patheon dosage capabilities

6
Solid and Sterile Finished Dose Forms

Upload: hariharan90

Post on 21-Feb-2016

15 views

Category:

Documents


1 download

DESCRIPTION

Patheon Operational Capabilities

TRANSCRIPT

Page 1: Patheon Dosage Capabilities

For more information on our services or products, contact your Patheon Representative or email us at [email protected]

Solid and SterileFinished Dose Forms

All the Choices and Expertise You Need to Succeed

Solid Dose Forms – Specialized and Conventional With the experience of thousands of projects, Patheon provides access to a wide range of conventional solid dose form as well as specialized combinations and controlled-release technologies. All solid dose form choices are carried out with the expansive scientific resources and expertise to build high-quality formulations for even the most complex drug products.

Softgels Bolstered by the acquisition of Banner Pharmacaps, Patheon is your new highly capable ally in the development and manufacture of softgel products. We give you access to a host of patent-protected specialized technologies to meet the specific needs of your molecules and markets. This includes advanced solutions for enhancing solubility and bioavailability, as well as unique controlled-release and oral delivery technologies.

Sterile Products Patheon offers extensive sterile product development and manufacturing capabilities in Europe and North America, including world-class expertise in lyophilization and ready-to-use dose formats. We have developed more than 100 large molecules for customers that include eight of the top ten biotech companies. Because the challenges you face are ones we’ve likely overcome before, you can be confident of your success. That plus our exceptional regulatory track record, Right First Time and On-Time performance, and three consecutive years of European Outsourcing Awards.

Develop and Launch Products Anywhere in the World

Published 9/14 PATH0340R1

Americas Europe

Cincinnati USA

High Point USA

Greenville USA

Toronto Canada

Whitby Canada

Manati Puerto Rico

Mexico City Mexico

Bourgoin France

Monza Italy

Ferentino Italy

Milton Park UK

Swindon UK

Tilburg Netherlands

Solid Dose Forms

Spec

ializ

ed

Trilayer Tablets l l l l lMicrotablets l l

Beads in Capsules l l lCoated Beads l l l

Tablets in Capsules l l lFast Dispersible Tablets l l l l l

Laser-Drilled Controled-Release Tablets l l l l l lLiquid-Filled Capsules l

Biphasic Liquid-Filled Capsules l l lBilayer Chewable Tablets l l

Beads in Liquid-Filled Capsules l l l lHydrophilic Gel Matrix l

Polymer Matrix l l l l l l lWax Matrix l l l

Pulsatile Release l l lPolymer Coating l l l l

Sublingual Tablets l l l l l

Con

vent

iona

l Uncoated l l l l l l l lCoated l l l l l l l l

Powder-Filled Capsules l l l l l l l lPowders and Granules l l l l l l l l

Coated Beads l l lMultiparticulates l l l

Softg

els

Softgel Capsules l l lTwist-Off Softgels l l l

EnteriCare® Enteric Softgels l l lLiquiSoft™ Chewable Liquid-Filled Softgels l l l

Versatrol™ Controlled-Release Softgels l lSolvatrol™ Enhanced Solubility Softgels l l

Soflet® Gelcaps l lChewels® Chewable Gels l l

Sterile Products

Vials l l l lLyophilized Vials l l l l

Prefilled Syringes lCartridges l

US HeadquartersPatheon Inc. 4721 Emperor Blvd, Suite 200 Durham, NC 27703-8580 USA P: +1 919 226 3200 F: +1 919 474 2269 www.patheon.com

European Headquarters Patheon UK Ltd. Kingfisher Drive Covingham, Swindon Wiltshire SN3 5BZ UK P: +44 1793 524411 F: +44 1793 487053 www.patheon.com

Japan Office Patheon K.K. 7F Wakamatsu Building, 3-3-6 Nihonbashi Hon-cho, Chuo-ku, Tokyo 103-0023 Japan P: +81 3 6202 7666 F: +81 3 6202 7676 www.patheon.com/home-japan.aspx

Page 2: Patheon Dosage Capabilities

Liquid-Filled Vials— Aseptic filling, terminal sterilization when required— Solutions, suspensions or emulsions— Extensive range of sizes and stopper/cap combinations— Clear or amber glass vials

Lyophilized Vials— World-class scientific and technical expertise— Wide selection of vial sizes, including ISO standard— Small- and large-scale manufacturing

Prefilled Syringes— Broad range of sizes and configurations with handles— Glass or polymeric — Fill range from 0.1 ml to 20 ml

