Appendix 2 of Johnson, Mol Vis 2014; 20:1228-1242.

Appendix 2.

To access the data, click or select the words “Appendix 2.” Excipients used in the Softgel and Table formulations. The AREDS1 excipients are those used in the dosage forms investigated in this study; the AREDS2 excipients are those used in the dosage forms in that Trial, here for reference. For tablets, oil-based nutrients were provided as gelatin-coated beadlets dispersible in a mixture of solid actives, flow controlling powders such as microcrystalline cellulose and dicalcium phosphate, lubricants like magnesium stearate that contribute to proper flow rheology during blending and compression, and antioxidants or stabilizers to assure stability of actives during manufacture and storage. A number of minor ingredients that originate in preparations of the raw material actives often are reported as excipients. Polymers and colorants provide an exterior region that contributes to the esthetics of the tablet presentation. For softgel capsules, similarly there are two separate regions, a liquid, or at least flowable, core and an enclosing capsule. The core is composed of actives, oils, viscoelastic and suspending agents sufficient to assure uniformity in composition during manufacture, minor ingredients accompanying the actives, and like the tablets antioxidants and stabilizers to assure stability. The polymer capsule is routinely comprised primarily of a biopolymer, which in these formulations is gelatin to which plasticizers and other minor ingredients are added to assure compatibility with the core, proper flow, and adherence during fusion of the capsule halves at the time of manufacture. The levels of excipients are proprietary.