FI59769B - FOERPACKNING AVSEDD FOER FOERVARING OCH FOERDELNING AV PULVER - Google Patents

Description

rftl ANNOUNCEMENT _ _ „„ Ä [J (1) utlAggninqsskrift 5 9 769 C (45) 1 ^ (51) ifeJuWa3 B 65 D 83/14 FINLAND —FINLAND (21) Mw »« e »k * mm-P« « itMweknln * 7731 ^ 9 (22) HakamlspUvl —AneBknlnpdaf 2U.10.77 '' (23) Alkuptlvt —Glltl | h «udi | 2U.10.77 (41) Interpreters Public - Bllvlt offantllf 29.0U. 78. ,. . (44) Date of issue of the date. -, "

Patani och registerstyrelsan v 'An * ökan utiagd oeh utUkrHtM pubiicmd 30.06.8l (32) (33) (31) ^ y4 * tty «tuelkeut — euiird prleritet 28.10.76

England-England (GB) UU878 / 76 Proven- Styrkt (71) Unilever N.V. , Burgemees * ter s'Jacohplein 1, Rotterdam, The Netherlands (NL) (72) Martin Callingham, London, Dwaipayan Chaudhuri, Ashford, Middlesex,

The present invention relates to a package for storing and dispensing a powder, comprising a container with an aerosol-spray valve in combination with a container for storing and dispensing a powder -Förpackning avsedd för förvaring och fördelning av Powder , which dispenses the liquid as an aerosol, and a mixture inside the container consisting of a powder suspended in a liquid medium consisting of a mixture of a liquid carrier and a liquefied propellant.

When the mixture is removed as an aerosol from a pressurized container, some aerosol particles may be inhaled by the user or some other person in the vicinity. The removed part of the product that enters and remains in the lungs is referred to herein as the "breath fraction" of the product. The goal of the industry is that the user is not unnecessarily exposed to particles entering the lungs. It is an object of the present invention to reduce the respiratory fraction of powdered aerosol spray products.

The present invention is based on the finding that new, better aerosol products with sprays containing less respiratory fractions can be prepared by selecting combinations of aerosol product parameters in a particular manner. These parameters are the pressure of the aerosol can, the area of the outlet or outlet, the area of the valve vapor inlet and the area of either the valve inlet or the valve submersible hole, whichever is smaller, the ratio and the sedimentation rate.

The package according to the invention is characterized in that the ratio of the area of the valve outlet opening of the package -3 2 is at least 2 x 10 cm, the ratio of the area of the valve steam intake opening to the area of either the valve inlet or the valve immersion pipe opening, whichever is smaller. at most 0.05 and the sedimentation volume of the mixture is at least 40%, and that preferably the vapor pressure inside the vessel is 0.35 to 2.1 kg cm-2 at 20 ° C.

The sedimentation volume of a mixture means the volume used by the powder after the mixture has been shaken and allowed to stand for 24 hours, expressed as a percentage of the total volume of the mixture. In practice, the sedimentation volume is determined by filling that part of the transparent substance into a container and expressing the height of the sediment after 24 hours as a percentage of the total height of the mixture.

For the structure of aerosol valves, reference is made to Paul A. Sanders, "Principles of Aerosol Technology, Chapter 6 (1970).

Although the actuator may be a standard actuator or a mechanical breakup actuator, a standard actuator is preferred. It is practically limited by the desired spray properties of the valve. In the normal case that the outlet is located in the actuator, the limited size of the actuator also limits the upper limit of the area of the opening. The area of the outlet is usually between -3 2 -3 2 -3 2 2x10 cm -8x10 cm and is preferably at least 3 x 10 cm.

Today, aluminum chlorohydrate is the most widely used active antiperspirant, but other antiperspirants may be used in the aerosol package of this invention. Such other suitable agents are well known and include those mentioned in English Patent Nos. 1,393,860,1,353,916, 1343,653, U.S. Patent Nos. 3,792,068, 3,726,968 and 3,903,258, and Dutch Patent Application 7,601,377.

Although the current commercial aluminum chlorohydrate grades have average particle sizes in the range of about 10 to about 25 microns, they contain a fraction with a particle size of less than 7 microns. We have surprisingly found 3 59769 that the inhalable fraction decreases as the percentage by weight of a powder less than 7 microns in size increases. Currently commonly used antiperspirants consist of particles of which at least 25% (in number) are between 0 and 6 microns in size. The present invention is particularly applicable to products containing these substances, although the invention is not, of course, in any way limited to the use of such substances.