Cartridges — Range of cartridge configurations— Glass or plastic

Bilayer Tablets 2 IRs or IR+CR/SR fixed-dose combination

Trilayer Tablets 3 IRs or IR+placebo+CR/SR fixed-dose combination

Microtablets IR or CR/SR; low-dose tablets; via device, capsule or sachet

Tablets in Capsules IR or CR/SR, over-encapsulation for blinded clinical supply

Chewable Tablets IR or CR/SR single or bilayer fixed-dose combinations; ideal for pediatrics and high-dose compounds

Fast Dispersible Tablets IR, disintegrates/disperses as suspension in water, divisible into 4 parts for titration, ideal for pediatrics

Sublingual Tablets IR, single layer tablets for sublingual administration.

Beads in Hard-Shell Capsules IRs and/or CRs/SRs fixed-dose combination, uncoated or polymer coated; extrusion, spheronization or drug layering

Beads in Liquid-Filled Capsules IRs and/or CRs/SRs fixed-dose combination, hard shell, coated beads in liquid vehicle

Liquid-Filled Capsules IR or CR/SR; hard shell; options to improve solubility, bioavailability and absorption; ideal for Phase I and beyond

Biphasic Liquid-Filled Capsules IR or CR/SR; hard shell; biohasic vehicle to improve solubility, bioavailability and absorption; ideal for Phase I and beyond

Laser-Drilled Controlled-Release Tablets

CR/SR; hard shell; osmotic, zero-order, controlled-release over a defined time period

Hydrophilic Gel Matrix Controlled-release technology

Polymer Matrix Controlled-release technology

Wax Matrix Controlled-release technology

Pulsatile Release Controlled-release technology

Polymer Coating Controlled-release technology

Tablets IR or CR/SR, single-layer tablets, coated or uncoated, with or without break line or embossing, range of shapes and sizes

Powder-Filled Capsules IR, two-piece gelatin or HPMC capsules in a range of sizes and multiple color combinations

Powders, Granules, Coated Beads Multiparticulates

IR, bottles and sachets, packaged in bottles and sachets of varying dimensions and fill weights

Softgel Capsules— Immediate-release soft gelatin capsules— Clinical development scale production— 13.7B capsule commercial manufacturing capacity— Extensive range of sizes, colors and imprinting options

Twist-Off Softgels— Precise unit dosing for oral liquid and topical products— Hermetic seal helps preserve API— Portable convenience improves patient compliance— Consistent dosing for reliable results in clinical trials

EnteriCare® Enteric Softgels— Enteric properties are integrated into the gelatin shell— Eliminates risk of reflux and gastric irritation— Protects acid-labile compounds— Compatible with SMEDDS, hydrophilic and viscous fills

Versatrol™ Controlled-Release Softgels

— Unique matrix system to fine-tune release— Controlled-release capabilities integrated into fill— Lipophilic and hydrophilic formulations— Suitable for compounds with low solubility

Solvatrol™ Enhanced Solubility Softgels

— Enhances the solubility and bioavailability — Lipophilic and hydrophilic formulations— Provides a stable solvent delivery system— Reduces plasma level variability

LiquiSoft™ Chewable Liquid-Filled Softgels

— Solid dose for oral liquid formulations— Soft, chewable shell with a pleasant burst of liquid Enhances

performance of poorly soluble compounds— Flavors and aromas mask unpleasant tastes and odors

Soflet® Gelcaps— Patented technology enrobes tablets— Traditional gelatin or non-animal gelatin— Safely encases highly potent compounds— Perfect for clinical trial blinding

Chewels® Chewable Gels— Chewable for patient comfort and convenience— Rapid onset of action and relief of symptoms— Pursue pediatric and geriatric markets— Patented technology

Conventional Solid Dose Forms

Specialized Solid Dose Forms Softgels

Liqu

id-F

illed

Via

l

Sterile Doses Commercial DevelopmentVial Size* (ml)  Stopper Size (mm) Greenville, USA Monza, Italy Ferentino, Italy Ferentino, Italy Greenville, USA

2 13 l l l l l4 13 l l5 20 l l6 20 l l7 20 l8 20 l l

10 20 l l l l l12 20 l13 1315 20 l20 20/13 l l l l l25 20 l l30 20 l l l l50 20/32 l l60 28 l

