©t Comtent uniformity tes 国生 Processing Problems Capping ard laminatio Low hardness 口口 Picking and sticking able,it could maska wide in content.So it is nec body of the. Weight variatio通 Hardness vuriatioe ●Lamieation腰教ske separation of a tablet ino rwoor moredist马es. Failure of dissolt 象Content variation ④4生Cmnation 国 Low hardness Picking and sticking Too much fine powder 患Picking片神descnbes the Compressibility of ingredients m Too dry granules tablet that is to and Adhesive being removed from the Singlepunch press ⊕Moisture tablet's surface by a puch. 邮 Rapid coepress Deep concave punches Lubricants Sucking枯refers to ble Large compression ⊕Prcs c， Wom punched Too much pressure Poor lubricability int s bstaoces in the e.not cant.rough surface of pnch and ete 国生 Mottling Moling is an unequ distnbution of ol onatabet,with Weight variation Failure of disintegration ·Compress power Differen colors of dnugs andexcipies ·Poor porosity Colors of degradation peoducts ·Gde amount i通feeder ·Poor mixing ·Strong binder Hardness vartat山on Ursuitable disintegrants particle is too large. Hygroscopic effect 1515 Shanghai Jiao Tong University Content uniformity test For low-dose drugs, even though tablets weight variation looks acceptable, it could mask a wide variation in content. So it is necessary for the tablets containing such a drug to determine content uniformity. Shanghai Jiao Tong University Processing Problems Capping and lamination Low hardness Picking and sticking Mottling Weight variation Hardness variation Failure of disintegration Failure of dissolution Content variation Shanghai Jiao Tong University Capping and lamination Capping顶裂 is a term used to describe the partial or complete separation of the top or bottom crown of a tablet from the main body of the tablet. Lamination腰裂 is the separation of a tablet into two or more distinct layers. a 顶裂； b 腰裂 Shanghai Jiao Tong University Capping and lamination Too much fine powder Low plasticity Too dry granules Single punch press Rapid compression and decompression Deep concave punches Large compression pressure Worn punched Too much pressure Poor lubricability Shanghai Jiao Tong University Low hardness Compressibility of ingredients Adhesive Moisture Lubricants Press Shanghai Jiao Tong University Picking and sticking Picking粘冲 describes the surface material from a tablet that is sticking to and being removed from the tablet’s surface by a punch. Sticking粘壁 refers to tablet material adhering to the die wall. 上 冲 c 粘冲； d 粘壁 Due to excessive moisture, hygroscopic or low melting point substances in the mixture, not enough lubricant, rough surface of punch and etc. Shanghai Jiao Tong University Mottling Mottling is an unequal distribution of color on a tablet, with light or dark areas standing out in an otherwise uniform surface. Reasons • Different colors of drugs and excipients • Colors of degradation products • Migration of dyes to the surface of granules during drying • The use of colorants in direct compression formulations can lead to mottling if the dye is not well dispersed or its particle is too large. Shanghai Jiao Tong University Weight variation • Poor flowability • Granule size and size distribution • Granule amount in feeder • Poor mixing Hardness variation • Hardness variation is a problem that has the same causes as weight variation Shanghai Jiao Tong University Failure of disintegration • Compress power • Poor porosity • Poor wettablility • Strong binder • Unsuitable disintegrants • Hygroscopic effect