Issue link: https://www.e-digitaleditions.com/i/1173734
48 October 2019 Tablets & Capsules dosage form as well as the dose and inherent properties of the API. For example, it seems possible that the tested dry binders cannot s uf f iciently improve DCP-based DC for mulations to justif y their addition. For MCC-based DC for- mulations, although both binders could significantly improve com- pactability, friability, and dissolu- tion, they might not bring a bene- fit in terms of disintegration time. For lac to s e-ba s ed D C for mu la- tions, adding the dry binders may improve compactability, friability, and disintegration time but might have no effect on dissolution. For high-dose NCC DC formulations, while adding the tested dry bind- ers may yield significant benefits in compactabilit y and f r iabilit y, disintegration time will depend on the binder used. Generally, Omya- phar m 50 0 -OG improved disin- tegration time more than copovi- done, which could become relevant for companies developing fast-dis- integrating tablets. A nother var iable to consider when selecting which dry binder to use could be its potential incompat- ibility with the API. While Omya- pharm 500-OG might provide a hos- tile environment to alkaline-sensitive APIs, copovidone might contain per- Figure 6 Effect of adding dry binders to 90% NCC DC formulation (85% NCC + 5% dry binder after addition) a. Hardness versus compression force Hardness (newtons) 160 140 120 100 80 60 40 20 0 Main compression force (kilonewtons) 2 4 6 8 10 12 14 16 18 NCC DC NCC DC + 5% Omyapharm 500-OG NCC DC + 5% copovidone b. Friability versus compression force Friability (%) 2.00 1.80 1.60 1.40 1.20 1.00 0.80 0.60 0.40 0.20 0.00 Main compression force (kilonewtons) 2 4 6 8 10 12 14 16 18 NCC DC NCC DC + 5% Omyapharm 500-OG NCC DC + 5% copovidone c. Disintegration time versus compression force Disintegration time (seconds) 500.0 450.0 400.0 350.0 300.0 250.0 200.0 150.0 100.0 50.0 0.0 Main compression force (kilonewtons) NCC DC NCC DC + 5% Omyapharm 500-OG NCC DC + 5% copovidone 2 4 6 8 10 12 14 16 18 The choice of the appropriate filler- binder and dry binder combination will depend on the intended properties of the final dosage form as well as the dose and inherent properties of the A PI.