FORMULATION, MANUFACTURE COMMERCIALISATION OF MEDICINAL PLANTS PRODUCTS

FORMULATION, MANUFACTURE COMMERCIALISATION OF MEDICINAL PLANTS PRODUCTS

اسلاید 1: www.tabaye.ir

اسلاید 2: FORMULATION, MANUFACTURE & COMMERCIALISATION OF MEDICINAL PLANTS PRODUCTS.ZAINAB, U. SHARIFF (MRS)MANAGING DIRECTOR,NIGERIAN MEDICINAL PLANTS DEVELOPMENT COMPANY (NMPDC), ASOKORO, ABUJAPRESENTATION ATIPAN WORKSHOP, 2011 In Collaboration with NMPDC, NAFDAC & NIPRD 2

اسلاید 3: The World Health Organization (WHO) estimates that about 80% of the world populations rely totally on herbal medicine for some aspect of primary health care. WHO notes that between 25 – 40% of pharmaceutical medicines are derived from plants. It is also noted that 40 – 50% of medicines are direct or synthetic copies of plant ingredients.(Shariff, Z, 2000)Roughly 50,000 species of higher plants (about 1 in 6 of all species) have been used medicinallyThere are over 400,000 vegetable species on planet earth (Encyclopedia of Med. Plants, Vol. 1) Introduction3

اسلاید 4: India is currently the largest producer of medicinal plants with 15,000 – 20,000 species of medicinal plants documented in Traditional Medicine. Today, the list of plants with known medicinal properties is around 5,800 in Chinese material medica. The demand for such plants is rising in the industrialized world where people are resorting to natural health remedies more and more. According to the WHO, the global market for medicinal herbs and herbal products is estimated to touch US $ 5 trillion by 2050 and is currently worth over US $80 billion. This indicates the tremendous potential and demand in this sector which should be harnessed through improved formulation, manufacturing and commercialization efforts in Nigeria so as to tap from the huge source of foreign exchange for any country. 4

اسلاید 5: DefinitionsHerbal Medicine: Herbal Medicines are according to WHO finished labeled medicinal products that contain as active ingredients aerial or underground parts of plants or the plant material or combination thereof, whether in the crude state or as plant preparations. Plant materials include juices, gums, fatty oils, essential oils and any other substances of this nature. Herbal medicine may contain excipients in addition to the active ingredients. Medicinal Plants: These are large groups of plants used in medicine or veterinary practice for therapeutic or prophylactic purposed due to the presence in their organs of active substances, such as alkaloids, flavonoids, glycosides, vitamins, tannins and coumarin compounds which physiologically affect the bodies of humans and animals or which are biologically active in relation to the causative agents of various diseases. 5

اسلاید 6: Formulation: This is the act or process of developing a preparation with therapeutic value using a combination of one or more medicinal plants parts. The formulator must study the formulation to be manufactured or processed, combination of herbal drugs to be used, clinical and long term usage. 6

اسلاید 7: Selection of medicinal plants or herbal ingredients:-based on thorough knowledge, long term usage etc.Number of herbal ingredients for efficacy plus safetyDosage: Minimum therapeutic dosage by any pharmacopeia or scientific work.Safety and Efficacy of Formulation.Cost Management.Category of Formulation.Type of product and market needs.Good book on formulation should be consulted.Quality parameters of formulation must be determined before marketing. Regulatory requirement must be determined before marketing of the products.Market Acceptability.Formulation Procedures. Forensic Considerations and legal aspects involved for marketing and sales. Guidelines on Herbal Formulations.7

اسلاید 8: LeavesStemsSeedsRootsFlowersBerriesAnd bark of herbs.Etc.PLANT PARTS USED IN MED PLANT FORMULATION.8

اسلاید 9: CapsulesPillsSyrupsJuicescreams and ointmentoilsinfusionssuppositorieslinimentextractstincturesTypes of Dosage Form9

اسلاید 10: Herbs are available in a variety of forms, including fresh, dried, in tablets or capsules, or bottled in liquid form. You can buy them individually or in mixtures formulated for specific conditions. Whatever type of product you choose, the quality of an herbal preparation-be it in capsule, tablet, tea, tincture, bath, compress, poultice, or ointment form-is only as good as the quality of the raw herb from which it was made.To produce top-quality products, herb farmers require a great deal of specialized knowledge. For maximum potency, it is important that different ways of preparing medicinal herbs for use all aim at; Making administration of the plant easier.To increase the concentration of any active component of the plant, putting into consideration its physical-chemical properties.To favor the presentation of the plant or its preparations, depending on the stability.Common Herbs and Herbal Preparations10

