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Formulation Development and In-Vitro Characterization of Loratadine Melt in Mouth Discs (MMD).

Sridhar Gumudavelli, and Sricharan G

The objective of fast disintegrating drug delivery systems is to enhance absorption and bioavailability while improving patient compliance. Somehow, most of the existing fast disintegrating drug delivery systems are compromised with one or more quality attributes including patient compliance, therapeutic effect and manufacturing method. This research work attempts to develop a fast disintegrating drug delivery system with multidimensional attributes to improve patient compliance and manufacturing process while enhancing absorption and bioavailability. A fast disintegrating Melt in Mouth Disc (MMD) was developed to enhance absorption via GI tract and oral mucosa. Loratadine was selected as a model drug for the study. MMD was developed by a direct compression method using a rotary compressed tablet machine using water soluble and insoluble diluents, and super disintegrants. The relationship between input materials, critical processing parameters and critical quality attributes was established through Quality by Design using a 23 factorial design. Results demonstrated that ratio between water soluble/insoluble diluents, and type of super disintegrants, significantly affect the response variables. The compressed thin tablets were characterized for uniformity of weight, hardness, disintegration time, dissolution, and wetting time. Optimized formulation exhibited a hardness of 5.0 N, disintegration time <20 seconds, wetting time < 25 seconds, and drug release 99% within 5 minutes.