Capsule Types, Shell Materials, and Manufacturing Quality

All flashcards

How do hard-shelled and soft-shelled capsules differ?

A hard-shelled capsule has a separate body and cap and commonly contains dry powders or pellets. A soft-shelled capsule is a single-piece shell used mainly for oils and ingredients dissolved or suspended in oil.

What is a capsule gelling agent?

It is a material in an aqueous solution that forms the capsule shell. Examples include gelatin, plant polysaccharides, carrageenans, and modified starches or cellulose.

What do plasticizers such as glycerin do in capsule shells?

They decrease shell hardness, helping adjust the capsule's physical properties.

Why may softgels be suitable for poorly soluble drugs?

The liquid fill can include ingredients that help improve drug solubility or permeability across membranes, and liquids are difficult to include in many other solid dosage forms.

What did the Accogel process make possible?

Developed in 1949, Accogel enabled powders to be accurately filled into soft gelatin capsules.

Quiz questions

1. Which sequence describes the manufacture of hard gelatin capsule shells by the dipping method?Answer: Dipping, rotation, drying, stripping, trimming, and joining.
2. Compared with loose powder filling, what is a tradeoff of using compressed powder slugs in hard capsules?Answer: They reduce weight variation but require more complex machinery.
3. For a two-piece hard capsule, where is the customary full-line reference for fill volume?Answer: At the top of the smaller-diameter body.
4. What does ullage mean in a finished hard capsule?Answer: The airspace that may remain after the cap is placed on the body.
5. Which methods can be used to monitor hard-capsule filling in real time?Answer: Near-infrared or vibrational spectroscopy, along with in-line weight checks.