Development of a 50% (w/v) aluminium chloride hexahydrate solution as haemostatic agent

Abstract

Objectives: Acceleration of the haemostasis process after dermatological surgery predominantly relies on mechanical methods, such as the use of sutures or staples. To our knowledge, there is currently no commercialised haemostatic agent for this specific application. Due to the protein precipitation properties of the 50% (w/v) aluminium chloride hexahydrate solution, its physicochemical stability and maintenance of sterility over a 6 month period were assessed.

Methods: Aluminium chloride hexahydrate was dissolved in sterile water to obtain a 50% (w/v) solution, which was subsequently sterilised through filtration. The solution was then placed in brown glass vials and kept at 20-25°C. The physicochemical stability and sterility of the solution were assessed at four different time points (D0, M1, M3 and M6). At each time point, pH and osmolality were measured, the chloride concentration of the sample was evaluated using the Mohr method, and aluminium identification was carried out through a precipitation method. In addition, the sterility of the solution was also assessed at each time point, according to the European Pharmacopoeia method.

Results: The pH, osmolality and chloride concentration values remained stable and were concordant with the expected values throughout the study. Aluminium was identified in each sample. The sterility of the solution was maintained over the study period.

Conclusions: The physicochemical stability and sterility of the 50% (w/v) aluminium chloride hexahydrate solution were maintained for 6 months. These results indicate that the solution can be prepared in advance.

Keywords: DERMATOLOGY; DRUG STABILITY; Drug Compounding; Manufacturing and Industrial Facilities; PHARMACEUTICAL PREPARATIONS; Quality Control.