اسلاید 11: Compresses and FomentationsCompresses are used by socking a cloth in a warm or cool herbal solution and applied directly to the affected area e.g. green tea, while fomentations are applied by socking a cloth in very hot water, for respiratory tract infections, throat and trachea inflammations, etcDecoctionCan be made from the bark, root, seed or berry of a plant. A decoction is made by simmering the part in water (do not boil)for 5 to 10 minutes even up to 30 minutes if materials is very hardExtractsAre obtained by pressing herbs with a heavy hydraulic pressure, and soaking them in alcohol or water. The excess alcohol or water is allowed to evaporate, yielding a concentrated extract. They are suitable for people with severe illness or mal-absorption problems. Herbal extracts are generally diluted before use, example includes celery, ginger, garlic, and pumpkin etc. of particular importance is the emersion of herbs into apple cider vinegar or malt vinegar and left to stand for two or more weeks.InfusionsParts of the leaves, flowers or the delicate parts of plants are grinded and cut into pieces for twigs, stem or other larger parts and steeped, not boiled for 5-10 minutes in hot water to allow for active ingredients in the herb to diffuse into water. E.g. herbal tea. such as Artemisa t ea, Morigvite tea. The aromatic volatile ingredients, vitamins and essences are removed by infusion averagely. One and the half-one ounce of herb in a pint of water is usually applied or 1-3 tea spoonful of dried herb in a cup of boiling water. The infusion is allowed to set and carefully strained into a cup of water for drinking as directed.Methods & Types of Formulations.11

اسلاید 12: TincturesVery concentrated extract of a herb in a alcoholic solutions. They are well preserved form of previously fresh herbs. Tinctures are prepared by putting a well-dried, ground plant in alcohol at room temperature for two or three days, or even up to 15 days, such as in the case of arnica.Ointments and creamsThe base used here are mostly Vaseline, oil, lanolin, or animal fats. The ointment is obtained simply by addition of extract, infusion, or pressed juice or powdered herb to the base. A thorough mix of this gives an ointment which can be applied to the affected areas, e.g. henbane and monkshood, used as calming substances for neuralgia, persistence headache. Ointments are solid at room temperatures and soften when rubbed on the skin. Creams are prepared with other fatty substances currently produced by Pharmaceutical companies. Methods of Formulations (Contd)12

اسلاید 13: PoulticesIs the application of powdered or granulated herbs in a hot, soft, moist or mass of herbs, flowers, mustard or other substances spread on muslin or loosely woven cloth and applied for 20-30 minutes on a sore or inflamed area of the body to relieve pain and inflammation. A poultice must not be allowed to become cold, replace with a second one after removing the first one. E.g. of herbs used in uncle gum Arabic, hyssop, chickweed, are excellent for distinct organs or protrusions such as breast, groins, prostates, eruptions, boils e.t.c.it is advisable to clean the area before applying poultice also of note is the use of onions and carrot poultice. Applied to stimulate indolent sores and boils that are slow to heal.The preparation involves boiling the onions/carrots until soft or used as raw mash to pulp and some vegetable oil to keep them from hardening, spread over a cloth for application.Powdered herbsThe part of the herbs containing the active ingredient is dried and grounded into powder or made into capsules, tablets or solutions. Methods of Formulations (Contd)13

اسلاید 14: Syrups Herbal syrups are made by the addition of powdered herbs or tincture blended with simple syrups. Simple syrup is made by dissolving 1 cup of sugar in a cup of boiling water until a thick consistency is achieved. When tincture or powdered herbs are added to syrup, it is advisable to stir thoroughly and sieve before bottling, e.g. lemon juice is prepared by boiling one part of lemon juice for 10mins, strain, add three parts of sugar and boil a little longer. Honey and brown sugar preferably must be employed in the preparation of syrups. E.g. onion, ipecaccuana, barberry, raspberry etc. SalvesFresh leaves, flowers, roots, bark and dried powders are used here. They are cut into fine pieces; a pound of herbs is added to one and a half pounds of pure. Vegetable oil, 4 ounces of bees wax, mix thoroughly, cover and place in hot sun or oven turn (low hours; strain and leave to cool. This will produce a firm preparation ready to use.LinimentsLiniments are an emulsion (mixture) of medicinal herb extracts with oil and/or alcohol. They have a constituency, and are applied to the skin by gentle rubbing. The active substances penetrate through the skin into deeper tissues and therefore used for rheumatic and muscular symptoms.JuicesAre made from fresh plants, soon after they are picked by mashing them in a mortar and then filtering them. Electric blenders may be used to make them. Juices are made from herbaceous plants or from leaves and fruits E.g. Aloe juice, orange juice. Some juice preparation need to be diluted with water before administration and some taken in small doses.Formulations14