Although the present invention is particularly applicable to powdered antiperspirant aerosol sprays, the powder may be other than an anti-perspirant powder because the quality of the powder is not critical to the invention. S.C. An article by Elvin entitled "Powder Aerosols", Aerosol Age, September 1971, page 26, mentions many powders that can be used in aerosol powder sprays.

The powder may furthermore be a moisture-absorbing organic polymer, in particular a polymer capable of absorbing at least a quantity of moisture corresponding to its own weight. Such polymers are described in British Patent 1,485,373.

Other examples of powders that can be used in the kit of the invention are powders having deodorant properties, for example sodium bicarbonate, sodium carbonate and hexachlorophene.

Mixtures of powders can also be used.

The amount of powder in the mixture can vary within wide limits, but is usually between 1 and 25% by weight of the mixture.

In the case of an antiperspirant powder, the amount is preferably from about 1 to about 10% by weight of the mixture, especially from 2 to 7% by weight.

The powder is suspended in a liquid medium consisting of a mixture of a liquid carrier and a liquefied propellant. Such mixtures are conventional in the art, and a number of useful substances have been proposed.

The liquid carrier may be, for example, a non-volatile non-hygroscopic liquid as proposed in U.S. Patent 3,968,203.

4,5969

Particularly useful are liquid carriers with emollient properties, many of which are disclosed in British Patent 1,393,860. Particularly preferred are fatty acid esters such as isopropyl myristate and esters disclosed in U.S. Patent 4,045,548 such as dibutyl phthalate and diisopropyl adipate.

Many other various liquid carriers for powder suspension aerosols have been proposed in U.S. Patent Nos. 3,974,270, 3,949,066, 3,920,807, 3,833,721 and 3,833,720 and in English Patent Nos. 1,411,547, 1,369,872, 1,341,748 and 1,341,748. Volatile liquid carriers such as ethanol, such as in South American Patent Publication No. 75/3576, and volatile silicones, as described in English Patent Publication No. 1,467,676, may also be used.

The ratio of the total dry matter content of the mixtures to the liquid carrier can vary within wide limits, for example from 0.01 to 3 parts of powder per part by weight of the liquid carrier.

The liquefied propellant may be a hydrocarbon, a halogenated hydrocarbon or a mixture thereof. The above patents provide examples of substances that can be used as propellants. These include trichlorofluoromethane, dichlorodifluoromethane, dichlorotetrafluoroethane, monochlorodifluoromethane, trichlorotrifluoroethane, propane, butane, 1,1-difluoroethane, 1,1-difluoro-1-chloroethane, dichlorominofluoromethane, methylene chloride and isobutane alone, or isobutane, either. Preferred are chlorochloromethane, dichlorodifluoromethane, dichlorotetrafluoroethane and isobutane, either alone or mixed. The propellant or propellant mixture is selected to give a pressure of 0.35 to 2.1 kg cm 2 at 20 ° C, preferably 1.0 to 2.1 kg cm 2.

It is common practice to add a substance to the powdered aerosol spray compositions which helps to suspend the powder in the liquid medium. These substances prevent the condensation of the powder and can also act as thickeners or gelling agents for the liquid medium. Hydrophobic clays and colloidal silicas are particularly preferred. Hydrophobic clays are available under the tradename 5 59769

Bentone, for example Bentone-34 or Bentone-38, and their use as suspending agents have been described in many patents, including U.S. Patent No. 3,773,683. Suitable colloidal silicas include Aerosil 200 and Cab-O-Sil M-5 and other grades.

In the package according to the present invention, the suspending agent in the liquid medium gives the mixture a sedimentation volume of at least 40%, preferably at least 50%. This volume of sedimentation can be obtained by selecting an appropriate amount of suspending agent and using it in the addition of suspending agent under mixing conditions with high shear forces. The amount of suspending agent may range from about 0.1 to about 2 weight percent of the mixture.

Various minor optional ingredients, such as perfumes, may also be added.

The respiration fraction of the particles produced by the aerosol package was determined in the following experiments using a Hexhlet apparatus (Brit. J. industr. Med., 1954, 11, 284), which separates the particles in air based on their fall rates. The aerosol is aspirated at a controlled horizontal speed through an assay device with parallel plates; the vertical distance between the plates is such that the particles which settle on them as the aerosol passes through the analyzer correspond to particles which would differ aerodynamically in the upper human airway. Thus, the particles that pass through the assay device and are collected on the filter paper describe the particles that would pass into the human lungs. The upper limit of the aerodynamic size of the respirable particles collected in the Hexhlet is about 7 microns.

