CA2829731A1 - Use of sterile intravenous or intracavernous glycerin in destruction of bacterial biofilm - Google Patents

Use of sterile intravenous or intracavernous glycerin in destruction of bacterial biofilm Download PDF

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CA2829731A1
CA2829731A1 CA2829731A CA2829731A CA2829731A1 CA 2829731 A1 CA2829731 A1 CA 2829731A1 CA 2829731 A CA2829731 A CA 2829731A CA 2829731 A CA2829731 A CA 2829731A CA 2829731 A1 CA2829731 A1 CA 2829731A1
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solution
volume
glycerin
certain percentage
normal saline
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Thomas B. Bryan
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Priority claimed from US13/912,060 external-priority patent/US9549904B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Disclosed is the use of a sterile intravenous normal saline solution containing glycerin and amino acids for preventing or inhibiting biofilm formation by a population of bacteria. In some embodiments, the concentration of glycerin in the normal saline solution is approximately 3%. In some embodiments, the concentration of amino acids in the normal saline solution is approximately 3%. In some embodiments, the intravenous solution is administered for 48 hours at 80 cc/hour. In some embodiments, the solution is infused via intracavernous administration into an infected body cavity.

Description

USE OF STERILE INTRAVENOUS OR INTRACAVERNOUS GLYCERIN
IN DESTRUCTION OF BACTERIAL BIOFILM
BACKGROUND OF THE INVENTION
[0001] Field of Invention This invention pertains to the use of sterile intravenous or intracavernous glycerin solutions to treat biofilms that infect humans and animals.
[0002] Description of Related Art [0003] A biofilm occurs when bacteria stick to each other on a surface. These adherent cells are frequently embedded within a self-producing matrix of extra cellular polymeric substance. Biofilms are also referred to as slime. The polymeric conglomeration is generally composed of extra-cellular DNA, proteins and polysaccharides. Initially the biofilm is weak and adhesion is by van der Waals forces. Later, the bacteria form cell adhesion structures such as pili. Once colonization has begun the biofilm grows through a combination of cell division and recruitment.
[0004] The development of biofilm may allow for an aggregated cell colony to be increasingly antibiotic resistant. Bacteria from the biofilm can disperse which causes the spread and colonization of new surfaces. The matrix protects the bacteria within it and facilitates communication among them through biochemical signals. Biofilm has been implicated in such problems as urinary tract infections, endocarditis, cystic fibrosis and infections of prosthesis and heart valve. Invariably the only recourse for treating prosthetics such as mechanical heart valve is to have them replaced. Biofilms are present on the removed tissue of 80% of patients undergoing surgery for chronic sinusitis.
[0005] In the 1980's Danish pioneers first connected biofilms with human disease and then antibiotic resistant infections. They discovered that once these biofilm infections had begun they are difficult to get rid of in the body. The immune system can mop up free-floating bacteria in the blood but reaching bacteria in biofilms is difficult.
[0006] Even if an antibiotic reaches a biofilm, a large portion of the bacteria would be insensitive to the specific antibiotic as bacteria in a biofilm occupied a spectrum of physiological state from rapid growing to dormant. The dormant bacteria are not vulnerable to the antibiotic. Later, these dormant bacteria can quickly renew the biofilm. Low oxygen concentration in the biofilm also protects the bacteria from some antibiotics.
[0007] The CDC claims that 65% of bacterial infections that are treated by physicians develop biofilm. Biofilm have been implicated in chronic infections. Most notable among them is staphylococcus aureus especially the methicillin resistant variety, staphylococcus epidermis and pseudomonas aeruginosa. Topical glycerin can treat biofilm in the mouth such as halitosis.
[0008] A 66 year old female developed cellulitis and an open ulcer on her leg.
This was treated by oral antibiotics and was also treated at an outpatient wound care center. When the outpatient care was not successful she was admitted to the hospital for intravenous antibiotics. After 3 weeks there was no sign of improvement and the ulcer was enlarging. At this stage the ulcer measured 3 cm by 1 1/2 cm in size and there was surrounding redness suggestive of inflammation. She was then given intravenous glycerin. The intravenous glycerin was given as a solution of 3% glycerin and 3% amino acids. This is currently the only commercially available source of intravenous glycerin. She was given the infusion at a rate of 80 cubic centimeters (cc) per hour. At the end of 48 hours there was evidence of healing in the ulcer. During these 48 hours she was continued on intravenous antibiotics.