اسلاید 15: CultivationHarvesting and StoragePre-production ProcessSortingPickingProduction ProcessDryingGrindingSievingMixingValidation and Quality ControlSpecific ProcessesInternal use e.g.Herbal tea,infusionsExternal use e.g.Ointments,herbal teaLabelling plus PackagingNAFDAC Inspection and RegistrationFormulation Pathway15

اسلاید 16: PRACTICAL LESSONS IN MEDICINAL PLANT FORMULATIONS:Vermia amigladineBasil ocimumZingiber officinaleSyzygium aromaticumHibiscus SpMoringa oleiferaAllium sativumFor the management of the following:DigestionDiabetic SupportHypertensive Support16

اسلاید 17: CATEGORIZED AS FOLLOWS;……………..Pre-Production Processes.Production Processes.Post Production Processes.PROCESSING (MANUFACTURE) OF MEDICINAL PLANTS.17

اسلاید 18: This entails all the relevant activities prior to major production processes namely;Good Cultivation Practices (GCP).Good Harvesting Practices (GHP).Preliminary Drying (Usually by sun or air drying)Picking and Sorting of Impurities from biomass.Weighing.Good Storage Practices using appropriate container e.g paper etc.Pre-Production Processes18

اسلاید 19: This major production processess required for herbal preparations depends on;The nature of the raw materials (i.e plant part in use).Desired nature of the finished products.E.G if the intention is to process a particular herb (leaves) into tea (infusion), or standardized extract and or powder, then the major production processes required is represented in the processing chart belowMAJOR PRODUCTION PROCESS19

اسلاید 20: LOW HEAT DRYING OF BIOMASSSTANDARDIZED EXTRACTDISTRIBUTION/SALESPRE-PRODUCTION PROCESSESAPPROPRIAT E EXTRACTION SOLVENTEVAPORATE SOLVENTCRUSHING & SEIVINGMILLINGFILL INTO SATCHETSSTORAGE OF FINISHED PRODUCTSDISTRIBUTIONSALESFILLING INTO TEA BAGS& SATCHETINGSTORAGE OF FINISHED TEA PRODUCTSDISTRIBUTIONSALESRESEARCH & DEVELOPMENTQUALITY CONTROL & QUALITY ASSURANCE CONSIDERATIONS MUST BE TAKEN DURING ENTIRE PRODUCTION PROCESS BELOWNOTE THAT PROCESSES DEPEND ON NATURE OF FINISHED PRODUCTSOTHER PROCESSING TECHNOLOGIES:Manufacturing Of Standardized Extracts.Extraction Of Essential Oils.Extraction Of Phyto-Chemicals.Extraction Of Natural Colours.Extraction Of Oleo-resins.Other Technologies.

اسلاید 21: Includes all activities immediately succeeding major production processes like;Haulage of the finished products with the appropriate delivery vehicle to storage site.Storage of the finished products in a standard prescribed storage facility.Distribution of the finished products into desired sales channels.POST PRODUCTION PROCESSES21

اسلاید 22: THIS INCLUDE THE PRODUCTION SITE AND THE PRODUCTION EQUIPMENTS. ALL THESE MUST BE IN LINE WITH NAFDAC REQUIREMENTS AND MUST SUPPORT GOOD MANUFACTURING PRACTICE (GMP)FACILTIES22

اسلاید 23: QUALITY PERSONNEL IS REQUIRED TO HAVE APPROPRIATE SKILLS, QUALIFICATION AND EXPERIENCE. THEY INCLUDE;QUALITY CONTROL ANALYST.SUPERVISORY PHARMACIST (WHERE REQUIRED)SCIENTISTS (MICROBIOLOGISTS, ENVIRONMENTALISTS, ETC)TECHNOLOGIST/ENGINEERSOTHER ATTENDANTS, ETC.NOTE: ALL PERSONNEL ARE TO BE WELL AND DECENTLY DRESSED IN AN OVERALL COAT DURING PRODUCTION PROCESS TO AVOID CROSS CONTAMINATION OF THE PRODUCTS.HUMAN RESOURCE/PERSONNEL23