The procedure was as follows. The dried and weighed filter was placed in a Hexhlet sampling device and the Pressure Pack to be tested was weighed. The vacuum was adjusted so that the Hexhlet pressure gauge reading was about 300 mm Hg. After thorough shaking, the aerosol was sprayed into the chamber at the front of the Hexhlet sampler. The length of each spray was 2 seconds, and the spraying was repeated while shaking every 20 seconds for a total of 20 sprays. Sampling was continued 5 minutes after the last spray. The package was reweighed to give the weight of the product removed. The filter was removed and heated to 6,596,769 for 24 hours at 50 ° C and then reweighed. In this way, the amount of non-volatile matter recovered was determined. This weight is expressed in mg per 100 g of product removed. This weight is a measure of the respirable non-volatile matter in the aerosol cloud and is denoted below by the letters HHJ (i.e. the non-volatile respiratory fraction). The use of the Hexhlet device in the determination of respiratory fractions is also described in Aerosol Age, Volume 21, No. 11, November 1976, pages 20-25.

The following describes experiments illustrating the effect of the above parameters on the nonvolatile respiratory fraction of an aerosol spray.

The standard kit used in the experiments described below contained a powdered aerosol spray mixture having the following formulation, all percentages being by weight unless otherwise indicated:%

Aluminum chlorohydrate powder (MICRO-DRY) 4.50

Isopropyl myristate 6.00

Pyrogenic silica (AEROSIL 200) 0.45

Perfume 0.44

Propellant (50:50 mixture of propellants 11 and 12) to 100.00 (Propellant 11 is trichlorofluoromethane) (Propellant 12 is dichlorodifluoromethane).

Concentrate, i.e. a mixture of aluminum chlorohydrate, isopropyl myristate, fumed silica and perfume, and a portion of the propellant was mixed and then subjected to high shear in a mixer for 20 minutes. The remainder of the propellant was then added and the resulting mixture was filled into an aerosol can.

This mixture gave a vessel pressure of 2.9 kg cm 2 at 23 ° C. Its sedimentation volume was 50%. The steam inlet of the valve was 0.51 mm in diameter, and the diameter of the inlet was 2.04 mm. An actuator with an outlet diameter of 0.51 mm was fitted to the valve. A standard immersion tube with an inner diameter of 3.8 mm was installed in the valve.

In the experiments described below, one or more of the above parameters were modified to demonstrate the effect of such a change on the respiratory fraction of the aerosol cloud formed by the aerosol package.

Experiments were performed with the above-mentioned standard formulation to demonstrate the effect of can pressure on the respiratory fraction of an aerosol powder spray. The composition of the formulation was varied by changing the ratio of propellants 11 and 12 to give different pressures to the jar. The package also differed from the above-mentioned package in that the diameter of the steam intake was 0.33 mm. The results are given in Table I.

Table I

Purkin pressure „

At 23 ° C (kg cm) HHJ

2.6 120 2.3 67 2.2 46 1.7 17 1.3 1

The results given in Table II show the effect of actuator outlet size on the non-volatile respiratory fraction (HHJ).

Table II

Actuator removal

hole diameter (mm) HHJ

0.33 346 0.38 330 0.45 209 0.51 183 0.64 115 0.76 97 1.02 73 8 59769

Experiments were also performed to show the effect of reducing the ratio of steam inlet to suction area from 0.06 to zero using valves with 0.51 mm, 0.33 mm and no valve at all. vapor uptake. The results of these experiments are shown in Tables III and IV. The results in Tables III> and IV were obtained using mixtures of propellants 11 and 12 which gave pressures of 2.1 and 1.8 kg cm-23 at 23 ° C, respectively.

Table III

Steam vent diameter (mm) HHJ

0.51 58 0.33 46 O 19

Table IV

Vapor diameter t (imm) HHJ

0.51 54 0.33 17 0 8

In experiments illustrating the finding that products with a higher sedimentation volume formed aerosol sprays with a lower respiratory fraction, mixtures obtained by varying the amount of fumed silica in the above mixture between 0.20 and 0.60% by weight were used.

