definiens: means the botanical and pharmaceutical formulatio n of proanthocyanidin polymeric composition, isolated from a Croton spp . or Calophyllum spp . Fulyzaq / Crofelemer includes proanthocyanidin polymeric compositions which prote ct the * * * Confidential Treatment Requested compositions from the acid environment of the stoma ch after oral administration, particularly enteric coated, and formulations of directly compressible proanthocyani din polymer compositions . In addition to the oral, solid formulation, Fulyzaq / Crofelemer also means other fo rmulations for oral administration, including, but not limited to, drug powders, crystals, granules, small particles ( which include particles sized on the or der of micrometers, such as microspheres and microcapsules ), particles ( which include particles sized on the order of millimeters ), beads, microbeads, pellets, pills, mi crotablets, compressed tablets or tablet triturates, molded tablets or tablet triturates, and in capsules, which are ei ther hard or soft and contain the composition as a powder, particle, bead, solution or suspension . also includes formulas and formulations f or oral administration as a solution or suspension in an aq ueous liquid, as a liquid incorporated into a gel c apsule or as any other convenient formulation for administration, or for rectal administration, as a suppository, e nema or other convenient form ; the proanthocyanidin polymer ic composition can also be provided as a controlled release system