PHARMACEUTICAL ASPECTS,
PHYSICAL STABILITY AND PACKING
1
• v•
=z-z
.
2
CONTENTS
• INTRODUCTION
• ADVANTAGES
• DISADVANTAGES
• PACKAGING OF CAPSULES
• PHARMACEUTICAL ASPECTS 3
DEFINITION
• Capsule is the most versatile of all dosage forms. Capsules are
solid dosage forms in which one or more medicinal and inert
ingrédients are enclosed in a Small Shell or containe r usually
made of gelatin.
4
ADVANTAGES OF CAPSULES
• Capsules mask the taste and odour of unpleasant drugs and can be easily
administered.
• They are slippery when moist and hence easy to swallow with a draught of
water.
• The shells are physiologically inert and easily and quickly digested in the
gastrointestinal tract.
6
SOME EXAMPLES OF OFFICAL CAPSULES
7
QUALITY CONTROL OF CAPSULES
8
QUALITY CONTROL OF CAPSULES
9
Quality control tests are divided into
10
PHYSICAL TESTS OF CAPSULES
11
Finally physical control processing and packing may be
accomplished by the following in line continuous operations
1.A capsule diameter sorter allows to pass to the next unit of any
capsule with in + or _ 0.020 inch of theoretical diameter .
12
DISINTEGRATION TEST-
14
15
WEIGHT VARIATION
FOR HARD CAPSULES
weigh 20 capsules individually and determine the avg weight
Remove the net content of each capsule with the aid of a small brush
Then determine the difference b/w each individual net content and
avg net content
LIMITS-
• Not more then 2 of the differences are greater then 10% of the avg
net content
17
If more then 2 ,but not more then 6 capsules deviate from the avg
b/w 10-25%
LIMITS-
• NMT 6 of 60 capsules does the difference exceed 10% of the avg
net content
• No case does the difference exceed 25%
18
CHEMICAL TESTS OF CAPSULES
20
DISSOLUTION TEST-
• Six capsules are tested and are accepted if each of them is not less
than monograph specified i.e., p +5%
• If the capsule still fails the test the additional 12 capsules are
tested and are accepted if the avg. of 24 is greater than to p, if not
more than two less than p-15% and none of them is less than p-
25%
22
T
23
DISSOLUTION PROFILE
Lart.
------
4 mins.
24
25
FACTORS AFFECTING DRUG DISSOLUTION
FROM HARD GELATIN CAPSULES
26
• Normally, shell ruptures and dissolves within
about 4 minutes.
27
CONTENT UNIFORMITY
10 capsules are taken and subjected to assay
And 10th capsule are beyond ±15% range then 20 capsules are
assayed
28
MOISTURE PERMEATION TEST
The degree and rate of moisture penetration is determined by
packaging the dosage unit together with a colour revealing
desiccant pellet
PROCEDURE-
gelatin is weighed into water to typically create a 6.67% sol n in
standard bloom bottles
The mix is then stirred and keep it for 3 hours at room temp
30
Allow the bloom jars to cool for 15 min at room temp
:w ..
31
when conducting gelatin bloom test,
the bloom jar is centred with the probe just above the sample
surface
32
CAPSULES PHYSICAL STABILITY
• Unprotected soft gelatin capsules rapidly reach equilibrium with
the atmospheric conditions under which they are stored.
33
• The physical stability of soft gelatin capsules is associated
primarily with the pick up or loss of water by the capsule shell .
35
chemists conducting the physical stability test in their own lab
should keep two important points in mind
36
Caps stabil
ule ity
• Stability to 30 % to 24 °
zo RH at 21 C
2 Effe of an Humi o Caps he
Tnb : ct Temperatu d dity n ule - ll
Tempersture
le re
Humiditv Effect on Capsule
21-24°(' 60~o \hell
Cap ule beceme
sefler.tackier and
Greater t~nn 45° bloated
Greater than 24°(' o ~lore rapid and
pronounced
effect -
unprotected 37
cap ules 1nelt
PACKAGING OF CAPSULES
38
PACKAGING AND STORAGE OF CAPSULES
40
• Plastic bottle with screw cap
(most popular package in USA)
• Clam shell blister (one piece plastic that folds over and locks
itself; no heating required)
41
• Blister pack (heat sealed blister on a cardboard)
• Plastic pouch zip locked (for sale via retail stores or route trucks
must be packed in outer case for shipping )
42
43
PHARMACEUTICAL ASPECTS
44
PHARMACEUTICAL ASPECTS –
45
3.Dissolution and disintegration-
Nelson ,in his review, points out that the availability of a drug
for absorption of solid dosage forms decreases as below:
SOLUTION>SUSPENSION>POWDER FILLED
CAPSULE>COMPRESSED TABLET >COATED TABLET
absorption profile
48
• 5.The pharmaceutical chemist should certainly consider the
bioavailability potential of soft gelatin formulations. The
biopharmaceutical characteristics of such formulations can be
altered easily than solid dosage forms .
Through the selection and use of liquids and combinations of
liquids that range from water immiscible through emulsifiable to
completely water miscible and by altering the type and quantity of
thickening or suspending agents .
49
When compared the ulcerogenic potential of soft gelatin capsule
of dexamethasone with tablet the capsule had reduced ulcerogenic
potential.
50
• REFERENCE –
Leon Lachman , Herbert A. Lieberman ,
The theory and practice of industrial pharmacy,
CBS publishers &distributors ,special Indian edition 2009.
WWW.GOOGLE.COM
51
52
53