Bulk Drugs Manufacturing viz. beta carotene,

 lycopene, phycocyanin

Technology/Process Description:

Beta Carotene:

 

Beta-carotene is a member of the carotenoid family. Carotenoids are yellow-to-red pigments found in all green plant tissues and in some species of algae. So far 21 different carotenoids have been found in human blood. The most abundant ones are alpha-carotene, beta-carotene, lutein, lycopene, cryptoxanthin and zeaxanthin. A molecule of alpha-carotene, beta-carotene, or cryptoxanthin can be split into two molecules of vitamin A in the body but the conversion of beta-carotene is by far the most effective. They are very effective in neutralizing a highly reactive for of oxygen called singlet oxygen. Low levels of beta-carotene in their blood have a higher incidence of heart disease and cancer, particularly lung cancer. The National Cancer Institute endorsed a study which found that Beta carotene lower chance of getting cancer, including breast cancer.

Natural beta carotene is used not only as a bountiful source of Vitamin A but also for reducing cholesterol and lipid levels, protection against strokes and cataracts, enhancing the immune system, preventing certain photo sensitivity disorders, improving antioxidant action and intra cellular communication, quenching singlet oxygen and dramatically reducing stress.

Natural Beta-carotene consists of two isomers. One is all trans isomer and other is 9 cis. In experiments, Ben-Amotz found that the natural 9-cis is the potent antioxidant that rapidly quenches free radicals. It gives natural beta-carotene a powerful advantage over the synthetic.

More recent research suggests that beta-carotene's prevention effect is due to its antioxidant property. It is extremely useful in the immune enhancement, mental functioning, arthritis and prostate cancer.

 

Lycopene:

Lycopene is a powerful antioxidant carotenoid and the pigment that gives tomatoes, watermelon, and pink grapefruit their characteristic red color. Clinical studies have indicated that Lycopene works through a number of mechanisms to support cardiovascular health and immune function. In addition, epidemiological studies have determined that lycopene may be particularly important for the support of prostate health, as well as for the health of the digestive tract.

 


Lycopene
Molecular weight = 536.89
Exact Mass= 536
Molecular Formula= C40H56
Molecular Composition= C 89.49% H 10.51%

 

It is a crystalline substance, C40H56, that is the main pigment of certain fruits, as the tomato and paprika, and is a precursor to carotene in plant biosynthesis.

Lycopene fights destructive "free radicals." Lycopene prevents oxidation of low-density lipoprotein (LDL) cholesterol and reduces the risk of developing atherosclerosis and coronary heart disease. Age-related macular degeneration (ARMD) is the most common form of blindness for elderly people. Lycopene is the only micronutrient whose serum level shown to be inversely related to the risk of ARMD. Lycopene was found to induce the formation of the protein connexin 43, one of the major building blocks of these channels, and thereby to restore gap junctions. Lycopene induces Phase II enzymes, which help to eliminate carcinogens and toxins from the body.

 

 

Technology/Product Specifications:

PRODUCT 1:  30% BETA CAROTENE

POLY CAROTENE 30% is an opaque reddish vegetable oil suspension of naturally occurring mixture of carotenoids extracted and concentrated from the green alga Dunailiella salina.

Usage: Beta-carotene is used in foods to provide color. It is sometimes added to products for its anti-oxidant effects, to keep fats from going rancid. It is sometimes added to foods or vitamin supplements as a nutrient. The long chains of conjugated double bonds that give the carotene strong color. It can mop up oxygen free radicals and dissipate their energy.

                                        Product Specifications

Total Carotenoids

30% minimum

Alpha-Carotene 1.0-2.0% typical

Beta- Carotene 25.0-27.0% typical

Lutein 0.5-0.8% typical

Zeaxanthin 0.5-0.8% typical

Cryptoxanthin 0.05-0.08% typical

Other Carotenoids 0.6-2.0% typical.

Vitamin A Activity

Each gram of this product contains not less than 420,000 I.U. of vitamin A activity. Biological activity: 1 mg of beta-carotene = 1,670 I.U. of vitamin A activity. (Martindale. The extra Pharmacopoeia, 30’th ed, Pg.1051)

Isomeric Form

Approximately 60% typical

cis-isomers and 40% typical transisomers.

Solubility

Soluble in oil and fats. Insoluble in water. Partially soluble in ethanol.

Peroxide value

10meg/kg max

Moisture

1.0% max.

