EP1450772A1 - Poudre filmogene micronisee comprenant une substance active - Google Patents
Poudre filmogene micronisee comprenant une substance activeInfo
- Publication number
- EP1450772A1 EP1450772A1 EP02803460A EP02803460A EP1450772A1 EP 1450772 A1 EP1450772 A1 EP 1450772A1 EP 02803460 A EP02803460 A EP 02803460A EP 02803460 A EP02803460 A EP 02803460A EP 1450772 A1 EP1450772 A1 EP 1450772A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- film
- forming powder
- micronized
- powder according
- micronized film
- 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.)
- Withdrawn
Links
Classifications
-
- 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
- A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/16—Masculine contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Definitions
- the present invention relates to a micronized film-forming powder, pharmaceutical, cosmetic or neutraceutical compositions containing this powder, as well as their methods of manufacture and their uses.
- the micronized film-forming powder according to the present invention has the particularity of forming a film in situ at the time of its application on a hydrated or wet support. It can be applied to the dermis and / or to a mucous membrane.
- this powder forms a film on the dermis or on the mucosa during its application, it allows the prolonged release of the, or of the active substances which it contains.
- This extended release can be done in several ways. For example, linearly or with a "burst effect” (immediate release of part of the active substance, followed by prolonged release), also called “bimodal release profile” or “rapid and sustained release effect” .
- a decisive advantage of this dosage form lies in the fact that the film erodes over time in order to leave no residue.
- Fluid compositions capable of forming films in situ during their application are already known.
- US Patents 5,081,157, US 5,081,158, and Patent Applications WO 96/30000, WO 97/31621, WO 00/10540, WO 00/38658, WO 01/13955, WO01 / 43722 describe film-forming compositions for transdermal and / or transmucosal application. These compositions can be in the form of a solution, a suspension or a gel.
- compositions already known in the prior art suffer from numerous drawbacks. Among these, mention may be made of the preparation difficulties associated with obtaining compositions which can then form a homogeneous film, the storage difficulties of these dosage forms due to the fact that they are often unstable, as well as the difficulties associated with their administration.
- liquids like gels, are difficult to position precisely on the dermis or mucous membranes, and tend to slide or move.
- muco-adhesive preparations known in the prior art have a thickness such that they cause a gene for the individual who uses them, in particular when these preparations are applied to the oral or vaginal mucous membranes.
- preparations known in the state of the art in particular preparations of the “Patch” or of the “Wafer” type, comprise a support which remains in place after the complete release of the active substance or substances, which requires intervention by the doctor for their removal, in particular after application to the internal mucous membranes such as the vaginal mucosa.
- the Applicant Companies have therefore sought to develop a dosage form which can overcome the drawbacks encountered by the previous formulations. They have thus succeeded in developing a micronized film-forming powder which has the properties of forming a cohesive continuous film when it is brought into contact with a hydrated or moist support, for example with the mucous membranes or else the skin previously hydrated.
- the film which is formed after application of the micronized film-forming powder on the hydrated or wet support has good adhesiveness to the support, as well as good cohesion.
- the film-forming composition in the form of a micronized powder according to the invention unlike the fluid products of the prior art, does not require any use of a liquid vehicle, in particular of solvents, during the administration of the product. This is obviously a decisive advantage for a product for pharmaceutical, cosmetic or neutraceutical use.
- the micronized powder form also allows a very good stability of the product during storage, superior to that of products in the form of solutions, suspensions or gels.
- the micronized film-forming powder according to the present invention therefore has numerous advantages over the dosage forms known in the prior art.
- the present invention relates to a micronized film-forming powder having a particle size of at most 100 ⁇ m and comprising the combination of at least one active substance, at least one biocompatible adhesive agent and at least one plasticizing agent.
- active substance is meant according to the invention any substance having a measurable activity of a cosmetic or neutraceutical therapeutic nature towards the organism, man or animal, to which this substance is applied or administered.
- biocompatible adhesive agent which can also be designated
- Bioadhesive agent means according to the invention any substance or any compound which has the property of adhering to a hydrated or wet biological tissue when said substance or said compound is applied to it, such as for example a mucous membrane or the previously hydrated dermis.
