Technologies

 

Drug Delivery Technologies

Innovative technologies that maximize efficacy, reduce side effects, reduce drug abuse and improve patient compliance comprising:

DisExx™, A Universal Solubility Enhancement Technology Platform

  • enhances clinical viability of poorly soluble drug substances

  • improve bioavailability and reduces dose strength

  • improves efficacy and reduces side effects

  • reduces or eliminates food effect

  • reduces inter- and/or intra-subject PK variability

  • applies to all poorly-soluble drug substances irrespective of their physicochemical properties

 

OptExx™, A Highly Versatile Modified Release Technology Platform

  • ensures physical and chemical stability of the dosage form, including dissolution stability, throughout the shelf-life of the products

  • uniquely integrates modified release with solubility enhancement in a single dosage form

  • prevents dose dumping due to food effect, dosage form breakage and concomitant alcohol ingestion

  • provides consistent drug plasma concentrations

  • provides highly reproducible and consistent dosage forms

  • improves patient compliance


Sync-Loc™, A Multibarrier Abuse Deterrent Technology Platform

  • prevents dosage form tampering and drug abuse by:

    • chewing/crushing followed by swallowing

    • milling followed by snorting/insufflation

    • extraction followed by injection

    • heating followed by smoking/inhalation

  • provides release profiles modulated by a hybrid mechanism

Manufacturing Technologies

Innovative manufacturing technologies that improve product quality and consistency, reduce manufacturing cost and reduce time-to-clinic and time-to-market as shown below:

  • Provide excellent content uniformity

  • Improve consistency by reducing batch-to-batch variability

  • Reduce production cycle time

  • Render scalability practically a non-issue

  • Minimize analytical testing

  • Permit the manufacture of CTM and commercial batches at the same site (or different sites) using the same equipment under the same processing parameters

  • Allow formulation and manufacturing process to be locked up early in development

  • Help generate sufficient stability data that permit final specifications to be established early in development since changes to formulation and process are minimal 

  • Prevent potential product recalls due to manufacturing issues

  • Permit real-time testing (PAT) when configured as such

Specialized Dosage Forms

 

Fixed Dose Combination Technology

  • permits the formulation of chemically incompatible drug substances

  • increases drug loading and minimizes dosage form size

  • overcomes content uniformity issues

  • permit the development of a single dosage form comprising combinations of release profiles

  • Utilizes pellets, single tablets and multilayer tablets

 

Pediatric/Geriatric Drug Delivery Technology

  • allows development of flexible dosage forms tailored to a specific age group of pediatric and geriatric populations

  • designed to provide immediate release, delayed release and extended release dosage forms or mixtures thereof

  • permits the development of dosage forms that could be packed into sachets, packed into bottles, or compressed into dispersible tablets

  • Suitable for taste-masking of bitter drug substances