GB2329939A - Self-lubricating valve stem for aerosol containers - Google Patents
Self-lubricating valve stem for aerosol containers Download PDFInfo
- Publication number
- GB2329939A GB2329939A GB9713382A GB9713382A GB2329939A GB 2329939 A GB2329939 A GB 2329939A GB 9713382 A GB9713382 A GB 9713382A GB 9713382 A GB9713382 A GB 9713382A GB 2329939 A GB2329939 A GB 2329939A
- Authority
- GB
- United Kingdom
- Prior art keywords
- valve
- valve stem
- stem
- metering chamber
- dispensed
- 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- Withdrawn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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
- B65D83/44—Valves specially adapted therefor; Regulating devices
- B65D83/52—Valves specially adapted therefor; Regulating devices for metering
- B65D83/54—Metering valves ; Metering valve assemblies
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S277/00—Seal for a joint or juncture
- Y10S277/935—Seal made of a particular material
- Y10S277/944—Elastomer or plastic
- Y10S277/945—Containing fluorine
Abstract
An aerosol container, for dispensing metered doses of an aerosol formulation such as medicament, comprises a valve body 1 having a valve stem 7 through which the formulation is dispensed. The valve stem 7 is sealed by a valve seals 9,12. The material of the valve stem 7 comprises a lubricant, such as fluorocarbon polymer polytetrafluoroethane (PTFE) which, due to its low coefficient of friction, acts as a lubricant against the valve seals 9,12. This ensures a smooth operation of the valve, and reduces the deposition of formulation on the valve stem 7 which can cause valve sticking.
Description
2329939 1 VALVE FOR AEROSOL CONTAINER This invention relates to a valve
for an aerosol container with the aid of which a quantity of the contents thereof can be dispensed. The invention has particular application to the dispensing of metered doses of medicaments, though it is applicable to the dispensing of aerosols generally.
The continuing use of aerosol formulations comprising conventional chlorofluorocarbon propellants is being debated due to the suspected role of such propellants in atmospheric depletion of ozone. Accordingly, formulations based on alternative propellants such as HFA-134a (1,1,1,2tetrafluoroethane) and HFA-227 (1,1,1,2,3,3,3-heptafluoropropane) are being developed to replace those conventional propellants thought to contribute to atmospheric ozone depletion.
Containers for aerosol formulations commonly comprise a via] body coupled to a valve. The valve comprises a valve stem through which the formulations is dispensed. Generally the valve includes a rubber valve seal intended to allow reciprocal movement of the valve stem while preventing leakage of propellant from the container.
It has been found that some conventional devices for delivering aerosols suffer impaired performance when used in connection with HFA-1 34a or HFA-227.
Selection of suitable materials for use in valves to contain aerosol formulations based on these alternative propellants is complicated by interactions between the valve component materials and the formulation components, including the propellant. In conventional devices, particularly with some drug formulations the valve stem tends to stick, pause, or drag during the actuation cycle with the result that the user perceives a 'notchiness'as the valve stem is depressed and released. This may be partly caused by the drug to be dispensed from the container sedimenting or precipitating out of the drug-propellant suspension or solution formulation and depositing on the internal valve components, the presence of drug on the sliding interface creating increased friction during operation.
2 International Patent Application No. PCT/US94106900 describes an aerosol valve wherein the rubber valve seal is made of a composition specially selected to minimise leakage of the propellant through the interface between the valve seal and valve stem upon firing. Smoothness of operation is also improved with some formulations compared to devices involving conventional thermoset rubber seals. However, although such seal compositions may improve valve performance, they do not prevent build up of deposit on the valve components, and the problem of notchiness may persist.
It is an object to provide a valve with improved smoothness of operation which alleviates the problem of valve sticking.
According to the present invention there is provided a valve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein, the valve comprising a valve body defining an aperture, a seal mounted at the aperture, and a valve stem having a dispensing passage, the valve stem being slideably moveable through the seal such that in a first position the valve is closed to prevent the substance to be dispensed from entering the dispensing passage, and in a second position the valve is open to allow the substance to be dispensed through the dispensing passage, characterised in that the valve stem is made from a material comprising lubricant.
Incorporating lubricant into the material of the valve stem ensures that the lubricant is comprised within the maximum area of the stemlseal contact surface, so providing improved lubrication and smoothness of operation for the life of the valve. The term'lubricant' means any material which reduces friction between the valve stem and seal.
