Micro-encapsulated lactobacilli for medical applications

• US 5,733,568 A
• Filed: 06/02/1995
• Issued: 03/31/1998
• Est. Priority Date: 12/03/1993
• Status: Expired due to Fees

• Current Assignee: Biofem Incorporated
• Original Assignee: Lafor Laboratories, Ltd.
• Inventors: Ford, Larry C.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/459,058
• Time in Patent Office: 1,033 Days
• Field of Search: 424/433, 424/DIG. 15, 424/489, 514/967, 435/853, 435/854
• US Class Current: 424/433
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 15/02 for disorders of the vagina
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: Y10S 424/15 Suppositories
• CPC Class Codes: Y10S 435/853 Lactobacillus
• CPC Class Codes: Y10S 435/854 Lactobacillus acidophilus

Abstract

Micro-encapsulated lactobacilli bacteria are orally administered to mammals, including humans, to treat or prevent antibiotic associated or other chronic or acute diarrhea. Micro-encapsulated lactobacilli bacteria are topically administered to the skin to treat or prevent recurrent skin infections, and are administered intra-vaginally to treat or prevent vaginal yeast infections.

Claims

1. A pharmaceutical composition adapted for intra-vaginal delivery to a human patient, comprising in a unit dose thereof at least approximately 10³ viable lactobacilli bacteria, said lactobacilli bacteria being micro-encapsulated whereby the lactobacilli bacteria stay viable during storage of the composition, the substance providing the encapsulating coating for the lactobacilli bacteria being such that it releases lactobacilli bacteria upon prolonged exposure to moisture.

2. The pharmaceutical composition of claim 1 which is a vaginal suppository.

3. The pharmaceutical composition of claim 2 wherein each suppository comprises at least approximately 10⁵ viable lactobacilli bacteria of the Lactobacillus acidophilus species or of its Lactobacillus rhamnosus variant.

4. A method of treating or preventing yeast infection in a female mammal, including a female human, by intra-vaginally delivering to said female a pharmaceutical composition comprising in a unit dose thereof at least approximately 10³ viable lactobacilli lactobacilli bacteria, said lactobacilli bacteria being micro-encapsulated whereby the lactobacilli bacteria stay viable during storage of the composition, the substance providing the encapsulating coating for the lactobacilli bacteria being such that it releases lactobacilli bacteria upon prolonged exposure to moisture in the vagina.

5. The method of claim 4 wherein the pharmaceutical composition is a vaginal suppository, comprising at least approximately 10⁵ viable micro-encapsulated lactobacilli bacteria of the Lactobacillus acidophilus species or of its Lactobacillus rhamnosus variant.