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DRUG DELIVERY SYSTEMS

DRUG DELIVERY SYSTEMS

MUCOSAL THIN FILMS DeliverybyDesign

n Redefine your drug… through formulation

n Redefine your patient… through convenience ORAL THIN FILMS

n Redefine your brand… through enhancement

TRANSDERMAL PATCHES

For more information visit www.adhesivesresearch.com/healthcare/arx

400 Seaks Run Rd. Glen Rock, PA 17327 USA Toll Free: (800) 445-6240 Phone: (717) 227-3326 Fax: (717) 227-8274 The entire contents of this brochure are subject to copyright protection. Copyright @2014. All rights reserved. Printed in USA. in Printed reserved. rights All @2014. Copyright protection. copyright to subject are brochure this of contents entire The ARx broch-final_Layout 1 10/29/14 4:33 PM

Drug Delivery Systems Delivery byDesign Leveraging strong competencies in formulation and processing, ARx’s delivery ARx, LLC Specialty Drug Product Development Process Development expertise is focused on transdermal and As an extension of your project team, ARx supports drug product filings and Optimization mucosal, including oral, buccal, and Delivery Systems are custom well beyond formulation and manufacturing. Our cross-functional ARx engineering and manufacturing sublingual routes of administration. designed to meet the specific needs team works collaboratively with each partner throughout the design experts develop processes based on control process to deliver supporting documentation for all chemistry, Quality by Design (QbD) principles, of the patient and therapeutic manufacturing and controls (CMC) elements. With continually assuring efficient scale-up from Mucosal Thin Films expanding in-house capabilities, ARx leads projects to achieve the indication. As an industry-leading initial feasibility trials through ultimate goal of commercialization. product registration and developer and manufacturer of commercial launch. Each drug Soluble Backing Formulation Development product is designed with a drug-loaded dissolvable film and ARx is a leader in developing custom thin film products by leveraging fundamental understanding Drug-Loaded-Mucoadhesive patch delivery systems for transdermal over 50 years of formulation and science expertise. of the formulation, excipients and processing Formulations are carefully designed to: equipment elements to achieve a robust, repeatable and mucosal, including oral, buccal, process that ensures uniformity in each unit dose. n achieve the target physical and chemical properties in each delivery system sublingual, routes of administration, Quality & Regulatory Support Oral Thin Films our work enhances the safety and n ensure the intended pharmacokinetic and With a team of pharmaceutical industry specialists pharmacodynamic profile dedicated to ensuring compliance with the relevant Soluble delivery profiles for new and existing n provide convenience for the patient in both branded monographs, agency requirements and current Good and applications. Manufacturing Practices (cGMPs), ARx focuses on Drug-Loaded-Film . Each system is formulated to delivering safe and efficacious products. We have an excellent regulatory inspection history and project improve patient compliance through Product Characterization and Testing experience that spans a range of therapies in support Our design efforts are supported by extensive product characterization easy and discrete dosing, when of ANDA and NDA applications. capabilities for APIs, excipients, developmental prototypes and drug compared to traditional dosage products to achieve robust product formulations. By characterizing products and understanding the fundamental behavior of each Commercial Manufacturing Transdermal Patches forms. The result is optimized excipient, the ARx team increases the likelihood for success in The ultimate ARx product development goals are: drug usage and enriched patient clinical trials and product filing. n regulatory approval well-being, yielding overall brand n reliable commercial supply Backing Membrane n favorable patient outcomes enhancement for our partners. Drug-Loaded-Adhesive Commercial production occurs with highly trained and experienced personnel operating within the framework Rate Controlling of a strong Quality System. Our GMP suites have an Membrane expansive range of mixing and coating capabilities for Skin Contact Adhesive incorporating APIs into dissolvable films and adhesive coatings under 21 CFR 211. Reliable supply is assured Release Liner through continually monitoring production capacity in consideration of market fluctuations and client needs.

Learn more about ARx and the specific benefits of thin Product Development Formulation Expertise Process Development Elements Quality and Regulatory Support Commercial Support film and patch delivery at: n Excipient procurement & qualification n 50 + years foundational knowledge n Critical parameter identification n FDA registered and cGMP compliant n cGMP manufacturing suites www.adhesivesresearch.com/ n Analytical method development & n Collaborative intellectual property n Cleaning verifications and validation n Raw material support packages n Product launch and reliable healthcare/arx validation strategy n GMP clinical and registration batch n Supplier quality management commercial supply n Stability study management n Single and multi-layer system design production n API, excipient and product release n Annual product review n Phase I & II clinical production n Critical target product profile and n Process optimization for and certification n Life cycle management n PMP-certified project management critical quality attributes definition commercialization n CMC filing support n Next generation technologies n Success in downstream processing n Process validation