Tablets & Capsules

TC0321

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32D March/April 2021 Tablets & Capsules tion 3, containing an elevated amount of calcium carbonate, developed the thickest gel raft. However, when compared to Formulation 2, Formulation 3 showed a lower raft strength. This may be a result of the inclusion of more and larger gas bubbles into the raft, reducing its overall robustness. As demonstrated by these results, raft strength and thickness are affected by the concentration of calcium car- bonate. Careful balancing of the calcium-induced gelling and the carbonate-related gas formation is required during formulation development. T&C References 1. Clarrett, D.: Gastroesophageal Reflux Disease (GERD), Missouri Medicine, 115 (3), 214-218 (2018). 2. Ness-Jensen, E. et al.: Lifestyle Intervention in Gas- troesophageal Reflux Disease, Clinical Gastroenterology and Hepatology, 14 (2), 175-182 (2016). 3. https://flexikon.doccheck.com/de/Magensaft 4. Marburger, A.: Alginate und Carrageenane - Eigen- schaften, Gewinnung und Anwendungen in Schule und Hochschule, Philipps Universitat Marburg (2003). 5. Badillo, R. and Francis, D.: Diagnosis and treatment of gastroesophageal reflux disease, World Journal of Gastro- intestinal Pharmacology and Therapeutics, 5 (3), 105-112 (2014). 6. Fossmark, R. et al.: Adverse Effects of Proton Pump Inhibitors-Evidence and Plausibility, International Journal of Molecular Sciences, 20 (20), (2019). 7. Kuen, Y.L. and Mooney, D.J.: Alginate: properties and biomedical applications, Progress in Polymer Science, Sci. 37(1): 106–126 (2012). 8. Mandel, K. G. et al.: Review Article: Alginate-Raft Formulations in the Treatment of Heartburn and Acid Reflux, Alimentary Pharmacology & Therapeutics, 14 (6), 669- 690 (2000). Sabine Wetzel is an application scientist at JRS Pharma (info@jrspharma.com, www.jrspharma.com). Effect of calcium on gel-raft strength Calcium-induced cross-linking is known to have a strengthening effect on alginate gels [6, 7]. To under- stand the influence of calcium on the robustness of the formed raft, researchers carried out a study comparing the raft strengths for three different anti-reflux formula- tions based on sodium alginate (Vivapharm PH R5, JRS Pharma). Formulation 1 contained no calcium, using only sodium carbonate as the source of CO 2 . Formulation 2 contained calcium in a concentration commonly found in commercial alginate-based anti-reflux products. Formulation 3 contained twice the regular amount of calcium. Table 1 shows the basic outline of a corresponding formulation. The appearance of the resulting rafts in 0.1 M hydrochloric acid is shown in Photo 1. The formulation without calcium produced the thinnest and weakest gel raft layers, as shown in Figure 4. Formula- Photo 1: Gel raft in 0.1 M hydrochloric acid without calcium carbonate (left), with a usual amount of calcium carbonate (middle), and with an elevated amount of calcium carbonate (right). Formulation 1 Formulation 2 Formulation 3 Figure 4 Raft strength of gels in 0.1 M hydrochloric acid without calcium carbonate (left), with a usual amount of calcium carbonate (middle) and with an elevated amount of calcium carbonate (right). Alginate formulation with Vivapharm sodium alginate pH R5 Without CaCO 3 Formulation 1 CaCO 3 Formulation 2 CaCo 3 Formulation 3 100 90 80 70 60 50 40 30 20 10 0 Raft strength [%]

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