Chemical Status: Pharmaceutical Ingredients

Dzulkifly Mat HashimFaculty of Food Science and Technology

University Putra Malaysia (UPM)

The First Gulf Conference on Halal Industry and its Services

24-26 January 2011Salmiyah, State of Kuwait -Holiday Inn Hotel, Al

مكونات ا�دوية: الحالة الكيميائية

ذو الكفلِ مات ھاشمكلية علوم وتقنية الغذاء، جامعة بوترا، ماليزيا

مؤتمر الخليج ا�ول لصناعة الحل وخدماته2011يناير 24-26

دولة الكويت–السالمية –فندق ھوليدي إن

: ~ USD2.1t

THE GLOBAL HALAL MARKET POTENTIAL

APPLICATION OF THE HALAL PRINCIPLES

In the selection of food and drink (therefore in extension to pharmaceutical and

consumer products), Islam has laid down a few very important guidelines:

� Whether the consumption of such food (product) is prohibited by Allah

(swt)

� Whether the food (product) is obtained through Halal or haram means

� Whether the food (product) has, at any stage of its production or processing,

been added or comes into contact with a prohibited ingredient

� Whether or not the material or any of its added composite is harmful to

health

THE PHARMACEUTICAL INDUSTRY IS HIGHLY REGULATED

LAWS OF MALAYSIA

Act 366POISON ACT 1952

Act 368SALE OF DRUGS ACT 1952

Act 290MEDICINES (ADVERTISEMENT AND SALE) ACT 1956

SALE OF FOOD AND DRUGS ORDINANCE 1952

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984

Definition : Halal Pharmaceuticals

SOURCE:MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

� Halal pharmaceuticals shall meet the following criteria:

� Does not contain a part or ingredients derived from human

(e.g. human placenta, blood, L-cystein from human hair)

� Do not comprise of or contain any part of an animal that is forbidden to be

used or consumed by a Muslim by Shariah Law, or that is not slaughtered

according to Shariah Law

� Do not contain any material or genetic modified organism (GMO) which

are decreed as najs according to Shariah Law

HALAL PHARMACEUTICALS

SOURCE:MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

� Is not prepared, processed, manufactured or stored using any equipment

that is contaminated with things that are najs according to Shariah Law.

� During its preparation, processing, manufacturing or storage, the

medicinal product is not in contact or near with any materials that does not

meet the requirements stated in items above

� Do not endanger the consumer or the user

HALAL PHARMACEUTICALS (cont’d)

SOURCE:MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

HALAL VALUE SUPPLY CHAIN

Suppliers ofRaw materials

Suppliers ofPackagingmaterials

Manufacturing Processing•Making•Filling

•HandlingRaw Materials andPackaging Storage

Finished ProductStorage

Logistics

Warehousing

Laboratory Equipment

Waste Water Treatment

Primary Supply Chain Process

Secondary Supply Chain Process

ISSUES IN THE HALAL SUPPLY

CHAIN

USE OF GELATINE IN PHARMACEUTICALS

GELATINECattle Bones & Hides (Type B Gelatin)

Pork skin (Type A Gelatin)

Gelatin is derived from collagen, an insoluble fibrous protein which is the principal constituent of connective tissues and bones.

Collagen is distinctive in that, it contains an unusually high level of the cyclic amino acids (imino acids) proline and hydroxyproline.

Collagen consists of three helical polypeptide chains wound around each other and connected by intermolecular cross-links.

Type A gelatin is produced from an acid process. It is mainly applied to pig skin, in which the collagen molecule is young.

Type B gelatin is formed form an alkaline and acid process. It is mainly applied to cattle skin and bone, in which the triple-helix collagen molecule is older, more densely cross-linked and complex.

