Development in Formulation and Evaluation of Levodopa- Tolcapone Orally Disintegrating Tablets

Advance in novel drug delivery system aims to enhance the safety and efficacy of the drug molecule by formulating a dosage form being for the administration. 1 Difficulty in swallowing is experienced by patient such as pediatric, geriatric, bedridden, disabled and mentally ill, including motion sickness and sudden episodes of allergic attacks, hence resulting in higher incidence of non-compliance and ineffective therapy. 2 To improve the quality of life and treatment compliances of such patients fast disintegrating or orally disintegrating tablets dosage form is a better alternative for oral medication. 3 Orally disintegrating tablets are solid dosage form containing medical substances which disintegrate rapidly, usually within few seconds when placed upon tongue requiring no additional water to facilitate swallowing. 4 Oral route of administration is most convenient for administrating drugs for systemic effect because of ease of administration and dosage adjustments. Swallowing conventional tablets can be further hindered by conditions such as allergic reactions, and episodes of coughing 5 . A solid dosage form containing medicinal substance, which disintegrates rapidly usually within of seconds, when placed upon the tongue also called as quick disintegrating tablet, rapid disintegrating tablet, porous tablet, mouth dissolving tablet 6 . Tablet that to be placed in the mouth where it disperses rapidly before swallowing. Absorption through the cheek allows the drug to bypass the digestive tract for rapid systemic distribution. The first ODTs disintegrated through effervescence rather than dissolution, and were designed to make taking vitamins more pleasant for children 7 . The ideal characteristic of oral disintegrating solid dosage form are Ease of administration, Taste of the medicament, Drug properties, Hygroscopicity, Friability, Taste masking:(sweet, salt, sour, bitter) 8,9,10 . The fast dissolving property of the tablet is attributable to a quick ingress of water into the tablet matrix resulting in its rapid disintegration. Hence the basic approach to developing fast dissolving tablet include maximizing the porous structure of the tablet matrix, incorporating the appropriate disintegrating agent and using highly water soluble excipients in the formulation. This method was adapted to pharmaceutical use with the invention of micro particles containing a drug, which would be released upon effervescence of the tablet and swallowed by the patient 11 . Dissolution became more effective than effervescence through improved manufacturing processes and ingredients (such as the addition of mannitol to increase binding and decrease dissolution time) 12 . In many ODT technologies based on direct compression, the disintergrants principally affect the rate of disintegration and hence the dissolution. Below critical concentration, tablet disintegration time is inversely proportional to disintegrants Article Info