Lactospore®

(LACTIC ACID BACILLUS)

Lactic Acid Bacillus was originally known in the literature as Lactobacillus sporogenes.

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A superior & effective probiotic

"Probiotic" simply means “for life”

“A live microbial feed supplement, which beneficially affects the host by improving its intestinal microbial balance”.

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Lactospore® An ideal probiotic for the following reasons:

Room temperature stable Naturally microencapsulated for stability

and ease of processing

Proliferates within the GI tract Produces L(+) Lactic acid only Aids in protein, lipid and carbohydrate

digestion Documented clinical effectiveness Compatible with nutrients and antibiotics Not artificially made resistant Japanese FDA approved probiotic

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Condition % cases showing improvement

Diarrhea due to chronic acute enteritis

93.7

Mal-digestion accompanied by diarrhea

85.9

Infantile diarrhea 87.9

Constipation 65.4

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A total of 567 cases in 19 institutions in Japan were evaluated.

A significant improvement of symptoms due to abnormalities in the intestinal flora was observed with the use of Lactobacilus sporogens.

Ref: Clinical study of Lacbon (Sporlac) compiled by the Sankyo Co. Ltd. Japan.

Lactospore in Gastrointestinal Health - Japan

Lactospore in Gastrointestinal Health - India

Condition % cases showing improvement

Diarrhea 81.7

Constipation 100.0

Jaundice 100.0

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Study 1: Cases of neonatal diarrhea responded well to L. sporogenes (SPORLAC) therapy. 60 diarrheal cases of which three also suffered from constipation and three from jaundice were studied.

Dose administered : 15 million spores per dayRecovery period: 1.8 days

Ref: Dhongade, R.K., Anjaneyulu, R. (1977). Abstract from Maharashtra Medical Journal Vol.XXIII No.1, Feb:473-474.

Lactospore in Gastrointestinal Health – India

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Study 2: 112 newborn infants in rural India were randomized to receive a daily oral dose of 100 million L. sporogenes or a placebo for one year. Morbidity was monitored each week for 12 months..

Ref: Chandra, R.K. Nutrition Research 22 (2002) 65–69

L. sporogenes Placebo pNumber of infants 55 57

Number of infants with episodes of rotavirus diarrhea

44 50 Not significant

Number of episodes 3.4(1.0) 8.6(1.7) <0.02

Duration of each episode (days) 3.6 (1.0) 6.8 (1.1) <0.05

Days ill/12 months 13(3) 35 (5) <0.01

Effect of L. sporogenes feeding on rotavirus diarrhea

Data are shown as mean (SD)

Other Clinical Studies: Healthy Serum Lipid Profiles

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Short term hypolipidemic effects of oral L. sporogenes therapy.

Dose: 360 million spores per day in tablet formSubjects: 7 patients (15 men and 2 women in the 32-61 year age

group) with type II hyperlipidemia in an open label fixed dose trial.Duration: 12 weeks

Atherogenic Lipid Ratios were improved:

Ref: J.C. Mohan, R. Arora & M. Khalilullah, Indian Journal of Medical Research [B], 92:431-432 (1990).

Total / HDL cholesterol ratio

Decreased by 24%

LDL/HDL ratio Decreased by 33.4%

Formulations with Lactospore®

* Lactospore® withstands mechanical processing - ideal for tableting and capsule making.

* Lactospore® is compatible with a wide range of drugs and antibiotics, including ampicillin.

* A dosage of 100 - 200 million spores is equivalent to 7 to 10 mg of Lactospore® 15 billion powder.

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Capsule dosage forms

Antibiotic formulation 1

Ampicillin Trihydrate equivalent to Anhydrous Ampicillin 250 mgLactobacillus sporogenes 6 million

Antibiotic formulation 2

Ampicillin Trihydrate equivalent to 500 mgAnhydrous AmpicillinLactobacillus sporogenes 6 million

Formulations with Lactospore ®

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Antibiotic formulation

Each 5 ml contains :Lactobacillus sporogenes 20 million Ampicillin trihydrate equiv. to 125 mg Ampicillin

Multi-vitamin formulation 1

Each 5 ml contains:Lactobacillus sporogenes 15 millionVit B1 Mononitrate 3.0 mgVit B2 3.0 mgVit B6 1.5 mgFolic Acid 300 μgVit B12 4.5 μ gNiacinamide 40 mgCalcium pantothenate 4.5 mgVit C 75 mg

Dry Syrup Dosage Forms

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Lactic Acid Bacillus Spores tabletsLactobacillus sporogenes 60 million spores

Multi-vitamin tabletsEach tablet contains:Lactobacillus sporogenes 40 millionVitamin B1 3 mgVitamin B2 3 mgVitamin B6 1 mgNiacinamide 25 mg

Tablet Dosage Forms

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Lactic Acid Bacillus Spores powderEach sachet containsLactobacillus sporogenes 150 million spores

For Oral Rehydration TherapyEach sachet (50 grams) contains:Calcium lactate 0.545% w/wPotassium chloride 2.337% w/wMagnesium sulfate 0.736% w/wSodium chloride 0.365% w/wSodium acid phosphate 0.975% w/wSodium citrate 1.839% w/wL. sporogenes 700 millionDextrose q.sPineapple flavor q.s

Dry Powder Dosage Forms

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Our Facilities

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Research & Development

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Sterile Area Facility - Indicating material transferthrough a pass box

Media Sterilization & Documentation

Automated pilot fermenter used for seed inoculum preparation

In Process Quality Control For Lactospore

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Fermentation Facility - Production & Seed Fermenters

CONCLUSION

Lactospore ® is an ideal probiotic with proven stability.

Lactospore ® can be incorporated in a wide range of formulations.

Documented clinical effectiveness.

Japanese FDA approved probiotic.

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