ISSN   0974-3618  (Print)                  www.rjptonline.org

            0974-360X (Online)

 

 

RESEARCH ARTICLE

 

Investigation to find out the Root Cause for Presence of Broken Tablet in the Marketed Blister Pack

 

Vamshi Krishna T, Lalit Kumar, M. Sreenivasa Reddy, Rajat Rao, M. Ankineedu,

Girish Pai K*

Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka State, India-576104

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

 

ABSTRACT:

The main objective of this study was to find out the root cause for broken tablet and black spots on tablets in primary pack of the marketed product containing Diclofenac sodium 50 mg and Paracetamol500 mg. In this study, we took tablets of same batch in which broken tablet (Batch A) was found and another batch (Batch B) from the same company was procured (for investigation) and they were evaluated for parameters like appearance, weight variation, hardness and friability. The results of (Batch A) and (Batch B) showed that weight variation, Friability was within limit according to Indian pharmacopeia, Hardness of both batcheswas found to be 9 kg.Based on the investigation, it was concluded that there was no formulation defect in the Batch-A tablets.Breakage of the tablet at the edge must be due to somephysical damage or some other reason. This wasconcluded from results of friability, weight variation andhardness tests. Appearance of black color spots on thetablet surface was not due to formulation problem. Itmay be due to instrumental problems like excessive useof oil- Based Lubricants etc. Finally to sum up, it isrecommended to carry out 100% tablet inspection beforeprimary packing activity which shall avoid defectivetablets getting packed into blister.  Broken tablet found in the (Batch A) was due to some physical damage or any other reason during shipping and storage. Black colour spots found on the surface of the tablet may be due excessive usage of oil lubricants, more amount fines in the powder blend.

 

 

 

INTRODUCTION:

The main objective of this study was to investigate and find out the root cause for presence broken tablet with in marketed blister pack [1, 2 and 3]. The product is an uncoated tablet and a fixed dose combination product containing 500 mg of paracetamoland 50 mg of diclofenac sodium [4]. The research started after observing a broken tablet with in blister pocket [5]. This complaint was reported by one of the authors of this article. The product was purchased from a famous medical shop in Udupi in Karnataka state, using the doctor’s prescription. Pictures of the product were taken and shown in Figure 1.

 

 

 

 

Received on 01.06.2015             Modified on 20.06.2015

Accepted on 23.06.2015           © RJPT All right reserved

Research J. Pharm. and Tech. 8(6): June, 2015; Page 707-709

DOI: 10.5958/0974-360X.2015.00112.2

 

The probable cause may be due to one of the following reasons.

·         Improper inspection of tablets after compression stage and primary packing stages

·         No inspection carried out

·         Formulation problems: Inadequate concentration of binder, over drying of granules etc

·         Manufacturing defects: Improper setting of compression machine

·         Improper handling of uncoated tablets

 

 

 

 

 

 

 

 

 

 

 

Fig 1: Pictures of the product containing broken tablet

 

MATERIALS AND METHODS:

MATERIALS:

Roche Friabilator, Monsanto hardness tester.

 

METHODS:

To find out the root cause, we performed following activities:

·         Purchased same batch number product (coded as batch-A) from the same medical shop in Udupi.

·         Purchased different batch number product (coded as batch-B) from the same medical shop in Udupi to cross check any observations related to formulation defects.

·         Performed few important quality control tests like weight variation, friability and hardness for both the batches.

 

Weight Variation Test:

20 tablets of each batch were individually weighed and average weight of 20 tablets of each batch was calculated. Then each tablet was compared with average weight of that batch and the percentage deviation from the average tablet weight of that batch was          calculated [6].

 

Friability:

Tablets weight equivalent to 6.5 g of each batch were taken separately and subjected to friability test for 4 minutes at 25 rpm. After that tablets were reweighed and percentage friability was calculated [6].

Hardness:

3 tablets of each batch were evaluated with respect to their hardness using Monsanto hardness tester and the average hardness value of each batch was reported [7].

 

RESULTS:

Friability:

Friability values for both the batches were well within the limits as per IP 2007.

