WO2004103232A1 - Dissolvable vaginal deodorizing films and methods of vaginal deodorizing utilizing pliable dissolvable film - Google Patents

Dissolvable vaginal deodorizing films and methods of vaginal deodorizing utilizing pliable dissolvable film Download PDF

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Publication number
WO2004103232A1
WO2004103232A1 PCT/US2004/014953 US2004014953W WO2004103232A1 WO 2004103232 A1 WO2004103232 A1 WO 2004103232A1 US 2004014953 W US2004014953 W US 2004014953W WO 2004103232 A1 WO2004103232 A1 WO 2004103232A1
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WIPO (PCT)
Prior art keywords
vaginal
deodorizing
film
dissolvable
lubricant
Prior art date
Application number
PCT/US2004/014953
Other languages
French (fr)
Inventor
Thomas Leon
Paul Gabel
Original Assignee
Apothecus Pharmaceutical Corp.
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Publication of WO2004103232A1 publication Critical patent/WO2004103232A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q13/00—Formulations or additives for perfume preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0216—Solid or semisolid forms
    • 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
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q15/00—Anti-perspirants or body deodorants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads
    • A61F13/8405—Additives, e.g. for odour, disinfectant or pH control
    • A61F2013/8408—Additives, e.g. for odour, disinfectant or pH control with odour control
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets

Definitions

  • the present invention is directed to dissolvable, vaginal deodorizing films comprising at least one fragrance, and methods of vaginal deodorizing utilizing dissolvable films comprising at least one fragrance.
  • vaginal deodorizers and methods for vaginal deodorizing, which can be applied discreetly, for example in a public restroom, or anytime and which can be applied and used without creating a messy condition.
  • Dissolvable films have been previously disclosed for use in delivering pharmaceutically-active ingredients to humans.
  • dissolvable films have been disclosed for delivering effective amounts of contraceptive pharmaceutical agents.
  • Such films comprise a binder such as polyvinyl alcohol, a lubricant such as glycerin, a solvent for the polyvinyl alcohol and glycerin such as water, the active ingredient nonoxynol-9 and at least one preservative.
  • Water is utilized as a solvent since the nonoxynol-9 is water soluble and can be readily dissolved into a mixture or slurry prior co formation of -he film. « '" ..
  • One aspect of the present invention is directed to various embodiments comprising dissolvable, vaginal deodorizing films.
  • the disclosed films are pliable, i.e., they can be folded repeatedly without breaking, which facilitate placement as well as comfort during use.
  • the films have relatively small mass relative to other known deodorizers such as douches and suppositories, and they begin to dissolve upon placement and typically-completely dissolve in about ⁇ 5- ' 20 minutes.
  • the films of the present invention do not include an effective amount of any pharmaceutically active agent.
  • the purpose of this aspect of the invention is to provide a dissolvable, pliable film for vaginal deodorizing and specifically excludes pharmaceutically effective amounts of pharmaceutical agents.
  • a second aspect of the present invention is directed to various embodiments comprising methods of vaginal deodorizing utilizing the films disclosed in the previous paragraph.
  • the present invention advantageously provides methods of vaginal deodorizing and specifically exclude pharmaceutically effective amounts of pharmaceutical agents.
  • One preferred embodiment of the present invention comprises a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant,, a minor amqr ⁇ fljie. ⁇ ' t ⁇ € ⁇ FB4- ⁇ ⁇ s ⁇ &t ⁇ ifi S ⁇ i *M£ m " i iR ⁇ iS S #53>r amounts of preservatives for shelf stability, at least one fragrance and preferably no other active ingredient, or, at most, less than an effective amount of any pharmaceutically active ingredient.
  • the films are hydrophilic.
  • One embodiment of this aspect of the present invention comprises a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, and an effective amount of at least one non- pharmaceutically-active fragrance.
  • Another preferred embodiment of the present invention compfi ⁇ ses a method of vaginal deodorizing comprising ' the steps of providing a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, a minor amount of surfactant for film forming, minor amounts of preservatives for shelf stability, at least one fragrance and preferably no other active ingredient, or, at most, less than an effective amount of any pharmaceutically active ingredient, and placing said film within the vaginal cavity.
  • the films are hydrophilic.
  • One embodiment of this aspect of the present invention utilizes a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, and an effective amount of at least one non- pharmaceutically active fragrance, but less than a pharmaceutically effective amount of any pharmaceutically active agent.
