1、Chapter 5 Capsules2007.1.281Introduction - The definition of capsulesCapsules 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 capsu
2、lesorally (whole or mixed with food or drink after opening capsules)2Introduction Advantages of capsules for oral administration1. conveniently carried2. readily identified3. easily taken4. prescribing flexibility5. Efficiently and productively manufactured6. Packaged and shipped at lower cost and w
3、ith less breakage7. More stable and have a longer shelf-life8. 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. 3Introduction - Dosage forms
4、that must be left intact Dosage forms that must be left intact include:enteric coated tabletsextended/controlled release dosage formssublingual or buccal tabletsIn instances in which a patient is unable to swallow an intact solid dosage form, an alternative product may be employed, such as chewable
5、tablet, instant dissolving tablet, oral liquid, suppository or injection. 4Types of capsulesGelatin capsule shells may be hard or soft depending on their composition.l Hard gelatin capsulesl Soft gelatin capsules5Hard gelatin capsulesThe application of hard gelatin capsulesl used to manufacture most
6、 medicated agentsl employed in clinical trialsl used in the extemporaneous compoundingThe empty capsule shells consist ofgelatin, sugar, water, colorants (various dyes), and opaquants遮光剂 (titanium dioxide).6Hard gelatin capsulesThe main quality control item of gelatin (continuned)l viscosity degrada
7、tion (粘度下降 )l moisture (水分 )l transparency (透明度 )l ash (灰分 )l pH valuel Iron: Its concentration depends on the iron content of the water used in its manufacture. 15ppm for gelatin used in soft gelatin capsules. 7Hard gelatin capsulesNormally, hard gelatin capsules contain between 13 to 16% of moistu
8、re.additional moisture is absorbed: become distorted and lose their rigid shapelose their contained moisture: become brittle and crumble when handleddesiccant (dried silica gel, clay, and activated carbon) in vitro dissolution bioavailability.The solubility property of gelatin:Insoluble in cold wate
9、r, soften through the absorption of up to ten times its weight of water; soluble in hot water and in warm gastric fluid.Gelatin, being a protein, is digested by proteolytic enzymes.8Two methods used to track the passage of capsules and tablets through the gastrointestinal tractl Gamma scintigraphy(闪
10、烁照相 )l Heidelberg capsule9The manufacture of hard gelatin capsule shellsThe shell consists of two parts, the capsule body(囊体 ) and the capsule cap(囊帽 ).The process of capsule shell production with the peg/pin method:dipping(蘸胶 ) drying stripping( 脱模 ) trimming(截割 ) joininga) The thickness of the gelatin walls must be strictly controlled.b) The caps are slightly larger in diameter than the bodies.10
