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WO1998006377A1 - Compositions pour administration par voie orale - Google Patents

Compositions pour administration par voie orale Download PDF

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Publication number
WO1998006377A1
WO1998006377A1 PCT/US1997/013042 US9713042W WO9806377A1 WO 1998006377 A1 WO1998006377 A1 WO 1998006377A1 US 9713042 W US9713042 W US 9713042W WO 9806377 A1 WO9806377 A1 WO 9806377A1
Authority
WO
WIPO (PCT)
Prior art keywords
water
herbal
chlorophenol
extraction
phenol
Prior art date
Application number
PCT/US1997/013042
Other languages
English (en)
Inventor
David Earl Rice
Brian Joseph Mccormick
Original Assignee
The Procter & Gamble Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Procter & Gamble Company filed Critical The Procter & Gamble Company
Publication of WO1998006377A1 publication Critical patent/WO1998006377A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

  • the present invention relates to method of manufacturing oral compositions containing combinations of herbal materials (preferably extracts thereof) or herbal matenals mixed with water insoluble noncationic agents, as antiplaque, anticalculus and antica ⁇ es agents
  • Plaque induced diseases including pe ⁇ odontitis and gingivitis, are believed to involve anaerobic bactenai infections
  • Periodontal disease affects the pe ⁇ odontium, which is the investing and supporting tissue surrounding a tooth (i e , the penodontal ligament, the gingiva, and the alveolar bone)
  • Gingivitis and penodontitis are inflammatory disorders of the gingiva and the periodontal ligament, respectively
  • Gingivosis and pe ⁇ odontosis are more severe conditions involving degenerative disorders of the tissue
  • Combinations of inflammatory and degenerative conditions are termed penodontitis complex
  • Periodontal disease is a major cause of tooth loss in adults Tooth loss from periodontal disease is a significant problem beginning at age 35, but even by age 15 it is estimated that about 4 out of 5 persons already have gingivitis and 4 out of 10 have penodontitis
  • Dental calculus or tartar as it is sometimes called, is a deposit which forms on the surfaces of the teeth at the gingival margin Supragingival calculus appears principally in the areas near the orifices of the salivary ducts; e g , on the lingual surfaces of the lower anterior teeth and on the buccal surfaces of the upper first and second molars, and on the distal surfaces of the posterior molars
  • Mature calculus consists of an inorganic portion which is largely calcium phosphate arranged in a hydroxyapatite crystal lattice structure similar to bone, enamel and dentine
  • An organic portion is also present and consists of desquamated epithelial cells, leukocytes, salivary sediment, food debris and various types of microorganisms
  • the chemical approach to calculus inhibition generally involves chelation of calcium ions and/or crystal growth inhibition which prevents the calculus from forming and/or breaks down mature calculus by removing calcium
  • T ⁇ closan and herbal materials have been disclosed individually for use in oral products to combat plaque and gingivitis
  • compositions of the present invention comprise water insoluble noncationic and/or specific herbal extract materials obtained using the disclosed process
  • safety and effective amount means sufficient amount of material to provide the desired benefit while being safe to the hard and soft tissues of the oral cavity
  • compositions of this invention are meant that various additional components can be conjointly employed in the compositions of this invention as long as the listed materials perform their intended functions
  • acceptable earner is meant a suitable earner which can be used to apply the present agent(s) to the oral cavity without undue toxicity, irritation, allergic response and the like, commensurate with a reasonable benefit/risk ratio
  • Water Insoluble Noncationic Agents Given below are examples of antibacterial agents useful in the compositions of the present invention which are water insoluble and noncationic.
  • Phenolic Compounds including phenol and its homologs, mono- and poly-alkyl and aromatic halophenols, resorcinol and its derivatives, bisphenolic compounds and halogenated salicylanilides).
  • Halogenated Salicylanilides 4',5-d ⁇ bromosal ⁇ cyian ⁇ l ⁇ de 3,4',5-tr ⁇ chlorosalcylan ⁇ i ⁇ de 3,4',5-tr ⁇ bromosal ⁇ cylan ⁇ l ⁇ de 2,3,3',5-tetrachlorosal ⁇ cylan ⁇ l ⁇ de 3, 3', 5-t ⁇ chlorosal ⁇ cy lani de 3,5-d ⁇ bromo-3'-tr ⁇ fiuoromethyl salicylanilide 5-n-octanoyl-3'-t ⁇ fluoromethyl sal ⁇ cylan ⁇ l ⁇ de 3, 5-d ⁇ bromo-4'-tr ⁇ fluoromethyl salicylanilide 3,5-d ⁇ bromo-3'-tnfluoromethyl salicylanilide
