Formulation and Evaluation of Metoclopramide Fast Dissolving Film (FDF)

The fast dissolving film (FDF) is a solid dosage form which disintegrates rapidly when placed in the mouth. The FDF releases its active ingredient(s) allowing for oral mucosal or gastrointestinal absorption to be achieved. Metoclopramide (MP) is a potent antiemetic drug used for the treatment of nausea and vomiting. Many trials were made to prepare a satisfactory MP FDF using solvent-casting method. Nine formulations of MP FDF were prepared (F1-F9). The effect of variable formulation factors on both mechanical and physical attributes of Mp FDF, in addition to the drug release profile, were evaluated. It was found that the prepared MP FDF that contains hydroxyl propyl methyl cellulose (HPMC) showed the fastest in-vivo disintegration time in the mouth among other investigated polymers. The results showed also that as the concentration of HPMC was increased, both the disintegration time in the mouth and the mechanical strength were accordingly increased. The MP FDF formula (F7) which contained MP (5 mg), HPMC (340 mg), glycerin (0.35 ml) and Tween 80 (0.15 ml) showed fast disintegration time in the mouth (23 sec) and satisfactory mechanical properties (folding endurance of 150) when a minimal amount of surfactant and plasticizer were used. In addition, formula F7 gave faster dissolution rate as compared with conventional MP tablet (Meclodin®). The overall findings suggested that the current MP FDF can be given orally when fast action is the target.