Technologies

 

Drug Delivery Technologies

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

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DisExx™, A Universal Solubility Enhancement Technology Platform

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• 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

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• 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

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• 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

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Manufacturing Technologies

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

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• 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

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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