  • the water insoluble noncationic agent when present, is present in the oral compositions of the present invention in an effective antiplaque amount, typically about 0 005-5% by weight, preferably about 0 005-1%
  • the agent is substantially water-insoluble, meaning that its solubility is less than about 1% by weight in water at 25°C and may be even less than about 0 1% If an lonizable group is present solubility is determined at a pH at which lonization does not occur
  • the extracts of herbal materials useful in the development described and claimed herein are extracts of honeysuckle flowers, extracts of golden thread, or mixtures thereof
  • One of the active agents in golden thread is berbenne
  • a reference disclosing berbenne is U S 5,407,921 April 18, 1995, to Katsuragi et al incorporated herein by reference in its entirety
  • Another patent disclosing berbenne is U S Patent 4,735,945, April 5, 1988, to Sakamoto et al also incorporated by reference herein in its entirety
  • Golden thread and honeysuckle flowers are natural materials and can be obtained from the plants themselves or the active components can be synthesized if desired
  • a supplier of these herbal materials is East Earth Herb, Inc , Eugene, Oregon
  • An active component of golden thread, berbenne, and of honeysuckle flowers, chlorogenic acid can be obtained from a number of different sources These for berbenne include the following
  • Honeysuckle flower substitutes include the following which are all mate ⁇ als which contain chlorogenic acid and/or luteo n flavonoids
  • the carrier for the active component(s) can be any vehicle suitable for use in the oral cavity
  • Such carriers include the usual components of mouthwashes, toothpastes, tooth powders, prophylaxis pastes, lozenges, gums and the like and are more fully described hereinafter. Dentifrices and mouthwashes are the preferred systems.
  • compositions may contain other antiplaque/gingivitis agents such as quaternary ammonium compounds, water, sta ⁇ nous salts and zinc salts These types of agents are described in U.S Patent 4,656,031 , April 7, 1987 to Lane et al , and U S. Patent 5,004,597, April 2, 1991 to Majeti et al All incorporated herein by reference in their entirety
  • the abrasive polishing material contemplated for use in the present toothpaste part invention can be any material which does not excessively abrade dentin
  • silicas including gels and precipitates, calcium carbonate, dicalcium orthophosphate dihydrate, calcium pyrophosphate, t ⁇ calcium phosphate, calcium polymetaphosphate, insoluble
  • Silica dental abrasives of various types, can provide the unique benefits of exceptional dental cleaning and polishing performance without unduly abrading tooth enamel or dentin Silica abrasive materials are also exceptionally compatible with sources of soluble fluoride and polyphosphonates For these reasons they are preferred for use herein
  • the silica abrasive can be precipitated silica or silica gels such as the silica xerogels described in Pader et al , U S Patent No 3,538,230, issued March 2, 1970 and DiGiu o, U S Patent No 3,862,307, June 21 , 1975, both incorporated herein by reference Preferred are the silica xerogels marketed under the tradename "Syloid" by the W R Grace & Company, Davison Chemical Division Preferred precipitated silica materials include those marketed by the J M Huber Corporation under the tradename, "Zeodent", particularly the silica carrying the designation "Zeodent 119" These silica abrasives are described in U S Patent No 4,340,583, July 29, 1982, incorporated here
  • the abrasive in the compositions described herein is present at a level of from about 6% to about 70%, preferably from about 15% to about 25% when the dentifrice is a toothpaste Higher levels, as high as 90%, may be used if the composition is a toothpowder
  • Flavoring agents can also be added to dentifrice compositions Suitable flavoring agents include oil of wintergreen, oil of peppermint, oil of spearmint, and oil of clove Sweetening agents which can be used include aspartame, acesulfame, saccharin, dextrose, levulose and sodium cyclamate Flavoring and sweetening agents are generally used in dentifrices at levels of from about 0 005% to about 2% by weight
  • Dentifrice compositions can also contain emulsifying agents Suitable emulsifying agents are those which are reasonably stable and foam throughout a wide pH range, including nonsoap anionic, noniontc, cationic, zwitte ⁇ onic and amphote ⁇ c organic synthetic detergents Many of these suitable surfactants are disclosed by Gieske et al in U S Patent No 4,051 ,234, September 27, 1977, incorporated herein by reference
  • Water is also present in the toothpastes of this invention
  • Water employed in the preparation of commercially suitable toothpastes should preferably be deionized and free of organic impurities
