Exploration of Alternative Brittle Fillers/Diluents for the Development of Lactose-Free, Vegan-Friendly Tablets by Direct Compression

Background: An increasing number of patients and consumers using health-related products are affected by lactose intolerance or follow vegan diets. These individuals seek pharmaceutical products, nutraceuticals, and dietary supplements that are free from animal-derived ingredients. Lactose is one of the most widely used pharmaceutical excipients, particularly in direct compression technology. Therefore, the use of alternative brittle fillers/diluents is justified from both technological and market perspectives. Methods: Formulations comprising 94.0–98.0% w/w of the selected brittle fillers/diluents, 1.0–5.0% w/w lubricant, and 1.0% w/w disintegrant were prepared. The tablet blends were characterized in terms of their physical properties and subsequently compressed into tablets at compression forces ranging from 10 to 25 kN, while ejection forces were simultaneously measured and recorded. The resulting tablets were evaluated with respect to selected physical properties. Results/Conclusions: This study demonstrated that the tested lactose grades could be replaced by alternative brittle fillers/diluents in direct compression formulations. Under the investigated conditions, dibasic calcium phosphates exhibited a distinctive combination of technological properties, with the anhydrous form showing good tabletability and the dihydrate form demonstrating relatively high process robustness. Spray-dried mannitol also exhibited favorable tableting performance.