- the adhesive agent must be compatible with use on the biological tissue, without causing undesirable reactions such as inflammation of the biological tissue.
- plasticizer is meant any substance or compound capable of improving the mechanical properties of the film formed from the micronized film-forming powder according to the invention in order to promote the physical integrity of said film during its formation and to maintain the physical integrity of said film after its formation, in particular by promoting cohesion between the particles initially contained in the micronized film-forming powder.
- the micronized film-forming powder according to the invention has the properties of forming a continuous cohesive film in contact with the aqueous medium, when the said powder is brought into contact with a wet or hydrated support, preferably the mucous membranes or the previously hydrated dermis.
- the film is formed very quickly, from the first minute after the application of the micronized film-forming powder to the surface of the moist or hydrated support, for example mucosa or previously hydrated dermis, as illustrated in the examples.
- the particle size of the micronized film-forming powder according to the invention is essential for obtaining a film which is cohesive and continuous over the entire surface of the support on which said powder is applied.
- a continuous and cohesive film having good adhesive properties is obtained on the hydrated or wet support with a micronized film-forming powder as defined above and having a particle size of at most 50 ⁇ m as well as with a micronized film-forming powder having a particle size of at most 20 ⁇ m, as described in the examples. Excellent results have also been obtained with a micronized film-forming powder having a particle size close to 10 ⁇ m.
- micronized film-forming powder also having a particle size of at most 10 ⁇ m is also part of the invention.
- the micronized film-forming powder has a particle size of at least 0.01 ⁇ m, preferably at least 0.1 ⁇ m and very preferably at least 1 ⁇ m.
- a micronized film-forming powder as defined above has a particle size between 0.01 ⁇ m and 100 ⁇ m, preferably between 0.1 ⁇ m and 70 ⁇ m and more preferably still between 1 ⁇ m and 50 ⁇ m.
- particle size of a micronized film-forming powder according to the invention is meant the average size of the grains which constitute it.
- the average grain size can be measured by any conventional technique known per se.
- a person skilled in the art can have recourse to a measurement using a laser granulometry device of the Beckman Coulter® or Malvern® type, as described in the examples.
- the Applicant has observed that the grain size distribution of the micronized film-forming powder according to the invention follows a narrow Gauss curve, the particle size value corresponding consequently to the actual size of the majority of the particles contained in said powder.
- the micronized film-forming powder of the invention advantageously has a residual humidity of between 0.1% and 10% and preferably between 2% and 8%, as measured with an analyzer type MA 30 humidity sold by Sartorius and used according to the manufacturer's recommendations, as illustrated in the examples.
- the low relative humidity of the micronized film-forming powder according to the invention allows a storage period of several months without affecting its particle size characteristics and without affecting its properties of forming a continuous and cohesive film when it is applied to a hydrated or wet support. .
- the continuous and cohesive film which is formed on the surface of the support has a reduced thickness of between 10 ⁇ m and 1 mm, preferably between 50 ⁇ m and 400 ⁇ m and very preferably between 100 ⁇ m and 300 ⁇ m.
- the small thickness of the continuous and cohesive film produced by application of the micronized film-forming powder of the invention avoids, or at the very least decreases, the feelings of discomfort which were felt with some of the previously known devices.
- the small thickness of the film thus formed due to the smaller average distance between the active substance or substances which it contains and the target sites of these active substances, for example the target sites located on the surface of a mucous membrane. , allows better accessibility or bio-availability of the active substances towards their target sites and promotes the release of all of the active substance or substances initially contained in said film.
- the adhesiveness of a film formed on a wet or hydrated support, from the micronized film-forming powder according to the invention, is illustrated by the fact that said film has an adhesiveness index or “tack” of between 1 N and 50 N, preferably between 2 N and 10 N.
- tackiness index or “tack” a person skilled in the art will advantageously have recourse to the so-called “Probe Tack” test carried out with a traction device, said test being defined in standard No. D 2979-01 of ASTM (“Standard Test Method for Pressure-Sensitive Tack of Adhesives using an Inverted Probe Machine” - American Society for Testing and Materials), as illustrated in the examples.
