EP1161221A1 - Procede de production de formulations cosmetiques ou pharmaceutiques par micromelange juste avant utilisation - Google Patents

Procede de production de formulations cosmetiques ou pharmaceutiques par micromelange juste avant utilisation

Info

Publication number
EP1161221A1
EP1161221A1 EP00918767A EP00918767A EP1161221A1 EP 1161221 A1 EP1161221 A1 EP 1161221A1 EP 00918767 A EP00918767 A EP 00918767A EP 00918767 A EP00918767 A EP 00918767A EP 1161221 A1 EP1161221 A1 EP 1161221A1
Authority
EP
European Patent Office
Prior art keywords
micromixer
mixed
components
storage chambers
passed
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
EP00918767A
Other languages
German (de)
English (en)
Inventor
Jutta Zur Lage
Hans-Jürgen DRILLER
Joachim BÜNGER
Annette Wagner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Patent GmbH
Original Assignee
Merck Patent GmbH
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 Merck Patent GmbH filed Critical Merck Patent GmbH
Publication of EP1161221A1 publication Critical patent/EP1161221A1/fr
Ceased legal-status Critical Current

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
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/06—Emulsions
    • A61K8/068—Microemulsions
    • 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
    • A61K8/04—Dispersions; Emulsions
    • A61K8/06—Emulsions
    • A61K8/066—Multiple emulsions, e.g. water-in-oil-in-water
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/30—Micromixers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/88—Two- or multipart kits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/04—Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/21—Mixing of ingredients for cosmetic or perfume compositions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/40—Mixing liquids with liquids; Emulsifying
    • B01F23/41—Emulsifying

