Designing oral formulations for children is very challenging, especially considering their peculiarities and preferences. The choice of excipients, dosing volume and palatability are key issues of pediatric oral liquid medicines. The purpose of the present study is to develop an oral pediatric solution of a model bitter drug (ranitidine) following a patient centric design process which includes the definition of a target product profile (TPP). To conclude on the matching of the developed solution to TPP, its chemical and microbiological stability was analyzed over 30 days (stored at 4 °C and room temperature). Simulation of use was accomplished by removing a sample with a syringe every day. Taste masking was assessed by an electronic tongue. The developed formulation relied on a simple taste masking strategy consisting in a mixture of sweeteners (sodium saccharine and aspartame) and 0.1% sodium chloride, which allowed a higher bitterness masking effectiveness in comparison with simple syrup. The ranitidine solution was stable for 30 days stored at 4 °C. However, differences were noted between the stability protocols (unopened recipient and in-use stability) showing the contribution of the simulation of use to the formation of degradation products. Stock solution was subjected to acid and alkali hydrolysis, chemical oxidation, heat degradation and a photo degradation stability assessment. The developed pediatric solution matched the TPP in all dimensions, namely composition suitable for children, preparation and handling adapted to hospital pharmaceutical compounding and adequate stability and quality. According to the results, in-use stability protocols should be preferred in the stability evaluation of pediatric formulations.

Oral mucositis is an inflammatory and ulcerative disease that affects patients undergoing cancer treatment, namely chemotherapy and radiotherapy, significantly compromising their quality of life. Despite its high incidence and clinical impact, current therapeutic options remain limited, reinforcing the need for new treatment approaches. In this context, the Instituto Português de Oncologia do Porto FG, EPE (IPO-Porto) developed an innovative mouthwash containing dexamethasone sodium phosphate (DSP), ascorbic acid, and sodium hyaluronate. In this work the physicochemical stability of this formulation was evaluated to ensure its quality and safety as compounded medicine. Exploratory studies were performed under accelerated aging conditions (40 ± 2 °C), followed by stability studies under real-time conditions (20 ± 2 °C) and refrigeration conditions (4 ± 2 °C), as well as in-use stability studies simulating daily patient handling. At each sampling time, physicochemical characterization was carried out (pH, color, odor, and precipitate formation) as well as the DSP quantification using high-performance liquid chromatography. The acceptable range of 90.0–110.0%, compared to the initial concentration of DSP, was used as the primary stability criterion. Results showed that the formulation remained stable at high temperatures (40 °C), on short exposures times (≤6 h), and for 30 days at 4 °C in closed amber glass bottles. In-use stability studies performed during the 7 days after opening (considering three daily applications) showed that the DSP concentration remained above 90%. The results obtained enabled us to establish a definition of storage conditions and beyond-use recommendations, since they showed that the prepared formulation is stable when stored under refrigeration. Further studies are currently being developed with a view to its clinical use as a compounded mouthwash in a hospital setting for the treatment of oral mucositis.