15.辅料功能性指标对制剂质量的影响_默克.pptVIP

* * xx/xx/xxxx Presentation title in footer | 00 Month 0000 * xx/xx/xxxx Presentation title in footer | 00 Month 0000 * * * Starlac, Ludiflash, F-Melt Typ M Parteck? Delta M : Unique Mannitol Crystals Several polymorphic forms of Mannitol have been classified (Walter-Levy 1968) Commercially available crystalline Mannitol is in beta form Beta crystals are the most stable form Parteck? Delta M has delta (δ) crystals During wet granulation the delta-polymorph transforms into beta These beta crystals are aggregates of fine crystalline primary particles with a large surface area This conversion is connected with a considerable increase in surface area and pore volume * B. Thekedar, June 2012 Parteck? Delta M : Unique Mannitol Crystals (continued…) In customer specific formulations this conversion resulted in Enhancement of compression properties Shortening of disintegration time Shortening of in-vitro drug release Harder tablets are achieved by Decrease in elastic deformation Increase in particle binding sites * B. Thekedar, June 2012 SEMs of beta-mannitol Before wet granulation After wet granulation * B. Thekedar, June 2012 SEMs of delta-mannitol Before wet granulation After wet granulation * B. Thekedar, June 2012 Parteck? Delta M : Surface-area BET - Method * B. Thekedar, June 2012 Parteck? Delta M : Compression profile Mannitol was granulated with 15% water and dried in a fluidized bed. Granules larger than 1 mm were removed. Granules were mixed for 5 min with 1.5 % MST and compressed on a single punch press at various compression forces (Korsch EKO DMS) Punch Tablet weight 11 mm, flat, facetted 400 mg * B. Thekedar, June 2012 Parteck? Delta M : Accelerated Disintegration * B. Thekedar, June 2012 B. Thekedar, June 2012 * Directly Compressible Mg: Parteck? Mg DC Parteck? Mg DC Direct Compressible Excipient Parteck? Mg DC 100% Magnesium carbonate Without any additives Declaration of Pharmacopoeia’s PH EU