CAPSULE
Capsules are a solid dosage form in which drug substance is enclosed in a water soluble shell
or an envelope.
The shell is made up of gelatin
Available as Hard and Soft gelatin capsule
The capsules are made up of gelatin blends, small amount of certified dye, opaquants,
preservative & plasticizer.
Gelatin: It is a heterogeneous product derived from hydrolytic extraction of animal collagen.
Type A gelatin is derived from acid treated precursor that exhibits an isoeletric point pH – 9.
It is manufactured from pork skin.
Type B gelatin is derived from acid treated precursor that exhibits an isoeletric point pH –
4.7. It is manufactured from animal bones.
Advantages
1. Taste masking (drug having unpleasant odor)
2. Can be easily swallowed
3. Economical
4. Easy to handle and carry
5. Therapeutically inert (gelatin)
6. Attractive in appearance
7. Available in various size, so desired quantity of drug in a single dose
8. Micro-encapsulation provides sustained release dosage form
Disadvantages
Hygroscopic drug cannot be filled in capsule. They absorb water present in capsule
shell and hence make it brittle- break into pieces.
Types of Capsules
Hard Gelatin Capsule:
Shell prepared from gelatin; Color and titanium dioxide to make it opaque.
Consists of body and cap.
Empty capsules numbered according to capacity of capsule
Capsule number Capacity (mg)
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100
Production of hard gelatin capsule shell
Steps:
1. Dipping
2. Spinning
3. Drying
4. Stripping
5. Trimming & joining
6. Polishing
Dipping: Pairs of stainless steel pins are dipped into the dipping solution to forms caps &
bodies. The dipping solution is maintained at the temp about 50⁰C in heated jacked dipping
pan.
Spinning: The pins are rotated to distribute the gelatin over the pins uniformly & to avoid the
formation of bead at the capsule ends.
Drying: The gelatin is dried at the blast of cool air to form the hard shell. The pins are moved
through the series of air drying kilns to remove the water.
Stripping: The series of bronze jaws strip the cap & body portion of the capsules from the
pins.
Trimming & joining: The stripped cap & body portion are trimmed to the required length by
stationary knives. After trimming to the right length, the caps & body portion are joined from
the machine.
Polishing:
Pan Polishing: Acela – cota pan is used to dust & polish.
Cloth dusting: Capsules are rubbed with the cloth.
Brushing: Capsules are filled under the soft rotating brush.
Excipients used in filling of capsules
1. Diluents: Added to make bulk, if quantity of drug is small.
Examples are Lactose, Mannitol, Sorbitol and Starch.
2. Absorbent: Sometimes drugs are physically incompatible with each other (eutectic
substance or hygroscopic substance). In such case, oxides and carbonates of
magnesium & calcium and Kaolin are added to powder drug.
These inert materials act as protective sorbent.
3. Glidant: Ensure flow of powder into machine.
Examples are Talc, Magnesium stearate and Calcium stearate
4. Anti dusting compound: During filling of capsule, a lot of dust comes out of
machine, to avoid this, some anti dusting compounds, inert edible oil are added to the
formulation.
Soft Gelatin Capsules:
For administration of liquid medicaments
Made from a more flexible plasticized gelatin film than hard gelatin capsules.
Gelatin is plasticized by the addition of glycerin, sorbitol etc.
May contain preservatives to prevent growth of fungi
Enclose liquid medicament like oils, suspension, food concentrates and ophthalmic
products.
Hard gelatin Soft gelatin
Body and Cap Single unit
Cylindrical in shape Round, oval and tube like shapes
Composition of soft gelatin capsules shell
Gelatin
Plasticizer: glycerin, sorbitol, PEG.
Water or moisture content (6–10%)
Preservative : Methyl & Proply Paraben (4:1)
Colourants: FD & C, Certified lakes.
Opacifier: Titanium Dioxide (0.2 to 1.2 %)
Flavouring Agent: Ethyl Vanillin (0.1%)
Fumaric acid is added to aid solubility & to reduce aldehyde tanning of gelatine, while
formalin treatment reduces the solubility of shells.
Container: Tightly closed glass or plastic container.
To prevent the capsules from rattling a tuft of cotton is placed over and under the capsules
in the vials.
In vials containing very hygroscopic capsules a packet-containing desiccant like silica gel
or anhydrous calcium chloride may be placed to prevent the absorption of excessive
moisture by the capsules.
Now a days capsules are strip packaged which provide sanitary handling of medicines,
ease in counting and identification
Storage: Stored at a temperature not exceeding 30⁰C.
