基于Chapter5Capsules.pptVIP

Chapter 5 Capsules 2007.1.28 Introduction - The definition of capsules Capsules are solid dosage forms in which medicinal agents and/or inert substances are enclosed within a small shell of gelatin. Gelatin capsule shells may be hard or soft depending on their composition. Administration route of capsules orally (whole or mixed with food or drink after opening capsules) Introduction – Advantages of capsules for oral administration 1. conveniently carried 2. readily identified 3. easily taken 4. prescribing flexibility 5. Efficiently and productively manufactured 6. Packaged and shipped at lower cost and with less breakage 7. More stable and have a longer shelf-life 8. Empty hard gelatin capsules are often used in the extemporaneous compounding of prescriptions. 9. Tablets and capsules are sometimes used as the source of a medicinal agent when it is not otherwise available. Introduction - Dosage forms that must be left intact Dosage forms that must be left intact include: enteric coated tablets extended/controlled release dosage forms sublingual or buccal tablets In instances in which a patient is unable to swallow an intact solid dosage form, an alternative product may be employed, such as chewable tablet, instant dissolving tablet, oral liquid, suppository or injection. Types of capsules Gelatin capsule shells may be hard or soft depending on their composition. Hard gelatin capsules The application of hard gelatin capsules used to manufacture most medicated agents employed in clinical trials used in the extemporaneous compounding The empty capsule shells consist of gelatin, sugar, water, colorants (various dyes), and opaquants遮光剂 (titanium dioxide). Hard gelatin capsules The main quality control item of gelatin (continuned) viscosity degradation (粘度下降) moisture (水分) transparency (透明度) ash (灰分) pH value Iron: Its concentration depends on the iron content of the water used in its manufacture. ≤15ppm for ge