  • Water generally comprises from about 10% to 50%, preferably from about 20% to 40%, by weight of the toothpaste compositions herein These amounts of water include
  • thickening agents are carboxyvinyl polymers of the type mentioned previously herein, xanthan gum, carrageenan, hydroxyethyl cellulose and water soluble salts of cellulose ethers such as sodium carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose
  • Natural gums such as gum karaya, gum arable, and gum tragacanth can also be used
  • Colloidal magnesium aluminum silicate or finely divided silica can be used as part of the thickening agent to further improve texture
  • Thickening agents in an amount from 0 10% to 5 0% by weight of the total composition can be used
  • humectant matenal in a toothpaste to keep it from hardening
  • Suitable humectants include glycerin, xylitol sorbitol, and other edible polyhydnc alcohols at a level of from about 5% to about 70%
  • Mouthwashes generally comprise from about 20 1 to about 2 1 of a water/ethyl alcohol solution and preferably other ingredients such as flavor, sweeteners, humectants and sudsing agents such as those mentioned above for dentifrices
  • the humectants give a moist feel to the mouth
  • the mouthwashes of the invention comprise 0% to 60% (preferably 10% to 25%) ethyl alcohol, 0% to 20% (preferably 5% to 20%) of a humectant, 0% to 2% (preferably 0 01% to 0 15%) emulsifying agent, 0% to 0 5% (preferably 0 005% to 0 06%) sweetening agent such as saccharin, 0% to 0 3% (preferably 0 03% to 0 3%) flavoring agent, and the balance water
  • pyrophosphate salts such as those described in U S 4,515,772, May 7, 1985 to Parran et al incorporated herein by reference
  • alkali metal bicarbonate such as sodium bicarbonate
  • a peroxide compound in separate compartments such as disclosed in U S 4,849,213 and U S 4,528,180, both to Schaeffer, incorporated herein by reference in their entirety
  • the pH of the present compositions and/or its pH in the mouth can be any pH which is safe for the mouth's hard and soft tissues Such pH's are generally from about 3 to about 10 preferably from about 4 to about 8 5 METHOD OF MANUFACTURE
  • compositions of the present invention can be made using methods which are common in the oral products area
  • toothpaste compositions may be prepared by mixing part of the humectant and water together and heating to 66 0 -71°C
  • the fluoride source, if present, is then added along with the sweetener, the herbal materials are then added followed by the opacifier and the flavor
  • the herbal extracts useful in the present inventions are formed using the processes set forth below
  • a Fitzmill comminuting mill is alternately used to a Retschmill for specific milling or reduced sizing needs (e g , coarse g ⁇ nding or cryogenic milling) Any grinding operation that achieves the respective particle size for extraction is acceptable
  • Crude herb extractibi ty is a critical function of exposed surface area of crude herb powder to water mass ratio
  • a singular particle size is preferred for process control
  • milling produces a mix of coarse and fine dust particulates
  • Suitable alternate extraction process for developing this water soluble extract include use of ultrasonic water extraction systems which can provide equivalent quality, depending on the herb, with up to 94% faster process cycles
  • Other suitable extraction processes include hydrolysis extracting reactors, fixed bed extracting reactors, desorption extraction columns,
  • Water-extracted herbal liquid is filtered (e g , 5-100 ⁇ filter cartridge, fine screen or cheesecloth) or centnfuged to remove coarse and/or insoluble particulates
  • Suitable driers that are used include fluidized bed, freeze d ⁇ er, vacuum plate, spray, drum- type and flash driers Drying efficiency is controlled for water content ( ⁇ 10%) and free water considerations ( ⁇ 0 80) to achieve shelf-stability Yield of soluble powder from the drying process is used as key to optimize herb water mass formula for extraction
  • Dried pure solid herbal extract powders are sized and packaged for shipment
  • a dessicating-mate ⁇ als such as a silica gel or other suitable FDA-approved, drying agent can be used to control relative humidity and to improve shelf-life
  • Tnclosan 99% (irgacare MP) 0280 Carbopol 956 0250
  • the herbs may be varied using levels set forth herein before Additionally, the compositions may contain other antiplaque/antigingivitis or anticaries components, such as black tea, oolong tea, green tea, quaternary ammonium compounds, and metal salts such as stannous salts and zinc salts Furthermore, members of the Ericaceae family may be used Green, oolong, and black teas are members of the general tea family (Camillia Sinenis) and may also be used in the compositions of the present invention

