Currently, malaria is still a serious disease causing high mortality in developing countries, especially in Africa. According to the World Health Organization (WHO), every year in Africa, there are from 350 to 500 million-malaria cases, of which about one million die, mostly children.
The drug Amodiaquine has been widely used to treat malaria since the beginning of 1950s. Since 1975 however, this drug has rarely been used in malaria prevention due to several side effects. However, recent studies have shown that when using Admodiaquine in combination with Artesunate, it increases the positive effects of treatment significantly. It somehow avoids the drug resistance of malaria parasites and reduces the side effects of the prescription. Now, WHO recommends using a combination of two ingredients, in malaria prevention worldwide. France’s Sanofi-Aventis pharmaceutical company produces the combination drug and is marketing under the name ‘Artesunat-Amodiaquine Winthrop’ (ASAQ) or ‘Coarsucam’.Vietnam imports Amodiaquine hydrochloride from China through several pharmaceutical companies for the production of a malaria prevention drug combining two ingredients including Amodiaquine hydrochloride and Artesunate.
Winthrop combination products for malaria treatment
With the aim of actively serving drug material for treatment and healthcare, in 2007, the Prime Minister approved a national key science and technology research programme for the development of pharmaceutical chemistry until 2020 (Pharmaceutical Chemistry Programme for short), focusing on researching and testing to produce medicinal materials such as antibiotics, cancer drugs and others.
In the framework of the project on researching the technology process to synthetize amodiaquine hydrochloride to produce a drug which combines two components, including amodiaquine hydrochloride and artesunate to treat malaria under this programme, Prof. Dr. Nguyen Van Hung, and his colleagues from the Center for Drug Research and Development, Institute of Marine Biotechnology, Vietnam Academy of Science and Technology have studied and successfully synthetized Amodiaquine hydrochloride on a 5kg per batch scale from 4.7-dichloroquinoline and 4-aminophenol initial components through three steps with 64% efficiency. The research team has synthetized more than 30 kg of Amodiaquine hydrochloride. Amodiaquine hydrochloride product is tested according to American pharmacopoeia standards USP 29 and met the criteria for qualitative and quantitative. In addition, the Amodiaquine hydrochloride product was also been tested for stability and acute toxicity at the National Institute of Drug Quality Control and met necessary requirements.
The Amodiaquine hydrochloride product can used in the pharmaceutical industry, production of drug which combines amodiaquine hydrochloride and artesunate in malaria treatment for national malaria prevention and can be exported to Africa that has high rate of malaria cases and mortality from malaria.
Several photos about researching to synthetize 5kg per batch pilot scale
Amodiaquine hydrochloride product
Quality testing notes
Translated by Tuyet Nhung
Link to Vietnamese Version