  • the binding agent which provides a plasticizer effect may - ⁇ ompri ⁇ s ⁇ e ⁇ " polyvinyl alcohol, methylcellulose compounds such a ⁇ hydroxypropyl methylcellulose (HPMC) or other gelatin or starch-based binders -either ' alone or in combination.
  • the final film preferably comprises about 60% to 97% by weight of the binding agent and most preferably about 50% to 70% by weight. Unless otherwise noted herein, all percentages noted herein are by weight.
  • the lubricant can comprise one or more of glycerin, propylene glycol, polyethylene glycols, fish oil, vegetable oil, and combinations thereof.
  • the lubricant is preferably present in the amount of about 1% to 4% and most preferably about 2% to 3% in the final film.
  • a solvent such as water or an organic solvent such as ethanol is preferably employed.
  • the initial formulation may comprise about 50%- 65% and the final film preferably comprises about 2% to 15% of solvent and most preferably about 3% to 7%. If desired, more than dine " - ⁇ Dlvi ⁇ S iridlT. " lie' ⁇ tfedBrow
  • preservatives such as methyl paraben, propyl paraben, ethylenediamine-tetraacetic acid (EDTA) , diazolidnyl urea, stearic acid, benzoic acid, sodium benzoate and combinations thereof in order to enhance shelf stability and prevent microbial contamination.
  • EDTA ethylenediamine-tetraacetic acid
  • Any such preservatives are present in amounts sufficient for shelf- stability of the product but in amounts which are less than amounts which would make them pharmaceutically effective.
  • preservatives can be present in amounts less than about 1%, or preferably less than about .5% in the final film.
  • the films of the present invention may also be formed utilizing ingredients helpful in the processing of the film.
  • ingredients helpful in the processing of the film For example, both examples discussed below comprise minor amounts of a surfactant octoxynol-9, for example, about 1-6%, more preferably less than 2% in the final film.
  • the deodorizing films of the present invention can also comprise inert, non- pharmaceutically active ingredients such as dyes.
  • the deodorizing films and films useful with the present invention can advantageously be manufactured on a bulk scale.
  • preferred embodiments are manufactured on a weight by weight concentration of the total product.
  • the base can be formulated to be either water soluble or non-water soluble.
  • ⁇ o ⁇ apou tmg Ingredients are individually weighed or otherwise measured. Some formulas may require an emulsion to be formed, based on the solubility of the ingredients. Some ingredients may need to be combined in a series of smaller tanks, prior to being added to a- larger tank, again depending on solubility, temperature and mixing characteristics.
  • the ingredients are preferably mixed and/or heated accordingly until a homogeneous solution or mixture is achieved. Because certain ingredients will require heat to aid dissolution, the tanks can be heated to reduce mixing time and increase ingredient solubility.
  • the bulk can be used hot or cooled based on viscosity and physical ( characteristics required for the next phase of manufacturing.
  • the second step involves the transfer of the bulk evenly and at the desired thickness onto a belt or sheet of material that will be passed into an oven or otherwise treated to remove the majority of the solvent, e.g. water, from the blend.
  • the belt itself can be made of a number of different materials including stainless steel, teflon, aluminum, a high temperature chemical resistant polymer, or metal alloy among others.
  • the belt's physical dimensions are based on the width of the bulk film roll desired, and the temperature of the oven.
  • the bulk can be pumped onto the belt and spread with a blade or brush type device into an even displacement. pressure, e.g. from about 10-200 psi., onto the belt with dimensions that provide an even displacement of liquid bulk. (3)
  • the bulk can be sprayed through a series of nozzles onto the belt.
  • the bulk can be spread thinly and evenly by mechanical means.
  • the bulk can be poured onto the belt and allowed to run or be blown by forced air to an even distribution.
  • the conveyor type belt system is set to move the product at a controlled speed to achieve the desired drying of the product. For example, the belt can advance the product from 2 to 35 feet per minute depending on the moisture in the product, drying rate, and the desired thickness.
  • the belt passes through an oven or other type environmental chamber at a controlled speed, humidity, ventilation, and temperature to eliminate enough of the solvent to produce a film of the desired consistency.
  • the belt speed and oven temperature is controlled to avoid any degradation of the components while eliminating enough solvent from the formulation to achieve the desired pliability of the finished film.
  • the optimal conditions are typically between about 35°C and 100°C. The result is sheets of film approximately the width of the belt and the desired thickness.