Preferably, the lubricant comprises a fuorocarbon polymer. Suitably the lubricant comprises polytetrafluoroethane (PTFIE).
PTFE has been found to be particularly advantageous as a lubricant due to its low coefficient of friction. Furthermore, PTFE significantly reduces the problem 3 of drug deposition on the valve stem, so removing one of the causes of valve sticking.
Suitably, the valve stem comprises up to 10% PTFE. Preferably, the valve stem comprises 5 to 10% PTFE.
PTFE can be plastic moulded and may be used effectively in small quantities constituting of the order of 5% by weight of the material of the valve stem. PTFE is also non-toxic, an important consideration for aerosol devices for dispensing medicaments.
Suitably, the valve is a metering valve comprising a metering chamber, a transfer passage through which a quantity of substance to be dispensed can pass from the container into the metering chamber, wherein in the first position the dispensing passage is isolated from the metering chamber and the metering chamber is in communication with the container via the transfer passage, and in the second position the dispensing passage is in communication with the metering chamber and the transfer passage is isolated from the metering chamber.
Suitably the substance to be dispensed is a medicament suspended in liquefied HFA-1 34a or HFA-227.
Medicaments suitable for this purpose are, for example for the treatment of respiratory disorders such as asthma, bronchitis, chronic obstructive pulmonary diseases and chest infections. Additional medicaments may be selected from any other suitable drug useful in inhalation therapy and which may be presented as a suspension. Appropriate medicaments may thus be selected from, for example, analgesics, e.g. codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g. diltiazem; antiallergics, e.g. cromoglycate, ketotifen or neodocromil; antfinfectives e.g. cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; antihistamines, e.g. methapyrilene anti-inflammatories, e.g. fluticasone propionate, beclomethasone dipropionate, flunisolide, budesonide or triamcinolone acetonide; antitussives, e.g. noscapine; bronchodilators, e.g. salmeterol, 4 salbutamol, ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, isoetharine, tulobuterol orciprenaline, or(-)-4-amino-3,5d ich loro-(x-[[[6-[2-(2-pyrid inyl)ethoxy]-hexyi]a m inol methyl] benzenemethanol; diuretics, e.g. amiloride; anticholinergics e.g. ipratropium, atropine or oxitropium; hormones, e,g, cortisone, hydrocortisone or prednisolone; xanthines e.g. aminophylline, choline theophyllinate, lysine theophyllinate or theophylline and therapeutic proteins and peptides, e.g. insulin or glucagon. It will be clear to a person skilled in the art that, where appropriate, the medicaments may be used in the form of salts (e.g. as alkali metal or amine salts or as acid addition salts) or as esters (e.g. lower alkyl esters) or as solvates (e.g. hydrates) to optimise the activity andlor stability of the medicament. Preferred medicaments are salbutamol, salbutamol sulphate, salmeterol, salmeterol xinafoate, fluticasone propionate, beclomethasone dipropionate and terbutaline sulphate. It is to be understood that the suspension or solution of medicament may consist purely of one or more active ingredients.
Preferably the medicament is salmeterol xinafoate.
The invention will now be described further with reference to the accompanying drawing in which Figure 1 is a section through a metering valve according to the invention.
A valve according to the invention is shown in Figure 1 and comprises a valve body 1 sealed in a ferrule 2 by means of crimping, the ferrule itself being set on the neck of a container (not shown) with interposition of a gasket 3 in a well known manner. The container is filled with a suspension of salmeterof xinafoate a in liquid propellant HFA134a.
The valve body 1 is formed at its lower part with a metering chamber 4, and its upper part with a sampling chamber 5 which also acts as a housing for a return spring 6. The words "upper" and "lower" are used for the container when it is in a use orientation with the neck of the container and valve at the lower end of the container which corresponds to the orientation of the valve as shown in Figure 1. Inside the valve body 1 is disposed a valve stem 7, a part 8 of which extends outside the valve through lower stem seal 9 and ferrule 2. The stem part 8 is formed with an inner axial or longitudinal canal 10 opening at the outer end of the stem and in communication with a radial passage 11.
The upper portion of stem 7 has a diameter such that it can pass slidably through an opening in an upper stem seal 12 and will engage the periphery of that opening sufficiently to provide a seal. The stem is made from HOSTAFORM X329 TM (Hoechst), which is moulded in a conventional manner.
