圈生一 Dissolution Apparatuses 国生 Dissolution test Chinese pharmacopoeia specifies that three Medium selection apparatuses could be used for determining Sink conditions:the capacity for the selected dissolution rate medium to solubilize the dose is at least three ·1-basket 一学 times the amount necessary. ·2-paddle An aqueous medium,typical pH range for ·3-small cup dissolution testing from pH I to pH 7.5,is recommended. .For poorly soluble drugs,the addition of surfactant may be required to increase the solubility. 国丛生 国生 ④Weight variation Drug content uniformity The weight of tablet is routinely measured to help ensure that a tablet contains a proper amount of drug. For low-dose drugs,even though tablets weight variation looks acceptable,it Average weight (g) Variation(%) could mask a wide variation in content. <0.30 ±7.5 So it is necessary for the tablets ≥0.30 ±5.0 containing such a drug to determine content uniformity 国生一 国秋生 ©Tablets coating Requirements of tablet core Protect the medicinal agent ·Mask the taste ·Smooth surface Separate reactive substances ·Physical shape Provide esthetics or distinction ·Mechanical strength Provide special release characteristics 22 Shanghai Jiao Tong University Dissolution Apparatuses Chinese pharmacopoeia specifies that three apparatuses could be used for determining dissolution rates. • 1 - basket • 2 - paddle • 3 - small cup Shanghai Jiao Tong University Dissolution test Medium selection • Sink conditions : the capacity for the selected medium to solubilize the dose is at least three times the amount necessary. • An aqueous medium, typical pH range for dissolution testing from pH 1 to pH 7.5, is recommended. • For poorly soluble drugs, the addition of surfactant may be required to increase the solubility. 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. Average weight(g) Variation(%) < 0.30 ±7.5 ≥ 0.30 ±5.0 Shanghai Jiao Tong University Drug content uniformity • 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 Tablets coating • Protect the medicinal agent • Mask the taste • Separate reactive substances • Provide esthetics or distinction • Provide special release characteristics Shanghai Jiao Tong University Requirements of tablet core • Smooth surface • Physical shape • Mechanical strength