Post on 06-Apr-2015
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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