Significantly, HOSTAFORM comprises 5% PTFE, which has the effect of reducing the friction between the valve stem and stem seals 9 and 12 during actuation, as explained below. PTFE also has the effect of reducing any build up of drug deposition on the surface of the valve stem, the presence of which on the sliding interface between the valve stem and seal could otherwise cause increased friction during actuation. Upper stem seal 12 is held in position against a step 13 formed in the valve body 1 between the said lower and upper parts by a sleeve 14 which defines the metering chamber 4 between lower stem seal 9 and upper stem seal 12. The valve stem 7 has a passage 15 which, when the stem is in the inoperative position shown, provides a communication between the metering chamber 4 and sampling chamber 5, which itself communicates with the interior of the container via orifice 16 formed in the side of the valve body 1.
Valve stem 7 is biased downwardly to the inoperative position by return spring 6 and is provided with a shoulder 17 which abuts against lower stem seal 9. In the inoperative position as shown in Figure 1 shoulder 17 abuts against lower stem seal 9 and radial passage 11 opens below lower stem seal 9 so that the metering chamber 4 is isolated from canal 10 and suspension inside cannot escape.
A ring 18 having a "U" shaped cross section extending in a radial direction is disposed around the valve body below orifice 16 so as to form a trough 19 around the valve body. As seen in Figure 1 the ring is formed as a separate component having an inner annular contacting rim of a diameter suitable to provide a friction fit over the upper part of valve body 1, the ring seating against 6 step 13 below the orifice 16. However, the ring 18 may alternatively be formed as an integrally moulded part of valve body 1.
To use the device the container is first shaken to homogenise the suspension within the container The user then depresses the valve stem 7 against the force of the spring 6. When the valve stem is depressed both ends of the passage 15 come to fie on the side of upper stem seal 12 remote from the metering chamber 4. Thus a dose is metered within the metering chamber. Continued depression of the valve stem will move the radial passage 11 into the metering chamber 4 while the upper stem seal 12 seals against the valve stem body. Thus, the metered dose can exit through the radial passage 11 and the outlet canal 10.
Releasing the valve stem causes it to return to the illustrated position under the force of the spring 6. The passage 15 then once again provides communication between the metering chamber 4 and sampling chamber 5. Accordingly, at this stage liquid passes under pressure from the container through orifice 16, through the passage 15 and thence into the metering chamber 4 to fill it.
It will be understood that the present disclosure is for the purpose of illustration only and the invention extends to modifications, variations and improvements thereto.
The application of which this description and claims form part may be used as a basis for priority in respect of any subsequent application. The claims of such subsequent application may be directed to any feature or combination of features described herein. They may take the form of product, method or use claims and may include, by way of example and without limitation, one or more of the following claims:
7
Claims (6)
1. Valve for an aerosol container for dispensing a suspension or solution of a substance in a liquid propellant contained therein, the valve comprising a valve body defining an aperture, a seal mounted at the aperture, and a valve stem having a dispensing passage, the valve stem being slideably moveable through the seal such that in a first position the valve is closed to prevent the substance to be dispensed from entering the dispensing passage, and in a second position the valve is open to allow the substance to be dispensed through the dispensing passage, characterised in that the valve stem is made from a material comprising lubricant.
2. Valve according to claim 1, wherein the lubricant comprises a fluorocarbon copolymer.
3. Valve according to claim 2, wherein the lubricant comprises PTFE.
4. Valve according to any of claims 1 to 3, wherein the valve is a metering valve comprising a metering chamber, a transfer passage through which a quantity of substance to be dispensed can pass from the container into the metering chamber, wherein in the first position the dispensing passage is isolated from the metering chamber and the metering chamber is in communication with the container via the transfer passage, and in the second position the dispensing passage is in communication with the metering chamber and the transfer passage is isolated from the metering chamber.