After 72 hours the patient was discharged home on oral antibiotics. When she was re-examined 3 weeks later there was no evidence of the ulcer and the surrounding inflammation that was caused by cellulitis had totally cleared. Ulcers such as this patient had develop bacterial biofilm and can have increased resistance to antibiotics that at times cause the antibiotics to be ineffective.
SUMMARY OF THE INVENTION
[0009] The use of intravenous normal saline solution containing glycerin and amino acids to prevent or inhibit internal biofilm formation by bacteria is disclosed.
[0010] In some embodiments, the concentration of glycerin in the normal saline solution is approximately 3%.
[0011] In some embodiments, the concentration of amino acids in the normal saline solution is approximately 3%.
[0012] In some embodiments, the intravenous solution is administered for 48 hours at 80 cc/hour.
[0013] In some embodiments, the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is infused into an infected body cavity.
[0014] In some embodiments, the bacterial infection comprises methicillin resistant staphylococcus aureus.
[0015] In some embodiments, the bacterial infection comprises staphylococcus epidermis.
[0016] In some embodiments, the bacterial infection comprises pseudomonas aeruginosa.
[0017] In some embodiments, the infected body cavity is a pleural cavity.
[0018] In some embodiments, the infected body cavity is a peritoneal cavity.
[0019] In some embodiments, approximately 500 cc of the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is infused into an infected body cavity.
[0020] In some embodiments, greater than 500 cc of the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is infused into an infected body cavity.
[0021] Also disclosed is the use of a normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution for optimizing therapeutic efficacy for treatment of a bacterial infection within a body cavity.
DETAILED DESCRIPTION OF THE INVENTION
[0022] Glycerin is a simple polyol compound. Tons of it is produced annually in the United States and Europe. It is made from animal fats and vegetable oils. Only one company in the United States makes a product that is sterile and used for intravenous administration. It has been used since 1976 as a non-glycemic source of carbohydrates as a source of nutrition in patients who are unable to process food via the gastrointestinal tract. It is remarkable for its safety profile and is free of allergic reactions. It is generally infused at a 3% concentration at a rate of 80-100 milliliters per hour. Those with heart failure and kidney failure may need a slower rate of infusion. As in the case outlined here it can diffuse a bacterial biofilm.
[0023] Glycerin can assist antibiotics and the immune system in conquering bacteria biofilm.
In this capacity it can reduce the ever-occurring resistance of bacteria to antibiotics. Cavity spaces such as the pleural cavity and the peritoneal cavity can develop infections with biofilms. Infusing these cavities with the 3% solution of Glycerin would help breakdown these biofilms. For example, half a liter of the solution would be infused into a pleural cavity.
A greater amount could be infused into the peritoneal cavity.
[0024] Embodiments are directed to use of an intravenous normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution for treating a biofilm-associated infection in a subject.
[0025] In some embodiments, the concentration of glycerin in the normal saline solution is approximately 3%.
[0026] In some embodiments, the concentration of amino acids in the normal saline solution is approximately 3%.
[0027] In some embodiments, the intravenous solution is administered for 48 hours at 80 cc/hour.
[0028] In some embodiments, the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is infused into an infected body cavity.
[0029] In some embodiments, the infusion occurs via intracavernous administration.
[0030] In some embodiments, the bacterial infection comprises methicillin resistant staphylococcus aureus.
[0031] In some embodiments, the bacterial infection comprises staphylococcus epidermis.
[0032] In some embodiments, the bacterial infection comprises pseudomonas aeruginosa.
[0033] In some embodiments, the infected body cavity is a pleural cavity.
[0034] In some embodiments, the infected body cavity is a peritoneal cavity.
[0035] A concentration higher than 3% of glycerin may be more effective.
[0036] Brand names include Procalamine from B. Braun Medical Inc.
[0037] ProcalAminee (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is a sterile, nonpyrogenic, moderately hypertonic intravenous injection containing crystalline amino acids, a nonprotein energy substrate and maintenance electrolytes.
[0038] A 1000 mL unit provides a total of 29 g of protein equivalent (4.6 g N) and 130 nonprotein calories.
[0039] All amino acids designated USP are the "U-isomer with the exception of Glycine USP which does not have an isomer.
[0040] Table 1 provides the component weights per 100 mL.

