Machines employing various dosing principles may be employed to fill powders into hard-shell capsules however, most fully automatic machines form powder plugs by compression and eject them into empty capsule bodies. In hard starch shell filling operations, the bodies and caps are supplied separately and are fed into separate hoppers of the filling machine. In hard gelatin capsule filling operations, the body and cap of the shell are separated prior to dosing. Starch capsules are sealed by the application of a hydroalcoholic solution to the recessed section of the cap immediately prior to its being placed onto the body. Since the two pieces do not telescope or interlock positively, they are sealed together at the time of filling to prevent their separation. Hard-shell capsules made from starch consist of two, fitted cap and body pieces. Factory-filled hard gelatin capsules may be completely sealed by banding, a process in which one or more layers of gelatin are applied over the seam of the cap and body, or by a liquid fusion process wherein the filled capsules are wetted with a hydroalcoholic solution that penetrates into the space where the cap overlaps the body, and then dried. Positive closure also may be affected by spot fusion (welding) of the cap and body pieces together through direct thermal means or by application of ultrasonic energy. Generally, there are unique grooves or indentations molded into the cap and body portions to provide a positive closure when fully engaged, which helps prevent the accidental separation of the filled capsules during shipping and handling. Hard gelatin capsules consist of two, telescoping cap and body pieces. Size 0 hard gelatin capsules having an elongated body (known as size OE) also are available, which provide greater fill capacity without an increase in diameter. 00 generally is the largest size acceptable to patients. 000, which is the largest, except for veterinary sizes. Capsules are solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or shell. The shells are usually formed from gelatin however, they also may be made from starch or other suitable substances.
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