- the good adhesion properties to the support of the film formed from the micronized film-forming powder according to the invention avoids, or at all the least considerably reduced, the risks of detachment of the film from the support on which said film is formed or else the risks of sliding or displacement of said film on the surface of the support, which further reduces the potential loss of molecules of active substances which '' do not reach the targeted sites.
- the film formed after application of the micronized film-forming powder according to the invention on a hydrated or wet support has good resistance to liquids, which constitutes a particularly advantageous technical characteristic taking into account the surfaces on which said micronized film-forming powder is likely to be mainly applied, namely the mucous membranes and the dermis.
- the good resistance to liquids of said film makes it possible to characterize it as a semi-permeable film.
- the semi-permeable nature of the film formed from the micronized film-forming powder of the invention is illustrated by the fact that, although the contact angle of said film decreases with the duration of exposure thereof to different types of liquids, no complete absorption of these different types of liquids is observed, whatever the acid, basic or neutral pH of the latter, as shown in the examples.
- the micronized film-forming powder according to the invention allows stabilization and high efficiency, in particular therapeutic, cosmetic or neutraceutical, of the final product.
- the micronized film-forming powder according to the invention comprises, relative to the total weight of the composition, from 0.001% to 90% by weight of active substance (s), from 1% to 90% by weight of biocompatible adhesive agent (s) and from 0.1% to 30% by weight of plasticizing agent (s).
- active substance s
- biocompatible adhesive agent s
- plasticizing agent s
- the powder has the physical, mechanical and chemical characteristics defined above for the film formed from this powder, in particular the characteristics of thickness, adhesiveness index, resistance to liquids and semi-permeability.
- the micronized film-forming powder will have a low proportion of biocompatible adhesive agent.
- the micronized film-forming powder according to the invention is characterized in that it can also comprise at least one compound chosen from a surfactant, a wetting agent, a binding agent, a retarding agent, a penetration promoter, a bioerodible diluting agent , a color, a flavor, a pH regulating agent or a combination of at least two of these compounds.
- a surfactant e.g., a wetting agent
- a binding agent e.g., a binding agent
- a retarding agent e.g., a penetration promoter, a bioerodible diluting agent
- a bioerodible diluting agent e.g., a color, a flavor, a pH regulating agent or a combination of at least two of these compounds.
- surfactants, wetting agents, binding agents, delaying agents, penetration promoters other than those already acting as a biocompatible adhesive agent or as a plasticizing agent, are added.
- the active substances of the micronized film-forming powder according to the invention can be selected from those conventionally used in the following pharmacotherapeutic families: allergology, anesthesia / resuscitation, oncology and hematology, cardiology and angiology, contraception and termination of pregnancy, dermatology, endocrinology , gastroenterohepatology, gynecology, immunology, infectiology, metabolism and nutrition, neurology / psychiatry, ophthalmology, otolaryngology, pneumology, rheumatology, stomatology, toxicology, urology / nephrology, as well as among analgesics and antispasmodics, anti-inflammatories , contrast media used in radiology, hemostats, and blood treatment products and derivatives.
- all cosmetic and nutraceutical substances are also selected.
- the active substances can be selected from the group consisting of active substances passing through the skin barrier and reaching the systemic circulation, such as cyproterone acetate, ⁇ 4 androstenedione, 3 keto-desogestrel, desogestrel, gestodene, estradiol and its derivatives, norethisterone acetate, progesterone, testosterone, trinitrine, fentanyl, nitroglycerin, nicotine (nicotine S (-)), scopolamine, clonidine, isosorbide dinitrate, levonorgestrel in combination with ethinylestradiol or with estradiol, androstanolone, alclometasone dipropionate, as well as their combinations .
