Abstract: Disclosed are compositions for competitive inhibition of pathogens against pathogenic infections comprising (a) Bacillus coagulans; (b) Bacillus subtilis; (c) citric acid; and (d) gallic acid including any combinations thereof. The compositions disclosed in this invention is capable to treat and prevent pathogenic infections of the genital organs as well as suitable for treatment and prevention of dermal infections. A method of preventing recurrence of the infections by way of supporting the growth of inherent natural doderlien microbial populations due to application of the compositions of the present invention are also disclosed. Further, use of the compositions of the present invention obviates the need of prior specific diagnosis of the infections due to its broad spectrum activity against multiple bacterial and fungal pathogens.
DESC:attached and uploaded ,CLAIMS:We Claim:
1. A composition for competitive inhibition of pathogens against but not limited to bacterial vaginosis, aerobic vaginitis, vaginal yeast and fungal pathogenic infections without the need of prior diagnosis thereof and restoration of microbial ecological balance comprising:
(a) Bacillus coagulans;
(b) Bacillus subtilis;
(c) citric acid; and
(d) gallic acid
including any combinations thereof.
2. The composition as claimed in claim 1, comprising Bacillus coagulans and Bacillus subtilis including any combinations thereof.
3. The composition as claimed in claim 1, comprising Bacillus coagulans, citric acid, and gallic acid including any combinations thereof.
4. The composition as claimed in claim 1, comprising Bacillus subtilis, citric acid, and gallic acid including any combinations thereof.
5. The composition as claimed in claim 1, wherein Bacillus coagulans is present at a concentration of up to 1 billion colony forming units (cfu), and Bacillus subtilis is present at a concentration of up to 1 billion colony forming units (cfu), citric acid between 10 mg to 100 mg and gallic acid between 10 mg to 100 mg per unit dose.
6. The composition as claimed in claim 1, wherein Bacillus coagulans is present at a concentration of 250 million cfu to 550 million cfu, preferably between 350 million cfu to 550 million cfu; Bacillus subtilis is present at a concentration of 250 million cfu to 550 million cfu, preferably between 350 million cfu to 550 million cfu; citric acid between 10 to 50 mg and gallic acid between 10 to 50 mg per unit dose.
7. The composition as claimed in claim 1, further including Bacillus laterosporus up to 1 billion colony forming units (cfu) per unit dose. .
8. The composition as claimed in claim 1, further comprising excipients selected from bioadhesives, disintegrating agents, binders, humectants, anticaking agents, foaming agents diluents and carriers.
9. The composition as claimed in claim 8, wherein the bioadhesive is selected from carbomers, carbopol, polycarbophil, disintegrating agents are selected from beta-cyclodextrin, sodium bicarbonate, adipic acid, boric acid, sodium glycolate, bnders are selected from starch and disaccharides, poly vinyl pyrollidone, humectant is selected from glycerine, aloevera, the anticaking agent selected from silicon dioxide, sodium bicarbonate, and adipic acid.
10. The composition as claimed in claim 8, provided in any of the form selected from a gel, ointment, cream, tablet, capsule, pessary, foam, washes, tampons, applicators, pads, for use as oral, or topical, or any site-specific mode of application.
11. The composition as claimed in claim 1, wherein Bacillus coagulans and Bacillus subtilis is present in the form of spores which germinates into vegetative forms as soon as contacted with the internal vaginal environment or the dermis optionally aided by the presence of citric acid and gallic acid.
12. The composition as claimed in claim 1 is stable for at least 2 years at temperatures up to 40oC in absence of cold chain storage conditions.
13. A method of competitive inhibition of pathogens and restoration of inherent doderlein bacteria without administering any lactobacillus bacteria from external sources thereby maintaining microbial ecological balance of the reproductive and genital organs particularly the vagina for treatment of bacterial vaginosis, aerobic vaginitis, vaginal yeast and fungal pathogenic infections without the need of prior diagnosis thereof using a composition comprising of
(a) Bacillus coagulans;
(b) Bacillus subtilis;
(c) citric acid; and
(d) gallic acid;
including any combination thereof, wherein Bacillus coagulans and Bacillus subtilis is present at a concentration up to 1 billion cfu in the form of spores, citric acid between 10 mg to 100 mg and gallic acid between 10 mg to 100 mg per unit dose.