Definitions

  • the present invention relates to a method for producing cosmetic or pharmaceutical formulations immediately before use, two or more liquid components from separate storage chambers being intimately mixed with one another by passing the liquid components through a micromixer. Furthermore, the present invention also relates to the lotions, emulsions, gels, creams and solutions produced by the process according to the invention, either for cosmetic use or, if appropriate pharmaceutical active ingredients have been incorporated, the pharmaceutical formulations prepared.
  • mixing is to be understood as basic operations which serve the greatest possible homogenization of substances.
  • Material flows should be combined in such a way that the individual components are composed as evenly as possible in partial volumes of the resulting mixture.
  • Homogenization is a special form of mixing. This is understood to mean mixing phases that are not miscible with one another. Homogenization is understood to mean changing the distribution state and particle size of the inner phase of emulsions and suspensions, so that microscopically, a homogeneous system is created and the distributed phase does not settle or cream without the action of external forces.
  • Dispersing is understood to mean a mixing of a material system consisting of two (or more) phases, in which one substance (disperse phases) is mixed in another (dispersion medium) in the finest form. divides (disperses). Both the particles of the disperse phase and the dispersant can be solid, liquid or gaseous. Examples of dispersions are aerosols, emulsions, suspensions and colloids.
  • Suspending in turn means the distribution of very small, but not molecular, particles of a solid in a liquid.
  • Suspensions like emulsions, are usually optically cloudy and tend to settle under the influence of gravity.
  • Emulsification processes are usually carried out according to the following scheme: Two substances that are insoluble in each other, namely fat and water, are mixed. In order to obtain a durable emulsion, the fat and water phases have to be mechanically crushed to below 10 ⁇ m and then stabilized with the help of an emulsifier. Normally, the oil and fat phases are introduced separately, heated to 50 - 70 ° C and then pre-emulsified. All water-soluble substances are in the water phase, all fat-soluble substances in the fat phase.
  • the pre-emulsion produced after the hot / hot process (both phases are heated separately to 50-70 ° C) is cooled to room temperature before the addition of perfume oil and dye and then emulsified.
  • Simple mixing vessels with different types of stirrers are often used to produce cosmetic formulations.
  • type of stirrer e.g. anchor, propeller, inclined blade, disc, EKATO-MIG stirrer, EKATO-Mizer disc
  • EKATO-Mizer disc e.g. anchor, propeller, inclined blade, disc, EKATO-MIG stirrer, EKATO-Mizer disc
  • 35 emulsions can arise in which the emulsified phase is very has different particle sizes, or the active ingredient distribution in a manufactured product is uneven.
  • the object of the invention is achieved by a process for the production of cosmetic or pharmaceutical formulations immediately before use, characterized in that two or more liquid components from separate storage chambers are mixed with one another by being passed through a micromixer.
  • two or more components can be passed in liquid form for mixing through a micromixer from separate storage chambers.
  • one or more liquid component (s) with one or more natural, synthetic or semi-synthetic oil (s) can be passed from separate storage chambers through a micromixer, mixing them together.
  • the object of the invention is also achieved by a process for the production of cosmetic formulations in the form of emulsions immediately before use, characterized in that a fat phase consisting of one or more natural, synthetic or semisynthetic oil (s) and one or more of Fat (s) which are solid at room temperature are liquefied in a storage chamber by heating, and this liquid fat phase is mixed with one or more liquid component (s) and optionally with another oil phase by passing them through a micromixer.
  • a fat phase consisting of one or more natural, synthetic or semisynthetic oil (s) and one or more of Fat (s) which are solid at room temperature are liquefied in a storage chamber by heating, and this liquid fat phase is mixed with one or more liquid component (s) and optionally with another oil phase by passing them through a micromixer.
  • the components to be mixed are pumped out of the storage chambers and are passed into the micromixer through subsequent thin tubes, which each end in a channel of a micromixer, and through the channels of the pump due to the pressure building up as a result of the pumping Micromixer are pressed with intensive mixing and formation of an emulsion.
  • the components to be mixed from pressurized storage chambers through subsequent thin tubes, which each end in a channel of a micromixer, to guide the components into the micromixer and through the channels of the micromixer due to the build-up Pressure with intensive mixing and formation of an emulsion.
  • the object of the invention is further achieved by a process for the preparation of liposome-containing formulations immediately before use, by one or more liquid component ⁇ ) with a component which contains liposome-forming ingredients O 00/54735 - 6 - PCT / EPOO / 01974
  • the components to be mixed can be conveyed from pressurized storage chambers and passed into the micromixer through adjoining thin tubes, which each end in a channel of a micromixer. Due to the pressure coming from the storage chambers, a sufficient pressure is built up in the micromixer, by means of which the components are pressed through the channels with intensive mixing and formation of a liposome-helpful formulation.
  • the present object is also achieved by means of lotions or solutions, emulsions, gels and creams which can be produced by the process according to the invention.
  • mixtures in the form of emulsions, suspensions and dispersions, lotions, solutions, gels and creams are possible, in which all ingredients are evenly distributed in the smallest parts by volume.
  • these mixtures can also be produced in the micro range under uniform temperature conditions, since the thin, possibly laminate-like no temperature drop forms, especially if the micromixer is designed for temperature control.
  • the energy input is the same in every, ie even in the smallest part of the volume. It has also been found that emulsions can be produced with a much more homogeneous droplet size distribution than in a stirred vessel.
  • micromixer Due to the multiple shear conditions of the communicating channels in the micromixer, droplet sizes in the micro range are inevitable, so that microemulsions are obtained which could only be produced in a stirred vessel in a very complex manner.
  • the use of a micromixer is therefore suitable for the production of very fine, homogeneous formulations.
  • Micromixers, associated connection and closure systems are suitable for carrying out the method according to the invention, which are described in patent applications DE 1 95 11 603, DE 1 97 46 583, DE 1 97 46 584,
  • Suitable micromixers can consist of suitable metallic, ceramic, polymeric materials or silicon.
  • Emulsions in the W / O field are emulsions, in particular those with high levels of vegetable triglycerides.
  • Emulsions without stabilizing waxes are often characterized by insufficient long-term viscosity constancy and OW lotions are generally more difficult to stabilize than creams.
  • These emulsions can therefore be produced particularly well using micromixers. It is particularly advantageous here that particularly small quantities can be produced by using micromixers, which advantageously in situ, i. H. can be made directly before use.
  • Microemulsions are thermodynamically stable if they arise spontaneously due to extremely low interfacial energy, that is, without the addition of external mechanical energy.
  • the droplet diameters are much smaller than with macroemulsions, they are in the range of 10-30 nm (nanometers), which means below the wavelength of visible light. Microemulsions are therefore colloidally disperse, optical transparent systems. According to POHLER, certain concentration ranges of the oil and water phases as well as the emulsifiers and auxiliary substances must be observed when formulating microemulsions:
  • Surfactants (mostly non-ionic surfactants) 15 - 40%
  • micromixers for the production of microemulsions makes it possible to considerably reduce the use of surfactants, so that the tolerance for particularly sensitive skin types can be significantly increased.
  • Stable microemulsions can be produced using less than 10% by weight of surfactants.
  • micromixers makes it possible to produce very small amounts of the desired cosmetic or pharmaceutical formulations immediately before use.
  • This has the advantage that the addition of emulsifiers, suspension and dispersion aids in the form of surfactants and other additives such as. B. stabilizers can be very limited or their use can be omitted entirely.
  • active ingredients or additives which are not compatible with one another in a formulation for a long time only immediately before use. Active ingredients that are only stable in the form of a derivative in a formulation, can be presented as such in a separate formulation and added directly before the rest of the mixture is used.
  • the user can also add different additives to small quantities of a base mixture at different times, as required. This can be of interest for both pharmaceutical and cosmetic formulations if different active ingredients are to be applied at different times.
  • additives can be added to a basic cosmetic formulation for the day than for the night.
  • Additives for the day can be UV filters, for example, while regenerative additives for the night.
  • Phases A, B and C are each placed separately in a storage container and heated to 75 ° C.
  • the thus liquid phases B and C are pumped out of the storage containers and passed through a micromixer heated to 75 ° C. and mixed.
  • the mixture emerging from the micromixer is then pumped with phase A through a micromixer heated to 75 ° C. and homogenized.
  • the emulsion obtained is in a
  • Viscosity 43000 mPa.s (Brookfield RVT, spindle C, 5 rpm, Helipath) at 25 ° C 0.05% propyl 4-hydroxybenzoate (Merck KGaA, item no.130173), 0.15% methyl 4- hydroxybenzoate (Merck KGaA, Art. No. 13 0174), 0.30% Germall 115 (ISP, Frechen)
  • Both phases A and B are placed separately in a storage container. After mixing, which can be done either by stirring or by shaking in small vessels, the phases are pumped out of the storage containers and passed together through a micromixer, in which the phases are mixed intensively.
  • the homogeneously mixed milk can be used directly.
  • Glycerin (Item No. 4093) (1) 5.00
  • phase B tris (hydroxymethyl) aminomethane is dissolved in water in a storage vessel to neutralize Eusolex 232 and Eusolex 232 is added. After the solution has been completely dissolved, the remaining phase B raw materials are added. The components of phase A are premixed in a second storage vessel.
  • the two mixing phases are pumped together with the help of a pump through a micromixer connected via thin connecting tubes.
  • Viscosity 22,800 mPas (Brookfield RVT, Sp. C, 10 rpm) at 25 'C samples contain 0.05% propyl 4-hydroxybenzoate as a preservative (Merck item no. 7427)
  • Eumulgin B2 cetiol HE, Uniphen P-23 and the paraffin oil are placed in a storage vessel, melted while mixing and heated to approx. 95 ° C-105 ° C.
  • the water phase and the fat phase are pumped through a micromixer for intensive mixing.
  • the resulting microemulsion gel was stirred to cool.
  • microemulsion gel it is possible to pass the microemulsion gel through a further cooled micromixer, the outgoing channels of which have a further cross section, as a result of which the channels are not clogged and the formation of air pockets in the gel is prevented.
  • Example 5 At a temperature at which the microemulsion gel is just pourable, it is filled into the primary packaging.
  • phase C disperse the Pemulen TR-1 homogeneously in the water, add the preservative and swell. Enter phase B under homogenization in phase C. Dissolve phase A while heating and add slowly while homogenizing. Add phase D at 35 ° C and homogenize again.
  • Vitamin E acetate 1.0
  • a and B are heated to a temperature of 75 ° C. in separate storage containers.
  • Phases A and B / C are mixed intensively by pumping them through a micromixer heated to 75 ° C.
  • the resulting emulsion is collected in a storage vessel.
  • D is added after cooling to a temperature below 35 ° C.
  • Viscosity 43,000 mPa.s (Brookfield LVT T-bar spindle, E, rpm 6, 1 min.)
  • the mixture obtained is homogenized for a further 5 minutes.
  • composition specified under B is heated to a temperature of 80 ° C. with the exception of Keltrol. Keltrol is dispersed with stirring at constant temperature in the submitted composition.
  • compositions A and B are mixed in a micromixer as described above.
  • Viscosity 16,000 mPa.s (Brookfield LVT, T-) spindle D, rpm 6, min.)