- active substances passing through the skin barrier and reaching the systemic circulation such as cyproterone acetate, ⁇ 4 androstenedione, 3 keto-desogestrel, desogestrel, gestodene, estradiol and its
- They can also be selected from activated substances passing through the skin barrier and having a localized action such as: acetazolamide, acyclovir, adapalene, alclomethasone dipropionate, amcinonide, amleine, bamethan sulfate + escin, betamethasone valerate, betamethasone dipropionate, bufexamac, caffeine, calcipotriol monohydrate, cetrimonium bromide, clobetasol propionate, crilanomer, deonide, dexpanthenol, diclofenac, diflucurone, diflucurone diphenydramine hydrochloride, econazole nitrate, erythromicin, flumetasone pivalate, fluocinolone acetonide, fluocinodine, fluocortolone, fluocortolone hexanoate, fluocortolone pivalate, hydrocortisone, hydrocortisone a
- ⁇ -3 adrenergic agonist the ⁇ -3 adrenergic agonist, growth hormone, oxybutinin, buprenorphine, pergolide, estradiol + nestorone, nestorone, 7 ⁇ -methyl-19 -nortesterone, mecamylamine (nicotine antagonist) + nicotine, salbutamol, selegiline, buspirone, ketotifen, lidocaine, testosterone + estradiol, ketorolac, eptazocine, insulin, interferon ⁇ , prostaglandins, 17 ⁇ estradiol + norethindrone acetate, 5 aminolevulinic acid, benzodiazepine alprozolam, diclofenac, fenoprofen, flubiprofen, ketoprofen, methylphenidate, miconazole, piroxicam, bruprenorphine, alprozolam, dexmedetomidine, prazosin (adrenergic antagonist), gestodene
- They can also be selected from the active substances known to undergo a first pass effect, such as:
- - Nicotine can be selected from the active substances which undergo gastrointestinal degradation, such as:
- They can be selected from the active substances which have a low bioavailability.
- the micronized film-forming powder may contain one or more active substances, in combination with one another.
- the active substance can be chosen from the group comprising emollient agents, moisturizing agents, vitamins, fruit amino acid complexes, antioxidant agents, etc.
- the active substance can be chosen from the group comprising vitamins, mineral salts, brewer's yeast, etc.
- the active substances are micronized before being mixed with the other ingredients. It is also possible to mix the non-micronized active substance with the other ingredients of the powder and then to micronize the final mixture. This promotes the homogeneity of the film as well as the cohesion and adhesion of the particles on its application support.
- powder spray systems are particularly well suited for spraying micronized products.
- the biocompatible adhesive agent of the micronized film-forming powder according to the invention is advantageously selected from the group consisting of ethylcellulose, methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose sodium, polyvinylpyrrolidone, polyvinyl alcohols, polyisobutylene, polyisopropene, xanthum gum, "locust bean” gum, chitosan, chitosan chloride, polycarboxylates, carbomers such as carbopol, acrylic / methacrylic acid copolymer, acrylic acid / acrylamide copolymer, acrylic acid / methyl methacrylate copolymer, acrylic acid / polyethylene glycol copolymer, polyacrylic acid / butyl acrylate copolymer, HEMA (2 hydroxyethyl methacrylate) copolymerized with Polymeg ® (polytetramethylene glycol
- the plasticizing agent of the micronized film-forming powder according to the invention is advantageously selected from the group consisting by dibutylphthalate, dibutylsebacate, acetyl-tributyl citrate, acetyltriethyl citrate, tributyl citrate, tributyl ethyl citrate, triacetin, PEG, propylene glycol, glycerol, glycerol monoesters and derivatives, and castor oil as well as their mixtures and derivatives.
- the micronized film-forming powder according to the invention may also comprise one or more surface-active agents, preferably nonionic, such as polyoxyethylene sorbitan (fatty acid ester, polyoxyethylene alkyl ether, polyoxyethylene derived from castor oil as well as their mixtures and derivatives.
- the micronized film-forming powder can also comprise a wetting agent selected from the group consisting of polyols such as sorbitol, or glycerin, PEG and their mixtures.
- the micronized film-forming powder according to the invention can also comprise a binding agent selected from the group consisting of acacia, alginic acid, sodium carboxymethylcellulose, microcrystalline cellulose, dextrins, ethylcellulose, gelatin, glucose, guar gum, hydroxypropyl methylcellulose, methylcellulose, polyethylene oxide, povidone, pregelatinized starch, as well as their mixtures and derivatives.
