دورية أكاديمية
Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops.
| العنوان: | Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops. |
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| عنوان ترانسليتريتد: | Estudio de estabilidad fisicoquímica y microbiológica de dos nuevos colirios de metilprednisolona sin conservantes. |
| المؤلفون: | Merino-Bohórquez V; Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, España; Departamento de Farmacología, Facultad de Farmacia, Universidad de Sevilla, Sevilla, España. Electronic address: vicente.merino.sspa@juntadeandalucia.es., Berisa-Prado S; Servicio de Farmacia, Clínica Universitaria de Navarra, Navarra, España., Delgado-Valverde M; Servicio de Microbiología Clínica, Hospital Universitario Virgen Macarena, Sevilla, España., Tirado-Pérez MJ; Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, España., García-Palomo M; Servicio de Farmacia, Hospital Universitario de Toledo, Toledo, España., Alonso-Herreros JM; Servicio de Farmacia, Hospital General Universitario de Los Arcos del Mar Menor, Murcia, España., Cañete-Ramírez C; Servicio de Farmacia, Hospital Universitario Vall´d Hebron, Barcelona, España., Dávila-Pousa MD; Servicio de Farmacia, Complexo Hospitalario Universitario de Pontevedra, Pontevedra, España. |
| مؤلفون مشاركون: | & Grupo de Trabajo de Farmacotecnia de la Sociedad Española de Farmacia Hospitalaria |
| المصدر: | Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria [Farm Hosp] 2024 Jul-Aug; Vol. 48 (4), pp. 145-152. Date of Electronic Publication: 2024 Apr 03. |
| نوع المنشور: | Journal Article |
| اللغة: | English; Spanish; Castilian |
| بيانات الدورية: | Publisher: Elsevier España Country of Publication: Spain NLM ID: 9440679 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2171-8695 (Electronic) Linking ISSN: 11306343 NLM ISO Abbreviation: Farm Hosp Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2023- : Madrid : Elsevier España Original Publication: Madrid : Editorial Garsi, |
| مواضيع طبية MeSH: | Ophthalmic Solutions*/chemistry , Drug Stability* , Preservatives, Pharmaceutical* , Methylprednisolone*/administration & dosage , Drug Storage*, Humans ; Drug Contamination |
| مستخلص: | Objective: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 mg/ml and 10 mg/ml eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome. Method: The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5 ±3 °C), at room temperature (25 ± 2 °C), and at 40 °C (±2 °C). In accordance with the USP (United States Pharmacopeia), physicochemical controls of the active ingredient content were carried out by HPLC-UV (High Performance Liquid Chromatography with Ultraviolet detection), together with controls of pH, osmolality, and visual examination. Microbiological sterility was also tested under refrigerated conditions up to 30 days in open containers and up to 90 days in closed ones. Results: The eye drops stored at 5 °C were the most stable; in the 1 mg/ml eye drops, degradation of the drug fell below 90% from day 21, and in the 10 mg/ml eye drops, from day 42. pH change did not vary by ≥1 unit in formulations stored at 5 °C, unlike the other formulations. Changes in osmolality did not exceed 5% on day 90 in any storage conditions. Samples of non refrigerate eye drops at 10 mg/ml, presented a white precipitate from day 14 and 28 respectively. Non-refrigerated 1 mg/ml eye drops presented suspended particles on day 90. There were no color changes. Microbiological analysis showed that sterility was maintained for over 90 days in the closed containers, although microbial contamination was detected from day 21 in the open containers. Conclusions: 1 mg/ml MTPSS eye drops show physicochemical and microbiological stability for 21 days under refrigeration, compared to 42 days for 10 mg/ml eye drops stored under the same conditions. However, since they do not include preservatives in their composition, they should not be used for more than 7 days after opening. (Copyright © 2024 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Drug stability; Dry eye syndrome; Estabilidad de medicamentos; Glucocorticoides; Glucocorticoids; Ophthalmic solutions; Sjögren´s syndrome; Soluciones oftálmicas; Síndrome de Sjögren; Síndrome del ojo seco |
| المشرفين على المادة: | 0 (Ophthalmic Solutions) 0 (Preservatives, Pharmaceutical) X4W7ZR7023 (Methylprednisolone) |
| تواريخ الأحداث: | Date Created: 20240403 Date Completed: 20240711 Latest Revision: 20240711 |
| رمز التحديث: | 20240712 |
| DOI: | 10.1016/j.farma.2024.01.007 |
| PMID: | 38570209 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2171-8695 |
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| DOI: | 10.1016/j.farma.2024.01.007 |