Development and Evaluation of Mouth Dissolving Tablets of Montelukast Sodium Using Co-processed Excipients

Abstract

Background: The concept of formulating ODT containing montelukast sodium offers an appropriate, practical approach to accomplish fast release of the drug. Absorption of these tablets takes place directly into the systemic circulation which bipass the hepatic first-pass metabolism of montelukast sodium which ultimately results in the improvement in the bioavailability.
 Method: In the present study ODT tablets of montelukast sodium were prepared by using different Superdisintegrants like natural and synthetic (tulasi, hibiscus, orange peel powder, Ispaghula, banana peel powder, Crospovidone). Thirteen formulations were designed, using a two level of Superdisintegrants (minimum and maximum concentration) and employing two Superdisintegrants at a time by using the co-processed technique.
 Results: No significant drug and excipients interaction was observed. The prepared tablets were evaluated by weight variation, thickness, hardness, friability, drug content uniformity, disintegration time, wetting time, in-vitro dissolution studies. A formulation containing 6mg of natural and synthetic Superdisintegrants was offered the relatively rapid release of montelukast sodium when compared with other concentrations employed in this investigation.
 Conclusion: Montelukast sodium formulation were prepared by Crospovidone and ispaghula combination of Superdisintegrants were releases 98.91% drug in 30 min.

A Review on Multifunctional Excipients with Regulatory Considerations

“…The two or more parent excipients composition is made as per the requirement for production of multifunctional excipients. Further optimization of characteristics for the excipients and finally drying of optimized mixture of excipients is done [3].…”

“…The fusion is then heated with constant blending which breaks the mass into agglomerates which is further chilled to room temperature and eventually screened to acquire granules of required size. This technique does not utilize water or some other solvents [3].…”

“…API is that which has the therapeutic action and the excipients are those which are referred as pharmacologically inactive ingredients [1]. These excipients are fused with API during development process for various functions so as to formulate a dosage form that is ready for stated use [2,3]. Co-processing of excipients would result in the enhancement and improvement in the characteristics of individual excipients as compared to the physical mixture of multiple excipients.…”

“…These multifunctional excipients after their evolution have to be examined using different testing techniques. Co-processed excipient is the consolidation of at least two pharmacopeial and/or non-pharmacopeial excipients to genuinely modify their properties [3]. Co-processing is a method of designing that empowers the mixture of at least two excipients to make single compound excipient with better usefulness compared with simple blend of excipients [8].…”

“…Developments in drug formulations and delivery system led to the development of multifunctional excipients which have added functions apart from their main purpose. Producing the new chemical excipient is inefficient and must have to pass through various regulatory approvals which states about the safety and non-toxicity of the excipient [3].…”