  • the physical dimensions of the finished product typically can range in size from about 10-80 millimeters square, depending on the size of the dose to be delivered.
  • the films of the present invention generally should have thicknesses not greater than about preferably about 0.001 to about 0.010 of an inch, and a weight of not greater than about 1 g preferably not greater than about 0.75 g, more preferably .1 to about .5 grams, most preferably weigh about .2 grams.
  • the films of the present invention can be formed in various shapes without departing from the scope of the present invention.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Birds (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
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  • Medicinal Chemistry (AREA)
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Abstract

The various embodiments of the present invention comprise dissolvable, vaginal deodorizing films and methods of vaginal deodorizing. The disclosed films are pliable, i.e., they can be folded repeatedly without breaking, do not include an effective amount of any pharmaceutically active agent, and quickly dissolve to provide a discreet, non-messy vaginal deodorizer.

Description

DISSOLVABLE VAGINAL DEODORIZING FILMS AND METHODS OF VAGINAL DEODORIZING UTILIZING PLIABLE
DISSOLVABLE FILM
The present invention is directed to dissolvable, vaginal deodorizing films comprising at least one fragrance, and methods of vaginal deodorizing utilizing dissolvable films comprising at least one fragrance.
BACKGROUND
Various products and methods for deodorizing the vaginal cavity have previously been suggested. Prior products and methods, however, have certain disadvantages. For example, common douches require copious amounts of liquids and are, therefore, messy to administer. Deodorizing suppositories are also messy in that, after application, they tend to run.
It would therefore be desirable to provide a vaginal deodorizers, and methods for vaginal deodorizing, which can be applied discreetly, for example in a public restroom, or anytime and which can be applied and used without creating a messy condition.
Dissolvable films have been previously disclosed for use in delivering pharmaceutically-active ingredients to humans. For example, dissolvable films have been disclosed for delivering effective amounts of contraceptive pharmaceutical agents. Typically such films comprise a binder such as polyvinyl alcohol, a lubricant such as glycerin, a solvent for the polyvinyl alcohol and glycerin such as water, the active ingredient nonoxynol-9 and at least one preservative. Water is utilized as a solvent since the nonoxynol-9 is water soluble and can be readily dissolved into a mixture or slurry prior co formation of -he film. «'".. T ••■ ' 5.Ji "WBϋ'le'' ibiiiw ':*;y *'ii^fl!' ft' aceuR©^US-#58i-ve ingredients have been disclosed, dissolvable films have not previously been used or suggested for reasons other than delivering effective agents, such as pharmaceutically active agents.
SUMMARY OF THE INVENTION One aspect of the present invention is directed to various embodiments comprising dissolvable, vaginal deodorizing films. The disclosed films are pliable, i.e., they can be folded repeatedly without breaking, which facilitate placement as well as comfort during use. The films have relatively small mass relative to other known deodorizers such as douches and suppositories, and they begin to dissolve upon placement and typically-completely dissolve in about ϊ5-'20 minutes. The films of the present invention do not include an effective amount of any pharmaceutically active agent. The purpose of this aspect of the invention is to provide a dissolvable, pliable film for vaginal deodorizing and specifically excludes pharmaceutically effective amounts of pharmaceutical agents.
A second aspect of the present invention is directed to various embodiments comprising methods of vaginal deodorizing utilizing the films disclosed in the previous paragraph. The present invention advantageously provides methods of vaginal deodorizing and specifically exclude pharmaceutically effective amounts of pharmaceutical agents.
DETAILED DESCRIPTION
One preferred embodiment of the present invention comprises a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant,, a minor amqrøfljie.■' tø€ϊFB4- ■■sύ &tΕβifi Sά i *M£ m "i iRΘiS S #53>r amounts of preservatives for shelf stability, at least one fragrance and preferably no other active ingredient, or, at most, less than an effective amount of any pharmaceutically active ingredient. According to preferred embodiments of the present invention, the films are hydrophilic.
One embodiment of this aspect of the present invention comprises a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, and an effective amount of at least one non- pharmaceutically-active fragrance.
Another preferred embodiment of the present invention compfi~ses a method of vaginal deodorizing comprising' the steps of providing a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, a minor amount of surfactant for film forming, minor amounts of preservatives for shelf stability, at least one fragrance and preferably no other active ingredient, or, at most, less than an effective amount of any pharmaceutically active ingredient, and placing said film within the vaginal cavity. According to preferred embodiments of the present invention, the films are hydrophilic.
