top of page

Development Capabilities

Modified & Targeted Delivery

lab05s.jpg

Modified-release and target delivery systems are important and comparatively modern pharmaceutical innovations that have proven time and again their ability to improve drug efficacy, mitigate side effects, enhance bioavailability and increase patient compliance.

 

Modified-release technologies involve delayed or extended release of an oral dosage product upon administration. Targeted-delivery technologies are special delayed delivery systems that release at the site of action.

Covar has deep experience in developing modified & targeted delivery products including:

​

  • Coating with pH sensitive polymer on pellets or tablets

  • Coating with sustained release polymer

  • Osmotic release polymer

  • Multiple coatings

  • Matrix tablets

  • Matrix tablets plus coating

  • Pellet coating

  • Bilayer tablets

  • Bilayer tablets with functional coating

lab08s.jpg

The above technologies can be used independently or in combination to achieve the following target delivery profils:

​

  • Delayed release characteristics to achieve enteric coating properties for drugs prone to degrade in the stomach or irritate the stomach

  • Delayed release characteristics to achieve delayed release at the lower GI track, e.g. improve bioavailability and/or avoid first pass metabolism

  • Extended release using diffusion control polymers to improve patient compliance, e.g. “once a day” therapy

  • Extended release using erosion control polymers

  • Combination of the above delivery profiles with a single drug substance

  • Combination of the above delivery profiles with two synergistic drug substances (fixed-dose combination product)

The Covar advantage is our strength in biopharmaceutics (pharmacology and pharmacokinetics) and adoption of Quality by Design concepts (including IVIVC as per FDA requirements). Early resolution of formulation challenges is essential to avoiding major losses of investment capital and development time caused by product design failures in late phase trials.

 

The complexity of manufacture processes for modified and targeted delivery products can lead to challenges in reproducibility, including dissolution profiles and bioavailability. Even seemingly identical batches can deviate greatly in performance due to subtle differences in manufacture parameters or excipient characteristics. More sophisticated formulations are typically necessary to protect active ingredients from degradation caused by interactions with the specialized excipients required and to achieved specialized release profiles (e.g. for highly soluble drugs with medium release profile). Certain considerations usually reserved for late phase studies, such as alcohol dumping, are also essential to address early on due to the difficulty of changing modified and targeted delivery formulations during scale up.

bottom of page