Product Information
`
`Brochure
`
`SURELEASE
`
`AQUEOUS ETHYLCELLULOSE DISPERSFONS
`
`Extended release aqueous coating systems utilizing ethylceilulose
`as the rate controlling polymer for drug release.
`
`Colorcon
`
`rm
`
`Amerigen Ex. 1036, p. 1
`Amerigen Ex. 1036, p.
`1
`
`

`
` Drug release by diffusion through insolubie permeable membrane
`
`The principal means of drug release is by diffusion through the Surelease
`
`membrane and is directly controlled by film thickness. Simply increasing
`
`or decreasing the applied quantity of Sureiease modifies the rate of drug
`release. Surelease provides consistent uniform drug release, which is
`
`independent of pH.
`
`Sureiease was developed for the extended release coating of
`
`multiparticulates. Drug particles coated with Sureiease have also been
`successfuily compressed into tablets. Line extensions offer enhanced
`
`stability over time. improved reproducibility and extended shelf life
`
`(24 months).
`
`Time Savings in Development and Production
`- Totally aqueous dispersion. fully piasticized formulation
`0 Easy adjustment of release profile to meet specific needs
`0 Eiiminates the use of and exposure to organic solvents: no need for costly solvent
`recovery
`
`Safe to Use
`- Components meet the requirements of the major pharmacopoeia
`0 Registered product approvals around the world
`
`Proven Performance and Scalability
`0 Process optimization ensures the coating is fully coalesced. eliminating the need for a
`curing step
`0 Consistent results from lab development through scale—up to production
`- Simple one-step process: fluid bed coating is the preferred technique
`
`Coiorcon Applications and Technical Support
`0 Coating optimization for granules, pellets. beads and drug particles
`I Fluid bed. wet granulation and extrusion./spherization pilot capabilities
`0 Starling formulations available for many actives
`
`Full supporting product and applications literature is available through the
`Coiorcon website.
`
`Deliv.er'hieh-p;erfon11anc.e
`Ceiorcon
`
`Choose‘ Solomon". ieaderin phannaceutical
`'_-_s'o_1i_d‘o'rel,dose,so|utio'n's'.._as'afcrrriulatien
`_pe__rtner_ln_-"every; ph'_as__e of your product-
`de"veiopine_nt. Our solution capabilities
`orig__inate_ fr'_on1 two main areas"of‘exp'eriJ_‘se:.
`
`Formulation Technologies:
`
`0 Full range of functional excipients
`
`- Technologies for development and
`production of deiayedfenteric release
`and extended"/controlled release
`tablets and n1_uitiparticulates
`
`' i-"ly_p_erStart‘.'_ service a_r_I__d'I§>.¢i_en'sive
`applications data to provide
`starting" foritiulatibns to ‘save you
`development time and money
`- Extensive formulation know-how
`and technical support to achieve the
`exact drug release profile desired
`
`Film Coatings:
`
`0 Optimized forrnuiations specifically for your
`application and regulatory needs including
`customized colors and color matching
`
`- innovative products for mechanical
`integrity. gloss. peariescence. and
`environmental protection
`
`I Brand enhancement concepts. consulting
`and services to build a strong brand image
`and stand out fron1 the competition
`
`From formulation and tablet design through
`product differentiation and branding.
`Colorcon gives you everything you need
`to deliver high-performance products.
`
`For more information. contact your Colorcon representative or call:
`
`North America
`
`+1-215-699-7733
`
`Europe/Middle East{Africa
`+44-{0}-1322-293000
`
`Asia Pacific
`+55-6438-D313
`
`Latin America
`+54-11-4552-1565
`
`coiorco‘''n ‘
`
`DBPSJ iinldinns LLB. 2ElID.‘I'iIa information contained in
`[his document is proprietary to caiurcon and may not he
`used or dlsssmlnaled Inappropriaiety.
`All trademarks. except where noted. are pwnarty of
`EFSI l-iuidlnus LLB.
`
`You can also visit our website at www.co|orcon.corn
`
`|t|l:i_sure|ease_v2_DE.2fl1fl
`
`Amerigen Ex. 1036, p. 2
`Amerigen Ex. 1036. p. 2