One embodiment of this aspect of the present invention utilizes a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, and an effective amount of at least one non- pharmaceutically active fragrance, but less than a pharmaceutically effective amount of any pharmaceutically active agent.
The comfort and convenience of the present invention
Figure imgf000005_0001
RΘUS«#5i3 s of ' vaginal deodorizing are enhanced by the fact that the films are pliable, and are therefore not felt by the user after placement. Additionally, the films have relatively little mass, preferably about .2 grams. Therefore, upon dissolution in the vaginal cavity, will not tend to result in a messy discharge. This preferred weight of the films of the present invention is significantly less than that of popular deodorizing suppositories. For example, samples of known suppositories sold under the name NORFORMS® were weighed and found to have an average weight of 1.88 grams, almost nine times the weight of the film of the preferred embodiment of the present invention.
The binding agent which provides a plasticizer effect may -ϋompri~s~e~ "polyvinyl alcohol, methylcellulose compounds such a≤ hydroxypropyl methylcellulose (HPMC) or other gelatin or starch-based binders -either ' alone or in combination. The final film preferably comprises about 60% to 97% by weight of the binding agent and most preferably about 50% to 70% by weight. Unless otherwise noted herein, all percentages noted herein are by weight.
The lubricant can comprise one or more of glycerin, propylene glycol, polyethylene glycols, fish oil, vegetable oil, and combinations thereof. The lubricant is preferably present in the amount of about 1% to 4% and most preferably about 2% to 3% in the final film.
In order to properly blend the binding agent and lubricant, a solvent such as water or an organic solvent such as ethanol is preferably employed. The initial formulation may comprise about 50%- 65% and the final film preferably comprises about 2% to 15% of solvent and most preferably about 3% to 7%. If desired, more than dine"- ≤DlviβS iridlT. " lie'^ tfedB „
It is also in the scope of the present invention to include preservatives such as methyl paraben, propyl paraben, ethylenediamine-tetraacetic acid (EDTA) , diazolidnyl urea, stearic acid, benzoic acid, sodium benzoate and combinations thereof in order to enhance shelf stability and prevent microbial contamination. Any such preservatives are present in amounts sufficient for shelf- stability of the product but in amounts which are less than amounts which would make them pharmaceutically effective. For example, preservatives can be present in amounts less than about 1%, or preferably less than about .5% in the final film.
The films of the present invention may also be formed utilizing ingredients helpful in the processing of the film. For example, both examples discussed below comprise minor amounts of a surfactant octoxynol-9, for example, about 1-6%, more preferably less than 2% in the final film.
In addition to the ingredients noted above, the deodorizing films of the present invention can also comprise inert, non- pharmaceutically active ingredients such as dyes.
The following are non-limiting examples of films and films used in practicing the present invention.
EXAMPLE 1
FRESH FLOWERS SCENTED VAGINAL DEODORIZING FILM
Batch Raw Material Description Quantity
60.5% Purified Water 90.75 kg.
23.96 Gal.
34.15% Polyvinyl Alcohol film former 51.225 kg.
1„2£ Octoxynol-9 surfactant 1.8 kg.
Figure imgf000007_0001
Figure imgf000007_0002
solvent lubricant
1.5% Fragrance: Fresh Flowers 2.25 kg.
0.326% Methyl Paraben, NF 0.489 kg. preservative
0.324% Propyl Paraben
Color: FD&C Red # 40 0.00045 kg.
0.45 gms .
EXAMPLE 2
BABY POWDER SCENTED VAGINAL DEODORIZING FILM
Batch Raw Material Description Quantity
60.5% Purified Water 90.75 kg.
23.96 gal.
_34.15% Polyvinyl Alcohol^ 51.21 kg.
1.2% Octoxynol-9 1.8 kg.
2.0% Glycerin 99.7%, USP 3.0 kg.
1.5% Fragrance: Baby Powder 2.25 kg.
0.326% Methyl Paraben, NF 0.489 kg.
0.326% Propyl Paraben, NF 0.489 kg.
0.004% Color: FD & C Blue # 1 0.006 kg.