- a binding agent selected from the group consisting of acacia, alginic acid, sodium carboxymethylcellulose, microcrystalline cellulose, dextrins, ethylcellulose, gelatin, glucose, guar gum, hydroxypropyl methylcellulose, methylcellulose, polyethylene oxide, povidone, pregelatinized starch, as well as their mixtures and derivatives.
- the micronized film-forming powder according to the invention can also comprise a retarding agent, hydrophilic or not, selected from the group consisting of hydroxypropylmethylcellulose acetate or succinate, hydroxypropylmethylcellulose, hydroxypropylcellulose, ethylcellulose, hydroxyethylcellulose, carboxymethylcellulose sodium, polyvinyl alcohols, hydrocolloids such as: pectins, alginates, guar gums, xanthan, arabic, agar, dextrin, caragheenan, polyethylene oxide, carbomers, polymers and copolymers of acrylic acid, methyl methacrylate, polyvinyl acetate, of carboxymethylylacetate as well as their mixtures.
- a retarding agent hydrophilic or not, selected from the group consisting of hydroxypropylmethylcellulose acetate or succinate, hydroxypropylmethylcellulose, hydroxypropylcellulose, ethylcellulose, hydroxyethylcellulose, carboxymethylcellulose sodium
- the micronized film-forming powder according to the invention can also comprise a bioerodible diluting agent, selected from the group consisting of calcium carbonate or bicarbonate, sodium, sucrose, mannitol, xylitol, sorbitol, lactose, cellulose powder. or microcrystalline cellulose, starch and its derivatives, dibasic calcium phosphate, tribasic calcium phosphate, calcium sulfate, dextrates, dextrins, dextrose excipients, fructose, kaolin, lactitol and mixtures thereof.
- a bioerodible diluting agent selected from the group consisting of calcium carbonate or bicarbonate, sodium, sucrose, mannitol, xylitol, sorbitol, lactose, cellulose powder. or microcrystalline cellulose, starch and its derivatives, dibasic calcium phosphate, tribasic calcium phosphate, calcium sulfate, dextrates, dextrin
- the micronized film-forming powder according to the invention can also comprise a penetration-promoting agent which can be selected from the group consisting of esters of aliphatic fatty acids such as isopropyl myristate, fatty acids such as oleic acid; alcohols or polyols such as ethanol, propylene glycol and polyethylene glycol; components oils "essential and terpene derivatives (such as eugenol, geraniol, nerol, eucalyptol, menthol); surfactants, moisturizers such as glycerin, urea, keratolytic agents such as alpha-hydroxy acids.
- a penetration-promoting agent which can be selected from the group consisting of esters of aliphatic fatty acids such as isopropyl myristate, fatty acids such as oleic acid; alcohols or polyols such as ethanol, propylene glycol and polyethylene glycol; components oils "essential and terpene derivatives (such as
- the micronized film-forming powder according to the invention may also comprise a dye, selected from the group comprising Curcumino, Lactoflavin (riboflavin), Tartrazine, Quinoline yellow, Orange yellow S, Cochineal carminic acid Azorubine, Amaranth, Cochineal red A Patent blue V, Indigotine (indigo carmine), Chlorophylls, Cupric complexes of chlorophylls and chlorophyllins, Caramel, Black, Brillant BN, Carbo medicinalis vegetalis, Carotenoids, alpha, beta or gamma carotene, Bixine, Norbixin, (annatto annatto), Capsantéine, Capsorubine , Lykopene, Xanthophylls, Flavoxanthin, Lutein, Kryptoxanthin, Rubixanthin, Violoxanthin, Rhodoxanthin, Beet red, Betanin, Anthocyanins, Calcium
- the micronized film-forming powder according to the invention can also comprise an aroma, selected from the aromas conventionally used in pharmacy.
- the micronized film-forming powder according to the invention can also comprise a pH-regulating agent.
- the pH regulating agents make it possible to stabilize or promote the passage of the active substance (s) through the biological support on which the micronized film-forming powder according to the invention is applied.