14. The method of claim 13, wherein the composition comprising Bacillus coagulans and Bacillus subtilis including any combination thereof.
15. The method of claim 13, wherein the composition comprising Bacillus coagulans, citric acid, and gallic acid including any combination thereof.
16. The method of claim 13, wherein the composition comprising Bacillus subtilis, citric acid, and gallic acid including any combination thereof.
17. A method of prevention and reduction of recurrence of pathogenic infections using a composition comprising
(a) Bacillus coagulans;
(b) Bacillus subtilis;
(c) citric acid; and
(d) gallic acid;
including any combinations thereof wherein the growth of doderlein lactobacillus bacteria in presence of Bacillus coagulans and Bacillus subtilis is more than the growth of doderlein lactobacillus bacteria without the presence of Bacillus coagulans and Bacillus subtilis.
18. The composition as claimed in claim 1, claim 13 and claim 17 wherein the Bacillus coagulans is Bacillus coagulans SNZ1969, and Bacillus subtilis is Bacillus subtilis SNZ1972.
| Section | Controller | Decision Date |
|---|---|---|
| # | Name | Date |
|---|---|---|
| 1 | 201941005414-NBA INTIMATION TO APPLICANT COMPLY WITH REQUIREMENT-24-01-2023.pdf | 2023-01-24 |
| 1 | 201941005414-PROVISIONAL SPECIFICATION [12-02-2019(online)].pdf | 2019-02-12 |
| 2 | 201941005414-Annexure [22-04-2022(online)].pdf | 2022-04-22 |
| 2 | 201941005414-POWER OF AUTHORITY [12-02-2019(online)].pdf | 2019-02-12 |
| 3 | 201941005414-Written submissions and relevant documents [22-04-2022(online)].pdf | 2022-04-22 |
| 3 | 201941005414-FORM 1 [12-02-2019(online)].pdf | 2019-02-12 |
| 4 | 201941005414-Proof of Right [12-02-2020(online)].pdf | 2020-02-12 |
| 4 | 201941005414-Annexure [05-04-2022(online)].pdf | 2022-04-05 |
| 5 | 201941005414-FORM-26 [12-02-2020(online)].pdf | 2020-02-12 |
| 5 | 201941005414-Correspondence to notify the Controller [05-04-2022(online)].pdf | 2022-04-05 |
| 6 | 201941005414-FORM 3 [12-02-2020(online)].pdf | 2020-02-12 |
| 6 | 201941005414-CERTIFIED COPIES-CERTIFICATE U-S 72 147 & UR 133-2 [30-03-2022(online)].pdf | 2022-03-30 |
| 7 | 201941005414-US(14)-HearingNotice-(HearingDate-07-04-2022).pdf | 2022-03-08 |
| 7 | 201941005414-ENDORSEMENT BY INVENTORS [12-02-2020(online)].pdf | 2020-02-12 |
| 8 | 201941005414-CORRESPONDENCE-OTHERS [12-02-2020(online)].pdf | 2020-02-12 |
| 8 | 201941005414-CLAIMS [05-02-2022(online)].pdf | 2022-02-05 |
| 9 | 201941005414-COMPLETE SPECIFICATION [12-02-2020(online)].pdf | 2020-02-12 |
| 9 | 201941005414-FER_SER_REPLY [05-02-2022(online)].pdf | 2022-02-05 |
| 10 | 201941005414-OTHERS [05-02-2022(online)].pdf | 2022-02-05 |
