国生 国生一 Appearance Tablet Evaluation ·Appearance Tablet-to-tablet uniformity Weight variation 金k-o-unimy ·Hardness and Breakage of anyident fying Absence of physical flaws Pressure ·Dissolution test Content uniformity 国生 Weight variation 国生 图生一Tabe The weight of tablet is routinely measured to help The peocess which the tablet is ensure that a tablet contains a proper amount of Hardness:>40-60N ricdsiscaleddiiregntion. drug. 片相的平均重量，g 片剂差异限度，% Breakage:<1%weight loss <0.30 ±7.5 ≥0.30 ±5.0 图t生isinegration(Chinese pharmco间 ©生Tablet disintegration 片周喝内便有片行鞋片为两片期衣青薄硬衣片不衣有 The dissolution test providesa measure ofe am包c tuid,simun rate of drug release froado fmintoos A move the b medium under a set of specified test conditions. et up an gh a d Dissolution methodsare developed to evae the poential 1313 Shanghai Jiao Tong University Factors affecting tablet formation Properties of drug and excipients • Plasticity and elasticity • Melting point • Crystalline Binders Lubricants Moisture Pressure Shanghai Jiao Tong University Tablet Evaluation • Appearance • Weight variation • Hardness and Breakage • Disintegration test • Dissolution test • Content uniformity Shanghai Jiao Tong University Appearance Visual identity and overall elegance Tablet-to-tablet uniformity lot-to-lot uniformity Legibility of any identifying markings Absence of physical flaws Shanghai Jiao Tong University Weight variation The weight of tablet is routinely measured to help ensure that a tablet contains a proper amount of drug. 片剂的平均重量，g 片剂差异限度，% < 0.30 ±7.5 ≥ 0.30 ±5.0 Shanghai Jiao Tong University Hardness: >40~60N Breakage: < 1% weight loss Shanghai Jiao Tong University Tablet disintegration The process which the tablet is breakdown into small particles is called disintegration. Shanghai Jiao Tong UniversityDisintegration test (Chinese pharmacopoeia) Tablet disintegration tester has 6 tubes with 2-mm screen at the bottom. To test for disintegration time, one tablet is placed in each tube, and the basket rack is positioned in water, simulated gastric fluid, simulated intestinal fluid, or other solutions, at 37± 1℃ . A motor-driven device is used to move the basket up and down through a distance of 55±2mm at a frequency of 30 to 32 cycles per minute. Shanghai Jiao Tong University Tablet disintegration The tablets performing dissolution test don’t perform the disintegration test. 片剂 普通片 浸膏片 分散片 泡腾片 糖衣片 薄膜衣片 肠溶衣片 崩解时限 （min） 15 60 3 5 60 30 人工胃液中2h内不 得有裂缝、崩解或 软化现象，人工肠 液中lh全部崩解并 通过筛网。 Shanghai Jiao Tong University Tablet dissolution Dissolution refers to the rate and extent of drug dissolving from solid dosage forms in certain solution. The dissolution test provides a measure of the extent and rate of drug release from a dosage form into an aqueous medium under a set of specified test conditions. Dissolution methods are developed to evaluate the potential in vivo performance of a solid oral dosage form, and as quality control tests demonstrating the appropriate performance of drug products