Background and Importance The digestive endoscopy department sought the expertise of pharmaco-technology to develop a sterile hospital preparation aimed at facilitating mucosectomies. This hyperosmolar solution assists in separating digestive mucus and submucus layers, facilitating polyp removal during endoscopy.

Aim and Objectives The study aims to assess producing a 5% fructose, 10% glycerol solution, and methodically preparing and controlling 30 bags of 100 mL using a sterile isolator and automated filling.

Material and Methods The study entailed literature review, European Pharmacopoeia evaluation, Rennes Hospital Centre procedure analysis, and Civil Hospices of Lyon stability study. Protocols were drafted, followed by test productions. Concentrated solution with 150 g fructose, 240 mL non-sterile glycerol, and 250 mL sterile 0.9% sodium chloride (NaCl) was prepared in a safety cabinet, transferred to an isolator in a sealed Erlenmeyer flask, then filtered into an empty 3 L bag. 0.9% NaCl was added via peristaltic pump, and solution was distributed into 100 mL bags. Sterility was ensured through aseptic processing and 0.22 µm filtration. Controls included osmolality, pH, sodium via inductively coupled plasma optical emission spectrometry, gravimetric checks, and sterility testing.

Results Results validated solution feasibility, process efficacy, and quality controls. Mean osmolality was 1698.11 [±33.70] mOsmol/L, pH 5.64 [±0.11], and sodium 134.37 [±4.39] mM within 10% range around theoretical 137.06 mM. Average weight was 103.42 g, density 1.06, confirming volume per 100 mL. Sterility test passed on Day 14.

Conclusion and Relevance Discussion highlighted challenges like non-sterile raw materials, peristaltic pump use in isolator, batch size, consumable volume, and 0.22 µm filter integration. Fructose and glycerol measurements posed difficulties. Sodium measurements were lower due to fructose’s impact on added 0.9% NaCl volume. Bag quantity variation stemmed from NaCl pouch overfilling variability. Preparation feasibility and controls were validated. In conclusion, this study successfully demonstrated the feasibility of producing the hyperosmolar solution, outlined effective preparation processes, and established stringent quality controls for its hospital-scale implementation.

Conflict of Interest No conflict of interest.