Abstract:
Chewable lozenges are easy to use, and highly flavored oral dosage forms used to deliver active ingredients, while providing high patient compliance rates. This work targets the development of chewable lozenges containing multiple natural active ingredients for the treatment of erectile dysfunction. Five batches were developed and analyzed consecutively by adjusting specific processes and material parameters such as the compounding procedure, and excipient quantities based on the physical appearance, stickiness, texture, chewiness, and taste of the lozenges. The most optimal batch obtained is batch “5” and includes adjustments to the compounding procedure to prepare the gelatin base separately while maintaining a heating temperature of 65-70˚C and a mixing speed of 750 rpm and maintaining a lower temperature of 50-60˚C with a mixing speed of 500 rpm while adding the active ingredients. Adjustments of the total liquid content was made to obtain a volume of 1.55 ml/lozenge and a water content of 0.30 ml/lozenge. In addition, the rotary evaporation technique was implemented to remove 6.7 ml (55.83%) of ethanol from the Black Maca liquid extract. Among other adjustments, these were the most significant in impacting the physical parameters and more specifically the stickiness of the lozenges. This project illustrates the successful development of chewable lozenges as a dosage form for the delivery of multiple active natural ingredients with distinct mechanisms of action. Water and solvent contents like ethanol, and process parameters can impact the physical characteristics of the chewable lozenges.
