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Multiparticulate (MP) technologies are heavily utilized for today’s increasingly specialized medicines and focus on patient-centricity.  Multiparticulates are highly flexible in terms of meeting required drug delivery profiles, incorporating taste and odor masking, multiple dose ranges and ease of administration. 

MP formulations continue to grow in application due to their inherent advantages, including the greater flexibility they offer compared with monolithic formats:

  • offer a wide range of flexibility in drug-release profile for single or multiple drug combinations and enable formulation as modified release, immediate release, bioavailability-enhanced, and/or taste-masked dosage forms
  • provide predictable and consistent GI transit and lower chances of undesirable events associated with tablets (e.g. dose dumping)
  • can be formulated into encapsulated, tablet or sachet formats
  • can facilitate ease of swallowing, an attribute increasingly important in targeted medications for pediatric and geriatric populations

We utilize four distinct and proven MP technologies for designing and developing drug products. The selection of a specific MP technology is typically dependent upon the API characteristics and target product profile.

We have extensive experience in designing, formulating and scaling multiparticulate dosage forms at feasibility, pilot and clinical / commercial scale across our technology options.

Proven multiparticulate technologies


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*enTRinsic™ Drug Delivery Technology generates hard capsule shells from several established and approved enteric polymers thereby eliminating the need for enteric coating

 

  • spray-layered multiparticulates (SLMs)
    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.

We have extensive experience in designing, formulating and scaling MP dosage forms at feasibility, pilot and clinical / commercial scale across all technology options.

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