100 20/28/32 l200 28/32 l250 32 l300 28 l500 28/32 l

Lyop

hiliz

ed V

ial

2 13/20 l l l l l3 13 l4 13 l5 13/20 l l l l l6 20 l l l l7 20 l8 20 l l l

10 20 l l l l l12 20 l l15 20 l17 20 l20 20 l l l l l25 20 l l30 20 l l50 20 l l

100 20 l

Capsules Required Container Size (cc) by Fill Count

Size Fill Volume Range (CC) 60 Count 100 Count 250 Count 500 Count

Ova

l

2 0.089-0.111 60 60 75 150

3 0.182-0.228 60 75 120 200

4 0.209-0.261 60 100 150 250

5 0.312-0.389 75 100 150 300

6 0.318-0.397 75 100 150 400

7.5 0.386-0.482 75 100 225 400

9 0.469-0.586 100 120 300 600

10 0.567-0.709 100 120 300 600

Obl

ong

3 0.181-0.227 75 75 200 350

4 0.243-0.304 100 120 250 400

5 0.285-0.356 100 120 300 750

6 0.338-0.422 100 120 400 750

8 0.452-0.564 120 200 500 950

14 0.863-1.079 200 300 750 1250

16 0.975-1.218 250 400 950 1500

Rou

nd

2 0.073-0.123 60 60 75 150

3 0.138-0.183 60 75 120 200

4 0.173-0.244 60 100 150 250

5 0.195-0.305 75 100 150 300

6 0.279-0.367 75 100 150 400

7 0.305-0.428 75 100 225 400

15 0.737-0.922 150 225 500 750

Vial SizeMonza, Italy Ferentino, Italy Greenville, USA

Sterile Area 1

Sterile Area 2

Sterile Area 3

Sterile Area 1

Sterile Area 2 Sterile

Area 2Development Sterile Unit

Line 1 Line 2 Line 3Cytotoxic CTM

External OD (mm)

Example Fill2 Twin Lyo

Units2 Twin Lyo

Units2 Twin Lyo

UnitsLyo Unit 1 Lyo Unit 2 3 Lyo Units 3 Lyo Units 3 Lyo Units

16 2, 4 138,000 111,000 127,000 120,000 153,000 37,000 24,000 490,000 318,000 329,000 43,000 8,600

21 5 81,000 65,000 74,000 69,000 89,000 19,000 14,000 295,000 200,000 206,000 27,000 5,400

22 6 73,000 58,000 67,000 67,000 86,000 18,000 12,500 265,000 179,000 185,000 24,000 4,800

24 10, 15 61,000 49,000 55,000 55,000 69,000 14,000 10,000 174,000 117,000 121,000 16,000 3,200

30 20, 25, 30 37,000 30,000 35,000 35,000 45,000 9,500 6,400 142,000 95,000 98,000 13,000 2,600

42 15 17,000 13,000 15,000 17,000 22,000 4,700 3,500 65,000 42,000 44,000 5,000 1,000

Lyo Batch Sizes for the Most Readily Available Vial Sizes

* ISO standard and non-standard vials can be accommodated.

Sterile Products

Softgels Shapes and Sizes

Other shapes and sizes available. Formulation can effect options.

Page 3: Patheon Dosage Capabilities

Liquid-Filled Vials— Aseptic filling, terminal sterilization when required— Solutions, suspensions or emulsions— Extensive range of sizes and stopper/cap combinations— Clear or amber glass vials

Lyophilized Vials— World-class scientific and technical expertise— Wide selection of vial sizes, including ISO standard— Small- and large-scale manufacturing

Prefilled Syringes— Broad range of sizes and configurations with handles— Glass or polymeric — Fill range from 0.1 ml to 20 ml

Cartridges — Range of cartridge configurations— Glass or plastic

Bilayer Tablets 2 IRs or IR+CR/SR fixed-dose combination

Trilayer Tablets 3 IRs or IR+placebo+CR/SR fixed-dose combination

Microtablets IR or CR/SR; low-dose tablets; via device, capsule or sachet

Tablets in Capsules IR or CR/SR, over-encapsulation for blinded clinical supply

Chewable Tablets IR or CR/SR single or bilayer fixed-dose combinations; ideal for pediatrics and high-dose compounds

Fast Dispersible Tablets IR, disintegrates/disperses as suspension in water, divisible into 4 parts for titration, ideal for pediatrics

Sublingual Tablets IR, single layer tablets for sublingual administration.

