15.辅料功能性指标对制剂质量的影响默克2讲义教材.ppt

The influence of functionality parameters on the quality of finished dosagesDr. Bhushan ThekedarField Marketing Manager, Asia – PCS;Overview;High Functional Excipients; Flowability Particle size distribution for the active(s) in the formulation Hygroscopicity Compressibility Drug loading capacity Friability;;;Properties of an ideal DC-excipient ...;Excipients for Direct Compression;Tablet Manufacturing by Direct Compression Process Flow Chart;;Ideal Requirements;B. Thekedar, June 2012;Mannitol Positioning ;Parteck? M : A unique product;Granular Mannitol ;Polymorph and BET-surface;Parteck? M: Compressibility;;;;;;No significant deviations in tablet weight and hardnesses were observed The good flow and compressibility of Parteck? M is ideal for high-through put production on fast rotary presses Content uniformity was in defined range (+/- 1,8 %);Parteck? M: Reducing sugars;Excipient for Wet Granulation: Parteck? Delta M;Tablet Manufacturing by Wet GranulationProcess Flow Chart;Tablet Manufacturing by Wet GranulationProcess Flow Chart;Properties of Parteck? Delta M;Parteck? Delta M : Unique Mannitol Crystals;Parteck? Delta M : Unique Mannitol Crystals (continued…);SEMs of beta-mannitol;SEMs of delta-mannitol;;Parteck? Delta M : Compression profile;Parteck? Delta M : Accelerated Disintegration;B. Thekedar, June 2012;Parteck? Mg DC;Parteck? Mg DC: Benefits for the Customer;Parteck? Mg DC: Solid Dose Applications;Parteck? Mg DC: Unique, Functional Particle;Parteck? Mg DC: BET Surface Area ;Parteck? Mg DC: Compression Profile (I);Parteck? Mg DC: Compression Profile (II);Parteck? Mg DC: Friability;Excipient for Orally Disintegrating Tablets:  Parteck? ODT;What is ODT?;Benefits of ODT Products;Parteck? ODTIntroduction – composition, production, regulatory;Parteck? ODT or mechanical mixture? ;Parteck? ODT: Direct Compression Profile;Parteck? ODT: Disintegration time;Features of Parteck? ODT;B. Thekedar, June 2012;Parteck? Lubricants Lubrican