The deodorizing films and films useful with the present invention can advantageously be manufactured on a bulk scale. In order to achieve the desired concentration of fragrance in the film, preferred embodiments are manufactured on a weight by weight concentration of the total product. While the following description utilizes water-soluble ingredients, based upon the solubility of the fragrance, the base can be formulated to be either water soluble or non-water soluble. ^oϊapou tmg Ingredients are individually weighed or otherwise measured. Some formulas may require an emulsion to be formed, based on the solubility of the ingredients. Some ingredients may need to be combined in a series of smaller tanks, prior to being added to a- larger tank, again depending on solubility, temperature and mixing characteristics. The ingredients are preferably mixed and/or heated accordingly until a homogeneous solution or mixture is achieved. Because certain ingredients will require heat to aid dissolution, the tanks can be heated to reduce mixing time and increase ingredient solubility. The bulk can be used hot or cooled based on viscosity and physical ( characteristics required for the next phase of manufacturing.
Distribution and/or transfer onto belt : The second step involves the transfer of the bulk evenly and at the desired thickness onto a belt or sheet of material that will be passed into an oven or otherwise treated to remove the majority of the solvent, e.g. water, from the blend. The belt itself can be made of a number of different materials including stainless steel, teflon, aluminum, a high temperature chemical resistant polymer, or metal alloy among others. The belt's physical dimensions are based on the width of the bulk film roll desired, and the temperature of the oven. There are a number of ways to cast or spread a bulk solution onto the belt evenly and in a manner which advantageously free from bubbles and striations. The following are some of these methods. (1) The bulk can be pumped onto the belt and spread with a blade or brush type device into an even displacement.
Figure imgf000009_0001
pressure, e.g. from about 10-200 psi., onto the belt with dimensions that provide an even displacement of liquid bulk. (3) The bulk can be sprayed through a series of nozzles onto the belt. (4) The bulk can be spread thinly and evenly by mechanical means. (5) The bulk can be poured onto the belt and allowed to run or be blown by forced air to an even distribution. The conveyor type belt system is set to move the product at a controlled speed to achieve the desired drying of the product. For example, the belt can advance the product from 2 to 35 feet per minute depending on the moisture in the product, drying rate, and the desired thickness.
Evaporation :
The belt passes through an oven or other type environmental chamber at a controlled speed, humidity, ventilation, and temperature to eliminate enough of the solvent to produce a film of the desired consistency. To accomplish this, the belt speed and oven temperature is controlled to avoid any degradation of the components while eliminating enough solvent from the formulation to achieve the desired pliability of the finished film. The optimal conditions are typically between about 35°C and 100°C. The result is sheets of film approximately the width of the belt and the desired thickness.
The physical dimensions of the finished product typically can range in size from about 10-80 millimeters square, depending on the size of the dose to be delivered. The films of the present invention generally should have thicknesses not greater than about
Figure imgf000010_0001
preferably about 0.001 to about 0.010 of an inch, and a weight of not greater than about 1 g preferably not greater than about 0.75 g, more preferably .1 to about .5 grams, most preferably weigh about .2 grams. The films of the present invention can be formed in various shapes without departing from the scope of the present invention.

Claims

QUKIHS,
1. A dissolvable, vaginal deodorizing film consisting essentially of: a fragrance; at least one binding agent; at least one lubricant; and at least one solvent for said binding agent and said lubricant, wherein said fragrance, binding agent, lubricant and solvent are biologically-acceptable and non-irritating to vaginal mucousal membrane.
2. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film is supple enough to bend repeatedly without ' breaking.
3. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film weighs less than about 1 gram.
4. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film weighs less than about 0.5 grams.
5. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film weighs less than about .2 grams.
6. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film has a moisture content of about 3% - 7% by
7. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film has a moisture content of about 4 - 6% by weight.
8. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film has a moisture content of about 4.5% - 5.5% by weight.
9. A dissolvable, vaginal deodorizing film according to claim 1 wherein said lubricant is selected from the group consisting of glycerins, glycols, oils and combinations thereof.
10. A dissolvable, vaginal deodorizing film according to claim 1 wherein said lubricant comprises propylene glycol.
11. A dissolvable, vaginal deodorizing film according to claim 1 wherein said lubricant comprises a fish oil.
12. A dissolvable, vaginal deodorizing film according to claim 1 wherein said lubricant comprises a vegetable oil.
13. A dissolvable, vaginal deodorizing film according to claim 1 wherein said binder comprises polyvinyl alcohol.
14. A dissolvable, vaginal deodorizing film according to claim 1 wherein said binder comprises a methylcellulose. wherein said binder comprises hydroxypropyl methycellulose.