Beads in Hard-Shell Capsules IRs and/or CRs/SRs fixed-dose combination, uncoated or polymer coated; extrusion, spheronization or drug layering

Beads in Liquid-Filled Capsules IRs and/or CRs/SRs fixed-dose combination, hard shell, coated beads in liquid vehicle

Liquid-Filled Capsules IR or CR/SR; hard shell; options to improve solubility, bioavailability and absorption; ideal for Phase I and beyond

Biphasic Liquid-Filled Capsules IR or CR/SR; hard shell; biohasic vehicle to improve solubility, bioavailability and absorption; ideal for Phase I and beyond

Laser-Drilled Controlled-Release Tablets

CR/SR; hard shell; osmotic, zero-order, controlled-release over a defined time period

Hydrophilic Gel Matrix Controlled-release technology

Polymer Matrix Controlled-release technology

Wax Matrix Controlled-release technology

Pulsatile Release Controlled-release technology

Polymer Coating Controlled-release technology

Tablets IR or CR/SR, single-layer tablets, coated or uncoated, with or without break line or embossing, range of shapes and sizes

Powder-Filled Capsules IR, two-piece gelatin or HPMC capsules in a range of sizes and multiple color combinations

Powders, Granules, Coated Beads Multiparticulates

IR, bottles and sachets, packaged in bottles and sachets of varying dimensions and fill weights

Softgel Capsules— Immediate-release soft gelatin capsules— Clinical development scale production— 13.7B capsule commercial manufacturing capacity— Extensive range of sizes, colors and imprinting options

Twist-Off Softgels— Precise unit dosing for oral liquid and topical products— Hermetic seal helps preserve API— Portable convenience improves patient compliance— Consistent dosing for reliable results in clinical trials

EnteriCare® Enteric Softgels— Enteric properties are integrated into the gelatin shell— Eliminates risk of reflux and gastric irritation— Protects acid-labile compounds— Compatible with SMEDDS, hydrophilic and viscous fills

Versatrol™ Controlled-Release Softgels

— Unique matrix system to fine-tune release— Controlled-release capabilities integrated into fill— Lipophilic and hydrophilic formulations— Suitable for compounds with low solubility

Solvatrol™ Enhanced Solubility Softgels

— Enhances the solubility and bioavailability — Lipophilic and hydrophilic formulations— Provides a stable solvent delivery system— Reduces plasma level variability

LiquiSoft™ Chewable Liquid-Filled Softgels

— Solid dose for oral liquid formulations— Soft, chewable shell with a pleasant burst of liquid Enhances

performance of poorly soluble compounds— Flavors and aromas mask unpleasant tastes and odors

Soflet® Gelcaps— Patented technology enrobes tablets— Traditional gelatin or non-animal gelatin— Safely encases highly potent compounds— Perfect for clinical trial blinding

Chewels® Chewable Gels— Chewable for patient comfort and convenience— Rapid onset of action and relief of symptoms— Pursue pediatric and geriatric markets— Patented technology

Conventional Solid Dose Forms

Specialized Solid Dose Forms Softgels

Liqu

id-F

illed

Via

l

Sterile Doses Commercial DevelopmentVial Size* (ml)  Stopper Size (mm) Greenville, USA Monza, Italy Ferentino, Italy Ferentino, Italy Greenville, USA

2 13 l l l l l4 13 l l5 20 l l6 20 l l7 20 l8 20 l l

10 20 l l l l l12 20 l13 1315 20 l20 20/13 l l l l l25 20 l l30 20 l l l l50 20/32 l l60 28 l

