Oral Drug Delivery

LLS Health has unrivaled expertise in formulation development for complex oral solid and liquid dosage forms. We employ a range of techniques to increase bioavailability or achieve controlled release for even the most challenging APIs. We have experience developing new formulation approaches and optimizing existing products, including oral solid dose (OSD), liquids, solutions, films, and suspensions.

Taking on complex APIs

We are expert in overcoming the challenges of oral drug delivery. Our team has experience formulating APIs with poor water solubility/bioavailability (BCS Class II/IV), low membrane permeability (BCS Class III), and inadequate stability. We are also equipped to handle highly potent APIs, DEA controlled substances (Schedule I-V), and large molecules, such as peptides and nucleotides. We tailor our excipient selection and formulation development efforts to achieve your desired drug elution profile, whether you are looking for controlled or immediate release. Our team can also formulate advanced oral delivery systems such as mucoadhesive tablets and films and combinations of multiple APIs.

Multiple solubility and bioavailability enhancement techniques

We utilize multiple formulation techniques to increase the bioavailability of poorly soluble APIs for oral drug delivery. Our team will explore different approaches for your product until we find the solution that meets your needs, including:

  • Amorphous solid dispersions (ASDs)
    • Hot melt extrusion (HME)
    • Spray drying
  • Nano- and microparticle technologies
    • Nanomilling
    • API encapsulation
  • Multi-particulate systems
    • Fluid bed coating, granulation, and drying
  • Complexation
  • Combination with functional excipients

Analytical capabilities and ICH stability

All formulation development and optimization for oral drug delivery is supported by our analytical services team, which works closely with formulators on method development and validation as projects progress from R&D to GMP production. In-house characterization of complex oral solid dosage forms includes drug assay and related substances, encapsulation efficiency, in vitro dissolution testing, Karl Fisher moisture analysis, particle size distribution analysis, and more.

We also offer on-site design and execution of ICH stability programs. Our facility is equipped with state-of-the-art temperature and humidity controlled and monitored chambers for accelerated and long-term stability testing. LLS Health is prepared to be your partner from early-stage development through stability and release testing.

We keep the end formulation goal at the center of what we do and adapt our methods accordingly.

Related Services

Analytical Method Validation

Our analytical services range from early stage method development through commercial validation. We are expert in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.

Formulation

Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability.  Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.

Drug Release Testing

We have over two decades of experience developing and validating release assays for a variety of drug products, including semi-solid formulations, implantable devices, and oral solid dosage forms. Our GMP/GLP facilities are equipped with specialized equipment and seasoned analytical scientists who perform both routine and custom drug release testing.

Micro and Nanotechnology

We employ several microsphere and nanotechnology approaches, designing custom programs around specific APIs and client goals. Our team is uniquely positioned to transfer in proprietary technologies or processes and bring them into GMP production. We can produce micro and nanoparticle dosage forms under aseptic conditions at clinical and commercial scale.