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

*Corresponding Author E-mail: girish.pai@manipal.edu

 

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 alualu 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.

 

REFERENCES:

1.       Vamshi Krishna T., Girish Pai K., M. Sreenivasa Reddy, Y. S. S. Kishan, V. Aditya, G. Bhanuprakash, M. Vishnu Datta. Study on the effectiveness of various types of primary packaging on the physical parameters of telmisartan uncoated tablets. 2012. Research J. Pharm. and Tech. 5(7): 962-967

2.       Girish Pai K., Vamshi Krishna T., M. Sreenivasa Reddy, Y. S. S. Kishan, V. Aditya, G. Bhanuprakash, M. Vishnu Datta. Physical evaluation of the uncoated tablets of Glimepiride with different types of primary packaging. 2012. Research J. Pharm. and Tech. 5 (3):404-407

3.       http://en.wikipedia.org/wiki/Blister_pack

4.       http://www.supermakfoils.com/html/alu_alu_blister. htm

5.       http://www.sgmindia.biz/alu_alu_blister.html

6.       Pharmaceutical Methods, General Chapters, Indian Pharmacopoeia, 2007, 5th edition, Vol-1, pp. 177-183.

7.       Gilbert SB. and Neil RA. Tablets. In the Theory and Practice of Industrial Pharmacy. Edited by Leon Lachman, Herbert AL and Joseph LK. New York. 1987: 3rd edition: pp.293-373.

 

 

 

Received on 20.12.2012       Accepted on 02.02.2013     

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Asian J. Pharm. Res. 3(1): Jan.-Mar. 2013; Page 03-05