In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:
• Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”.
• Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
Both of these classes of capsules are made from aqueous solutions of gelling agents, such as animal protein (mainly gelatin) or plant polysaccharides or their derivatives (such as carrageenans and modified forms of starch and cellulose). Other ingredients can be added to the gelling agent solution including plasticizers such as glycerin or sorbitol to decrease the capsule's hardness, coloring agents, preservatives, disintegrants, lubricants and surface treatment.
• Contents
• Definition, types of capsules, advantages and limitations, and raw materials including gelatin and other materials.
• Manufacture of gelatin.
• Hard gelatin capsule: Manufacturing of hard gelatin capsule shells, size, size selection, sealing, storage, defects of shells.
• Hard capsule fill formulation aspects: Large scale manufacturing.
• Filling of hard capsule shells, types of fills and excipients.
• Filling equipments: classification-volumetric, dosator type and tamping type (one example of each type of equipment).
• Humidity control in capsule manufacturing and filling area.
• Problems in capsule filling & remedies
• Soft gelatin capsules: Properties, nature of shell and contents, Formulation aspectsconcepts(minim/gm)
• Large scale manufacturing- Rotary Die Process
• Quality Control of empty capsule shell and hard and soft gel capsules.
• Layout of capsule section
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