 

For batch A:

Initial weight of tablets = 6.623g

Final weight of tablets = 6.598g

 

                        Initial weight- final weight

% Friability=  ---------------------------------- X 100

                            Initial weight

                          6.623-6.598

                   = ----------------------------- X100

                             6.623

                  = 0.377%

 

For batch B:

Initial weight of tablets = 6.657g

Final weight of tablets = 6.639g

 

                         Initial weight- final weight

% Friability=  ---------------------------------- X 100

                            Initial weight

                          6.657-6.539

                   = ----------------------------- X100

                             6.657

               

= 0.377%

 

= 0.271%

 

Weight Variation:

All the tablets of both the batches were within the limits as per IP 2007 with respect to weight variation test. The results are shown in the Table 3. Percentage deviation was calculated using the following equation.

 

 

                   Individual weight- average weight

% Deviation =  ----------------------------------------- X 100

                            average weight                        

 

 

Hardness:

The average hardness for both the batches of tablets was found to be 9kg/cm2. The results are mentioned in the Table 4.

 

 

 

 

 

 

Table 3: Weight variation test :

 

Batch A

Batch B

S. No.

Initial weight(mg)

% deviation

Initial weight(mg)

% deviation

1

610

0.60

603

-0.07

2

607

0.11

596

-1.23

3

602

-0.72

602

-0.24

4

610

0.60

605

0.26

5

603

-0.55

599

-0.74

6

601

-0.88

609

0.92

7

605

-0.22

600

-0.57

8

609

0.44

596

-1.23

9

605

-0.22

607

0.59

10

613

1.10

600

-0.57

11

609

0.44

609

0.92

12

602

-0.72

614

1.75

13

611

0.77

606

0.42

14

608

0.27

601

-0.41

15

600

-1.05

598

-0.90

16

611

0.77

601

-0.41

17

604

-0.39

611

1.25

18

609

0.44

600

-0.57

19

607

0.11

604

0.09

20

601

-0.88

608

0.75

 

 

Table 4: Hardness of both batches

S.No.

Batch A(kg/cm2)

Batch B(kg/cm2)

1

9

9

2

9

9

3

9

9

Average

9

9

 

DISCUSSIONS:

·         Both Batch A and Batch B passed the weight variation test as per Indian Pharmacopeia 2010.

·         Friability of Batch A was found to be 0.377% and Friability of Batch B was found to be 0.271%.

·         Hardness of both batches of the tablet was found to be 9 kg.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONCLUSION:

There was no formulation defect in the Batch-A tablets. Breakage of the tablet at the edge must be due to some physical damage or some other reason. This was concluded from results of friability, weight variation and hardness tests. Appearance of black color spots on the tablet surface was not due to formulation problem. It may be due to instrumental problems like excessive use of oil- Based Lubricants etc. Finally to sum up, it is recommended to carry out 100% tablet inspection before primary packing activity which shall avoid defective tablets getting packed into blister.

 

REFERENCES

1.        Vamshi Krishna T., Girish Pai K., Sreenivasa Reddy M.,Kishan Y.S.S., Aditya, V., Bhanuprakash G., Vishnu Datta M., 2012.Study on the Effectiveness of Various Types of Primary Packaging on the Physical Parameters of Telmisartan Uncoated Tablets. Research J. Pharm. and Tech., 5 (7), 962-967.

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

3.        Girish Pai K., Vamshi Krishna T., LalitKumar, Sreenivasa Reddy M., Shreenidhi G., Praneeth Reddy A., 2013.Comparative evaluation of the physical parameters of uncoated tablets of Amlodipine Besylate with different types of primary packaging materials. Asian Journal of Pharmaceutical Research, 3 (1), 03-05.

4.        Vamshi Krishna T., Girish Pai K., Hemanth G., Damodaram A., Sreenivasa Reddy M., 2013.Study of Various Physical Parameters of Marketed Products of Paracetamol. Research Journal of Pharmaceutical Dosage Forms and Technology, 5 (4), 227-231.

5.        Vamshi Krishna T., Lalit Kumar, Sreenivasa Reddy M., Muddukrishna B.S., Girish Pai K., 2013. Market complaints in Pharmaceuticals: A Brief review on its handling, investigation and reporting. Research J. Pharm. and Tech., 6(11), 1314-1316.

6.        Lachman L., Lieberman H.A., Kanig L.J., 2009. The Theory and Practice of Industrial Pharmacy. Special Indian ed., CBS Publishers and Distributers Pvt. Ltd., New Delhi.

7.        Pharmaceutical Methods, General Chapters, 2007, Volume 1, 5th ed., Indian Pharmacopoeia, Ministry of H and F, Govt. of India.