This Month’s Special Section: Filling and Packaging
Exploring new pMDI propellants for a greener future
The Kigali Amendment to the Montreal Protocol aims to phase-down global HFA consumption. While volumes of hydrofluoroalkane (HFA) gases used by the inhalation and respiratory healthcare industry are relatively small, it is likely we will see supply shortages in the future as other industries completely phase out their use. This article discusses ways the inhalation industry can prepare for and be ready to adopt new propellants to guarantee continued, reliable manufacture and supply of vital medicines for patients.
The Kigali Amendment and the Paris Agreement: What’s the difference?
A useful explanation is provided in a table that compares the Kigali Amendment to the Montreal Protocol and the Paris Agreement, with respect to substances, goals, criteria for entering into force, differences between developing/developed countries, approach and compliance. Reprinted with kind permission of the Montreal Protocol Division at the United Nations Industrial Development Organization (UNIDO).
General Features
How critical quality attributes of the drug substance can support orally inhaled and nasal drug product (OINDP) quality
This article presents case studies and highlights ways key physical properties of drug substance particles might be adjusted and measured to meet a quality target product profile (QTPP). Morphic form, particle shape and surface characterization were studied and a variety of analytical techniques were used. Characterization results for fluticasone propionate, fluticasone furoate, vilanterol trifenatate and/or salmeterol xinafoate powders, micronized by jet milling and/or wet polishing, and various process parameters for the techniques, are discussed.
Cross-Industry Organizations: IPAC-RS Regulatory Roundtable Series: A conversation with the US FDA: Perspectives in the time of COVID-19
This roundtable discussion among representatives of IPAC-RS and the US FDA covered a range of topics that have been top-of-mind for the OINDP industry during the COVID-19 pandemic. These include the global supply chain, inspections, audits, technology transfer and clinical trials. The FDA panelists also proved an update on the CMC MDI DPI guidance. All of the panelists agreed there will be many learnings from COVID-19 that will bring positive and lasting improvement.
Back Page: FARE announces $3 million global research competition and passage of FASTER Act in US
FARE (Food Allergy Research & Education) recently launch a global research competition, with $3 million in prize money, for development of a new diagnostic test to identify allergies in patients. They also announced passage of a new law in the United States requiring labeling of sesame in packaged foods and additional government focus on food allergy research.
August Content
Efficient data analysis (EDA): Size, mass and common sense
Applications of surface analytical techniques in characterization of dry powder formulations
Cross-Industry Organizations: The Aerosol Society and Drug Delivery to the Lungs 2021
Back Page: Strategies for improving inhalation technique in children
Issue Focuses
January: Reference and Buyer’s Resource
February: Product Development/ Contract Testing
April: Instruments
June: Nasal Delivery/Nebulizers
August: Particle Characterization
October: Devices
December: Quality/Compliance
Vicki Schuman
1155 Northland Drive
St. Paul, MN 55120
651-287-5600
Fax 651-287-5650
vschuman@cscpub.com
Inhalation Article Guidelines
Technical article requirements
The article should be technical and educational, but not promotional. It must be new, not previously published and must be at least 50% different from your previous articles or other articles you are simultaneously developing on the same subject.
All discussions of products or technologies must be in an unbiased, non-promotional, educational manner. If your article discusses products that have been commercialized or are in development, please be aware of the following: Inhalation takes a very limited approach in discussing products, usually listing only product name, delivered drug name and company name, unless a description is provided by the particular company that owns a product, such as in a case study article or product news release. In that way, each company can choose the information it wishes to discuss or disclose about its own products, rather than being discussed by an outside party with no ability to comment prior to publication. However, if an article is a case study, presentation of a novel technology or news article written by the owner company or its representative such as a scientist or consultant, we are happy to consider all information or data they wish to disclose, provided it is presented in a fair-balanced manner. Also, please avoid discussing product or development costs and do not make cost comparisons.
The article should be 2,500-3,500 words and must include at least five references or items for recommended reading.
We encourage images and/or data tables and have space for three or four of them. We’re flexible about that number so let us know if you need more image space. We also like to publish an additional photo or illustration at the beginning of the article. Images should be sent as separate files that meet the following specifications: high resolution, 300 dpi at a size of 7 x 7 inches and in only JPG, TIF or EPS formats.
Please be aware, due to copyrights, if you use figures or tables from articles that have been previously published in other journals, you must obtain permission from those journals in order to use the images. If you are an author on the published article in question, you may still need permission but there should be no fees from the other journal. If you are not an author and the other journal wants to charge you fees for usage, please contact us before proceeding. We do not want authors incurring costs in order to publish in Inhalation and there may be alternate approaches to citing information that could be used. Also, “open journals” do not charge for image use. If you have any questions or concerns, please contact us.
Editorial board review and production
All of our articles are peer-reviewed and must be accepted by our editorial board or a designated reviewer in order to be published. When you send us the article, it will go to a member of the board and we will coordinate communication between you. Once an article is accepted, we handle production and you will see the final article in layout before it goes to print or is published in the digital edition.
Contract Testing
Excipients