- the pH regulating agents can regulate the pH of the film thus formed between pH 2.0 and pH 9.0.
- the pH regulating agent is selected from the group comprising citric acid and its derivatives, phosphoric acid and its derivatives, tartaric acid and its derivatives, bicarbonic acid and its derivatives, or alternatively a combination of at least two pH regulators above.
- the invention also relates to a pharmaceutical, cosmetic or neutraceutical composition
- a pharmaceutical, cosmetic or neutraceutical composition comprising the micronized film-forming powder as defined in the present description.
- This composition can be applied to the dermis or the mucous membranes. When administered mucosally, it can be applied, for example, to the oral mucosa, the nasal mucosa or the vaginal mucosa.
- micronized film-forming powder according to the invention When administered transdermally, it will have a systemic effect and / or a local effect depending on the nature of the active substance as well as the other components present in the powder.
- the composition according to the invention comprising the micronized film-forming powder, is in a sprayable dry form. This allows easy delivery of a precise dose.
- the invention also relates to a process for the preparation of a micronized film-forming powder.
- micronized film-forming powder All the methods known to those skilled in the art can be used in the context of the production of this micronized film-forming powder.
- a powder preparation method mention may be made of: granulation, wet or dry, by extrusion, by atomization, followed by micronization in order to obtain a micronized powder.
- the active substance is micronized and then mixed with the excipients in the form of powder, and the mixture thus obtained is granulated, by wet granulation or by dry method, before a new micronization step.
- the process for manufacturing the micronized film-forming powder of the invention necessarily includes a micronization step of the mixture comprising the active substance, the biocompatible adhesive agent and the plasticizing agent.
- the conventional air jet method is preferably used, for example using an air jet micronization device of the ALPINE or JET MILL type, according to the manufacturer's recommendations.
- the preferred parameters for micronization on a GALETTE Alpine 200AS micronizing device are as follows:
- the powder before micronization had an average grain size (particle size) of 1 10 ⁇ m.
- the micronized film-forming powder obtained had a particle size of 3 ⁇ m.
- micronized film-forming powder according to the invention can be used with or in any device allowing its application on the surface of a moist or hydrated support, such as the mucous membranes or the previously hydrated dermis.
- the invention also relates to any device for applying or dispersing the powder on the surface of a support, usable in cosmetics, in pharmacy and in neutraceuticals.
- FIG. 1 illustrates the grain size distribution profile of the micronized film-forming powder prepared in Example 2.
- the curve on the right represents the grain size distribution profile before micronization.
- the left curve represents the grain size distribution profile after micronization.
- FIG. 2 illustrates the grain size distribution profile of the micronized film-forming powder prepared in Example 3.
- the right curve represents the distribution profile of the grain sizes before micronization.
- the left curve represents the grain size distribution profile after micronization.
- the various components are mixed in a mixer-granulator of the ROTOLAB ZANGHETTA mixer-granulator-vacuum type or equivalent until the mixture is homogenized. Then, a wetting solution or suspension is incorporated with stirring in order to obtain a wet granule.
- This granule is then dried under suitable conditions in order to evaporate the granulation solvent. This granule is then calibrated.
- a powder is prepared having the weight composition detailed in Table 5 below. Table 5
- Controls on finished product -Granulometry carried out using a MASTER SIZER 2000 laser granulometer equipped with a Scirocco 2000 vibrator.
- This test is similar to the so-called “Probe Tack” test - ASTM D 2979 standard, it is carried out with a traction device.
- a powder is prepared having the weight composition detailed in Table 7 below.
- the various components are mixed in a mixer-granulator of the mixer-granulator-dryer type Fluidized air bed equipped with a top spray nozzle or equivalent until the mixture is homogenized. Then, a wetting solution or suspension is sprayed using a spray nozzle, on the moving product in order to simultaneously distribute the solution evenly and dry it to evaporate the granulating solvent.
- This granule is calibrated and then micronized using an air jet micronization device of the GALETTE ALPINE 200 AS type, according to the following parameters: Injector: 7 Bars; Crown: 6 Bars; Speed: 25 kg / h. Controls on finished product
- the contact angle decreases significantly over time, the liquid is not completely absorbed by the adhesive, the film is semi-permeable.
