SOLID DOSAGE FORMS:

CAPSULE
Capsule
! Capsules are solid preparations in which drug
substance(s) and/or excipients are enclosed in
either a soft or hard soluble shell.  The shell is
normally made from gelatin or other suitable
polymeric material and results in a simple,
tasteless, odorless, elegant, easy-to-swallow
dosage form without need for a secondary
coating step.
Types of capsules

! Hard gelatin capsules also known as two-piece capsules or dry-filled
capsules are solid dosage forms in which one or more drug
substances and/or excipients are enclosed within a small shell. The
shell consists of two parts: the body designed to contain the drug
and the diluent, and the cap that is approximately half as long as
the body.
Types of capsules
! Soft gelatin capsules Soft gelatin capsules also referred to as soft shell
capsule, soft elastic capsule, or soft gel  are single-unit solid dosage
form, consisting of a liquid, semi-solid, dry powders, or even
preformed tablets fill enveloped by a one-piece hermetically sealed
elastic outer gel.
Sizes of Capsules
 Difference between Hard Gelatin Capsules and Soft Gelatin
Capsules

! Hard gelatin capsules have two separate parts namely a body and a cap whereas
soft gelatin capsules are hermetically sealed one-piece capsules and cannot be
separated.
! Hard shell capsules are manufactured in a two-step process; the shells are
manufactured by one type of machine and the filling achieved by a different
machine whereas the manufacture, feeding and sealing of soft gelatin capsules are
achieved by only one machine.
! Hard gelatin capsules usually contain dry powders, slightly compressed plugs,
granules, or tablets. whereas soft gelatin capsules typically contain liquids and
semisolids.
! Hard gelatin capsules are cylindrical in shape while soft gelatin capsules are
available in round, oval and tubular shapes.
! The ratio of plasticizer to gelatin is less in a hard gelatin capsule (0.4 : 1.0) than in soft
gelatin capsule (0.8 : 1.0).
 Preparation of Capsules
Methods of Preparation of Hard Gelatin capsules
 Dipping
Spinning
Drying
Stripping
Trimming
Joining
Methods of preparation: Using a filling
machine
Methods of preparation: Manual Filling
Methods of preparation: Manual Filling
 Preparation of Capsules
Methods of Preparation of Soft Gelatin
Capsules
 Droplet Method
Pressing Method/Rotary Die Process
Reciprocating Die
Accogel Machine
Methods of Preparation of Soft Gelatin
capsules
Methods of Preparation of Soft Gelatin capsules: Droplet
Method
Methods of Preparation of Soft Gelatin capsules
Methods of Preparation of Soft Gelatin capsules
Methods of Preparation of Soft Gelatin capsules: Pressing
Method
Important QC tests for Hard Gelatin
Capsule Dosage Form:
!Weight Variation Test
!Content Uniformity Test
!Dissolution Test
!Disintegration Test
1. Content of active ingredient/ Potency:
Objective: The test is done to verify that the average amount of active ingredient
per capsule is in accordance with the label claim of the product.
Specifications: A range is allowed comprising lower and upper limits. A
generalized allowance is taken as ± 5% to ± 10% of the label claim although it
varies from product to product. The limits are also different in different
pharmacopoeias.
Number of units required: usually 20 capsules.
Method: average content of the drug is determined by adopting suitable
physical, chemical or microbiological analysis.
Potency calculation: (calculated amount/ label claim)× 100
Examples: Dosage Forms, BP Limits, USP Limits, Amoxicillin Capsules %,
Cefradine Capsules %, Chloramphenicol Capsules %
2. Weight Variation Test Method: Weigh an intact capsule
Objective: The test is done to verify that the average amount of active ingredient per capsule
is in accordance with the label claim of the product.
•Open the capsules and remove the content.
•Weigh the shell.
•Determine the weight of filled material (difference between the weightings)
•This is done for all 20 capsules.
•Determine the average fill weight.

Specifications (BP):
In order to pass the test, not more than 2 of the individual weights deviate from the average
weight by the following percentage and none deviates from by more than twice that
percentage.
The weight variation test is not only a finished product QC test but also effectively
utilized as an in-process QC test to detect filling problems from the very beginning of
production.
3. Content Uniformity Test
Objective: This test is done to ensure correct dose administration and is a
direct approach for controlling the amount of active ingredient per capsule.
Number of units required: 10 capsules in the first stage. Additional 20
capsules may be required if first stage fails.

Method: The active ingredient of 10 capsules is determined individually by

suitable analytical method.
Specifications(BP): The preparation complies with the test if not more than
one individual content is outside the limits of 85% to 115 % of the average
content and none is outside the limits of 75% to 125% of the average
content.
4. Disintegration Test Disintegration Test:
Objective: to determine whether the capsules disintegrate and pass through screen
of specified pore size within the prescribed time when placed in a liquid medium
under experimental condition.
• Important: QC parameter
• Apparatus: Disintegration Test Apparatus
• Screen pore size: 2.0±0.2 mm(10 mesh size)
• Movement :29-32 cycles/min
• Temperature of the medium: 37±2 degree C
• Medium: water, 0.1 M HCl, Artificial gastric juice
Disintegration Test Number of units required: 6
Specifications (BP): For normal capsule D.T. is within 30 minutes.
For other types of capsules, such as enteric coated capsules and sustained release
capsules, the DT specifications are different for obvious reasons.
5. Dissolution Test:
Objective: A drug must be in solution in relevant body fluid before absorption
can take place. It ensures that a minimum amount of drug will be released
and dissolved from the dosage form within a specified time for subsequent
absorption.
-Indicator of bioavailability.
-Apparatus: USP dissolution apparatus type 1(basket) and type 2 (paddle).

Dissolution medium: water, 0.1M HCl, Phosphate buffer (6.5 or 7.2)

Temperature of the medium: 37 degreeC
Rotation speed: 50 rpm, 75 rpm and 100 rpm
Number of units required: 6 (stage 1), 6 (stage 2), 12 (stage 3)
Dissolution Test Specifications (USP):
For stage 1, each unit ≥ Q+5% wherein:
Q = drug dissolved within a given time period,
expressed as percentage of the label content.
For many products, Q=75% at time 45 minutes.
Various other specifications have also been
stated in the pharmacopoeias. For stage 2 and
stage 3 different acceptance criteria are
mentioned.
References:
The Theory and Practice of Industrial Pharmacy by
Leon Lachman and Herbert A. Lieberman

Solid-Dosage Forms: Capsules

Bacolores, Shenaiah
Cabanos, Jordane
De Laza, Nicka
Orale, Beverly
Uduba, Elizabeth
Drug Delivery Systems - 2Y2-IRR1
Ms. Maritess Abad