100 20/28/32 l200 28/32 l250 32 l300 28 l500 28/32 l

Lyop

hiliz

ed V

ial

2 13/20 l l l l l3 13 l4 13 l5 13/20 l l l l l6 20 l l l l7 20 l8 20 l l l

10 20 l l l l l12 20 l l15 20 l17 20 l20 20 l l l l l25 20 l l30 20 l l50 20 l l

100 20 l

Capsules Required Container Size (cc) by Fill Count

Size Fill Volume Range (CC) 60 Count 100 Count 250 Count 500 Count

Ova

l

2 0.089-0.111 60 60 75 150

3 0.182-0.228 60 75 120 200

4 0.209-0.261 60 100 150 250

5 0.312-0.389 75 100 150 300

6 0.318-0.397 75 100 150 400

7.5 0.386-0.482 75 100 225 400

9 0.469-0.586 100 120 300 600

10 0.567-0.709 100 120 300 600

Obl

ong

3 0.181-0.227 75 75 200 350

4 0.243-0.304 100 120 250 400

5 0.285-0.356 100 120 300 750

6 0.338-0.422 100 120 400 750

8 0.452-0.564 120 200 500 950

14 0.863-1.079 200 300 750 1250

16 0.975-1.218 250 400 950 1500

Rou

nd

2 0.073-0.123 60 60 75 150

3 0.138-0.183 60 75 120 200

4 0.173-0.244 60 100 150 250

5 0.195-0.305 75 100 150 300

6 0.279-0.367 75 100 150 400

7 0.305-0.428 75 100 225 400

15 0.737-0.922 150 225 500 750

Vial SizeMonza, Italy Ferentino, Italy Greenville, USA

Sterile Area 1

Sterile Area 2

Sterile Area 3

Sterile Area 1

Sterile Area 2 Sterile

Area 2Development Sterile Unit

Line 1 Line 2 Line 3Cytotoxic CTM

External OD (mm)

Example Fill2 Twin Lyo

Units2 Twin Lyo

Units2 Twin Lyo

UnitsLyo Unit 1 Lyo Unit 2 3 Lyo Units 3 Lyo Units 3 Lyo Units

16 2, 4 138,000 111,000 127,000 120,000 153,000 37,000 24,000 490,000 318,000 329,000 43,000 8,600

21 5 81,000 65,000 74,000 69,000 89,000 19,000 14,000 295,000 200,000 206,000 27,000 5,400

22 6 73,000 58,000 67,000 67,000 86,000 18,000 12,500 265,000 179,000 185,000 24,000 4,800

24 10, 15 61,000 49,000 55,000 55,000 69,000 14,000 10,000 174,000 117,000 121,000 16,000 3,200

30 20, 25, 30 37,000 30,000 35,000 35,000 45,000 9,500 6,400 142,000 95,000 98,000 13,000 2,600

42 15 17,000 13,000 15,000 17,000 22,000 4,700 3,500 65,000 42,000 44,000 5,000 1,000

Lyo Batch Sizes for the Most Readily Available Vial Sizes

* ISO standard and non-standard vials can be accommodated.

Sterile Products

Softgels Shapes and Sizes

Other shapes and sizes available. Formulation can effect options.

Page 4: Patheon Dosage Capabilities

Liquid-Filled Vials— Aseptic filling, terminal sterilization when required— Solutions, suspensions or emulsions— Extensive range of sizes and stopper/cap combinations— Clear or amber glass vials

Lyophilized Vials— World-class scientific and technical expertise— Wide selection of vial sizes, including ISO standard— Small- and large-scale manufacturing

Prefilled Syringes— Broad range of sizes and configurations with handles— Glass or polymeric — Fill range from 0.1 ml to 20 ml

Cartridges — Range of cartridge configurations— Glass or plastic

Bilayer Tablets 2 IRs or IR+CR/SR fixed-dose combination

Trilayer Tablets 3 IRs or IR+placebo+CR/SR fixed-dose combination

Microtablets IR or CR/SR; low-dose tablets; via device, capsule or sachet

Tablets in Capsules IR or CR/SR, over-encapsulation for blinded clinical supply

Chewable Tablets IR or CR/SR single or bilayer fixed-dose combinations; ideal for pediatrics and high-dose compounds

Fast Dispersible Tablets IR, disintegrates/disperses as suspension in water, divisible into 4 parts for titration, ideal for pediatrics

Sublingual Tablets IR, single layer tablets for sublingual administration.

Beads in Hard-Shell Capsules IRs and/or CRs/SRs fixed-dose combination, uncoated or polymer coated; extrusion, spheronization or drug layering

Beads in Liquid-Filled Capsules IRs and/or CRs/SRs fixed-dose combination, hard shell, coated beads in liquid vehicle

Liquid-Filled Capsules IR or CR/SR; hard shell; options to improve solubility, bioavailability and absorption; ideal for Phase I and beyond

Biphasic Liquid-Filled Capsules IR or CR/SR; hard shell; biohasic vehicle to improve solubility, bioavailability and absorption; ideal for Phase I and beyond

Laser-Drilled Controlled-Release Tablets

CR/SR; hard shell; osmotic, zero-order, controlled-release over a defined time period

