Formulation and In-vitro Evaluation of Chewable Tablets of Montelukast Sodium

Laxman Devkota, Bhupendra Kumar Poudel*, Junu Khatri Silwal

Institute of Medicine (IOM), Tribhuvan University, Nepal.

Available online: 30th September, 2015


The objective of the present study is to develop chewable tablets containing different pharmaceutical compositions with simple manufacturing procedures using different excipients. Mannitols, L-HPC 11, Aspartame, Crospovidone, Crospovidone, Aerosil, and Magnesium Stearate are used as excipients for effective formulation of anti-asthmatic drug Montelukast. Montelukast is a selective, orally acting leukotriene receptor antagonist that is used for the treatment of asthma and seasonal allergic rhinitis. Montelukast chewable tablets were prepared by Direct Compression methods using suitable excipients. The chewable tablets were better presented using artificial sweetener Aspartame as flavouring agent. A total of forteen formulations were prepared and the granules were evaluated for pre-compression parameters. The formulated tablets were evaluated for post-compression parameters .The results showed that all the physical parameters were within the acceptable limits. The in vitro release study of all the formulations showed good release. The study concludes that aforementioned excipients can be used to design chewable montelukast sodium tablets.

Key Words: Chewable Tablets, Mannitol, Crospovidone, Aerosil, Magnesium Stearate.

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Today in the world of pharmacy around 90% of the tablets manufactured are ingested orally8. Administration of drugs through oral route is the most common and the easiest way to administer a drug. However, pediatric, geriatric and bedridden patient shows inconvenience swallowing conventional tablets or capsules due to difficulties in swallowing with lesser amounts of water with the medication, unable to tolerate the taste of many drugs when formulated as liquid dosage forms, resulting in poor patient compliance. The rationalized approach in case of medication leads to the development of chewable tablets. These are formulated and manufactured so that they may be chewed in the mouth producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter a unpleasant taste. Chewable tablets are the tablets which are required to be broken and chewed in between the teeth before ingestion. These tablets are given to the children who have difficulty in swallowing and to the adults who dislike swallowing. Successfully tablet formulation development involves the careful selection of ingredients in order to manufacture a robust solid dosage form. Choosing the appropriate excipients to perform a specific function in a tablet formulation, such as disintegration or lubrication can be critical to achieving acceptable manufacturing performance. Sweeteners, both naturally occurring and synthetic, are one type of functional excipients commonly used in chewable tablet formulations to mask unpleasant tastes and facilitate pediatric dosing1. Ideally chewable formulations should have smooth texture upon disintegration, pleasant taste and no bitter or unpleasant after taste. Upon chewing, they are broken down in the mouth and release their ingredients in the process and therefore, do not have much lag time as required for the disintegration of tablets before absorption from stomach2. Montelukast is an oral leukotriene receptor antagonist that is used for the treatment of asthma and seasonal allergic rhinitis. Leukotrienes are a group of naturally occurring chemicals in the body that promote inflammation in asthma and seasonal allergic rhinitis. It is used for the treatment of asthma, seasonal allergic rhinitis, and prevention of exercise induced bronchospasm and begins working after 3 to 14 days of therapy. It should not be used for the treatment of an acute asthmatic attack. The recommended dose of montelukast in adults is 10 mg daily for treating asthma and allergic rhinitis and 10 mg two hours before exercising for prevention of exercise induced bronchospasm. Montelukast should be taken in the evening with or without food when used for asthma or allergic rhinitis. The 4 and 5 mg tablets are used in children6. Children find it difficult to swallow the normal tablets of Montelukast. So in order to avoid this problem, chewable tablets are most preferable. Hence it was decided to formulate montelukast chewable tablet to improve the compliance in children. Additionally, chewable tablets facilitate more rapid release and hence more rapid absorption of active ingredients and provide quick onset of action3.


