Comparative
evaluation of the physical parameters of uncoated tablets of Amlodipine Besylate with
different types of primary packaging materials
Girish Pai
K.*, Vamshi Krishna T., Lalit
Kumar, M. Sreenivasa Reddy, G. Shreenidhi,
A. Praneeth Reddy
Manipal College of Pharmaceutical Sciences, Manipal
University, Manipal, Karnataka, India
ABSTRACT:
The objective of this study was to compare the physical
parameters of uncoated tablets of Amlodipine Besylate in strip, blister and alu-alu
type of primary packages under prescribed storage conditions recommended by the
manufacturer, and finally to conclude the efficient primary package. The strip,
blister and alu-alu packaging of antihypertensive
drug Amlodipine Besylate
5mg of the same formulation type (uncoated tablets) were randomly collected
from the pharmacy outlets. These tablets were subjected for various physical
parameters testing like description (appearance), hardness, weight variation,
friability and disintegration time. After performing Quality Control tests and
comparing the results obtained, it was observed that the physical stability of
the tablet has been retained very well and results were comparable in all three
types of primary packages, i.e., strip, blister and alu-alu
packaging. Based on supporting data we can conclude that if the formulation is
stable enough, packing in aluminum strip or blister type of primary packaging
shall take care of the product with respect to physical stability. Thus packing
in alu – alu can be avoided
which calls for additional product cost. This circumvents unnecessary cost
burden on the patients and consumers. However it is better to use specifically alu-alu type of package for a sensitive product since it
provides greater protection from the environmental conditions under the
prescribed storage conditions recommended by the manufacturer.
KEYWORDS: Amlodipine Besylate, Alu-alu, Blister, Strip, Primary packaging.
INTRODUCTION:
In the present study we are evaluating the effect of
different types of primary packing on the physical parameters of the uncoated
tablets of antihypertensive drug Amlodipine Besylate 5mg. The different types of primary packages
evaluated are strip, blister and alu-alu types1,2,3.
The primary component of a blister pack is a cavity or pocket made from a
formable web, usually a thermoformed plastic. This usually has a backing of
paperboard or a lidding seal of aluminum foil or
plastic like poly vinyl chloride (PVC) and polyvinylidene
chloride (PVdC). The strip packing may be of paper with
plastic laminate or aluminum foil, here the tablet is sealed in between two
layers of paper with plastic laminate or aluminum foil.
Alu-alu is the recent packing used for better protection of
tablets from environmental conditions and it consists of three layers namely
outer layer is a protective OPA (Oriented Poly Amide), in the middle is the
aluminum layer and the innermost is PVC layer3,4,5. These tablets
are subjected to evaluation of the physical parameters like appearance1,2,
hardness1,2, weight variation6, friability6
and disintegration time6.
MATERIAL AND METHODS:
Materials
For the present work uncoated tablets of the Amlodipine Besylate 5mg
formulation with different primary packing types (strip, blister and alu-alu types) were procured randomly from pharmacy
outlets.
Equipment
Weighing balance:
FB-200 model of Essae, Friabilator:
EF-1W model of Electrolab, Disintegration test
apparatus: ED-2L model of Electrolab, Hardness
tester: Monsento, Magnified lens to check the
appearance of uncoated tablets and miscellaneous items like Hand glove, butter
paper, calculator, work sheets etc.
Methods:
The tablets were checked for their physical parameters
like appearance, weight variation, hardness, disintegration time and
friability. Indian Pharmacopoeia limits were followed for weight variation,
friability & disintegration tests.
Appearance: The tablets were visually checked by using a
magnified lens & white paper background for presence of any black specs,
charred particles, chipping7, cracks or any other observation with
respect to description of uncoated tablets.
Hardness: The hardness of the tablets was checked by
using Monsanto hardness tester. The tablets are kept in between the two jaws of
hardness tester and pressure is applied by rotating the screw like base which
is connected to the lower jaw7.
Weight variation: 20 tablets are taken out from the primary
pack and their weights are recorded individually using digital balance to
determine the weight variation and test was performed as per Indian Pharmacopoeia
(IP) specifications.
Friability: The friability of tablets was checked by
taking the required number of tablets in a friabilator
and the test was performed as per IP guidelines. The percent difference between
the initial and final weights gives the friability value.
Disintegration time: The disintegration time of the tablets was
observed using a disintegration test apparatus and was performed as per IP
guidelines.
RESULTS:
Appearance:
The description or visual appearance was observed using
a magnified lens and a white colored background. The tablets in the alu-alu, blister and strip packaging showed similar
appearance in color (white), shape (round), texture (smooth) and having distinct
break line on one side. Tablets packed in strips were found to have strength
embossed on one side and tablets packed in blister were found to have company
logo embossed on one side. Deformations like chipping, discolorations, black particles
or other stain marks were not observed in the above tablets. Hence the tablets
were complying with respect to description test. The tablets of blister pack
were more elegant with pleasing appearance than the tablets packed in alu-alu and strip packs.
Hardness:
The hardness of the tablets
was checked using a hardness tester. The reading was noted down which
corresponds to pointed mark on graduations scale. The hardness was found be
high in tablets packed in alu-alu primary package
whereas tablets packed in strip and blister showed almost comparable values. The
results are detailed in figure 1 as shown below.
Figure-
1
Weight
variation: The tablets of
all the three types of primary packs have passed the test for weight variation
as all of them are well within the limit of percent deviation by ±7.5% from the
average weight as per IP guidelines. The calculated percentage deviation was in
a narrow range for tablets packed in alu-alu when
compared with tablets packed in strip and blister which showed distinct range
of deviation. The results are represented as graphical representation in Figure
2 as shown below.
Friability:
The tablets of all the
three types of primary package have passed the friability test. Friability
values were comparable for tablets packed in all three types of primary
package. No Tablets showed any kind of chipping, cracks or dust was not
generated. This confirms the intactness of tablets in all types of primary
package under study. The results are given in Figure 3.
Disintegration
test: The disintegration
time of the tablets in strip, blister and alu-alu
were 10 seconds, 35 seconds and 18 seconds respectively. The results are shown
graphically in Figure 4.
Figure
2: Weight variation data
Figure-3
Figure
4
CONCLUSION:
All physical parameters that were evaluated
like appearance, hardness, weight variation, friability and disintegration time
in all three types of primary packs complied to the requirements and official
tests like weight variation, friability & disintegration time confirmed
with respect to IP specifications.
Based on the supporting data, it can be
concluded that if strip or blister type of primary pack is effective in
protecting the physical stability of uncoated tablets, then there is no need to
pack these tablets in alu-alu form which
unnecessarily increases the burden of medicine cost on poor patients. Companies
should try to understand this basic concept and should go for alu-alu type of primary pack based on formulation
requirements and if the uncoated tablet is sensitive to extreme environmental
conditions.
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Received on 20.12.2012 Accepted on 02.02.2013
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Press All Right Reserved
Asian J. Pharm.
Res. 3(1): Jan.-Mar. 2013;
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