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
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enhances clinical viability of poorly soluble drug substances
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improve bioavailability and reduces dose strength
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improves efficacy and reduces side effects
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reduces or eliminates food effect
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reduces inter- and/or intra-subject PK variability
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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
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uniquely integrates modified release with solubility enhancement in a single dosage form
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prevents dose dumping due to food effect, dosage form breakage and concomitant alcohol ingestion
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provides consistent drug plasma concentrations
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provides highly reproducible and consistent dosage forms
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improves patient compliance
Sync-Loc™, A Multibarrier Abuse Deterrent Technology Platform
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prevents dosage form tampering and drug abuse by:
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chewing/crushing followed by swallowing
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milling followed by snorting/insufflation
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extraction followed by injection
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heating followed by smoking/inhalation
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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:
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Provide excellent content uniformity
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Improve consistency by reducing batch-to-batch variability
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Reduce production cycle time
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Render scalability practically a non-issue
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Minimize analytical testing
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Permit the manufacture of CTM and commercial batches at the same site (or different sites) using the same equipment under the same processing parameters
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Allow formulation and manufacturing process to be locked up early in development
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Help generate sufficient stability data that permit final specifications to be established early in development since changes to formulation and process are minimal
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Prevent potential product recalls due to manufacturing issues
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Permit real-time testing (PAT) when configured as such
Specialized Dosage Forms
Fixed Dose Combination Technology
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permits the formulation of chemically incompatible drug substances
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increases drug loading and minimizes dosage form size
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overcomes content uniformity issues
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permit the development of a single dosage form comprising combinations of release profiles
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Utilizes pellets, single tablets and multilayer tablets
Pediatric/Geriatric Drug Delivery Technology
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allows development of flexible dosage forms tailored to a specific age group of pediatric and geriatric populations
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designed to provide immediate release, delayed release and extended release dosage forms or mixtures thereof
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permits the development of dosage forms that could be packed into sachets, packed into bottles, or compressed into dispersible tablets
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Suitable for taste-masking of bitter drug substances