[Translated article] Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops.

Objective: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 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 Harmonization 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).

Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops.

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).

Development of a carbocysteine 10% + urea 5% cream for the topical treatment of congenital ichthyosis.

Objective: Optimization of a topical formula of N-acetylcysteine and urea for  the topical treatment of ichthyosis.

Method: We reviewed the chemical structure of the N-acetylcysteine molecule  and its metabolic processes. A search was conducted of possible alternative  molecules with a chemical structure similar to that of N-acetylcysteine that  could have improved organoleptic properties.

pH determination as a quality standard for the elaboration of oral liquid compounding formula.

Objective: pH is a critical factor for all those medications prepared as aqueous  liquid forms, because it has an impact on the solubility of the molecule, determining the stability of medications, the biological tolerability of  the formulation, and the activity of the molecule. The objective of this study is to determine the optimum pH range for the oral liquid formulations more frequently prepared at the Pharmacy Unit, in order to standardize and incorporate said  value into the standard protocols of action as a quality control criterion.

Method: The study was conducted in three stages.

Physicochemical and microbiological stability of two news oral liquid formulations of clonidine hydrochloride for pediatric patients.

Pediatric patients present changing physiological features. Because of the lack of land suitable for commercial management, pediatric specialties very often need to prepare extemporaneous formulations to improve the dosage and administration of drugs for children. Oral liquid formulations are the most suitable for pediatric patients.