16. A dissolvable, vaginal deodorizing film according to claim 1 wherein said solvent comprises water.
17. A dissolvable, vaginal deodorizing film according to claim 1 wherein said solvent comprises an organic solvent.
18. A dissolvable, vaginal deodorizing film according to claim 1 wherein said solvent comprises ethanol.
19. A "dissolvable, vaginal deodorizing film according to claim 1 wherein said film further comprises at least one preservative for shelf stability.
20. A dissolvable, vaginal deodorizing film according to claim 1 wherein said film further comprises at least one surfactant to aid in film forming during manufacture.
21. A dissolvable, vaginal deodorizing film according to claim 1 wherein said preservative is selected from the group consisting of methyl paraben, propylparaben, ethylenediamine-tetraacetic acid
(EDTA) , stearic acid, diazolidinyl urea, imdiazolidinyl urea, and combinations thereof. i f- δ (^ *!1 ■":,i'*-i| αd-eBUUV8TJI&( »vag-a;na±",Qθ<3(ia©rα.z'iτrg- mm' accorαing to Claim 1 wherein said fragrance is distributed homogeneously throughout said film.
23. ■ A dissolvable, vaginal deodorizing film according to claim 1 wherein said fragrance is distributed non-homogeneously throughout said film.
24. A dissolvable, vaginal deodorizing film according to claim 1 wherein said fragrance is disposed within micro-capsules distributed throughout said film.
25. A dissolvable, vaginal deodorizing film according to claim 1 comprising a plurality of pharmaceutically active components.
26. A dissolvable, vaginal deodorizing film according to claim 1 wherein said pliable film is hydrophilic.
27. A dissolvable, vaginal deodorizing film comprising a fragrance, at least one binding agent, at least one lubricant, at least one solvent for said binding agent and said lubricant, wherein said fragrance, binding agent, lubricant and solvent are in the form of a biologically-acceptable, pliable film which is non-irritating to vaginal mucousal membrane and which is devoid of an effective amount of any pharmaceutical agent. U---II,.,. iiώ-σβ. »»jHi.ιαιss«j.vaore,i' agιwa« "^e<l<abiirlrzttt^/ iIln/ifet3fcώording to claim 27 wherein said film weighs less than about 1 gram.
29. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film weighs less than about 0.5 grams.
30. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film weighs less than about .2 grams.
31. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film has a moisture content of about 3% - 7% by weight.
32. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film has a moisture content of about 4 - 6% by weight.
33. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film has a moisture content of about 4.5% - 5.5% by weight .
34. A dissolvable, vaginal deodorizing film according to claim 27 wherein said lubricant is selected from the group consisting of glycerins, glycols, oils and combinations thereof.
35. A dissolvable, vaginal deodorizing film according to claim 27 wherein said lubricant comprises propylene glycol.
Figure imgf000016_0001
7 wherein said lubricant comprises a fish oil.
37. A dissolvable, vaginal deodorizing film according to claim' 7 wherein said lubricant comprises a vegetable oil.
38. A dissolvable, vaginal deodorizing film according to claim 7 wherein said binder comprises polyvinyl alcohol.
39. A dissolvable, vaginal deodorizing film according to claim 7 wherein said binder comprises a methylcellulose.
"40. A dissolvable, vaginal deodorizing film according to claim 7 wherein said binder comprises hydroxypropyl methycellulose.
41. A dissolvable, vaginal deodorizing film according to claim 7 wherein said solvent comprises water.
42. A dissolvable, vaginal deodorizing film according to claim 27 wherein said solvent comprises an organic solvent.
43. A dissolvable, vaginal deodorizing film according to claim 27 wherein said solvent comprises ethanol.
44. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film further comprises at least one preservative for shelf stability.
45. A dissolvable, vaginal deodorizing film according to claim 27 wherein said film further comprises at least one surfactant to aid in film forming during manufacture.
46. A dissolvable, vaginal deodorizing film according to claim 27 wherein said preservative is selected from the group consisting of methyl paraben, propylparaben, ethylenediamine-tetraacetic acid (EDTA) , stearic acid, diazolidinyl urea, imdiazolidinyl urea, and combinations thereof.
47. A dissolvable, vaginal deodorizing film according to claim l~wlϊereiή said fragrance is distributed homogeneously throughout said film.
48. A dissolvable, vaginal deodorizing film according to claim 27 wherein said fragrance is distributed non-homogeneously throughout said film.
49. A dissolvable, vaginal deodorizing film according to claim 27 wherein said fragrance is disposed within micro-capsules distributed throughout said film.
