Solid and sterile finished dosage forms. Delivered.

Transcription

1 Solid and sterile finished dosage forms. Delivered.

2 This is where your discoveries take form. Oral Solids Access a remarkable range of conventional and specialized oral solid dosage form capabilities and scale. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies. All these choices are executed with expansive scientific resources, expertise in complex formulations such as, solubility enhancement and capabilities for highly potent compounds and controlled substances. Tap the many clinical and technical advantages of softgels with a host of patent-protected specialized technologies. These include advanced solutions for enhancing solubility and bioavailability, as well as unique controlledrelease and oral delivery technologies. Create a product that stands out in the marketplace with a broad palette of shapes, sizes and colors. s Extensive sterile pharmaceutical development and manufacturing capabilities at all scales. Specialized expertise in terminal sterilization, aseptic processes and lyophilization. Dosage formats include a wide array of vial shapes, sizes and stoppers. You ll also have access to a state-of-the-art, commercialscale cgmp manufacturing suite for prefilled syringes and cartridges. 30 pre-approval inspection waivers

3 Specialized oral solids Bilayer Tablets Trilayer Tablets 2 IRs or IR+CR/SR fixed-dose combination. 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, biphasic vehicle to improve solubility, bioavailability and absorption. Ideal for Phase I and beyond. Laser-Drilled Controlled-Release Tablets CR/SR, osmotic, zero-order, controlled-release over a defined time period. Hydrophilic Gel Matrix Polymer Matrix Wax Matrix Pulsatile Release Conventional oral solids Polymer Coating Tablets Powder-Filled Capsules IR or CR/SR, single-layer tablets, coated or uncoated, with or without break line or embossing, range of shapes and sizes. IR, two-piece gelatin or HPMC capsules in a range of sizes and multiple color combinations. Powders, Granules, Coated Beads and Multiparticulates IR, packaged in bottles and sachets of varying dimensions and fill weights.

4 Softgel Capsules Twist-Off EnteriCare Enteric Versatrol Controlled-Release Solvatrol Enhanced Solubility LiquiSoft Chewable Liquid-Filled Soflet Gelcaps Chewels Chewable Gels Immediate-release soft gelatin capsules. Clinical development scale production. 13.7B capsule commercial manufacturing capacity. Extensive range of sizes, colors and imprinting options. 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. 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. Unique matrix system to fine-tune release. Controlled-release capabilities integrated into fill. Lipophilic and hydrophilic formulations. Suitable for compounds with low solubility. Enhances solubility and bioavailability. Lipophilic and hydrophilic formulations. Provides a stable solvent delivery system. Reduces plasma level variability. Solid dose for oral liquid formulations. b bsoft, chewable shell with a pleasant burst of liquid. Enhances performance of poorly soluble compounds. Flavors and aromas mask unpleasant tastes and odors. Patented technology enrobes tablets. Broad array of color and imprinting choices. Safely encases highly potent compounds. Perfect for clinical trial blinding. Chewable for patient comfort and convenience. Rapid onset of action and relief of symptoms. Ideal for pediatric and geriatric markets. Patented technology. Softgel shapes and sizes Oval Oblong Round Capsules Required Container Size (cc) by Fill Count Size Fill Volume Range (CC) 60 Count 100 Count 250 Count 500 Count Other shapes and sizes available. Formulation can effect options.

5 s Liquid-Filled Vials Lyophilized Vials Prefilled Syringes Aseptic filling, terminal sterilization when required. Solutions, suspensions or emulsions. Extensive range of sizes and stopper/cap combinations. Clear or amber glass. World-class scientific and technical expertise. Wide selection of vial sizes, including ISO standard. Small- and large-scale manufacturing. Broad range of sizes and configurations with handles. Fill range from 0.1 ml to 20 ml. Glass or polymeric. Cartridges Range of cartridge configurations. Glass or polymeric. Liquid-Filled Vial Lyophilized Vial Dosage Format Commercial Development Vial Size* (ml) Stopper Size (mm) Greenville, Ferentino, Monza, Greenville, Ferentino, / / /28/ / / / / Lyophilization batch sizes for the most available vial sizes. External OD (mm) Vial Size Example Fill Line 1 Line 2 Line 3 3 Lyo Units 3 Lyo Units Greenville, Ferentino, Monza, 3 Lyo Units Cytotoxic CTM Area 1 Lyo Unit 1 Area 2 Lyo Unit 2 Area 2 Development Unit Area 1 2 Twin Lyo Units Area 2 2 Twin Lyo Units Area 3 2 Twin Lyo Units 16 2, 4 490, , ,000 43,000 8, , ,000 37,000 24, , , , , , ,000 27,000 5,400 69,000 89,000 19,000 14,000 81,000 65,000 74, , , ,000 24,000 4,800 67,000 86,000 18,000 12,500 73,000 58,000 67, , , , ,000 16,000 3,200 55,000 69,000 14,000 10,000 61,000 49,000 55, , 25, ,000 95,000 98,000 13,000 2,600 35,000 45,000 9,500 6,400 37,000 30,000 35, ,000 42,000 44,000 5,000 1,000 17,000 22,000 4,700 3,500 17,000 13,000 15,000 * ISO standard and non-standard vials can be accommodated.

6 A world of choices. Delivered. Cincinnati High Point North America Greenville Toronto Canada Whitby Canada Manati Bourgoin Puerto Rico France Monza Ferentino Europe Milton Park U.K. Swindon U.K. Tilburg Netherlands Oral Solid Dosage Forms Specialized Conventional Bilayer Tablets Trilayer Tablets Microtablets Beads in Capsules Coated Beads Tablets in Capsules Fast-Dispersible Tablets Laser-Drilled Controlled-Release Tablets Liquid-Filled Capsules Biphasic Liquid-Filled Capsules Bilayer Chewable Tablets Beads in Liquid-Filled Capsules Hydrophilic Gel Matrix Polymer Matrix Wax Matrix Pulsatile Release Polymer Coating Sublingual Tablets Uncoated Coated Powder-Filled Capsules Powders and Granules Multiparticulates Softgel Capsules Twist-Off EnteriCare Enteric LiquiSoft Chewable Liquid-Filled Versatrol Controlled-Release Solvatrol Enhanced Solubility Dosage Forms Soflet Gelcaps Chewels Chewable Gels Liquid-Filled Vials Lyophilized Vials Prefilled Syringes Cartridges

7 PATHEON

8 80% of our clients are emerging or midsize 75 number of countries products we make are distributed to 33% of products we develop, we manufacture Patheon 4815 Emperor Blvd, Suite 300 Durham NC P: F: Patheon Kingfisher Drive Covingham, Swindon Wiltshire SN3 5BZ UK P: F: Patheon 7F Wakamatsu Building, Nihonbashi Hon-cho, Chuo-ku, Tokyo Japan P: F: PATHEON a a doingbusiness@patheon.com Published 9/15 PATH0340R3