Preparation # 5

Aspirin Capsules

Compiled by: Ivy Rose C. Orozco,RPh

PHARMACEUTICS1L – Pharmaceutical Dosage Forms, Drug Delivery Systems
and Medical Devices
 Aspirin Capsules

● Category: Non-steroidal Anti-inflammatory

drug
● Synonym: Acetyl salicylic acid
● Final Product: transparent capsule containing
finely divided powders of acetyl salicylic acid
● Uses: to reduce pain, fever, and/or
inflammation, used as antithrombotic.
● Label: White label for internal use, taken orally
● Container: blister pack, foil or may be
packaged in amber bottle, protected from
light, and tightly sealed container
Capsules
• Capsules are solid dosage forms in
which medicinal agents and/or inert
substances are enclosed in a small
shell of gelatin.
• Gelatin capsule shells may be hard (2-
piece capsules) or soft (One-piece
capsule), depending on the
composition.
• Shells – body and cap
 Capsules
• Hard-gelatin capsules – clinical trials,
extemporaneous compounding
• Empty capsule – gelatin, sugar and water
(clear, colorless, tasteless)
• Titanium dioxide – opaquant
• Gelatin – obtained by partial hydrolysis of
collagen obtained from the skin, white
connective tissues, and bones of animals;
soluble in water and gastric fluid, digested by
proteolytic enzymes
• Hard gelatin cap – 13-16% moisture
Capsules
• Capsule parts:
• Capsule body and short cap - locked
Preparation of Filled Hard Gelatin Capsule
1. Developing and preparing the formulation and
selecting the capsule size
2. Filling the capsule shells
3. Capsule sealing (optional)
4. Cleaning and polishing the capsule
Soft Gelatin Capsule
• Made of gelatin, glycerin, sorbitol
• Contain more moisture, w/ preservative
(methylparaben, propylparaben)
• Oblong, round, oval shaped
• Single-colored,two-toned with or w/o
imprinting
• Hermetically seal liquids, suspensions and
pasty materials
• Pharmaceutically elegant and easier to
swallow
Preparation of Soft Gelatin Capsule
• Plate process – warm sheet of plain colored
gelatin plate at the bottom of the mold, pour
the medication containing liquid, second sheet
of gelatin plate is placed on top
• Pressure is applied to seal
Uses of Soft Gelatin Capsule
1. For water-immiscible volatile and non-volatile
liquids
2. Water-miscible non-volatile liquids
3. Water-miscible and relatively nonvolatile
compounds
Compendial Requirements for Capsules
1. Added substances must be inert, do not
exceed the minimum amount required to
provide intended effects, do not impair
product bioavailability, do not interfere with
requisite compendial assays/tests
2. Containers must be light resistant, tight or
well-closed (combination)
3. Must pass the disintegration test
4. Must pass the dissolution test
5. Weight variation test must also be passed
Compendial Requirements for Capsules
6. Must pass the Content uniformity test
7. Content labeling
8. Stability Testing
9. Moisture permeation test
End of Discussion