Abstract

Cette invention concerne un procédé de production de formulations cosmétiques ou pharmaceutiques juste avant leur utilisation. Au moins deux composants fluides, provenant de chambres de stockage séparées, sont intimement mélangés en passant à travers un micromélangeur. De plus, la présente invention concerne les lotions, émulsions, gels, crèmes et solutions produits selon le procédé de l'invention, lesquels sont destinés soit à un usage cosmétique, soit, à condition d'y incorporer des principes actifs pharmaceutiques adéquats, à la réalisation desdites formulations pharmaceutiques.
EP00918767A 1999-03-17 2000-03-07 Procede de production de formulations cosmetiques ou pharmaceutiques par micromelange juste avant utilisation Ceased EP1161221A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19911777A DE19911777A1 (de) 1999-03-17 1999-03-17 Verfahren zur Herstellung von kosmetischen Formulierungen
DE19911777 1999-03-17
PCT/EP2000/001974 WO2000054735A1 (fr) 1999-03-17 2000-03-07 Procede de production de formulations cosmetiques ou pharmaceutiques par micromelange juste avant utilisation

Publications (1)

Publication Number Publication Date
EP1161221A1 true EP1161221A1 (fr) 2001-12-12

Family

ID=7901216

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00918767A Ceased EP1161221A1 (fr) 1999-03-17 2000-03-07 Procede de production de formulations cosmetiques ou pharmaceutiques par micromelange juste avant utilisation

Country Status (7)

Country Link
EP (1) EP1161221A1 (fr)
JP (1) JP2002538947A (fr)
CN (1) CN1344145A (fr)
AU (1) AU768399B2 (fr)
CA (1) CA2367391A1 (fr)
DE (1) DE19911777A1 (fr)
WO (1) WO2000054735A1 (fr)

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CA2367391A1 (fr) 2000-09-21
WO2000054735A1 (fr) 2000-09-21
CN1344145A (zh) 2002-04-10
DE19911777A1 (de) 2000-09-21
AU768399B2 (en) 2003-12-11
AU3961100A (en) 2000-10-04
JP2002538947A (ja) 2002-11-19

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