50. A dissolvable, vaginal deodorizing film according to claim 27 comprising a plurality of pharmaceutically active components. _lj_γΛ, i, *n„ι
Figure imgf000018_0002
p * yiHiβi' a«jασr . ϋ-j.ιrg-
Figure imgf000018_0001
«<_Λ;orαιιιy u<J <JJ.ct.L-u
27 wherein said pliable film is hydrophilic.
52. A method of vaginal deodorizing comprising the steps of providing a film consisting essentially of a fragrance, at least one binding agent, at least one lubricant, and at least one solvent for said binding agent and said lubricant, wherein said fragrance, binding agent, lubricant and solvent are biologically- acceptable and non-irritating to vaginal mucousal membrane; and placing said film within the vaginal cavity.
53. A method of vaginal deodorizing according to claim 52 "WheTeϊn" said film is supple enough to bend repeatedly without breaking.
54. A method of vaginal deodorizing according to claim 52 wherein said film weighs less than about 1 gram.
55. A method of vaginal deodorizing according to claim 52 wherein said film weighs less than about 0.5 grams.
56. A method of vaginal deodorizing according to claim 52 wherein said film weighs less than about .2 grams.
57. A method of vaginal deodorizing according to claim 52 wherein said film has a moisture content of about 3% - 7% by weight. , . wherein said film has a moisture content of about 4 - 6% by weight.
59. A method of vaginal deodorizing according to claim 52 wherein said film has a moisture content of about 4.5% - 5.5% by weight.
60. A method of vaginal deodorizing according to claim 52 wherein said lubricant is selected from the, group consisting of glycerins, glycols, oils and combinations thereof.
61. A method of vaginal deodorizing according to claim 52 "wherein" said lubricant comprises propylene glycol.
62. A method of vaginal deodorizing according to claim 52 wherein said lubricant comprises a fish oil.
63. A method of vaginal deodorizing according to claim 52 wherein said lubricant comprises a vegetable oil.
64. A method of vaginal deodorizing according to claim 52 wherein said binder comprises polyvinyl alcohol.
65. A method of vaginal deodorizing according to claim 52 wherein said binder comprises a methylcellulose.
66. A method of vaginal deodorizing according to claim 52
67. A method of vaginal deodorizing according to claim 52 wherein said solvent comprises water.
68. A method of vaginal deodorizing according to claim 52 wherein said solvent comprises an organic ' solvent .
69. A method of vaginal deodorizing according to claim 52 wherein said solvent comprises ethanol.
70. A method of vaginal deodorizing according to claim 52 whe"r"eιn~ said' film further comprises at least one preservative for " shelf stability.
71. A method of vaginal deodorizing according to claim 52 wherein said film further comprises at least one surfactant to aid in film forming during manufacture.
72. A method of vaginal deodorizing according to claim 52 wherein said preservative is selected from the group consisting of methyl paraben, propylparaben, ethylenediamine-tetraacetic acid
(EDTA) , stearic acid, diazolidinyl urea, imdiazolidinyl urea, and combinations thereof.
73. A method of vaginal deodorizing according to claim 52 wherein said fragrance is distributed homogeneously throughout said
74. A method of vaginal deodorizing according to claim 52 wherein said fragrance is distributed non-homogeneously throughout said film.
75. A method of vaginal deodorizing according to claim 52 wherein said fragrance is disposed within micro-capsules distributed throughout said film.
76. A method of vaginal deodorizing according to claim 52 comprising a plurality of pharmaceutically active components.
77. A method of vaginal deodorizing according to claim 52 wherein said pliable film is hydrophilic.
78. A method of vaginal deodorizing comprising a fragrance, at least one binding agent, at least one lubricant, at leastOne solvent for said binding agent and said lubricant, wherein said fragrance, binding agent, lubricant and solvent are in the form of a biologically-acceptable, pliable film which is non-irritating to vaginal mucousal membrane and which is devoid of an effective amount of any pharmaceutical agent.
79. A method of vaginal deodorizing according to claim 78 wherein said film weighs less than about 1 gram.
.$ Vl.pr."JA6 'foGtn°W*xrt>'
Figure imgf000022_0001
Lc*c«)«Ilng to claim 78 wherein said film weighs less than about 0.5 grams.
81. A method of vaginal deodorizing according to claim 78 wherein said film weighs less than about .2 grams.
82. A method of vaginal deodorizing according to claim 78 wherein said film has a moisture content of about 3% - 7% by weight.