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- Coloring Foods And Improving Nutritive Qualities (AREA)
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Abstract
Description
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Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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FR0115069 | 2001-11-21 | ||
FR0115069A FR2832311B1 (fr) | 2001-11-21 | 2001-11-21 | Poudre filmogene, compositions la comprenant, leurs procedes de preparation et leurs utilisations |
PCT/FR2002/004000 WO2003043612A1 (fr) | 2001-11-21 | 2002-11-21 | Poudre filmogene micronisee comprenant une substance active |
Publications (1)
Publication Number | Publication Date |
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EP1450772A1 true EP1450772A1 (fr) | 2004-09-01 |
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Application Number | Title | Priority Date | Filing Date |
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EP02803460A Withdrawn EP1450772A1 (fr) | 2001-11-21 | 2002-11-21 | Poudre filmogene micronisee comprenant une substance active |
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Country | Link |
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US (2) | US20030096012A1 (fr) |
EP (1) | EP1450772A1 (fr) |
JP (1) | JP2005515185A (fr) |
AU (1) | AU2002365961B2 (fr) |
BR (1) | BR0214254A (fr) |
CA (1) | CA2468018A1 (fr) |
FR (1) | FR2832311B1 (fr) |
HU (1) | HUP0402280A3 (fr) |
IL (1) | IL162110A0 (fr) |
MX (1) | MXPA04004791A (fr) |
NO (1) | NO20042367L (fr) |
PL (1) | PL370777A1 (fr) |
RU (1) | RU2314796C2 (fr) |
WO (1) | WO2003043612A1 (fr) |
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2001
- 2001-11-21 FR FR0115069A patent/FR2832311B1/fr not_active Expired - Fee Related
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2002
- 2002-03-14 US US10/097,781 patent/US20030096012A1/en not_active Abandoned
- 2002-11-21 AU AU2002365961A patent/AU2002365961B2/en not_active Ceased
- 2002-11-21 HU HU0402280A patent/HUP0402280A3/hu unknown
- 2002-11-21 MX MXPA04004791A patent/MXPA04004791A/es active IP Right Grant
- 2002-11-21 WO PCT/FR2002/004000 patent/WO2003043612A1/fr active Application Filing
- 2002-11-21 PL PL02370777A patent/PL370777A1/xx not_active Application Discontinuation
- 2002-11-21 EP EP02803460A patent/EP1450772A1/fr not_active Withdrawn
- 2002-11-21 CA CA002468018A patent/CA2468018A1/fr not_active Abandoned
- 2002-11-21 US US10/496,094 patent/US20050042173A1/en not_active Abandoned
- 2002-11-21 BR BR0214254-6A patent/BR0214254A/pt not_active Application Discontinuation
- 2002-11-21 JP JP2003545293A patent/JP2005515185A/ja active Pending
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- 2002-11-21 RU RU2004118487/15A patent/RU2314796C2/ru not_active IP Right Cessation
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Also Published As
Publication number | Publication date |
---|---|
IL162110A0 (en) | 2005-11-20 |
AU2002365961A1 (en) | 2003-06-10 |
FR2832311A1 (fr) | 2003-05-23 |
HUP0402280A2 (hu) | 2005-09-28 |
MXPA04004791A (es) | 2005-02-17 |
BR0214254A (pt) | 2004-12-14 |
RU2314796C2 (ru) | 2008-01-20 |
JP2005515185A (ja) | 2005-05-26 |
FR2832311B1 (fr) | 2004-04-16 |
PL370777A1 (en) | 2005-05-30 |
RU2004118487A (ru) | 2005-04-20 |
WO2003043612A1 (fr) | 2003-05-30 |
NO20042367L (no) | 2004-06-07 |
AU2002365961B2 (en) | 2008-01-03 |
HUP0402280A3 (en) | 2012-07-30 |
CA2468018A1 (fr) | 2003-05-30 |
US20030096012A1 (en) | 2003-05-22 |
US20050042173A1 (en) | 2005-02-24 |
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