High Value Pharmaceutical Raw Material from Food Processing Waste

Raw materials (85% imported)

Size 120 licensed plants (production: $ 6.6 bn) (growth rate 11% through 2015)

Egyptian Pharmaceutical Industryhttp://www.oxfordbusinessgroup.com/economic_updates/egypt-regulating-pharmaceuticals-production

- Natural- Synthetic

- sustainable at a comparatively reasonable price- safeguards purity, health and safety - protects the environment

Orange Production in Egypt-Production:

-Fresh orange (3.5 million MT in 2012) ranked # 6 in the world

-Export:-Fresh orange (> one million MT in 2012)

ranked #4 in the world -Orange Juice (3000 ton in 2012)

ranked #19 in the world)-Domestic use > 2 million MT in 2012-Waste “Orange peel” >40% of orange wt.

Orange peel contain > 20% pectin- Pectin production in Egypt ZERO

Sources of Pectin

Citrus peelsOrangesApplesCarrotsApricotsCherries

>20.0%0.5–3.5%1.0–1.5%1.4%1.0%0.4%

Levels of pectin in plants (fresh weight)

Citrus fruits are rich source of pectinPeel contains > 20% pectin

Pectin (powdered form)

Top ten Countries in Production of Orange in 2011(million ton)

Rank Country Production Rank Country Production

1 Brazil 19.8 6 Egypt 3.5

2 USA 8 7 Spain 2.8

3 China 5.8 8 Italy 2.4

4 India 4.5 9 Indonesia 1.8

5 Mexico 4 10 Turkey 1.7http://faostat.fao.org/site/339/default.aspx

(US$ 300-600 per ton) in 2011 (US$1,000 per ton) in 2012

Pectin peel : Dried Orange PeelIn Egypt(US$10 per ton of raw peel)

Pectin value exported in 2012 (US$ 11,212/ton)

World US$ > 427 million 38,102 ton Germany 14,184 tonCzech republic 3,987 tonBrazil 4,191 tonChina 3,445 tonEgypt 0

Pectin value imported in 2012 (US$ 12,000/ton)Egypt US$ 4,38 million 365 ton

PectinEnvironmentally-friendly, safe food additive (E440, GRAS) Application of Pectin

JamsYogurtJuices

gelling agents, viscosity builders, Stabilizers, protective colloids

-Controlled release formulations-Carrier for colon-specific drug delivery - Medical &OTC, personal care, air care-Nutraceuticals; as dietary fiber (anti-diabetic, reduce cholesterol, anti-diarrheal)-wound healing, medical adhesive, demulcent (throat lozenges), spa products, etc..

- Pharmaceutical industry - Food industry, etc..

Wide Objective to produce high value Pharmaceutical raw material from food processing waste material in compliance with international standards.

Specific Objective to prepare a feasible and profitable

industrial prototype scale unit for the production of:

a)-Pharmaceutical grade Pectin from orange peels (as a primary target),b)-Food grade pectin (as a secondary target)

Objective

(I)- Lab scale level for extraction of pectin using: 1)- conventional method boiling with H2O, pH 1-2 / 2-3 hr 2)- ultrasound-assisted extraction with hot H2O, pH 1.6, 37 min, 395 W3)- Industry guided extraction method

3 (II)- Industrial pilot-scale level the method that gives the best extraction yield, quality

and economic feasibility will be applied using an industrial pilot-scale unit

Implementation levels

Pectin testing “for characterization and standardization”

D-galacturonic acid units (GalA)

The tests will be carried out according to FAO manual and will include; test for pectin, test for amide group, purity, loss on drying, residual solvents, acid insoluble ash, nitrogen content and galactouronic acid content, etc..

Project Management

Prof. Dr. Meselhy Ragab Meselhy: Project PI (FOCU, Academic applicant): Managing the whole project, leading the phyto. activity

Dr. Amr M. Helal: CO PI (ITM- Industrial partner): Co PI, leading the business activity

Prof. Dr. Omaima Elgazayerly leading pharm. activity

Prof. Dr. Ali Abdel-Aziz consultant for food sc. activity

1. Expected project out puts (products and prototype)- Pilot scale unit for pectin production from orange peels.- Dried, ground pectin peels ready for pectin extraction or for export at high price (lateral output).- Dried pectin produced on industrial scale- Pectin based Pharmaceutical dosage formula 2. Publications- Expected patent concerning pectin preparation - Publications about orange oil, bioactives, pectin preparation and extraction on industrial scale.- M.Sc. Thesis about raw material preparation from food stream residues.

Expected Project Outcomes and Impact

3. Business development- Up scaling of the project through large Egyptian enterprise in the field of orange business.- Registration at MOH for Pectin based products to be sold as Nutraceutical and/or functional food- Local marketing of the produced pectin.

