Modified & Targeted Delivery / Drug Product Services

Accelerate your Drug Product Development with our Pharmacokinetics Expertise

Expertise in Modulating Pharmacokinetics

Modulating pharmacokinetics is a core strength of our drug design and development services. We utilize a full range of established modified release technologies, often in combination with solubility-enhancing technologies, to meet target product profiles. Our product development teams utilize specialized processing techniques and phase-appropriate equipment to ensure effective product development and manufacturing from concept, through clinical studies to commercialization.

Immediate release, delayed release and enteric protection, extended release, fixed dose combinations, dual and pulsatile release, and site specific targeting, including colonic delivery, are routinely utilized to meet our customers’ target product profiles and commercial objectives. These highly flexible technologies for pharmacokinetic modulation are formulated into either monolithic or multiparticulate drug product formats. Our product development teams work closely with you to define problem statements, and choose the best formulation approach.

*AMT = osmotic asymmetric-membrane technology
*SCT = osmotic swellable-core technology
*LMP = lipid multiparticulate technology

Experts demonstrate a systematic approach to development, implementing QbD principles to link critical process parameters to the spray-layered dispersion potency for a fluid bed coating process.

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Determination and Scale-up of Fluid Bed Coating Through the Use of Process Analtytical Tools

Our modified & targeted delivery offer

Numerous drivers, both clinical and product driven impact the design and development of dosage forms incorporating targeted delivery mechanisms, including:

Improving bioavailability
Achieving site-specific delivery
Meeting clinical needs for specific plasma time-course profiles
Avoiding site-specific degradation in the GI tract
Improving patient compliance
Enabling line extensions, new indications and/or product repositioning
Enabling combination formulations and dual-release profiles

Specialized formulations are routinely developed utilizing complementary enabling technologies:

Pediatric applications can utilize one of several multiparticulate processing approaches, often combined with taste-masking technologies
Fixed-dose combinations can utilize a range of approaches, including multiparticulate technologies, bi- and tri-layer matrices, and capsule-in-capsule formats
Osmotic tablet technologies are increasingly utilized with solid dispersion technologies to achieve zero order release of solubilized API
Abuse deterrent approaches can be built into the formulation design where applicable, for example with opioids

Technology selection methodologies are utilized for selecting viable and phase-appropriate formulation approaches to modulate pharmacokinetics that both achieve target product profiles and are easily scaled.