Capsules: solid dosage forms in which one or more medicinal or additives are

enclosed within small shell of gelatin.

It’s classified to: Hard: solid filling material
Soft: semisolid-liquid material

Hard gelatin capsules: 2 parts – 3 separated procedures

Soft capsules: 1 part – 1 procedure for all

Gelatin: is obtained by the partial hydrolysis of animal collagen obtained from the
skin, and bones.

Advantages:
1. Mask the unpleasant taste, aromas or appearance of drug.
2. They allow powders to be dispensed in an uncompressed form. Cause
quicker dissolution and absorption.
3. They offer the pharmacist versatility to prepare any dose desired for a
variety of administration routes.
4. They may be easier than tablets for some people to swallow
5. Can be made to alter the release rate of the drug.

Disadvantages:
1. Easily tampered.
2. Subjected to the effects of humidity and microbial contamination.
3. May be difficult for some people to swallow\because of their adherence to
the esophagus.
4. Shouldn’t be used for packaging of highly water soluble materials.

Empty hard capsule shells: made from gelatin, water, sugar (13-16%)
Production of empty hard capsule shells:
Mechanical dipping of pins or pegs of the desired shape and diameter into the
milted gelatin mixture.
1. Pigs are affixed to plates, each holds up to 500 pegs.
2. Each plate is mechanically lowered to the gelatin solution, the pegs dipped
to the desired depth and for the desired period of time to achieve the
proper length and thickness
3. The plate and pegs are slowly withdrawn from the gelatin solution and the
gelatin dried by a gently flow of temperature and humidity controlled air.
4. When dried, each capsule part is trimmed mechanically to the proper
length by rotating blades. Capsule bodies and caps are removed from the
pegs and joined together.
Capsule size: from 000 (largest capacity) to 5.

Coni-snap capsule: hard capsule in which the two halves of capsule shells
positively joined through locking grooves tightly. The rim of capsule body is not
straight\this reduces the risk of the two capsule part rims

Coni-snap supro: the upper capsule part (Cap) extends so far over the lower part
(Body) that only the rounded edge of the latter is visible.
Opening of such capsule is difficult.\ because the lower surface offers less
gripping surface to pull the two halves apart. This increase the security of the
contents and integrity of capsules.
Materials to be filled:
• Diluents: lactose, microcrystalline cellulose (MCC), starch
• Disintegrants: croscarmellose, sodium starch glycolate
• Lubricants or glidants: magnesium stearate, silicon dioxide.
• Surface-active agent: sodium lauryl sulphate\to overcome hydrophobic
effect of magnesium stearate.
• Coated pellets designed.
Filling the capsule shells: punch method:-
1. Ingredients are triturated to the same size and then mixed by geometric
dilution.
2. The powder is placed on a powder paper and smoothed with a spatula, the
powder mix is formed into a cake. Depth 1/4 to 1/3 the length of capsule
body/ to keep both hands and capsules clean.
3. The body of capsule is held vertically by the thumb and forefinger and the
open end is repeatedly pressed until it’s filled. Cap is then replaced to close
the capsule
4. Weighed using an empty capsule
5. Powder is added or removed until the correct weight.
Sealing and locking the capsule: small scale:-
• Moistening the upper part of the body with a cotton swab dipped in warm
water to soften gelatin.
• Coating inner part with warm gelatin solution immediately prior to
placement on the filled capsule body.
• Heat welding process.
• Liquid wetting agent: contact area (the stem area).
• Self-locking.
Soft gelatin capsules (soft gel): they are oval-oblong-tube capsules made from
gelatin, water, half quantity of sugar and plasticizer\ to give flexibility to the shell.

Advantages:
1. Improve patient compliance.
2. High accuracy.
3. Reduce dustiness.
4. Can make specialty shapes.
5. Improved bioavailability.
6. Enhance drug stability.
Disadvantages:
1. Not appropriate for more than one kind of fill is same capsule.
2. More expensive.
3. Some liquids can migrate.
Materials to be filled:
• Water-miscible non-volatile solvents.
• Water-immiscible solvents Volatile or non-volatile: ethers, esters, alcohol.
Preparation:
• Plate process:
o Warm plasticized gelatin sheet is placed on the bottom of the mold,
and the liquid or paste medication is poured on it.
o Second sheet of the prepared gelatin is carefully laid in place on top
of the medication, and the top plate of the mold is put in place
o The entire mold is then subjected to pressure\to form, fill and seal
the capsule simultaneously.
o Capsules are removed and washed with a harmless solvent.
• Rotary die process:
o Liquid gelatin flowing from an overhead tank into two continuous
ribbons by the rotary die machine.
o Metered fill material is injected between the ribbons precisely at the
moment that the twin dies form pockets.