Hydrophilic Gel Matrix Controlled-release technology

Polymer Matrix Controlled-release technology

Wax Matrix Controlled-release technology

Pulsatile Release Controlled-release technology

Polymer Coating Controlled-release technology

Tablets IR or CR/SR, single-layer tablets, coated or uncoated, with or without break line or embossing, range of shapes and sizes

Powder-Filled Capsules IR, two-piece gelatin or HPMC capsules in a range of sizes and multiple color combinations

Powders, Granules, Coated Beads Multiparticulates

IR, bottles and sachets, packaged in bottles and sachets of varying dimensions and fill weights

Softgel Capsules— Immediate-release soft gelatin capsules— Clinical development scale production— 13.7B capsule commercial manufacturing capacity— Extensive range of sizes, colors and imprinting options

Twist-Off Softgels— Precise unit dosing for oral liquid and topical products— Hermetic seal helps preserve API— Portable convenience improves patient compliance— Consistent dosing for reliable results in clinical trials

EnteriCare® Enteric Softgels— Enteric properties are integrated into the gelatin shell— Eliminates risk of reflux and gastric irritation— Protects acid-labile compounds— Compatible with SMEDDS, hydrophilic and viscous fills

Versatrol™ Controlled-Release Softgels

— Unique matrix system to fine-tune release— Controlled-release capabilities integrated into fill— Lipophilic and hydrophilic formulations— Suitable for compounds with low solubility

Solvatrol™ Enhanced Solubility Softgels

— Enhances the solubility and bioavailability — Lipophilic and hydrophilic formulations— Provides a stable solvent delivery system— Reduces plasma level variability

LiquiSoft™ Chewable Liquid-Filled Softgels

— Solid dose for oral liquid formulations— Soft, chewable shell with a pleasant burst of liquid Enhances

performance of poorly soluble compounds— Flavors and aromas mask unpleasant tastes and odors

Soflet® Gelcaps— Patented technology enrobes tablets— Traditional gelatin or non-animal gelatin— Safely encases highly potent compounds— Perfect for clinical trial blinding

Chewels® Chewable Gels— Chewable for patient comfort and convenience— Rapid onset of action and relief of symptoms— Pursue pediatric and geriatric markets— Patented technology

Conventional Solid Dose Forms

Specialized Solid Dose Forms SoftgelsLi

quid

-Fill

ed V

ial

Sterile Doses Commercial DevelopmentVial Size* (ml)  Stopper Size (mm) Greenville, USA Monza, Italy Ferentino, Italy Ferentino, Italy Greenville, USA

2 13 l l l l l4 13 l l5 20 l l6 20 l l7 20 l8 20 l l

10 20 l l l l l12 20 l13 1315 20 l20 20/13 l l l l l25 20 l l30 20 l l l l50 20/32 l l60 28 l

100 20/28/32 l200 28/32 l250 32 l300 28 l500 28/32 l

Lyop

hiliz

ed V

ial

2 13/20 l l l l l3 13 l4 13 l5 13/20 l l l l l6 20 l l l l7 20 l8 20 l l l

10 20 l l l l l12 20 l l15 20 l17 20 l20 20 l l l l l25 20 l l30 20 l l50 20 l l

100 20 l

Capsules Required Container Size (cc) by Fill Count

Size Fill Volume Range (CC) 60 Count 100 Count 250 Count 500 Count

Ova

l

2 0.089-0.111 60 60 75 150

3 0.182-0.228 60 75 120 200

4 0.209-0.261 60 100 150 250

5 0.312-0.389 75 100 150 300

6 0.318-0.397 75 100 150 400

7.5 0.386-0.482 75 100 225 400

9 0.469-0.586 100 120 300 600

10 0.567-0.709 100 120 300 600

Obl

ong

3 0.181-0.227 75 75 200 350

4 0.243-0.304 100 120 250 400

5 0.285-0.356 100 120 300 750

6 0.338-0.422 100 120 400 750

8 0.452-0.564 120 200 500 950

14 0.863-1.079 200 300 750 1250

16 0.975-1.218 250 400 950 1500

Rou

nd

2 0.073-0.123 60 60 75 150

3 0.138-0.183 60 75 120 200

4 0.173-0.244 60 100 150 250

5 0.195-0.305 75 100 150 300

6 0.279-0.367 75 100 150 400

7 0.305-0.428 75 100 225 400

15 0.737-0.922 150 225 500 750

Vial SizeMonza, Italy Ferentino, Italy Greenville, USA

Sterile Area 1

Sterile Area 2

Sterile Area 3

Sterile Area 1

Sterile Area 2 Sterile

Area 2Development Sterile Unit

Line 1 Line 2 Line 3Cytotoxic CTM

External OD (mm)