Montelukast sodium API and standard were obtained as a gift sample from Lomus Pharmaceutical Pvt. Ltd. All other reagents and chemicals were of analytical grade obtained from the university laboratory. Chewable tablets containing 10mg of Montelukast were prepared with a total tablet weight of 150 mg by Direct Compression Method. Exactly Weighed quantities of Mannitol (intragranular), Montelukast, L-HPC 11 and aspartame were weighed and were pass through #30 mesh. Diluents were weighed according to ratio and sifted through #30mesh and added to the above and mixed for 5 m in a poly bag. Shift the dried granules through #30 mesh along with the remaining quantity of Mannitol (extra granular) Superdisintegrant crospovidone weighed was also added. The final blend was mixed thoroughly for 2-3 minutes in polybag; tablets were compressed in 7 mm round flat punches. The formulation is:

Evaluation of Tablets4

The tablets were evaluated for their physicochemical parameters such as weight variation, thickness, friability, drug content, and in-vitro dissolution.

Weight Variation

For the determination of weight variation of each batch, tablets were randomly sampled and individual weight of 20 tablets was taken in analytical balance. Mean ± standard deviation (SD) was calculated.


From randomly sampled tablets, thickness of 10 tablets was measured individually using digital vernier caliper. Then mean ± SD was calculated


Hardness of 10 tablets was measured individually using pre-calibrated digital hardness tester. Then mean ± SD was calculated.


Twenty tablets were weighed in a balance having readability of 1 mg. These tablets were transformed into a friabilator set 100 revolutions. After the completion of revolution dust was removed completely, weighted again in the same balance and percentage loss was calculated.

Preparation of Calibration Curves

Various dilute solution of Montelukast sodium concentration ranging in ppm was prepared in water. The response of individual solution was measured at the maximum absorbance wavelength in UV Visible spectrophotometer. Calibration curve were prepared by plotting the absorbance versus concentration of the montelukast sodium.

Determination of Drug Content5

Drug content in all formulations was estimated by U.V Spectrophotometric method. A tablet from each batch was taken into 0.5% SLS containing in 100ml Volumetric Flask. Finally the volume was made upto 100ml with 0.5% SLS. It was filtered through whatman filter paper no: 41. First10ml was discarded. The clear filtrate was collected and diluted suitably with 0.5% SLS and measured at 350nm.

In-Vitro dissolution study5

Dissolution test has been performed by using dissolution apparatus USP Type II with a paddle. The dissolution fluid was 900ml of distilled water with 0.5% SLS and a speed of 50 rpm and a temperature of 37±0.5˚C. The samples of dissolution medium (5ml) were withdrawn through a filter of 0.45μm at different time intervals, suitably diluted and assayed for Montelukast by measuring absorbents at 350nm. Samples withdrawn were analyzed for the percentage of drug released.


Calibration curve

Formulation Development

Total of 14 formulations were prepared varying MCC PH-101, Mannitol and CCS.

Study of post compression parameters 

The study of post compression parameters was done by studying hardness, weight variation, thickness, friability, wetting time, dissolution and content uniformity as:


It can be concluded that montelukast sodium chewable tablets with aforementioned excipients can be prepared for asthmatic patients. 


  1. Deepak Prashar, Sanjay Saklani. Formulation and Eavaluation of Anthelmintix Chewable Tablets, Internationale Pharmaceutica Sciencia, 2(1), 2012, 13-16.
  2. Biradar, Formulation and Evaluation of chewable tablets, Int J Pharmacy and Pharm Sci, 2, 2006, 461 – 464.
  3. Jagdale, Formulation and Evaluation of chewable tablets of Levamisole, Int J Res Pharm Sci, 1, 2010, 282-289.
  4. Lachman L., Lieberman H. A., Kanig J. The Theory and Practice of Industrial Pharmacy, 3rd edition. Bombay: Varghese publishing house; 2007.pp-296-300.
  5. The Indian Pharmacopoeia, Ministry of Health and Family welfare, Govt of India, Controller of Publications, New Delhi, 2007, 2, 973, 1377,144,736.