Inhalation

INH0820

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This special section, presented as service to our readers, is a quick reference guide….A list of companies whose ads appear in this issue 30 AUGUST 2018 Inhalation Capsugel, Lonza Pharma & Biotech Lonza Pharma & Biotech o ers a full range of services, from proof of concept (POC) and formulation identi cation to powder manufac- ture for clinical studies, cGMP manufacturing and capsule lling optimized for respiratory drug development. https://go2.lonza.com/rs/552- NMO-481/images/Lonza- SMM- PulmonaryDelivery- TechBrief.pdf Proveris ® Laboratories Proveris Laboratories will partner with you to use its 25+ years' experience in the ONIDP space to help you complete your develop- ment projects on time and bud- get. Testing includes traditional US FDA required analytical meth- ods as well as new contract ser- vice o erings to support alterna- tive approaches to in vitro bio- equivalence outlined in the recent US FDA Guidances. https://www.proveris.com/ why-proveris/ MSP MSP, a Division of TSI, has devel- oped a new tool to help guide developers through selecting the recommended pharmaceutical inhalation testing system for their application. https://www.tsi.com/MSP- Pharmaceutical-Inhalation- Product-Selector/ Experic Experic's experienced team pro- vides customized and scalable lling, packaging and logistics solutions at clinical and com- mercial scale for reservoir and single-dose dry powder inhala- tion devices. https://expericservices.com/ services/drypowderinhalation/ ?utm_source=inhalation_maga zine&utm_medium=literature _review&utm_campaign= 0036-ongoing-media-support Hovione With 60 years of experience in t h e m a n u f a c t u r e of A c t i v e Pharmaceutical Ingredients, Hovione is a leader in the scien- ti c understanding and particle characterization of drug sub- stances for nasal and inhalation complex generics. https://www.hovione.com/ products-and-services/patent- api-products Delivering the Quality Target Product Profile (QTPP) of a generic of a suspension-based Nebulization, MDI or Nasal product or that of a DPI requires establishment of the physical, chemical and microbiological characteristics of the Drug Substance from an early development stage to ensure the desired product performance. Hovione's QbD development approach guarantee that crystallization, drying and milling processes are designed to meet the Critical Quality Attributes (CQAs) of the Active Pharmaceutical Ingredient (API) while providing a future robust scaling-up, manufacturing consistency and reproducible product quality. FDA's regulatory science advancements in establishing alternative in-vitro bioequivalence pathways to the comparative clinical endpoint bioequivalence constitute an enormous opportunity to lower development costs of OINDPs and increase patient's accessibility to inhalation drugs. Such vital opportunity can only be fully materialized by knowledge exchange between the API supplier and the Drug Product manufacturer to intersect the morphic and morphologic properties of the Drug Substance with the required performance of the Generic drug product. FDA has issued Product Specific Guidances for nasal and MDI suspensions which provide alternate approaches based on validated advanced particle characterization methodologies to accurately measure the T/R comparability and demonstrate in-vitro bioequivalence. Nasal and Inhalation APIs at Hovione Fluticasone propionate Fluticasone furoate Mometasone furoate Salmeterol Xinafoate Glycopyrrolate Albuterol/ Salbutamol Vilanterol Umeclinidium Aclinidium The Critical Attributes of the Drug Substance in the development of Inhalation and Nasal Generics SEM images of Hovione's Salmeterol Xinafoate Inhalation Grade Jet-Milled (Left) and Wet-Polished (Right) "We do well what is difficult, to give our customers what they cannot find elsewhere" Hovione has over 60 years of experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product. With four FDA inspected sites in the USA, China, Ireland and Portugal, Hovione offers off-patent APIs for complex generics and repurposed drugs and contract development and manufacturing services for clinical and commercial supplies. https://www.hovione.com/products-and- services/patent-api-products ADVERTISER INDEX A Astech 7 C Catalent Pharma Solutions Cover 2 Cliantha Research 19 Copley Scienti c 3 E Experic 9 H Hovione 31 L Lonza/Capsugel 17 M Merxin Ltd. 8 MSP, a division of TSI 1 P Proveris 27 R RDD 5

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