Nonprotein energy source:
Glycerin USP (glycerol) 3.0 g Essential amino acids Isoleucine USP 0.21 g Leucine USP 0.27 g Lysine (as Lysine Acetate USP 0.31g) 0.22 g Methionine USP 0.16 g Phenylalanine USP 0.17 g Threonine USP 0.12 g Tryptophan USP 0.046 g Valine USP 0.20 g Nonessential amino acids Alanine USP 0.21 g Glycine USP 0.42 g Arginine USP 0.29 g Histidine USP 0.085 g Proline USP 0.34 g Serine USP 0.18 g Cysteine (as Cysteine HC1=H20 USP <0.020) <0.014 g Sodium Acetate=3H20 USP 0.20 g Magnesium Acetate=4H20 0.054 g Calcium Acetate=H20 0.026 g Sodium Chloride USP 0.12 g Potassium Chloride USP 0.15 g Phosphoric Acid NF 0.041 g Potassium Metabisulfite NF (as an antioxidant) <0.05 g Water for Injection USP QS
pH adjusted with Glacial Acetic Acid USP pH 6.8 (6.5-7.0) Calculated Osmolarity 735 mOsmol/liter [0041] These descriptions and drawings are embodiments and teachings of the present invention. All variations are within the spirit and scope of the present invention. This disclosure is not to be considered as limiting the present invention to only the embodiments illustrated.

Claims (18)

1) Use of an intravenous normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution for treating a biofilm-associated infection in a subject.
2) The use of the intravenous solution of claim 1 wherein the certain percentage concentration by volume of glycerin in the normal saline solution is approximately
3%.
3) The use of the intravenous solution of claim 1 wherein the certain percentage concentration by volume of glycerin of amino acids in the normal saline solution is approximately 3%.
4) The use of the intravenous solution of claim 1 wherein the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is administered for 48 hours at cc/hour.
5) The use of the intravenous solution of claim 1 wherein the certain percentage concentration by volume of glycerin in the normal saline solution is greater than 3%.
6) The use of the intravenous solution of claim 1 wherein the biofilm-associated infection comprises methicillin resistant staphylococcus aureus.
7) The use of the intravenous solution of claim 1 wherein the biofilm-associated infection comprises staphylococcus epidermis.
8) The use of the intravenous solution of claim 1wherein the biofilm-associated infection comprises pseudomonas aeruginosa.
9) Use of a normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution for optimizing therapeutic efficacy in treatment of a bacterial infection within a body cavity.
10) The use of the solution of claim 9 wherein the normal saline solution is administered via intravenous connection.
11) The use of the solution of claim 9 wherein the normal saline solution is infused via intracavernous administration.
12) The use of the solution of claim 9 wherein the bacterial infection comprises methicillin resistant staphylococcus aureus.
13) The use of the solution of claim 9 wherein the bacterial infection comprises staphylococcus epidermis.
14) The use of the solution of claim 9 wherein the bacterial infection comprises pseudomonas aeruginosa.
15) The use of the solution of claim 9 wherein the body cavity is the pleural cavity.
16) The use of the solution of claim 9 wherein the body cavity is the peritoneal cavity.
17) The use of the solution of claim 9 wherein a volume of approximately 500 cc of the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is infused into the infected body cavity.
18) The use of the solution of claim 9 wherein a volume greater than 500 cc of the normal saline solution comprising a certain percentage concentration by volume of glycerin and a certain percentage by volume of an amino acid solution is infused into the infected body cavity.
CA2829731A 2013-06-06 2013-10-15 Use of sterile intravenous or intracavernous glycerin in destruction of bacterial biofilm Abandoned CA2829731A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/912,060 US9549904B2 (en) 2012-06-06 2013-06-06 Method of destroying bacterial biofilm using sterile intravenous or intracavernous glycerin
US13912060 2013-06-06

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Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9480669B2 (en) * 2015-01-06 2016-11-01 The Regents Of The University Of California Method of destroying and preventing bacterial and fungal biofilm by amino acid infusion
EP3263115A1 (en) 2016-06-30 2018-01-03 Technische Hochschule Mittelhessen Invention relating to an agent combating pseudomonas aeruginosa
WO2018226987A1 (en) 2017-06-07 2018-12-13 The Regents Of The University Of California Compositions for treating fungal and bacterial biofilms and methods of using the same

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9549904B2 (en) * 2012-06-06 2017-01-24 Thomas Bryan Method of destroying bacterial biofilm using sterile intravenous or intracavernous glycerin
US20130123319A1 (en) * 2011-11-15 2013-05-16 Thomas Benedict Bryan Medthod of Treating a systemic inflammatory disorder and damaged internal tissues

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GB201318577D0 (en) 2013-12-04
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