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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
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