Application of Co-processed Excipient as a Novel Method to Compound Orally Disintegrating Tablets.

Co-processed excipients were prepared by incorporating one excipient into the particle structure of another and a combination of two or more compendia or noncompendia excipients to physically modify their properties, which cannot be achievable by simple physical mixing. The co-processed multicomponent-based excipients were introduced to achieve better characteristics and tableting properties. This objective of this study was to develop and evaluate a co-processed excipient for amlodipine orally disintegrating tablets to simplify the compounding process. The co-processed excipients were prepared by wet granulation with 5% of polyvinylpyrrolidone and croscarmellose sodium, five different percentages of microcrystalline cellulose, and lactose monohydrate. After sieving and drying, the co-processed excipients were evaluated for flowability and compressibility. The co-processed excipients were mixed with the amlodipine powder and magnesium stearate and compressed into tablets. The amlodipine tablets were evaluated for weight variation, content uniformity, thickness, hardness, friability, disintegration, and dissolution tests. Formulation 4 was chosen as the optimum formulation because the results showed this formulation had the excellent flowability and compressibility of a co-processed excipient. It showed uniformity of weight, content, thickness, and hardness, weight loss less than 1%, fast disintegration time, and dissolution results. The developed co-processed excipient can be used by the pharmaceutical industry in the future to compound amlodipine orally disintegrating tablets in a fast and economical way.