Pharmacy Unit, Hospital Universitario Virgen Macarena, Sevilla, Spain
Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, Universidad de Sevilla, Sevilla, Spain.
Eur J Hosp Pharm. 2022 Nov;29(6):313-318. doi: 10.1136/ejhpharm-2020-002534. Epub 2020 Dec 16.
Topical resorcinol 15% is a self-treatment for painful hidradenitis suppurativa nodules and abscesses with good results in reducing pain and lesion duration. The aim of this study is to establish a 15% topical resorcinol formula, to develop a physicochemical and microbiological stability study and to further determine the compounding shelf-life in different package conditions following the European Pharmacopoeia (Ph. Eur.) specifications.
Physicochemical and microbiological stability studies of the formulation were conducted for 12 months at room temperature (25°C±2°C) in different package conditions: aluminium tubes (aluminium A7-99.7% varnish DF-6172), plastic tubes (low density polyethylene) and amber plastic containers (polyethylene terephthalate). High performance liquid chromatography (HPLC) was developed as a method of indicating the stability of the resorcinol formulation. A microbiological growth assay was also validated according to the Ph. Eur. Physical properties were inspected to determine parameters such as odour, colour, pH, emulsion phase and extensibility index and its evolution.
The HPLC method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. At day 365, visual inspection remained unchanged only for preparations packaged in aluminium tubes. The pH did not vary by more than 0.3 units in all conditions. The extensibility index decreased in the preparations packaged in plastic and amber plastic containers. HPLC analysis conducted over 1 year did not show a degradation greater than 7% of resorcinol in the preparation in plastic and aluminium packages. The ability of ATCC strains to grow in resorcinol formulation was confirmed under the suitability test. Resorcinol packed in aluminium tubes achieved microbiological stability at day 365.
Only the formulation package in aluminium tubes showed physicochemical and microbiological stability of resorcinol for 12 months at room temperature (25°C±2°C).
15%浓度的外用间苯二酚是一种治疗疼痛性化脓性汗腺炎结节和脓肿的自我疗法，可显著减轻疼痛并缩短病变持续时间。本研究旨在建立 15%浓度的外用间苯二酚配方，并根据欧洲药典（Ph. Eur.）的规定进行理化和微生物稳定性研究，进一步确定不同包装条件下的复合保质期。
在不同的包装条件下（铝管（99.7%铝漆 DF-6172）、塑料管和琥珀色塑料容器（聚对苯二甲酸乙二醇酯）），在室温（25°C±2°C）下进行配方的理化和微生物稳定性研究，为期 12 个月。高效液相色谱法（HPLC）被开发为指示间苯二酚配方稳定性的方法。根据 Ph. Eur.，还验证了微生物生长测定法。检查物理性质以确定参数，如气味、颜色、pH 值、乳化相和伸展性指数及其变化。
HPLC 方法根据国际人用药品注册技术协调会（ICH）指南进行了验证。在第 365 天，仅用铝管包装的制剂外观保持不变。在所有条件下，pH 值变化均不超过 0.3 个单位。在塑料和琥珀色塑料容器中包装的制剂中，伸展性指数降低。在塑料和铝包装制剂中，经过 1 年的 HPLC 分析，间苯二酚的降解不超过 7%。在适宜性试验中，证实了 ATCC 菌株在间苯二酚制剂中生长的能力。装在铝管中的间苯二酚在第 365 天达到了微生物稳定性。
只有在室温（25°C±2°C）下，用铝管包装的制剂才能在 12 个月内保持间苯二酚的理化和微生物稳定性。