Microbiology

Total aerobic microbial count. 1000/g.max

Stability

POLYCAROTENE 30% is stabilized with 0.35 natural tocopherols. Its shelf life is 24 months when stored in cool and dry place in unopened original containers

Uses

As dietary supplements and nutrient.

Packaging

POLYCAROTENE 30% is available in 1.0kg and 5.0kg container under nitrogen.

Labeling

Products formulated using POLYCAROTENE 30% can be labeled as containing “all natural” or “natural-source” carotenoids.

Storage

POLYCAROTENE 30% is sensitive to air, light and heat. Store in tightly closed containers.

Other variants available: 7.5%, 15% and 20%


PRODUCT 2: LYCOPENE /TOMATO OLERESIN

Lycopene is an open-chain unsaturated carotenoid that imparts red color to tomatoes, guava, rosehip, watermelon and pink grapefruit. Lycopene is a proven antioxidant.

Specifications:

Plant Origin: Lycopersicon esculentum

Molecular Formula: Open chain unsaturated carotenoid

Specification: 6%/10% HPLC Oil

Plant part

Fruit Extract

Solvent

Ethanol

Water Carrier Used

None

Appearance

Oil suspension

Color

Reddish yellow

Odor

Characteristic

Taste

Characteristic

Solubility

Unsolvable in water, sparingly in carbinol, ethanol, soluble in ether, own alkane, acetone, easily soluble in chloroform, benzene, sulphurate carbons

Heavy Metals

<20ppm

Arsenic:

<1ppm

Assay Lycopene by HPLC

> 6%

Total Plate count

1,000cfu/G

Yeast & Mold

<100cfu/G

E.Coli

Negative

Salmonella

Negative

Shelf life

Two years when properly stored

Storage

Tightly seal in clean, cool and dry area.

Lycopene Crystal

Synonyms

Tomato oleoresin

Molecular formula

open-chain unsaturated carotenoid

Appearance

Dark red needle like crystal

Odor

Characteristic

Taste

Peculiar

Solubility

Unsolvable in water, sparingly in carbinol, ethanol, soluble in aether, own alkane, acetone, easily soluble in chloroform, benzene, sulphurate carbons

Heavy metal

<= 10 ppm

Mercury

< 2PPM

Lead

< 2PPM

Total plate count

< 2000/gr

E-coil

Negative in 1 gr

Salmonclla

Negative in 20 gr

Shigella

Absent

Yeast & mould

<= 1000 cfu/g

Colon bacillus

No

Storage

Refrigerate or freeze

 

Company Profile

Company Name

ABL Biotechnologies Ltd.

Address

55, 3rd East Street, Kamaraj Nagar, Thiruvanmiyur,Chennai-600041, Tamil Nadu, India

Contact person

Mr. T. Surya Kumar

Phone

+91-44-42020501,42020502

Fax

+91-44-42020501,42020502

E-mail

mdo@ablbiotechnologies.com

Web Site

www.ablbiotechnologies.com

Year of Establishment

1992

Product(s) Manufactured

Bulk Drugs- 30% Beta Carotene, Phycocyanin, DHA, 10% Lycopene

Production (FY-05) (Products contributing most to the sales)

30% Beta Carotene    600 Kg

Sales Turnover

FY 05: USD 1.7 Mn

FY 04: USD 1.1 Mn

FY 03: USD 0.8 Mn

Conformity to Standards

Nil

Compliance to ISO

Nil

Foreign Collaboration

Nil

Manpower Total (Nos.)

150

Raw Materials / Equipment used

Spray Drier, Centrifuges, Race way, Content Testing, Quality Testing

Effluent Generated

Non Polluting

 


 

Broad Profile of Project Offer

 

Project 

To Manufacture Bulk Drugs  viz. Beta Carotene, Lycopene, Phycocyanin

Capacity per Annum

·          Phycocyanin                1.2 Ton

·          10% Lycopene             1.2-1.5 Ton

·          30% Beta Carotene       600 Kg.

Land Requirements/ Building Requirements

20,000 Sq. M

Plant & Machinery and Test Equipment

Raw Material depending upon Drug, Spray Drier, Centrifuges, Race way, Content Testing, Quality Testing

Electrical Installation

120 HP

Implementation Period

5 Months

Manpower Required

150

Raw Materials / Equipment Required

Spray Drier, Centrifuges, Race way, Content Testing, Quality Testing

Total Project Cost

USD  2.5 Mn (Approx.)

Expected Annual Sales

USD 0.25 Mn

Profitability

25%

Form of Offer

Turnkey Project

 

 

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