations showed good stability at the studied conditions during the time-points studied.
Bamosiran 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 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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