Gelatin Industry Worldwide GELITA Group

Source : www.gelita.com

SOURCES OF GELATIN RAW MATERIAL

• In 2008, total annual production is around 330,000 tonnes

• Gelita Group makes up nearly 30% of total gelatine supply

MAIN APPLICATION AREAS (2007)

GELITA Group ProductionGelatin Industry Worldwide

Source: www.gelita.com

GELATIN – APPLICATION IN

PHARMACEUTICALS

• Capsule (soft and two-piece hard capsule)

• Tablets (binding, moisturizing and coating agent)

• Lozenges and cough drops

• Excellent stabilizer and emulsifier in pharmaceutical emulsions

• External application of drugs to treat various skin disorder

Apart from the active ingredient(s), a tablet basically contains (excipient):

(1) Diluent

(2) Binder

(3) Disintegrator

(4) Lubricant

� Diluent is a substance or a mixture of substances added to a tablet to increase the bulk in order to

make the tablet a practical size for compression.

� Binder is a substance or a mixture of substances added to a tablet to impart a cohesiveness to the

tablet formulation which insures the tablet remaining intact after compression.

� Disintegrator is a substance or a mixture of substances added to a tablet to facilitate its breakup or

disintegration after administration.

� Lubricant is a substance or a mixture of substances added to a tablet to improve the flowability and

to prevent adhesion of the tablet material to the surface of the dies and punches, reduce inter-particle

friction, and facilitate the ejection of the tablets from the die cavity.

TABLET COMPOSITION

Gelatin is used as Diluent, Binder and Disintegrator in Vitamin B12 (6 mcg tablets)

1. Vitamin B12 (powder, active ingredient) = 0.006 mg/tablet

2. Gelatine (Powder) = 199.804 mg/tablet

3. Magnesium stearate (powder, lubricant) = 0.190 mg/tablet

Total Weight = 200.000 mg/tablet

TABLET FORMULATION

� An aqueous solution of gelatin is often used in wet granulation.

� Its dry form, powder or granules, has never been directly used

in tablet compression.

� In its dry form, with its strong binding, cohesive, and

hydrophilic properties, can be utilized as tablet diluent, and/or

binder, and/or disintegrator.

GELATIN IN TABLET

Gelatin is used in concentrations

from 0.1% to 99.9% of the tablet

weight

1. Enclosing the active substance

2. Capsules can be designed to remain intact for some hours

after ingestion in order to delay absorption

3. May contain a mixture of slow- and fast-release particles to

produce rapid and sustained absorption in the same dose

CAPSULE: GELATINOUS ENVELOPE

VITAMIN PRODUCTION

To prepare Liquid Vitamin into Free-flowing powders for compressed Tablet or Capsule

Step 1: To mix with combination of:

- Active material (emulsion containing active vitamin material)

- Gelatin + water + gum acacia + sugar and/or starch

Step 2: Collection of individual droplet in a mass of starchy form

Converting emulsion to droplet form

Step 3: Separating the vitamin-active particles from starchy collecting powder

DI-CALCIUM PHOSPHATE

DI-CALCIUM PHOSPHATE (DCP)

DI-CALCIUM PHOSPHATE (DCP)

ALCOHOL

Malaysia National Islamic Fatwa Committee

(JAKIM)

Cordials which contain any flavouring substances with a certain amount of

alcohol added as a stabilizer for the purpose as a drink, is allowed on the

condition that :

� The alcohol is not derived from ‘khamr (intoxicating alcoholic beverage

= liquor) production

� The quantity of alcohol in the flavour is small (insignificant) such that it

will not intoxicate

Decision made in the 22nd National Fatwa Committee Meeting,

24 November 1988

USES OF ALCOHOL (ETHANOL)

� Alcoholic beverages

� Solvent in the food, cosmetic and pharmaceutical

products

� Topical products

� Cough syrups and mouthwash

� Perfumes

INDUSTRIAL ALCOHOL

� Synthetic Alcohol

– Chemically Synthesized from Ethylene

Process:

1. Indirect hydration through addition of sulfuric acid

2. Direct catalytic hydration of ethylene

� Agricultural Alcohol

– Derived from Biological Fermentation Process of Carbohydrate Source

� Fermentation of Sugar

� Fermentation of Starch

AGRICULTURAL ALCOHOL

PRODUCTION OF SYNTHETIC ETHANOL

THANK YOU