MP formulations continue to grow in application due to their inherent advantages, including the greater flexibility they offer compared with monolithic formats. They:
*enTRinsic™ Drug Delivery Technology generates hard capsule shells from several established and approved enteric polymers thereby eliminating the need for enteric coating
SLMs are layered spherical particles approximately 100 to 1500 µm in diameter that contain one or more active ingredients. Typical applications include modified and programmed release, enhanced bioavailability and fixed-dose combination therapies. SLMs are produced by using a bottom-spray fluidized-bed coater to apply one or more coatings to a coating substrate.
LMPs are round, smooth matrix multiparticulates produced from safe, precedented excipients. Typically 50 to 300 µm in diameter, they can be used for applications requiring bioavailability enhancement, modified release, taste-masking, high-dose actives and fixed-dose combination therapies. Using a continuous spinning-disk process developed by Lonza, a drug is uniformly distributed within a carrier with optional drug release-rate modifiers.
Extrusion/spheronization is a very flexible process used to produce uniformly sized spheroid granules through agglomeration, typically 600 to 2000 micrometers in diameter. These dense granules are excellent for preparing dosage forms with a minimum of excipients and provide an excellent substrate for drug layering and functional coating. Extrusion/spheronization is routinely utilized to develop drug products with a range of drug release profiles, administer combination therapies and combine two incompatible drugs in a single dosing unit.
Mini-tablets are typically 2 to 3-mm tablets produced on a rotary tablet press by direct compression. They can be coated using aqueous or solvent-based films using fluidized-bed or pan coaters and then encapsulated to produce an immediate or modified-release multiparticulate dosage.