Physical Compatibility and Chemical Stability of Injectable and Oral Ranitidine Solutions

Abstract

Objectives: The physical compatibility and chemical stability of ranitidine hydrochloride injectable solutions and oral syrup were studied to define beyond-use dates (BUDs). Methods: Ranitidine hydrochloride injectable solutions of 25 mg/mL packaged in glass vials and 5 mg/mL in polypropylene (PP) syringes were prepared in triplicate. Samples were refrigerated and protected from light (PFL) or stored at 25°C and either exposed to light (ETL) or PFL. Ranitidine hydrochloride oral syrup 15 mg/mL in unit-dose amber PP syringes were prepared in triplicate and then kept at 25°C. Samples were collected at days 0, 7, 14, 28, 56, and 91. Additional samples were collected at 6 months and at 6, 9, and 12 months for the 25 mg/mL solution and oral syrup, respectively. Physical parameters of pH, clarity, and color were obtained at each collection time. A validated stability-indicating high-performance liquid chromatography (HPLC) method was used to determine the chemical stability. Results: Formulations had no significant change in pH or clarity. Although some samples yellowed, this was not associated with a decrease in concentration. The 25 mg/mL solution remained above 98.6% for 6 months, whereas the 5 mg/mL solution remained above 93.5% for 91 days under all storage conditions. At 25°C, the oral syrup retained greater than 98.8% for 12 months. Conclusions: The ranitidine hydrochloride injectable solutions were stable for 6 months and 91 days under the 3 storage conditions, respectively, for the 25 mg/mL solution in glass vials and 5 mg/mL solution in PP syringes. The 15 mg/mL oral syrup in unit-dose amber PP syringes was stable for 12 months at 25°C and PFL.

High‐fat diet promotes prostate cancer growth through histamine signaling

“…10,11 The solutions were freshly prepared once per week as they were reported to be stable for over a week only. 12,13 previous report. 14 Evaluation of the effects of these materials on prostate cancer was performed using 22-week-old mice, following our previously reported method.…”

“…The concentrations were determined based on previous reports 10,11 . The solutions were freshly prepared once per week as they were reported to be stable for over a week only 12,13 . LPS (0.05 mg, Lot #017M4112V, Sigma‐Aldrich, St. Louis, Missouri), isolated from Escherichia coli Oranitidine55:B5 or vehicle (saline) was injected into CD‐fed prostate cancer mice at 22 weeks of age, and samples were taken after 4 hours.…”

Overcoming Challenges in Pediatric Formulation with a Patient-Centric Design Approach: A Proof-of-Concept Study on the Design of an Oral Solution of a Bitter Drug

“…The dose volume is a major consideration for the acceptability of a liquid formulation. Typical target dose volumes for pediatric liquid formulations are <5 mL for children under 5 years and <10 mL for children of 5 years and older [20]. Increasing the drug loading favors low volume administration and also allows for more flexible dose adjustment in the course of therapeutic treatment.…”