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What is API Contract Manufacturing? عرض

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Partnering with the right contractor is one of the most critical decisions a pharmaceutical company can make

The active pharmaceutical ingredient (API) is the foundation of a final drug product and is a crucial consideration when choosing a Contract Development and Manufacturing Organisation (CDMO). To understand API contract manufacturing, first, it is necessary to understand what is meant by an “active ingredient.”Favipiravir (T-705, 6-fluoro-3-hydroxypyrazine-2-carboxamide) is a novel low molecular weight antiviral compound. It has shown activity against many types of RNA viruses (all strains of influenza А, В, С, arenovirus, bunyavirus, flavivirus, alphavirus, norovirus,as well as the Zika, Usutu,and Ebola viruses). The generally good tolerance of human patients to favipiravir and the high barrier to the development of resistant viral strains indicate that this drug holds great promise for clinical use around the world. It should be noted that a representative of the Zhejiang Hisun Pharmaceutical company from China has anounced that this company has received marketing authorization from the Chinese government for favipiravir as a possible medication against the coronavirus causing Covid-19.Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known.

METHODS

We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding.Nicotinamide Riboside (NR) is a next-generation vitamin B3 that has been found to be naturally-occurring in milk in trace amounts. The metabolism of NR is unique from that of other more commonly known forms of vitamin B3 , nicotinamide and nicotinic acid. Specifically, NR has been shown in a pre-clinical study to be the most effective form of vitamin B3 at increasing nicotinamide adenine dinucleotide (NAD+)2 .

Nicotinic acid (also known as niacin) and nicotinamide (also known as niacinamide) were discovered in the 1930’s to be the factors that cured pellagra . Niacin is known to cause severe flushing . In 2004, nicotinamide riboside emerged as a newly discovered NAD+ precursor and does not bind to the receptor responsible for flushing.

NR has pre-clinically demonstrated that it is superior to both niacin and nicotinamide, both of which are standard forms of vitamin B3 commonly used in vitamin supplements and foods, at boosting NAD+2 . This is due to the fact that NR is not reliant upon a conversion step requiring the enzyme “NAMPT” , see Figure below. The activity level of NAMPT determines the amount of nicotinamide that is converted into NAD+ , which is why this particular step in the process is often referred to as the “rate limiting step”. As normal aging occurs, the activity of NAMPT is thought to decrease. NR can be used by the cell to make NAD+ without this enzymatic step.

Chemical Properties of Nicotinamide

Nicotinamide" target="_blank">http://www.leadpharmaceutical.com/">Nicotinamide riboside (NR) is part of the B3 vitamin family. Like other forms of vitamin B3, nicotinamide riboside gets converted into nicotinamide adenine dinucleotide (NAD+), a coenzyme essential for life. For this reason, it is often called a NAD+ precursor because it is part of the series of chemical steps that are required to create NAD+.
Different biosynthetic pathways are responsible for converting the different B3 vitamins into NAD+. The enzyme nicotinamide phosphoribosyltransferase (Nampt) catalyzes the rate-limiting step of the two-step pathway converting nicotinamide to NAD+. NR kinase enzymes can also function as a salvage pathway for NAD+, but this pathway is not essential.