83. 'A method of vaginal deodorizing according to claim 78 wherein said film has a moisture content of about 4 - 6% by weight.
84. A method of vaginal deodorizing according to claim 78 wherein said film has a moisture content of about 4.5% - 5.5% by weight.
85. A method of vaginal deodorizing according to claim 78 wherein said lubricant is selected from the group consisting of glycerins, glycols, oils and combinations thereof.
86. A method of vaginal deodorizing according to claim 78 wherein said lubricant comprises propylene glycol.
87. A method of vaginal deodorizing according to claim 78 wherein said lubricant comprises a fish oil.
88. A method of vaginal deodorizing according to claim 78
89. A method of vaginal deodorizing according to claim 78 wherein said binder comprises polyvinyl alcohol.
90. A method of vaginal deodorizing according to claim 78 wherein said binder comprises a methylcellulose.
91. A method of vaginal deodorizing according to claim 78 wherein said binder comprises hydroxypropyl methycellulose.
92. A method of vaginal deodorizing according to claim 78 wherein said solvent comprises water.
93. A method of vaginal deodorizing according to claim 78 wherein said solvent comprises an organic solvent.
94. A method of vaginal deodorizing according to claim 78 wherein said solvent comprises ethanol .
95. A method of vaginal deodorizing according to claim 78 wherein said film further comprises at least one preservative for shelf stability.
96. A method of vaginal deodorizing according to claim 78 wherein said film further comprises at least one surfactant to aid
97. A method of vaginal deodorizing according to claim 78 wherein said preservative is selected from the group consisting of methyl paraben, propylparaben, ethylenediamine-tetraacetic acid
(EDTA) , stearic acid, diazolidinyl urea, imdiazolidinyl urea, and combinations thereof.
98. A method of vaginal deodorizing according to claim 52 wherein said fragrance is distributed homogeneously throughout said film.
99. A method of vaginal deodorizing according to claim 78 wherein said fragrance is distributed non-homogeneously throughout said film.
100. A method of vaginal deodorizing according to claim 78 wherein said fragrance is disposed within micro-capsules distributed throughout said film.
101. A method of vaginal deodorizing according to claim 78 comprising a plurality of pharmaceutically active components.
102. A method of vaginal deodorizing according to claim 78 wherein said pliable film is hydrophilic.
PCT/US2004/014953 2003-05-15 2004-05-12 Dissolvable vaginal deodorizing films and methods of vaginal deodorizing utilizing pliable dissolvable film WO2004103232A1 (en)

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US11094408B2 (en) 2010-05-06 2021-08-17 Aic Innovations Group, Inc. Apparatus and method for recognition of inhaler actuation
US10872695B2 (en) 2010-05-06 2020-12-22 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US11862033B2 (en) 2010-05-06 2024-01-02 Aic Innovations Group, Inc. Apparatus and method for recognition of patient activities
US11682488B2 (en) 2010-05-06 2023-06-20 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US10116903B2 (en) 2010-05-06 2018-10-30 Aic Innovations Group, Inc. Apparatus and method for recognition of suspicious activities
US10262109B2 (en) 2010-05-06 2019-04-16 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US11328818B2 (en) 2010-05-06 2022-05-10 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US10650697B2 (en) 2010-05-06 2020-05-12 Aic Innovations Group, Inc. Apparatus and method for recognition of patient activities
US10646101B2 (en) 2010-05-06 2020-05-12 Aic Innovations Group, Inc. Apparatus and method for recognition of inhaler actuation
CN105120827A (en) * 2013-03-14 2015-12-02 艾治疗技术公司 Apparatus and method for recognition of suspicious activties
WO2017077520A1 (en) 2015-11-06 2017-05-11 Ineb - Instituto Nacional De Engenharia Biomédica A composition for use in a method for prevention or treatment of human immunodeficiency virus infections
US11590145B2 (en) 2016-07-22 2023-02-28 Chemo Research S.L. Vaginal composition comprising a combination of estrogen and vitamin D
WO2018015503A1 (en) 2016-07-22 2018-01-25 Chemo Research S.L. Vaginal composition comprising a combination of estrogen and vitamin d
EP3272333A1 (en) 2016-07-22 2018-01-24 Chemo Research, S.L. Vaginal composition comprising a combination of estrogen and vitamin d
US11170484B2 (en) 2017-09-19 2021-11-09 Aic Innovations Group, Inc. Recognition of suspicious activities in medication administration

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