Example Fill2 Twin Lyo

Units2 Twin Lyo

Units2 Twin Lyo

UnitsLyo Unit 1 Lyo Unit 2 3 Lyo Units 3 Lyo Units 3 Lyo Units

16 2, 4 138,000 111,000 127,000 120,000 153,000 37,000 24,000 490,000 318,000 329,000 43,000 8,600

21 5 81,000 65,000 74,000 69,000 89,000 19,000 14,000 295,000 200,000 206,000 27,000 5,400

22 6 73,000 58,000 67,000 67,000 86,000 18,000 12,500 265,000 179,000 185,000 24,000 4,800

24 10, 15 61,000 49,000 55,000 55,000 69,000 14,000 10,000 174,000 117,000 121,000 16,000 3,200

30 20, 25, 30 37,000 30,000 35,000 35,000 45,000 9,500 6,400 142,000 95,000 98,000 13,000 2,600

42 15 17,000 13,000 15,000 17,000 22,000 4,700 3,500 65,000 42,000 44,000 5,000 1,000

Lyo Batch Sizes for the Most Readily Available Vial Sizes

* ISO standard and non-standard vials can be accommodated.

Sterile Products

Softgels Shapes and Sizes

Other shapes and sizes available. Formulation can effect options.

Page 5: Patheon Dosage Capabilities

For more information on our services or products, contact your Patheon Representative or email us at [email protected]

Solid and SterileFinished Dose Forms

All the Choices and Expertise You Need to Succeed

Solid Dose Forms – Specialized and Conventional With the experience of thousands of projects, Patheon provides access to a wide range of conventional solid dose form as well as specialized combinations and controlled-release technologies. All solid dose form choices are carried out with the expansive scientific resources and expertise to build high-quality formulations for even the most complex drug products.

Softgels Bolstered by the acquisition of Banner Pharmacaps, Patheon is your new highly capable ally in the development and manufacture of softgel products. We give you access to a host of patent-protected specialized technologies to meet the specific needs of your molecules and markets. This includes advanced solutions for enhancing solubility and bioavailability, as well as unique controlled-release and oral delivery technologies.

Sterile Products Patheon offers extensive sterile product development and manufacturing capabilities in Europe and North America, including world-class expertise in lyophilization and ready-to-use dose formats. We have developed more than 100 large molecules for customers that include eight of the top ten biotech companies. Because the challenges you face are ones we’ve likely overcome before, you can be confident of your success. That plus our exceptional regulatory track record, Right First Time and On-Time performance, and three consecutive years of European Outsourcing Awards.

Develop and Launch Products Anywhere in the World

Published 9/14 PATH0340R1

Americas Europe

Cincinnati USA

High Point USA

Greenville USA

Toronto Canada

Whitby Canada

Manati Puerto Rico

Mexico City Mexico

Bourgoin France

Monza Italy

Ferentino Italy

Milton Park UK

Swindon UK

Tilburg Netherlands

Solid Dose Forms

Spec

ializ

ed

Trilayer Tablets l l l l lMicrotablets l l

Beads in Capsules l l lCoated Beads l l l

Tablets in Capsules l l lFast Dispersible Tablets l l l l l

Laser-Drilled Controled-Release Tablets l l l l l lLiquid-Filled Capsules l

Biphasic Liquid-Filled Capsules l l lBilayer Chewable Tablets l l

Beads in Liquid-Filled Capsules l l l lHydrophilic Gel Matrix l

Polymer Matrix l l l l l l lWax Matrix l l l

Pulsatile Release l l lPolymer Coating l l l l

Sublingual Tablets l l l l l

Con

vent

iona

l Uncoated l l l l l l l lCoated l l l l l l l l

Powder-Filled Capsules l l l l l l l lPowders and Granules l l l l l l l l

Coated Beads l l lMultiparticulates l l l

Softg

els

Softgel Capsules l l lTwist-Off Softgels l l l

EnteriCare® Enteric Softgels l l lLiquiSoft™ Chewable Liquid-Filled Softgels l l l

Versatrol™ Controlled-Release Softgels l lSolvatrol™ Enhanced Solubility Softgels l l