Expected Project Outcomes and Impact (cont..)

It All Starts with RICE BRAN INNOVATIVE STABILIZATION

Previous Success StoryRice Residue managment

What is Rice Bran?

•Rice Bran is a byproduct of the milling process (conversion of brown rice to white rice •It is reported to have 65% of the nutritive value of the whole rice grain •In Egypt it is discarded or used as animal feed due to its extreme instability that renders it rancid and thus unfit for human consumption

What is a Nutraceutical?

A product isolated or purified from foods, and generally sold in medicinal forms and demonstrated to have a physiological benefit or provide protection against chronic disease

Different ImplementedProjects (2008-2012)

A)A) Rice Bran Stabilization (lab Scale) & (Industrial Rice Bran Stabilization (lab Scale) & (Industrial Scale)Scale)

B)B) Phytochemical and Nutritional study of the Stabilized Phytochemical and Nutritional study of the Stabilized Rice bran. Rice bran.

C)C) Implementations of the different rice bran products Implementations of the different rice bran products in food , pharmaceutical and cosmetic industries . in food , pharmaceutical and cosmetic industries .

Rice Bran – Stabilization Unit 1Capable of stabilizing the bran of 150 MT rice milling / day

Rice Bran – Stabilization Unit 2Capable of stabilizing the bran of 150 MT rice milling / day

Rice Bran Nutraceuticals

Contract Number C2/S1/118

Total cost of the action EURO 192000

Project Duration 18 months

Project PI Prof. Dr. M.T. Khayyal

Project Coordinator Dr. Amr M. Helal

Products

• Stabilized Rice Bran soft Gel Capsules (Under registration; Riciplex)• Rice Bran sachets (10gm; ORYZA, Under

registration).• School Nutrition Program ( in cooperation

with Ain Shams University)• Functional Food (flakes , in cooperation with

Mass Food Company)

Publications• Helal AM, Khayyal MT, Abd El Aziz HM, Abdel Salam RM Developing a nutraceutical from Egyptian Stabilized rice bran: pharmacological approach PlantaMed 2011:77: 1229-1472 Georg Thieme Verlag KG Stutgart. New Yourk. ISSN 0032-094

• Ramadan, Shimaa El-Saed, Amr M. Helal, Comparative Study on Egyptian Rice Bran Extracted by Solvents and Supercritical CO2. Advances in Food Sciences, 35 (1), 2013, 23-29. (Germany). ( Annex 2)

• Sahar Y. Al-Okbi, Nagwa M. Ammar, Doha A. Mohamed, Ibrahim M. Hamed, Ahmad, H. Desoky, Hagar F. El-Bakry, and Amr M. Helal. Egyptian rice bran oil: chemical analysis of the main phytochemicals. Accepted in La Rivista Italiana delle Sostanze Grasse in 25 January, 2013 (Italy).

• Sahar Y. Al-Okbi, Ahmed M.S. Hussein, Ibrahim M. Hamed, - Doha A. Mohamed and Amr M. Helal, Chemical, Rheological, Sensorial and Functional Properties of Gelatinized Corn- Rice Bran Flour Composite Corn Flakes and Tortilla Chips, Journal of Food Processing and Preservation, 2012 (Wiley) , doi:10.1111/j.1745-4549.2012.00747.x ( annex 4)

Publication (Cont.)• Hussein O Ammar, Sahar Y Al-Okbi, Dina M Mostafa and Amr M. Helal, Rice bran oil: Preparation

and evaluation of novel liquisolid and semisolid formulations. International Journal of Pharmaceutical compounding, 16 (6), 2012, 516-523 (USA).

• Rice bran solid lipid nanoparticles: Preparation and characterization Mohamed Hassan Hany and Omaima Naim El Gazayerly* Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt. Available online at http://www.urpjournals.com International Journal of Research in Drug Delivery Universal Research Publications

• Kaup RM, Khayyal MT, Verspohl EJ.Department of Pharmacology, Institute of Medicinal Chemistry,

University of Muenster, Hittorfstr. 58-62, 48149, Münster, Germany, Antidiabetic effects of a standardized Egyptian rice bran extract. Phytother Res. 2013 Feb;27(2):264-71. doi: 10.1002/ptr.4705. Epub 2012 May 8

• Stephanie Hagl; Alexa Kocher; Christina Schiborr; Schamim Eckert; Ion Ciobanu; Marc Birringer,

Ph.D.; Hesham Al-Askary, Ph.D.; Amr Helal, Ph.D.; Mohamed T Khayyal, Ph.D.; Jan Frank, Ph.D.;Walter E Muller, Ph.D.; Gunter P. Eckert, Ph.D. Rice bran extract protects from mitochondrial dysfunction in guinea pig brains.

Success Story in the Mediawww.ricencare.com

Awards

Awards (Cont.)