Formulation and Evaluation of Montelukast Sodium Chewabletablets by Direct Compression Method

Kavitha, - (2013) Formulation and Evaluation of Montelukast Sodium Chewabletablets by Direct Compression Method. Masters thesis, J.K.K. Nattraja College of Pharmacy, Komarapalayam.

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Abstract

The Present Study the goal of any drug delivery system is to provide a therapeutic amount of drug to the proper site of the body, to achieve promptly and then maintain the desired therapeutic drug concentration that elicits the desired pharmacological action and to minimize the incidence and the severity of unwanted adverse effects. For many decades, treatment of an acute disease or a chronic illness has been mostly accomplished by delivering drugs using various pharmaceutical dosage forms, including tablets, capsules, pills, suppositories, ointments, creams, liquids, aerosols, and injectables as carriers. Amongst various routes of drug delivery, oral route is perhaps the most preferred to the patients. The oral route of drug administration is the most important method of administering drugs for systemic effects. Nevertheless, it is probable that at least 90% of all drugs used to produce systemic effects are administered by oral route. It is very popular and successfully used for delivery of drugs because of convenience and ease of administration, greater flexibility in dosage form design, and ease of production and low cost of such a system. Chewable tablets are intend to be chewed in the mouth prior to swallowing and are not intended to be swallowed intact. The purpose of chewable tablet is to provide a unit dosage form of medication which can be easily administered to children or to the elderly, who may have problem in swallowing a tablet intact. It is also recommended to achieve rapid onset of action. Chewable tablets are preferred for the drugs having high dose, the tablets of which cannot be swallowed. Conversely, many patients are not able to tolerate the taste of many drugs when formulated as liquid dosage forms, thus leading to poor patient compliance in those cases. Lately recent developments in dosage form technology are concentrating on presenting the patient with variable dosage alternatives which provide good palatability and ease of administration at same time. This is especially valid when the preparation is to be administered to an infant or to an elderly patient. Hence it was decided to formulate Montelukast chewable tablets to improve the compliance in children and elderly patients. Additionally, chewable tablet facilitate more rapid release and hence more rapid absorption of active ingredients and provide quick onset of action. Montelukast sodium is a Leucotriene receptor antagonist used for the treatment of asthma. Montelukast blocks the action of Leucotriene D4 on the cysteinyl Leucotriene receptor in the lungs and bronchial tubes by binding to it. Its biological half life 2.7 to 5.5 hrs. The main objective of the present study was to formulate and evaluate Montelukast chewable tablets dosage form at the dose of 5 mg and to study the various formulation variables that affect the drug release by using the following exicipients like Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Aspartame, Magnesium stearate, Cherry black, Euroxide and Red iron oxide. From the above compiled data it was concluded that pharmaceutical tablets Can be produced by three methods viz, direct compression, dry granulation and wet granulation. Out of these three methods direct compression is the most convenient and cheaper method. Based on the optimization of the parameters concluded that chewable tablets of Montelukast sodium can be prepared by direct compression method using croscarmellose sodium as superdisintegrants. Chewable tablet of Montelukast sodium with 3% of croscarmellose sodium and 5% of microcrystalline cellulose shown better drug release of 101.0% at 30 minutes. The stability study of Formulation F8 revealed that the drug was stable under accelerated and long term stability conditions for 3 months. Hence the Formula F8 containing Montelukast sodium 5 mg has been formulated as a chewable tablet by direct compression method, which satisfied all the criteria for chewable tablets.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Montelukast Sodium Chewabletablets; Microcrystalline cellulose
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 09 Oct 2017 05:16
Last Modified: 09 Oct 2017 05:16
URI: http://repository-tnmgrmu.ac.in/id/eprint/3632

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