اسلاید 24: THIS IS CARRIED OUT IN ALL THE STAGES OF PRODUCTION TO GUARANTEE STANDARD AND QUALITY CONTROL.QUALITY CONTROL24

اسلاید 25: DEFINITION:Commercialization is defined as a process or cycle of introducing a new product into the market. The actual launch of a new product into the market is the final stage of a new product development and the one where the most money will be spent for advertising, sales promotion and other marketing efforts.COMMERCIALIZATION OF MEDICINAL PLANTS IN NIGERIA.25

اسلاید 26: The global market for herbal medicine in 2007 was estimated to be about USD $ 75billion; with China controlling 24% while nations like India and Thailand follow suit.India makes about USD $ 6billion from Moringa oleifera with annual purchase of 1.3million tons.Nigeria regrettably is not in the picture.The botanical market which include those of herbs & medicinal plants is worth an estimated USD $1.6billion per annum. China exports over 120,000 tons per annum and India exports some 32,000 tons per annum hence dominating the international markets.Europe annually imports an estimated 400,000 tons of medicinal plants with an average market value of USD $1billion from Africa and Asia.In China, about 40% of the total medicine consumption is attributed to the indigenous traditional medicines, while in Japan, medicinal plants preparations are more in demand than the mainstream pharmaceutical products. GLOBAL MARKET FOR MEDICINAL PLANTS26

اسلاید 27: In Africa, Cameroon exports Prunnus africana and made a revenue of USD$40million in 1993 alone. And the seed of Voacanga africana which is known to contain the alkaloid Jobasonin (a CNS depressant in geriatric patients).The major export earner for Madagascar is Catharanthus rosea which is for anticancer therapy whose constituent are Vincristine and Vinblastine.Burkinafaso and Mali export Entada africana.75 – 80 tons of Grafonia simplica seeds are exported to Germany.Tanzania exports Cadamon and Cloves.South Africa exports 3 plants out of the 24,000 indigenous species which are used in traditional remedies thereby generating a revenue of 500 million Rands per annum.AFRICAN MARKET FOR MEDICINAL PLANTS27

اسلاید 28: This is largely due to the resurgence in the use of herbal medicinal plants as a re-emerging health aid fuelled by;Utilization by 80% of population for health care.Availability of medicinal plants as cheaper alternatives and acceptability.Increasing cases of resistance to synthetic version.Bio-prospecting of new plants derived drugs ( R & D).Global economic benefit (about $80 billion)Job and wealth creation.Environmental sustainability to cope erosion and desertification.To beautify the environment.Promotion of commercialization of Agriculture through ‘cash crops” e.g Moringa 0leifera, Artemisia annua, e.t.c. (of the 1.2 million hectares of land available for cultivation in Nigeria, only 1/3rd is utilized.Rich Soil. WHY COMMERCIALISE MEDICINAL PLANTS.28

اسلاید 29: USES OF MEDICINAL PLANTS.Traditional medicines.Herbal teas.Health foods such as nutriceuticals and galenicals.Phyto-pharmaceuticals.Industrially produced pharmaceuticals.Pharmaceutical fragrances,flavours, and colour ingredients.Cosmetics.Food Security.WHY COMMERCIALISE MEDICINAL PLANTS.29

اسلاید 30: Inauguration of the Presidential Initiative Committee (PIC0 in 2006 on the development, promotion and commercialization of Nigerian herbal medicinal plants. The committee came up with a blue print of IM of traditional medicine.Establishment of ARTEMISININ DEVELOPMENT COMPANY (ADC) now NIGERIAN MEDICINAL PLANTS DEVELOPMENT COMPANY (NMPDC) under the supervision of the Federal Ministry of Agriculture and Rural Development. The company has succeeded in cultivation and commercialization of Artemisia annua and is currently working on the commercialization of six plants in six geo-political zones of the country as shown below.ROLE OF FEDERAL GOVERNMENT OF NIGERIA IN THE COMMERCIALISATION OF MEDICINAL PLANTS.30

اسلاید 31: Production of Nigerian herbal pharmacopoeia (1st edition with 42 monographs).Establishment of a unit of traditional medicine, Foods & Drugs Services in Federal Ministry of Health.Establishment of other agencies such as;RMRDC (Raw Materials Research and Development Council).NIPRD – Development of the Sickle Cell drug called NICOSAN.NCAC – National Council for Art and Culture, botanical gardens in Kano, Ebonyi and Bauchi.NAFDAC NAMPDA which established data for medicinal plants in all the geopolitical zones of the country.ROLE OF FEDERAL GOVERNMENT OF NIGERIA IN THE COMMERCIALISATION OF MEDICINAL PLANTS.

