Parenteral delivery device and methods of use
Inventors
Faulkner, Mark C. • Seymour, Deeannah
Assignees
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Publication Number
US-12011469-B2
Publication Date
2024-06-18
Expiration Date
Abstract
A parenteral delivery device and method of delivering a multi-system treatment to a centralized location where the delivery device includes at least an inner compartment encapsulating a first system and an outer compartment encapsulating a second system and the first and second systems have different mechanisms of action for use in the treatment of vaginal infection.
Core Innovation
The invention relates to a multi-compartment delivery device for treating vaginal infections, including a first compartment comprising a synbiotic and a second compartment comprising a slurry. The first compartment contains a synbiotic with about 75 mg to about 125 mg by weight of a dry prebiotic and about 100 mg to about 450 mg by weight of a dry probiotic, and the dry probiotic comprises Lactobacillus iners, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, or combinations thereof.
The second compartment consists of about 50 mg to about 600 mg hydrogen borate and about 150 mg to about 580 mg of an oil medium, and the second compartment is disposed about the first compartment. In particular vaginal delivery configurations specify hydrogen borate in a slurry with coconut oil, and the devices include first and second capsule forms.
The first capsule dissolves at a first dissolution rate and the second capsule dissolves at a second dissolution rate, including configurations where the first dissolution rate is greater than the second dissolution rate. The arrangement supports time-separated release from different capsule materials and relative capsule configuration.
The invention further defines compositions within the synbiotic, including dry prebiotic powders comprising short-chain fructo-oligosaccharide and dry probiotic powders comprising specified Lactobacillus species. In some embodiments, the synbiotic additionally comprises a preservative.
Claims Coverage
The independent claims are clm-00001, clm-00010, and clm-00015, and they each cover a multi-compartment vaginal delivery device that combines a synbiotic with a hydrogen-borate oil slurry in an adjacent, time-separated capsule arrangement. Across the independent claims, there are four inventive features.
Synbiotic first compartment with dry prebiotic and dry probiotic Lactobacillus species
A delivery device comprising a first compartment comprising a synbiotic, wherein the synbiotic comprises about 75 mg to about 125 mg by weight of a dry prebiotic and about 100 mg to about 450 mg by weight of a dry probiotic, wherein the dry probiotic comprises Lactobacillus iners, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, or combinations thereof.
Hydrogen borate and oil-medium slurry second compartment disposed about the synbiotic compartment
A delivery device comprising a second compartment comprising a slurry, wherein the slurry consists of about 50 mg to about 600 mg hydrogen borate and about 150 mg to about 580 mg of an oil medium, and wherein the second compartment is disposed about the first compartment.
Vaginal capsule device with hydrogen borate/oil slurry and synbiotic powder with faster-dissolving first capsule
A vaginal delivery device comprising a first capsule having a first dissolution rate and enclosing a slurry, wherein the slurry consists of about 200 mg to about 500 mg hydrogen borate and about 150 mg to about 580 mg coconut oil; a second capsule having a second dissolution rate and comprising a synbiotic powder, wherein the synbiotic powder comprises about 75 mg to about 125 mg by weight of a dry prebiotic powder and about 100 mg to about 450 mg by weight of a dry probiotic powder, wherein the dry probiotic powder comprises Lactobacillus iners, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, or combinations thereof; wherein the first capsule is disposed about the second capsule; and wherein the first dissolution rate is greater than the second dissolution rate.
Vaginal capsule device with hydrogen borate/oil slurry first capsule and synbiotic second capsule
A vaginal delivery device comprising a first capsule enclosing a slurry, wherein the slurry consists of hydrogen borate and an oil medium, wherein the oil medium is present in the slurry in an amount of about 150 mg to about 580 mg; a second capsule comprising a synbiotic, wherein the synbiotic comprises about 80 mg to about 140 mg by weight of a dry prebiotic powder and about 75 mg to about 400 mg by weight of a dry probiotic powder, wherein the dry prebiotic powder comprises a short chain fructo-oligosaccharide, and wherein the dry probiotic powder comprises Lactobacillus iners, Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii; and wherein the first capsule is disposed about the second capsule.
Across the independent claims, coverage centers on a delivery device with a synbiotic first compartment and a hydrogen borate/oil slurry second compartment, including vaginal delivery devices implemented as first and second capsules. The claims require specified ranges for dry prebiotic, dry probiotic, hydrogen borate, and oil-medium amounts, specified Lactobacillus species for the dry probiotic, and in certain vaginal embodiments a relative placement and dissolution-rate relationship where the first capsule dissolves faster than the second capsule.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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