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Technical articles presented by Inhalation’s advertisers as a service to readers. Content is provided by companies, with no preference intended. These technical articles are presented as a service to the readers of Inhalation. Click on the link to access the full article or type in the URL as shown. Content is provided by the companies listed. No product endorsement or preference is intended. White Papers Selecting a dosage form for drug delivery to the lungs Selecting a dosage form is a vi- tal part of inhalation product de- velopment programs. Download Recipharm's white paper to nd out more about the consider- ations when evaluating the most appropriate nished prod- uct for delivery to the lungs. https://www.recipharm.com/ sites/default/files/media/ Whitepaper_Selecting a % 2 0 d o s a g e % 2 0 f o r m _ 2017_0.pdf Advantages of capsule- based dry powder inhalers Pulmonary drug delivery is fo- cused on developing simple, cost-e ective devices that are able to administer consistent amounts of drug with high lev- els of lung penetration and al- low for multiple dosage. One attractive aspect of a cap- sule-based dry powder inhaler (DPI) is its simplicity. https://qualicaps.com/en/ knowhow/Library/Capsules/ articles Fast-screening impactor MSP has developed a new fast-screening impactor for R&D and QbD applications of inhaler testing based on its proven NGI technology. Full description available at: http://www.mspcorp.com/ products-detail.php/pharma ceutical/model-m185-fast- screening-impactor Using breathing simula- tors to enhance inhaled product testing Mark Copley, Sales Director, Copley Scienti c This white paper looks at the ca- pabilities o ered by advanced breathing simulator technology and reviews their application in OIP testing. It covers USP/Ph.Eur, testing of nebulizers and MDIs with spacers/VHCs and im- proved IVIVRs for MDIs and DPIs. http://www.copleyscientific. com/ les/ww/news/COP J O B % 2 0 2 5 1 _ U s i n g % 2 0 breathing simulators t o % 2 0 e n h a n c e % 2 0 i n h a l e d % 2 0 p r o d u c t % 2 0 testing.pdf SELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS Poonam Sheth, PharmD, PhD, Research Scientist, Inhalation Matthew T. Marmura, Research Scientist, Inhalation Recipharm is frequently asked to help its clients select and develop an appropriate dosage form for their inhalation product development programs. When choosing between metered dose inhaler (MDI), dry powder inhaler (DPI) and nebulised dosage forms, a wide range of technical, business and regulatory factors are worthy of evaluation. A few of those key considerations are discussed below. PHYSICOCHEMICAL FACTORS Salt form screening is an important early step in inhalation dosage form selection. Approximately 50% of active pharmaceutical ingredients (APIs) in approved products are salt forms 1 , and that proportion is slightly higher (~ 60%) for APIs in approved inhalation products. For each type of formulation (e.g. solution versus suspension) or dosage form, it is conceivable that a different salt form will be most amenable for development. As with all pharmaceutical development, understanding the physical and chemical properties of the active pharmaceutical ingredient (API), and its different forms if applicable, is critical in defining the dosage form design space. The following API characterisation studies may be warranted based on the inhalation formulations and dosage forms under consideration: MDIs and nebulised products may be formulated as solutions or suspensions. For a solution formulation, the API should be completely soluble in the formulation, with a safety margin to prevent precipitation during cold temperature excursions. For a suspension formulation, the API should be essentially insoluble in the formulation (e.g. < 0.1 ppm solubility 2 ), otherwise crystal growth ("Ostwald ripening") may occur. Most marketed MDIs are suspensions due to the challenges of solubilising APIs in hydrofluoroalkane (HFA) formulations. If solubilised, for example with the assistance of a co-solvent such as ethanol, chemical stability can then be an issue. As an early step in MDI formulation feasibility, Recipharm can evaluate solubility of the API in HFA formulations, as well as chemical stability. In contrast to MDIs, most nebulised products are solution formulations. But the solubility considerations for solutions and suspensions are the same as outlined above for MDIs. 1/6 Polymorph screening Amorphous content Hygroscopicity and moisture content Surface properties Solubility in the formulation matrix Morphology and size Density Flowability Chemical /physical stability Excipient and device compatibility QbD improves quality, safety and ef cacy Proveris Scienti c's QbD ap- proach helps customers acceler- ate successful development of inhaled and nasal drug products and e ective manufacturing pro- cesses for released products. goproveris.com/QbD NEW AT UPCOMING CONFERENCES To be featured at CPhI, AAPS and DDL Please visit Inhalation's advertisers who will be exhibiting at CPhI, AAPS or DDL. The following web page is updated several weeks before each conference and features information on the products and services the companies will be exhibiting. http://www.inhalationmag.com/ digital/INH_upcoming/INH_new_ upcoming.html