溶出度方法学验证-1.ppt

Dissolution testing of special dosage forms DISSOLUTION FOR DOSAGE FORMS OTHER THAN CONVENTIONAL TABLETS AND CAPSULES Oral dissolving/disintegrating Chewable tablets Chewing gums Powders, granules etc Suspensions Creams and ointments Liquid filled capsules Transdermals Suppositories Implants Stents Beyond Pharmacopeial methods. Some old ideas revisited New developments in dissolution testing Based on AAPS PharmSciTech 2003;4(1) Article 7 [] Buccal or sublingual tablets Generally flat, oval tablets intended to dissolve in the buccal pouch or beneath the tongue for absorption through the oral mucosa. Tablets intended for buccal administration are formulated to dissolve slowly (progesterone tablets) those for sublingual administration dissolve very promptly to give rapid drug effects (e.g. Nitroglycerin). Advantage: used for drugs that are destroyed by gastric juice and/or are poorly absorbed from the GI tract. Composition of simulated saliva KH2PO412 mM NaCl 40 mM CaCl21.5 mM NaOH to pH 6.2 Oral dispersible and chewable tablets For ODT conventional testing is suitable but how to put the sample in the apparatus as they often float and they dissolve immediately anyway? Also note that the EMA guidance regards these as different from other oral dosage forms because of the possibility of buccal absorption. Chewable-the same as ordinary tablets The patient may swallow rather than chew BUT these tablets do not disintegrate therefore they may give a slower release pattern in this test Higher rotation speed may be justified Powdering [chewing] the tablet first might be the best procedure [Garlic press] but there is no way of validating this reduction process Medicated chewing gums In the case of chewing gums, the intensity and frequency of shearing forces/activities (ie, chewing action) can have a large influence on drug release rate. The European Pharmacopoeia provides a description of a stainless steel 3-piston-apparatus that is required for testing of medicated che