Soflet® Gelcaps l lChewels® Chewable Gels l l

Sterile Products

Vials l l l lLyophilized Vials l l l l

Prefilled Syringes lCartridges l

US HeadquartersPatheon Inc. 4721 Emperor Blvd, Suite 200 Durham, NC 27703-8580 USA P: +1 919 226 3200 F: +1 919 474 2269 www.patheon.com

European Headquarters Patheon UK Ltd. Kingfisher Drive Covingham, Swindon Wiltshire SN3 5BZ UK P: +44 1793 524411 F: +44 1793 487053 www.patheon.com

Japan Office Patheon K.K. 7F Wakamatsu Building, 3-3-6 Nihonbashi Hon-cho, Chuo-ku, Tokyo 103-0023 Japan P: +81 3 6202 7666 F: +81 3 6202 7676 www.patheon.com/home-japan.aspx

Page 6: Patheon Dosage Capabilities

For more information on our services or products, contact your Patheon Representative or email us at [email protected]

Solid and SterileFinished Dose Forms

All the Choices and Expertise You Need to Succeed

Solid Dose Forms – Specialized and Conventional With the experience of thousands of projects, Patheon provides access to a wide range of conventional solid dose form as well as specialized combinations and controlled-release technologies. All solid dose form choices are carried out with the expansive scientific resources and expertise to build high-quality formulations for even the most complex drug products.

Softgels Bolstered by the acquisition of Banner Pharmacaps, Patheon is your new highly capable ally in the development and manufacture of softgel products. We give you access to a host of patent-protected specialized technologies to meet the specific needs of your molecules and markets. This includes advanced solutions for enhancing solubility and bioavailability, as well as unique controlled-release and oral delivery technologies.

Sterile Products Patheon offers extensive sterile product development and manufacturing capabilities in Europe and North America, including world-class expertise in lyophilization and ready-to-use dose formats. We have developed more than 100 large molecules for customers that include eight of the top ten biotech companies. Because the challenges you face are ones we’ve likely overcome before, you can be confident of your success. That plus our exceptional regulatory track record, Right First Time and On-Time performance, and three consecutive years of European Outsourcing Awards.

Develop and Launch Products Anywhere in the World

Published 9/14 PATH0340R1

Americas Europe

Cincinnati USA

High Point USA

Greenville USA

Toronto Canada

Whitby Canada

Manati Puerto Rico

Mexico City Mexico

Bourgoin France

Monza Italy

Ferentino Italy

Milton Park UK

Swindon UK

Tilburg Netherlands

Solid Dose Forms

Spec

ializ

ed

Trilayer Tablets l l l l lMicrotablets l l

Beads in Capsules l l lCoated Beads l l l

Tablets in Capsules l l lFast Dispersible Tablets l l l l l

Laser-Drilled Controled-Release Tablets l l l l l lLiquid-Filled Capsules l

Biphasic Liquid-Filled Capsules l l lBilayer Chewable Tablets l l

Beads in Liquid-Filled Capsules l l l lHydrophilic Gel Matrix l

Polymer Matrix l l l l l l lWax Matrix l l l

Pulsatile Release l l lPolymer Coating l l l l

Sublingual Tablets l l l l l

Con

vent

iona

l Uncoated l l l l l l l lCoated l l l l l l l l

Powder-Filled Capsules l l l l l l l lPowders and Granules l l l l l l l l

Coated Beads l l lMultiparticulates l l l

Softg

els

Softgel Capsules l l lTwist-Off Softgels l l l

EnteriCare® Enteric Softgels l l lLiquiSoft™ Chewable Liquid-Filled Softgels l l l

Versatrol™ Controlled-Release Softgels l lSolvatrol™ Enhanced Solubility Softgels l l

Soflet® Gelcaps l lChewels® Chewable Gels l l

Sterile Products

Vials l l l lLyophilized Vials l l l l

Prefilled Syringes lCartridges l

US HeadquartersPatheon Inc. 4721 Emperor Blvd, Suite 200 Durham, NC 27703-8580 USA P: +1 919 226 3200 F: +1 919 474 2269 www.patheon.com

European Headquarters Patheon UK Ltd. Kingfisher Drive Covingham, Swindon Wiltshire SN3 5BZ UK P: +44 1793 524411 F: +44 1793 487053 www.patheon.com

Japan Office Patheon K.K. 7F Wakamatsu Building, 3-3-6 Nihonbashi Hon-cho, Chuo-ku, Tokyo 103-0023 Japan P: +81 3 6202 7666 F: +81 3 6202 7676 www.patheon.com/home-japan.aspx