NEWS DETAIL: RMRDC, INTERCEDD, TO SET UP PLANT FOR LOVASTATIN PRODUCTION
Following are the details of the news:
As part of efforts to support the nation’s pharmaceutical industry through the commercialisation of research findings by the Raw Materials Research and Development Council (RMRDC) partnering with International Center for Ethnomedicine and Drug Development (InterCEDD) to establish a small scale plant for production of Lovastatin, an Active Pharmaceutical Ingredient (API) for the production of drugs used to treat coronary heart disease.
The DG/CEO RMRDC, Prof. Doko Ibrahim made this known in a meeting organized by the Council at NASRDA to fine tune modalities of the partnership for the establishment of the plant to produce Lovastatin as an Active pharmaceutical Ingredient derived from mushroom.
The plant, which will be the first of its kind in Nigeria, will be sited in National Space Research and Development Agency, (NASRDA) Abuja where RMRDC’S process equipment demonstration center is domiciled, the DG said.
Professor Ibrahim said the aim of establishing a small scale plant for the production of Lovastatin as an API is to support the pharmaceutical industry to source this major pharmaceutical raw material locally. He emphasized that the product is the first indigenously produced Active Pharmaceutical Ingredient (API) in the Country.
The RMRDC Boss also said that the facility that will house the equipment is ready at RMRDC Technology and Innovation Center, NASRDA, Airport Road, Abuja. He reiterated that RMRDC is working hard towards the procurement of the plant.
The DG said explained that it will be appreciated if InterCEEDD could take up the responsibility of managing the plant, though InterCEDD will take equity in the project while RMRDC will take the lead.
Earlier, the Chairman InterCEDD/BDG, Prof. Maurice Iwu in his response, commended the DG/CEO RMRDC for the many successes he has achieved since his assumption of office. He cited the instance of the R&D work by the Council on lovastatin production, which earned it the first position in the 2020 Technology and Innovation Exposition held in Abuja. He also stated that the DG/CEO RMRDC and the Council intervened promptly in solving the problems of Covid – 19 by responding to the request for local sourcing of Andrographis paniculata for the mass production of IHP Detox tea.
Speaking further, the former Independent National Electoral Commission (INEC) Boss said the DG had helped the Country immensely with his prompt response, and that considering many other vital roles he has been playing towards the development of local raw materials for the industries, his leadership style should be applauded. He further said that his organization is very much committed to partnering with the RMRDC in this project and to see to its logical completion. He added that by the time the product is 80% ready, Nigerians would be eager to subscribe to it because it is a product that would stand the test of the time.
Also speaking, Prof. Elijah Sokomba, National Coordinator InterCEDD added that the Covid – 19 products (IHP Detox tea) was undergoing clinical trials at University of Lagos and would be fully registered with the National Agency for Food and Drug Administration and Control (NAFDAC) after the exercise. He also appreciated the DG/CEO RMRDC and the Council for the forward-looking approach to issues and development of many industrial raw materials.
In his own contribution, Pharm. Bola Yusuf, the consultant advised that the Good Manufacturing Practices (GMPs) Section of the National Agency for Food and Drug Administration and Control (NAFDAC) should be invited to inspect the site and see the flow diagram of the plant before site modification. He said this would facilitate the registration of the product by NAFDAC.
Lovastatin is a naturally occurring drug found in food such as oyster mushroom and red yeast rice. It is member of the drug – class of statins used in combination with diet, weight loss and exercise for lowering cholesterol in individuals with hypercholesterolaemia, to reduce the risk of this cardio- vascular disease, which is a known killer disease in Nigeria today.
The oyster mushroom contains about 2.8% lovastatin. The amount depends on fruiting size, age and substrate composition.
Lovastatin is a white non-hygroscopic crystalline powder that is soluble in water and sparingly soluble in ethanol, methanol and acetonitrile. It is a secondary raw material and is the active component, compounded with other drug carriers and nutritional elements for the formulation of some statin drugs. Statin drugs are a popular way of lowering the risks of heart attack and stroke. The drugs work to hinder the production of an enzyme in the liver that makes cholesterol in the body. They are sold under different names and come in varying doses.
There are very few oyster mushroom cultivators in Nigeria. The technology of mushroom cultivation has not been widely publicized. Moreover, awareness created by the relevant government agencies such as the Raw Materials research and Development Council has been mainly on the cultivation of mushroom for culinary purposes, job and wealth creation.
Not much has been projected on Oyster mushroom as a source of secondary raw material for the Pharmaceutical industries in the production of anti – lipidemics.
The relevance of Lovastatin project to the Pharmaceutical sector of the nation’s economy cannot be over-emphasized. In line with Council’s mandate of industrialization through utilization of local raw material resources, it is imperative that Council intervenes in the local production of statin drugs from locally cultivated mushrooms. This will enhance commercialization of mushroom cultivation, create jobs and provide alternative source of raw materials for the pharmaceutical industries. Furthermore, statistics obtained from NAFDACPRS shows an increasing trend in the amount spent annually on the importation of statins drugs. It is also evident that the demand for the drug is increasing by the year; therefore, local production should be explored, since statin drugs are wholly imported into the country. This will save foreign exchange, reduce poverty, create jobs, and build capacity in mushroom production and lovastatin isolation technologies.
The project therefore meets the requirements for the goals of local raw material utilization, import substitution and commercialization.