The results obtained are shown in Table V ^ 9 59769

Table V

Sedimentation volume (%) HHJ

35 283 43 252 56 211 61 194 65 192

Tables I, III, and IV have HHJ values generally lower than Tables II and V. This is because the series of experiments compiled in Tables I, III, and IV were performed at a time when the ambient temperature in the laboratory was substantially lower. The actual HHJ value obtained with a particular Aero sol pack depends to some extent on the ambient temperature at which the assay is performed.

Table VI shows the results of further experiments showing the cumulative effect on the respiratory fraction achieved by reducing the pressure in the can, reducing the ratio of the areas of the vapor intake and suction openings, and increasing the sedimentation volume.

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Table VII shows the cumulative effect obtained by increasing the area of the actuator orifice and decreasing the pressure in the can. The diameter of the steam inlet in these experiments was 0.33 mm.

Table VII

Actuator Removal - Can Pressure __

orifice diameter at __23 ° C (kg cm ~ i__HHJ

2.1 46 0.51 mm --- 1.8 17 2.1 23 0.89 mm ---- 1.8 7

In experiments to determine the effect on respiratory fraction of using powders containing different amounts of respirable size particles, three different commercial grades of aluminum chlorohydrate were used. The substances used were manufactured by Reheis Chemical Company and sold as "CHLORHYDROL", "MICRO-DRY", "MICRO-DRY Ultrafine" and "Microspherical" grades respectively (CHLORHYDROL and MICRO-DRY are trademarks). Samples of these substances were examined by scanning electron microscopy. Table VIII gives the number and percentage of particles found in the range 0-6 microns.

Table VIII

Aluminum chlorine- Percentage by weight size Number of hydrate in the range o - 6 microns microns'

MICRO-DRY

Ultrafine 2.0 56 MICRO-DRY 1.4 35

Microspherical 0.4 20

Table IX gives the respiration fraction values when these different substances were used in a commercial product (differs from the standard product mentioned above and contains 3.5% aluminum chlorohydrate and 3.0% isopropyl myristate).

12 59769

Table IX

Aluminum chlorohydrate HHJ

MICRO-DRY Ultrafine 131 MICRO-DRY 135

Microspherical 185

Other experiments showed that the relatively high HHJ value of the product using aluminum chlorohydrate having at least 6 microns in number was not due to particle decomposition, but it was found that these particles are hollow spheres. In these other experiments, zero shear force and 50 minutes of shear stress of the product concentrate were used in the treatment step, and the sprayed product was examined with a scanning electron microscope. No signs of degradation were observed. Although the product containing a tiny number of aluminum chlorohydrate particles smaller than 6 microns produced the largest respiration fraction, it was also shown that the proportion of the substance to be named in this product, which was aluminum chlorohydrate, was the lowest of the three products. Also, if all of the powder particles were larger than the respirable size, the use of the combinations of conditions of the invention could still usefully reduce the respiratory fraction, which in this case would consist primarily of a liquid carrier.

Examples of packages according to the invention are given in Table X below, and Tables XI and XII show typical formulations for an aerosol mixture which can be used in such a package.

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Table XII

Seos: I J K

Sodium carbonate 3.0

Hexachlorophene - 0.3 -

Microcrystalline cellulose (AVICEL RC581) - - 3.0

Isopropyl myristate - 4.0 3.0

Isopropyl palmitate 6.5 - -

Pyrogenic silica2 qs qs qs

Perfume 0.2 1.0 0.2

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4Kts. Table XI.

Table XIII provides further examples of a package according to the invention.

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Claims (4)

A package for storing and dispensing a powder, comprising in combination a container having an aerosol spray valve which dispenses a liquid as an aerosol and a mixture inside the container consisting of a powder suspended in a liquid medium consisting of a mixture of a liquid carrier and a liquefied propellant, characterized in that the area of the valve outlet of the package is at least 2 x 10 cm, the area of the steam outlet of the valve and the area of either the inlet of the valve or the opening of the valve submersible pipe, whichever is smaller, is not more than 0.05 and the sedimentation volume of the mixture is at least Uo%, and that preferably the vapor pressure inside the vessel is 0.35 * LQ 2.1 kg cm at 20 ° C. A package according to claim 1, characterized in that the area of the outlet of the valve is at least 3 x 10 cm. Packaging according to one of Claims 1 or 2, characterized in that the pressure in the container is 1.0 to 2.1 kg cm at 20 ° C. U. A package according to any one of claims 1 to 3, characterized in that the valve does not have a steam intake opening. Packaging according to one of Claims 1 to U, characterized in that the sedimentation volume of the mixture is at least 50%.