“Among all the systems used for controlled release, multiparticulate systems are the most commonly used and can offer many unique advantages.” – Wen and Park, editors. Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice. John Wiley & Sons, 2011.
Modified-release dosage forms have many formats: extended release, delayed release, sustained release, targeted release and pulsatile release. Each of these release profiles has potential drug formats to support creating the correct pharmacokinetic curve. Multiparticulates, in particular, are well-suited for modified-release applications. As stated by Jagdale, et al., “Multiparticulate systems offer various advantages over single unit systems. These advantages include no risk of dose dumping, flexibility of blending units with different release patterns, as well as short and reproducible gastric residence times.”
Multiparticulate applications are often chosen for modified-release due to the ability to tune the formulation to an exact release profile. This is particularly ideal when following a 505(b)(2) pathway where matching release can result in reduced regulatory burden. Immediate-release to extended-release formulations can be achieved with multiparticulates. For example, the successful cyclobenzaprine IR to cyclobenzaprine XR used a multiparticulate platform.
A particularly difficult modified-release profile to formulate is pulsatile release. A 2009 review article in the Journal of Controlled Release discussed pulsatile drug delivery and noted that multiparticulates provide the flexibility to blend spheres with different release profiles. This allows for the novel modified-release profile of multiple pulses of the active ingredient over time.
Orbis Biosciences’ Precision Particle FabricationTM technology creates uniform microspheres that can be tailored to any release profile. These microspheres are ideal for multiple drug formats (e.g. suspensions, ODTs, sprinkles) due to their format-flexibility. Additionally, Orbis’ novel single-step microcapsule approach delivers pulse release capabilities without additional coating steps. Orbis is dedicated to developing medications that excel.