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Birds (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cosmetics (AREA)

Abstract

La présente invention a pour objet un procédé préféré de fabrication d'extraits de plantes et de séchage.
PCT/US1997/013042 1996-08-12 1997-08-06 Compositions pour administration par voie orale WO1998006377A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US69549096A 1996-08-12 1996-08-12
US08/695,490 1996-08-12

Publications (1)

Publication Number Publication Date
WO1998006377A1 true WO1998006377A1 (fr) 1998-02-19

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PCT/US1997/013042 WO1998006377A1 (fr) 1996-08-12 1997-08-06 Compositions pour administration par voie orale

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0917825A3 (fr) * 1997-11-19 2000-06-28 Akira Horigane Produits congelés ou lyophilisés, procédé et appareil pour leur fabrication
WO2002091848A1 (fr) * 2001-05-15 2002-11-21 The Procter & Gamble Company Compositions de confiserie
FR2825936A1 (fr) * 2001-06-18 2002-12-20 Malemba Jean Claude Mapangou Procede d'obtention d'un extrait sec riche en composes tensioactifs
US6706256B2 (en) 2001-05-15 2004-03-16 The Procter & Gamble Co. Oral care compositions

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5758613A (en) * 1980-09-26 1982-04-08 Lion Corp Composition for oral cavity application
JPS5785319A (en) * 1980-11-16 1982-05-28 Tsurui Yakuhin Kogyo Kk Agent for dental caries
JPS60163810A (ja) * 1984-02-06 1985-08-26 Dr Kawai Kurinitsuku:Kk 練り歯磨組成物
EP0227108A2 (fr) * 1985-12-27 1987-07-01 Lion Corporation Composition orale
JPH05124973A (ja) * 1991-11-06 1993-05-21 Masayuki Otsuki 漢方薬の有効成分を抽出する方法と装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5758613A (en) * 1980-09-26 1982-04-08 Lion Corp Composition for oral cavity application
JPS5785319A (en) * 1980-11-16 1982-05-28 Tsurui Yakuhin Kogyo Kk Agent for dental caries
JPS60163810A (ja) * 1984-02-06 1985-08-26 Dr Kawai Kurinitsuku:Kk 練り歯磨組成物
EP0227108A2 (fr) * 1985-12-27 1987-07-01 Lion Corporation Composition orale
JPH05124973A (ja) * 1991-11-06 1993-05-21 Masayuki Otsuki 漢方薬の有効成分を抽出する方法と装置

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, vol. 104, no. 2, 13 January 1986, Columbus, Ohio, US; abstract no. 10428 *
DATABASE WPI Week 9325, Derwent World Patents Index; AN 93-200448, XP002048814 *
PATENT ABSTRACTS OF JAPAN vol. 006, no. 169 (C - 122) *
PATENT ABSTRACTS OF JAPAN vol. 10, no. 4 (C - 322)<2061> *
PATENT ABSTRACTS OF JAPAN vol. 6, no. 131 (C - 114)<1009> *
STN, File Supplier, Karlsruhe, DE, File *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0917825A3 (fr) * 1997-11-19 2000-06-28 Akira Horigane Produits congelés ou lyophilisés, procédé et appareil pour leur fabrication
WO2002091848A1 (fr) * 2001-05-15 2002-11-21 The Procter & Gamble Company Compositions de confiserie
US6703000B2 (en) 2001-05-15 2004-03-09 The Procter & Gamble Co. Confectionery compositions
US6706256B2 (en) 2001-05-15 2004-03-16 The Procter & Gamble Co. Oral care compositions
FR2825936A1 (fr) * 2001-06-18 2002-12-20 Malemba Jean Claude Mapangou Procede d'obtention d'un extrait sec riche en composes tensioactifs

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