5. Valve according to claim 4, wherein, the substance to be dispensed is a medicament suspended in liquefied HFA134a.
6. Valve according to claim 5, wherein the medicament is salmeterol xinafoate.
Priority Applications (23)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9713382A GB2329939A (en) | 1997-06-26 | 1997-06-26 | Self-lubricating valve stem for aerosol containers |
EA199901077A EA002036B1 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
JP50527999A JP2001506211A (en) | 1997-06-26 | 1998-06-25 | Valves for aerosol containers |
HU0004081A HUP0004081A3 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
NZ501661A NZ501661A (en) | 1997-06-26 | 1998-06-25 | PTFE lubricated valve for aerosol container |
BR9810470-5A BR9810470A (en) | 1997-06-26 | 1998-06-25 | Valve for an aerosol type container and an aerosol type container. |
YU69499A YU69499A (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
EP98933641A EP0991578B1 (en) | 1997-06-26 | 1998-06-25 | Aerosol container for medicament |
CA002294391A CA2294391A1 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
AU83391/98A AU741641B2 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
DE69818048T DE69818048T2 (en) | 1997-06-26 | 1998-06-25 | AEROSOL CONTAINER FOR MEDICINAL PRODUCTS |
KR1019997012246A KR20010014173A (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
AT98933641T ATE249378T1 (en) | 1997-06-26 | 1998-06-25 | AEROSOL CONTAINERS FOR MEDICINAL PRODUCTS |
TR1999/03220T TR199903220T2 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container. |
IL13336198A IL133361A0 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
PL98337527A PL337527A1 (en) | 1997-06-26 | 1998-06-25 | Aerosol container valve |
US09/446,165 US6318603B1 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
PCT/EP1998/003872 WO1999000315A1 (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
CN98806111A CN1259919A (en) | 1997-06-26 | 1998-06-25 | Valve for aerosol container |
IDW991693A ID24058A (en) | 1997-06-26 | 1998-06-25 | VALVE FOR AEROSOL CONTAINERS |
IS5298A IS5298A (en) | 1997-06-26 | 1999-12-14 | Pressure spray tank cap |
NO996463A NO996463L (en) | 1997-06-26 | 1999-12-23 | Aerosol tank valve |
US09/990,668 US6474513B2 (en) | 1997-06-26 | 2001-11-16 | Valve for aerosol container |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9713382A GB2329939A (en) | 1997-06-26 | 1997-06-26 | Self-lubricating valve stem for aerosol containers |
Publications (2)
Publication Number | Publication Date |
---|---|
GB9713382D0 GB9713382D0 (en) | 1997-08-27 |
GB2329939A true GB2329939A (en) | 1999-04-07 |
Family
ID=10814889
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
GB9713382A Withdrawn GB2329939A (en) | 1997-06-26 | 1997-06-26 | Self-lubricating valve stem for aerosol containers |
Country Status (22)
Country | Link |
---|---|
US (2) | US6318603B1 (en) |
EP (1) | EP0991578B1 (en) |
JP (1) | JP2001506211A (en) |
KR (1) | KR20010014173A (en) |
CN (1) | CN1259919A (en) |
AT (1) | ATE249378T1 (en) |
AU (1) | AU741641B2 (en) |
BR (1) | BR9810470A (en) |
CA (1) | CA2294391A1 (en) |
DE (1) | DE69818048T2 (en) |
EA (1) | EA002036B1 (en) |
GB (1) | GB2329939A (en) |
HU (1) | HUP0004081A3 (en) |
ID (1) | ID24058A (en) |
IL (1) | IL133361A0 (en) |
IS (1) | IS5298A (en) |
NO (1) | NO996463L (en) |
NZ (1) | NZ501661A (en) |
PL (1) | PL337527A1 (en) |
TR (1) | TR199903220T2 (en) |
WO (1) | WO1999000315A1 (en) |
YU (1) | YU69499A (en) |
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FR3049275B1 (en) * | 2016-03-23 | 2019-07-19 | Aptar France Sas | DOSING VALVE AND DEVICE FOR DISPENSING FLUID PRODUCT COMPRISING SUCH A VALVE |
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GB201702406D0 (en) | 2017-02-14 | 2017-03-29 | Norton (Waterford) Ltd | Inhalers and related methods |
