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To contribute to reducing the risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals and nutritional supplements, Asahi Kasei now offers Ceolus microcrystalline cellulose (MCC) with nitrite levels of 0.1 microgram/g (ppm) or less. In 2018, a potentially carcinogenic nitrosamine impurity was detected in several pharmaceuticals. Since then, public awareness of the potential health hazards of nitrosamine has increased significantly worldwide. Guided by regional authorities such as the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA), the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of the impurities. One risk factor for the formation of nitrosamine is nitrosation - a reaction of secondary or tertiary amines with nitrites during or after the manufacturing process of drug substances and drug products. Reducing the concentration of nitrites in raw materials for pharmaceuticals is considered to be an effective way to lower the risk of nitrosamine formation. Asahi Kasei has been manufacturing Ceolus microcrystalline cellulose (MCC) in Nobeoka, Miyazaki, Japan since 1970. MCC is made from natural pulp, mainly used as an excipient for pharmaceuticals, nutritional supplements, and foods. Ceolus is primarily used as a tablet binder, an additive that provides shape and increases the volume of pharmaceutical tablets. High-performance grades of Ceolus in particular enable pharmaceutical and nutritional supplement manufacturers to realize challenging formulations, solve tableting issues, and produce unique and patient-friendly dosage forms. In order to reduce potential health hazards due to nitrosamine impurities, Asahi Kasei has succeeded in maintaining the nitrite concentration of Ceolus to 0.1 ppm or less. In Jan 2024, Asahi Kasei started full commercial operation of its second manufacturing facility for Ceolus at its Mizushima Works in Okayama Prefecture, Japan. This not only raises supply capacity but also enhances the stability of supply through production at multiple sites. Original source: Asahi Kasei Corp, website: https://www.asahi-kasei.com/, Copyright Asahi Kasei Corporation 2024., new material; plant restructuring; additives; cellulose; Ceolus; pharmaceutical excipients; Asahi [...]

Celanese Corporation, a global speciality materials and chemical company, announced on 12 Sep 2023 that it has entered into an agreement with the Population Council to supply its VitalDose Drug Delivery Platform for use in a new Multipurpose Prevention Technology (MPT) Intravaginal Ring (IVR). The IVR is being developed to provide both contraception and protection against HIV and is currently in a phase 1b clinical trial. Long-acting continuous drug delivery dose forms, like IVRs, offer fewer barriers to reliable use than oral forms requiring daily doses. Providing benefits for patients, like enhanced convenience, can lead to better outcomes and is the driver for developing patient-centric dose forms. The VitalDose Drug Delivery Platform has been used in patient-centric dose forms in women's health for over two decades, offering tuneable and consistent elution for a variety of active pharmaceutical ingredient (API) molecules. The VitalDose Drug Delivery Platform provides reliable, controlled-release performance for a wide range of molecule types and has a long history of use in approved parenteral drug products in the United States, Europe and many other geographies. Original source: Celanese, website: http://www.celanese.com/, Copyright Celanese Corporation 2023., sales agreement; drug delivery systems; pharmaceutical ingredients; VitalDose Drug Delivery Platform; [...]

UBE Corporation and HiLung Inc have received Orphan Drug Designation (ODD) from US Food and Drug Administration (FDA) for HL001 - a novel lysophosphatidic acid receptor-1 (LPA1) antagonist under joint development for idiopathic pulmonary fibrosis (IPF). IPF is an increasingly-debilitating chronic disease characterized by fibrosing stiff lungs and diminishing lung vital capacity, leading to an average mortality of over 50% in five years after diagnosis - the course of which has been overwhelmingly irreversible. HL001 is a promising drug candidate supported by a public R&D grant from AMED (Japan Agency for Medical Research and Development - the governmental funding agency for health sciences) with its 'Support Program for Orphan drug prior to Designation' intended for likely orphan therapeutics. US FDA has now granted ODD for HL001, based on preclinical datasets we submitted demonstrating plausible efficacy, including results from our unique in vitro pulmonary fibrosis assay that replicates pathologic shrinking and curative re-expansion in human induced pluripotent stem cell (iPSC)-derived alveolar organoids. This Designation allows for preferential incentives and R&D support from the FDA and other Federal Agencies, including a waiver of User Fee charged upon New Drug Application (NDA), deduction of Federal tax for clinical development, and a potential seven-year exclusivity once the drug is approved. These and other forms of support from public agencies will further accelerate the development of HL001, by facilitating multi-national, multi-institutional clinical trials that would be critical in drug development for rare diseases. Original source: Ube Industries Ltd, website: http://www.ube-ind.co.jp/, Copyright Ube Industries Ltd 2023., joint venture; regulations and rulings; research and development; respiratory disease treatments; HiLung; [...]