اسلاید 32: SBOTANICAL NAMECOMMON & LOCAL NAMESZONE1Vernonia amygdalina.Bitter leaf (Shuwaka, Ewuro & Onugbu)SE & SW2Moringa oleiferaDrumstick (Zogale, Ewe-iye & Okweoyibi)NW & NE3Occimum species ( Bassil & Grassissimum)Scent leaf (effirin, nchanwu & dodoya)SW & SS4Telifeira occidentalisPumpkin leaves (Ugwu, egusi-iroko)SE & SS5Zingiber officinalisGinger (junja, Aje/atale & Citta)NW & NC6Hibiscus sabdariferaSorrel, Roselle (Zobo, Isapa & Ojo)NW & NWRaw materials Research and Development Council (RMRDC) recently held a Moringa summit for the promotion and commercialization of Moringa oleifera.Ministry of Agriculture is also promoting Cocoa and a host of other medicinal plants.NMPDC COMMERCIALISATION EFFORTS

اسلاید 33: Despite the global resurgence of medicinal plant use, Nigeria is yet to benefit economically due to the following;The National Drug Policy whose primary objective is “To Promote Research On Herbal Medicines And Integrate Those Found To Be Safe and Efficacious Into The Health Cares System” and the Traditional Medicine Policy( 31st August, 2007) which has amongst its objectives;Harness potentials and economic benefits of traditional medicine in line with NEEDS.Goals: To incorporate Traditional Medicine into national health care delivery system.Reduce use of foreign currency in importation and promote exportation of medicinal plants. However, despite the above, Nigeria is yet to achieve the desired goals set by the government. Inaddition, the inability of the National Assembly to pass the bill on traditional medicine is a major set back.CHALLENGES & RECOMMENDATIONS ON COMMERCIALISATION OF MEDICINAL PLANTS IN NIGERIA.33

اسلاید 34: Inadequate support for research institutes (e.g NIPRD, IAR, Institute of Agricultural Research etc), Poor collaboration between researcher and industries or manufacturers for commercialization from laboratory to the market. Inadequate collaboration between government and stake holders to harmonize policies, programmes and drive implementation.Implementation of the blue print for the establishment of Nigerian Institute of Traditional Medicine by the Presidential Committee on Promotion, Development and Commercialization of herbal medicine in Nigeria.CHALLENGES & RECOMMENDATIONS (Contd)34

اسلاید 35: 4.Establishment of National Medicinal Plants Database. In addition to the good efforts by NMDA, Nigerian herbal pharmacopoeia.5.Awareness Programmes-continuous need for sensitization, enlightenment of the populace.6.Establishment of more industries forcommercialization and encourage more of public private partnership (PPP)7.Massive cultivation of medicinal plants with potentials for commercialization e.g Moringa oleifera, Artemisia annua and in additon to six medicinal plants of the six geopolitical zones.CHALLENGES & RECOMMENDATIONS (Contd)35

اسلاید 36: Issues of standardization, quality control.Conservation.Value addition forAgricultural products.Collaboration with international agencies for technical assistance andCHALLENGES & RECOMMENDATIONS (Contd)36

اسلاید 37: The Development Of Herbal Medicine Industry In The Developing World Like Nigeria Would Provide Jobs, And Stimulate Growth Of Local And National Economies. It Will Also Complement Government Efforts In Meeting The Health Needs Of Its Populace. Facilitate the attainment of MDG goals by 2020. The Nigerian Government Can Therefore Play A Vital Role In The Development Of Traditional Medicine Industry By Supporting, Commercialization, R & D Of Natural Medicinal Products, Through The Execution Of Carefully Planned And Workable Strategies That Would Involve Stake Holders, Including Universities, Research Institutes And Local Manufacturing Industries.CONCLUSIONS37