MP formulations continue to grow in application due to their inherent advantages, including the greater flexibility they offer compared with monolithic formats. They:
|MP Range||Process||Amorphous / Solubilized Form||Taste Making||Immediate Release||Delayed / Burst||Controlled Release|
|Fluid Layered MP's||pH trigger||Fluid bed|
|Time trigger||Fluid bed|
|Diffusion control||Fluid bed|
|Matrix MP's||Lipid matrix||Melt-spray congeal||
Plus coating if needed
|IR and MR granules||Wet / Dry granulation||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 atomization process developed by Lonza, a drug is uniformly distributed within a carrier with optional drug release-rate modifiers.
Wet and dry granulation are flexible processes used to produce particles through agglomeration, typically polydisperse and 100 to 500 micrometers in diameter. In addition to being common intermediates to tableting, granulations may also be directly dosed in suspension or encapsulated and can be functionally coated for certain applications. Roller compaction and wet granulation through either extrusion or top spray fluid bed coating is routinely utilized for manufacturing granulated intermediates. These approaches can be used to develop drug products with a range of release profiles, provide dose flexibility, and to administer combination therapies 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.