| 10 | 201941005414-Request Letter-Correspondence [26-02-2020(online)].pdf | 2020-02-26 |
| 11 | 201941005414-FER.pdf | 2021-10-17 |
| 11 | 201941005414-Power of Attorney [26-02-2020(online)].pdf | 2020-02-26 |
| 12 | 201941005414-Form 1 (Submitted on date of filing) [26-02-2020(online)].pdf | 2020-02-26 |
| 12 | 201941005414-FORM 18A [05-06-2021(online)].pdf | 2021-06-05 |
| 13 | 201941005414-CERTIFIED COPIES TRANSMISSION TO IB [26-02-2020(online)].pdf | 2020-02-26 |
| 13 | 201941005414-FORM28 [05-06-2021(online)].pdf | 2021-06-05 |
| 14 | 201941005414-MSME CERTIFICATE [05-06-2021(online)].pdf | 2021-06-05 |
| 15 | 201941005414-CERTIFIED COPIES TRANSMISSION TO IB [26-02-2020(online)].pdf | 2020-02-26 |
| 15 | 201941005414-FORM28 [05-06-2021(online)].pdf | 2021-06-05 |
| 16 | 201941005414-Form 1 (Submitted on date of filing) [26-02-2020(online)].pdf | 2020-02-26 |
| 16 | 201941005414-FORM 18A [05-06-2021(online)].pdf | 2021-06-05 |
| 17 | 201941005414-Power of Attorney [26-02-2020(online)].pdf | 2020-02-26 |
| 17 | 201941005414-FER.pdf | 2021-10-17 |
| 18 | 201941005414-Request Letter-Correspondence [26-02-2020(online)].pdf | 2020-02-26 |
| 18 | 201941005414-OTHERS [05-02-2022(online)].pdf | 2022-02-05 |
| 19 | 201941005414-COMPLETE SPECIFICATION [12-02-2020(online)].pdf | 2020-02-12 |
| 19 | 201941005414-FER_SER_REPLY [05-02-2022(online)].pdf | 2022-02-05 |
| 20 | 201941005414-CLAIMS [05-02-2022(online)].pdf | 2022-02-05 |
| 20 | 201941005414-CORRESPONDENCE-OTHERS [12-02-2020(online)].pdf | 2020-02-12 |
| 21 | 201941005414-ENDORSEMENT BY INVENTORS [12-02-2020(online)].pdf | 2020-02-12 |
| 21 | 201941005414-US(14)-HearingNotice-(HearingDate-07-04-2022).pdf | 2022-03-08 |
| 22 | 201941005414-CERTIFIED COPIES-CERTIFICATE U-S 72 147 & UR 133-2 [30-03-2022(online)].pdf | 2022-03-30 |
| 22 | 201941005414-FORM 3 [12-02-2020(online)].pdf | 2020-02-12 |
| 23 | 201941005414-Correspondence to notify the Controller [05-04-2022(online)].pdf | 2022-04-05 |
| 23 | 201941005414-FORM-26 [12-02-2020(online)].pdf | 2020-02-12 |
| 24 | 201941005414-Annexure [05-04-2022(online)].pdf | 2022-04-05 |
| 24 | 201941005414-Proof of Right [12-02-2020(online)].pdf | 2020-02-12 |
| 25 | 201941005414-Written submissions and relevant documents [22-04-2022(online)].pdf | 2022-04-22 |
| 25 | 201941005414-FORM 1 [12-02-2019(online)].pdf | 2019-02-12 |
| 26 | 201941005414-POWER OF AUTHORITY [12-02-2019(online)].pdf | 2019-02-12 |
| 26 | 201941005414-Annexure [22-04-2022(online)].pdf | 2022-04-22 |
| 27 | 201941005414-PROVISIONAL SPECIFICATION [12-02-2019(online)].pdf | 2019-02-12 |
| 27 | 201941005414-NBA INTIMATION TO APPLICANT COMPLY WITH REQUIREMENT-24-01-2023.pdf | 2023-01-24 |
| 1 | 2020050140E_02-08-2021.pdf |