国生一 国生 ©Crystalline form Polymorphism of active ingredients Hiestand tableting indices Polymorphism of excipients ·Strain index Polymorphic transformation during manufacturing ·Bonding index Brittle fracture index 国生一 国生 圈Variability ©Purity It is necessary to test the raw materials including Impurity may influence the tablet quality active ingredients and excipients to ensure uniformity 1与 of final product. 、7-13t-0492-n Table 3 Average Particle Data for Different Sources of 叫 Magnsium Stearate Size Surface Pore radius Source (m) area (m/g) United States 1.532 13.4 50 Great Britain 2152 12.2 Germany 4.1-6.9 7.4 61 Avoid the microbiological contamination of raw materials Italy 5591 4.6 36 国生一 ©Tablet excipients ·L.Fillers/diluents .2.Binders 圈Compatibility .3.Disintegrants ·4.Lubricants An incompatibility may be defined as an ·5.Glidants undesirable drug interaction with one or ·6.Buffering agents more components of a formulation, ·7.Sweeteners 。8.Wetting agents resulting in changes in physical, ·9.Absorbents chemical,microbiological or therapeutic ·10.Colorants ·11.Flavors properties of the dosage form. ·12.Coating agents 13.Matrix formers 55 Shanghai Jiao Tong University Crystalline form • Polymorphism of active ingredients • Polymorphism of excipients • Polymorphic transformation during manufacturing Shanghai Jiao Tong University Hiestand tableting indices • Strain index • Bonding index • Brittle fracture index Shanghai Jiao Tong University Variability • It is necessary to test the raw materials including active ingredients and excipients to ensure uniformity of final product. Shanghai Jiao Tong University Purity • Impurity may influence the tablet quality • Avoid the microbiological contamination of raw materials Shanghai Jiao Tong University Compatibility • An incompatibility may be defined as an undesirable drug interaction with one or more components of a formulation, resulting in changes in physical, chemical, microbiological or therapeutic properties of the dosage form. Tablet excipients • 1. Fillers/diluents • 2. Binders • 3. Disintegrants • 4. Lubricants • 5. Glidants • 6. Buffering agents • 7. Sweeteners • 8. Wetting agents • 9. Absorbents • 10. Colorants • 11. Flavors • 12. Coating agents • 13. Matrix formers