Issue link: https://www.e-digitaleditions.com/i/977310
40 May 2018 Tablets & Capsules kilonewtons) the friability decreased below 0.1 percent (Table 3). C o a t e d t a b l e t s . To obtain a final tablet hardness of about 80 newtons, as measured for the reference product, tablet cores with a crushing strength of 50 newtons were pressed and then coated with a weight gain of 4 percent. For both formulations, only low com- paction forces of 5.75 and 4 . 1 5 k i l o n e w t o n s w e r e required to form tablet cores with an adequate tablet hardness (Table 4). After the coating process, a crushing strength of 76 and 80 new- tons was determined in the lactose- and dextrates-based formulations, respectively. The coated tablets disinte- grated within 3 minutes and exhibited a comparable tab- let weight and height as the original cetirizine tablets. The dissolution profiles of t h e l a c t o s e - a n d d e x - trates-based tablets as well as the reference product showed a high degree of similarity (Figure 2). Slight differences between the for- mulations could be observed during the first few minutes, but after 10 minutes the total cetirizine amount was released in all formulations. Conclusion Like spray-dried lactose, dextrates is a water-soluble filler-binder with brittle frac- ture as the main binding mechanism. Dextrates and spray-dried lactose show great similarity in terms of particle morphology, bulk density, and flowability. Therefore, dextrates is an ideal substi- tute for spray-dried lactose when reformulating cetirizine tablets to make them suitable for lactose-intol- erant patients. The dextrates-based formulation was fully equivalent to the lactose-based tablets and the mar- keted product Reactine with respect to powder characteristics and tablet Figure 1 a. Powder flow of lactose- and dextrates-based formulations b. Ejection force of lactose- and dextrates-based formulations c. Compactibility of the lactose- and dextrates-based formulations Lactose formulation Dextrates formulation 30 25 20 15 10 5 0 8 9 10 12 Aperture size (mm) Powder flow (g) Lactose formulation Dextrates formulation 300 250 200 150 100 50 0 5 10 15 Compression force (kN) Ejection force (N) Crushing strength (N) 120 100 80 60 40 20 0 5 10 15 Compression force (kN) Lactose formulation Dextrates formulation parameters, such as compactibility, disintegration time and dissolution profile. References 1. Bopp, A. & Herbst, V. (2010). Handbuch Medikamente: vom Arzt verordnet: für Sie bewertet, 8. Auflage, Berlin: Stiftung Warentest. 2. Armstrong, A.W. & Kvedar, J.C. (2008). Histamine Pharmacology. In: Principles of Pharmacology - The Pathophysiologic Basis of Drug Therapy (eds. Golan, D.E. et al.), 2nd Edition, Baltimore (MD): Lippincott Williams & Wilkins.