On 23 Dec 2022, Asahi Kasei Pharma obtained approval to manufacture and sell Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg (generic name: isavuconazonium sulfate, development code: AK1820) in Japan for treatment of the fungal infections of aspergillosis, mucormycosis, and cryptococcosis. Isavuconazonium sulfate was created as a new antifungal agent by Basilea Pharmaceutica International Ltd, Allschwil (Basilea) of Switzerland. Asahi Kasei Pharma obtained exclusive rights to develop and commercialize isavuconazonium sulfate in Japan in Sep 2016, and after advancing its development, applied for approval to manufacture and sell it in Japan in Sep 2021. Original source: Asahi Kasei Corp, website: http://www.asahi-kasei.co.jp/asahi/en/, Copyright Asahi Kasei Corporation 2022., patents and technical know-how; regulations and rulings; antifungal drugs; Cresemba; isavuconazonium sulfate; Asahi Kasei Pharma; Basilea Pharmaceutica [...]

Throughout the pandemic, Stepan Company has responded to a surge in demand for cleaning, disinfection and personal wash products by increasing the production of key ingredients that contribute to the fight against the coronavirus. Stepan currently offers 35 end-use products (EUP) on the US Environmental Protection Agency's (EPA) list of disinfectants (List N) that the EPA expects to kill SARS-CoV-2, the virus that causes COVID-19. Of these 35 EUPs, 28 have off-label Emerging Viral Pathogen (EVP) claims and 13 have on-label SARS-CoV-2 claims (a given EUP can have one or both claims), allowing our customers to make statements regarding the efficacy of these products against SARS-CoV-2. Approved product applications include ready-to-use wipes, pump sprays and dilutable concentrate options. The EPA has recently approved five more Stepan Company end-use formulations as effective against SARS-CoV-2. These formulations are approved to kill the virus when used on hard, non-porous surfaces. Original source: Stepan, website: https://www.stepan.com, Copyright Stepan Company 2022., regulations and rulings; disinfectants; [...]

Mitsui Chemicals Inc announced on 29 Nov 2021 that its YOHTOL product range has been proven effective against viruses. YOHTOL is a range of iodine-based antibacterial and anti-mould agents containing diiodomethyl-p-tolyl sulfone (DMTS) as their active ingredient. Tests performed at Japan Food Research Laboratories found that YOHTOL DP95 and a product derived from it, YOHTOL DP-CD, inactivated the influenza virus. In viral infection tests on cells, the number of virus particles fell by 99% from the count at the start of the test in the two hours after YOHTOL DP95 was added. YOHTOL DP-CD brought about a 99.99% reduction in the number of virus particles in just 10 minutes. The water solubility of YOHTOL DP-CD is presumed to have contributed to its swifter action. In tests performed at the Japan Textile Products Quality and Technology Center, YOHTOL DP-CD was also confirmed to be effective in inactivating the SARS-CoV-2 virus that causes COVID-19. Similar viral infection tests showed that the number of virus particles fell by 99% within two hours of the agent's use. While YOHTOL DP-CD is not immediately effective, it is presumed capable of maintaining its antiviral effect for a certain length of time. Original source: Mitsui Chemicals, website: http://www.mitsuichem.com/, Copyright Mitsui Chemicals Inc 2021., research and development; antiviral agents; diiodomethyl-p-tolyl sulfone; iodine; YOHTOL; YOHTOL DP-CD; Mitsui [...]

Omya Inc has voluntarily recalled certain lots of food grade ground limestone products processed at its Superior, AZ plant because of the possible presence of Salmonella. There have been no [...]

Committed to delivering innovative solutions for the hygiene and medical industry, Dow Europe GmbH has announced the introduction of a new experimental linear low density polyethylene resin (LLDPE) for mono- [...]

The Dow Chemical Co and Mitsui & Co Ltd have announced the formation of a new joint venture and execution of a Memorandum of Understanding (MOU) aimed at providing innovative [...]