GB201702408D0 (en) | 2017-02-14 | 2017-03-29 | Norton (Waterford) Ltd | Inhalers and related methods |
FR3065891B1 (en) * | 2017-05-05 | 2021-12-24 | Aptar France Sas | METERING VALVE AND FLUID PRODUCT DISTRIBUTION DEVICE COMPRISING SUCH A VALVE. |
BE1025177B1 (en) * | 2017-09-21 | 2018-11-29 | Altachem Nv | VALVE FOR A HOLDER |
WO2019160163A1 (en) * | 2018-02-19 | 2019-08-22 | アース製薬株式会社 | Aerosol metering injection valve |
FR3085734B1 (en) * | 2018-09-11 | 2021-01-01 | Aptar France Sas | VALVE SEAL AND DOSING VALVE FOR FLUID PRODUCT DISPENSER. |
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1998
- 1998-06-25 IL IL13336198A patent/IL133361A0/en unknown
- 1998-06-25 NZ NZ501661A patent/NZ501661A/en unknown
- 1998-06-25 US US09/446,165 patent/US6318603B1/en not_active Expired - Lifetime
- 1998-06-25 HU HU0004081A patent/HUP0004081A3/en unknown
- 1998-06-25 AU AU83391/98A patent/AU741641B2/en not_active Ceased
- 1998-06-25 KR KR1019997012246A patent/KR20010014173A/en not_active Application Discontinuation
- 1998-06-25 ID IDW991693A patent/ID24058A/en unknown
- 1998-06-25 YU YU69499A patent/YU69499A/en unknown
- 1998-06-25 EA EA199901077A patent/EA002036B1/en not_active IP Right Cessation
- 1998-06-25 CA CA002294391A patent/CA2294391A1/en not_active Abandoned
- 1998-06-25 CN CN98806111A patent/CN1259919A/en active Pending
- 1998-06-25 PL PL98337527A patent/PL337527A1/en not_active Application Discontinuation
- 1998-06-25 BR BR9810470-5A patent/BR9810470A/en not_active Application Discontinuation
- 1998-06-25 DE DE69818048T patent/DE69818048T2/en not_active Expired - Lifetime
- 1998-06-25 EP EP98933641A patent/EP0991578B1/en not_active Expired - Lifetime
- 1998-06-25 JP JP50527999A patent/JP2001506211A/en active Pending
- 1998-06-25 AT AT98933641T patent/ATE249378T1/en not_active IP Right Cessation
- 1998-06-25 WO PCT/EP1998/003872 patent/WO1999000315A1/en not_active Application Discontinuation
- 1998-06-25 TR TR1999/03220T patent/TR199903220T2/en unknown
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1999
- 1999-12-14 IS IS5298A patent/IS5298A/en unknown
- 1999-12-23 NO NO996463A patent/NO996463L/en not_active Application Discontinuation
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2001
- 2001-11-16 US US09/990,668 patent/US6474513B2/en not_active Expired - Lifetime
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WO1997016360A1 (en) * | 1995-10-31 | 1997-05-09 | Valois S.A. | Low-friction valve stem |
Also Published As
Publication number | Publication date |
---|---|
IL133361A0 (en) | 2001-04-30 |
US6474513B2 (en) | 2002-11-05 |
HUP0004081A2 (en) | 2001-03-28 |
JP2001506211A (en) | 2001-05-15 |
DE69818048T2 (en) | 2004-07-15 |
GB9713382D0 (en) | 1997-08-27 |
TR199903220T2 (en) | 2000-07-21 |
WO1999000315A1 (en) | 1999-01-07 |
NZ501661A (en) | 2001-08-31 |
BR9810470A (en) | 2000-09-19 |
EP0991578B1 (en) | 2003-09-10 |
CA2294391A1 (en) | 1999-01-07 |
US6318603B1 (en) | 2001-11-20 |
NO996463L (en) | 2000-02-10 |
IS5298A (en) | 1999-12-14 |
HUP0004081A3 (en) | 2001-10-29 |
AU741641B2 (en) | 2001-12-06 |
KR20010014173A (en) | 2001-02-26 |
PL337527A1 (en) | 2000-08-28 |
EA199901077A1 (en) | 2000-06-26 |
AU8339198A (en) | 1999-01-19 |
EP0991578A1 (en) | 2000-04-12 |
US20020030068A1 (en) | 2002-03-14 |
ATE249378T1 (en) | 2003-09-15 |
NO996463D0 (en) | 1999-12-23 |
EA002036B1 (en) | 2001-12-24 |
YU69499A (en) | 2001-09-28 |
DE69818048D1 (en) | 2003-10-16 |
CN1259919A (en) | 2000-07-12 |
ID24058A (en) | 2000-07-06 |
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Legal Events
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WAP | Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1) |