OralogiK™

BDD has developed an erosion based modified release technology that provides unrivalled control of drug release and can be used to create unique and often complex drug release profiles.

The technology is an erodible barrier layer that is compressed around a drug containing tablet core to give a tablet in tablet dosage form. The barrier layer is designed to erode at a consistent rate independent of the location in the gastrointestinal (GI) tract and can achieve lag times of between 1 and 12 hours between dosing and drug release.

The erodible OralogiK™ layer creates a time-delayed drug release profile by physically preventing the release of the active pharmaceutical ingredient (API) from the core tablet until the barrier has completely eroded away, exposing the core tablet and allowing the API to be released for absorption or local action. Erosion is largely unaffected by factors such as pH, hydrodynamics and is not dependent on the microbiome for performance.

The timed-release layer acts independently of the drug contained in the core, making it suitable for most APIs.

This technology has been repeatedly tested in a the clinical setting, allowing our formulators to confidently develop an OralogiK™ formulation that works robustly in vivo. Through combining our knowledge of biopharmaceutics and this erosion-based system, BDD can create a variety of drug release profiles which are tailored specifically to your requirements.

Modified Drug Release Profiles

Sustained Release

By incorporating an API throughout the OralogiK™ erodible excipient layer it is possible to achieve sustained release profiles with some molecules. Rather than relying on matrix diffusion, the API can be released at a relatively constant rate as the granules erode away from the whole tablet which has particular benefits for larger molecules where diffusion from a standard matrix would not be possible.

Pulsatile Release

The OralogiK™ erodible barrier layer can be adjusted to delay the release of a drug from 1 to 12 hours depending upon the therapeutic need. Several doses / pulses of API can be incorporated into a single OralogiK™ tablet and our formulators have successfully developed dual and triple-pulse drug release tablets by compressing multiple layers of API and erodible components in different configurations.

Given the nature of wax being used in the erodible layer, this is also an effective technique at separating incompatible compounds within the same formulation.

Targeted Release

By combining our knowledge of the GI tract and the OralogiK™ technology, our formulators can target drug release to areas of the GI tract, such as the colon or upper and lower small intestine.

Reliably targeting delivery of API to the colon can be challenging due to the variable physiological environment and rates of transit along different sections of the GI tract. By applying an enteric coating around a delayed-release OralogiK™ tablet we can ensure that the erosion process only begins when the tablet has left the stomach. Knowledge of in vivo transit rates can be used to tailor the rate of OralogiK™ layer erosion to target delivery in the colon. The advantage of the erosion mechanism inherent in the barrier layer technology is that the outer layer is gradually shed from the core tablet, and on exposure of the core in the low fluid, low agitation environment of the colon, API release is relatively unimpeded by the physical presence of inert materials.

OralogiK™ has been designed to work independently of inter-individual differences such as pH, hydrodynamics and is not dependent on the microbiome for performance.

Complex Release

OralogiK™ tablets can be customized to produce specific drug release profiles for our clients. The separate techniques for each release profile can be combined modularly within a single tablet. This includes immediate and sustained release, or multi-pulse release. This can be applied to a single API or to combination products. Coatings can be added to aid in modified release or for other benefits such as branded colours or taste-masking.

Opportunities offered by OralogiK™

  • Targeted delivery of drugs during the night – improves action for conditions that flare up or have symptoms that peak in the night; also has the potential for reduced side effects with a more targeted dose
  • Pre-wake-up delivery of drugs – dosing of a tablet before going to bed, where the drug is released prior to waking-up, ensuring that the patient wakes free from symptoms
  • Once daily tablets – for improved patient compliance
  • Fixed dose combination tablets – more than one API which are often dosed together in a daily regimen can be incorporated into an OralogiK™ dosage form. This could be for pre-treating side effects of an API or enhancing a therapeutic advantage. The separation of API by time can be used to separate incompatible drugs or to dose two drugs which have different fed / fasting dosage requirements
  • Target regions of GI tract – can reduce API requirements or improve product performance by releasing a drug at the target site or at a known site of absorption

What can OralogiK™ do for you

  • Bring new products affordably and quickly to market
  • Capitalise on your brand names with product line extension
  • Patented protection for your products
  • Offer a novel health solution in a highly competitive market
  • Design value-added products to both enhance patient lives and compliance