CA1068571A - Packaged eye lotion assembly - Google Patents

Abstract

ABSTRACT

A packaged assembly comprising an eye lotion in one or more single application units in sterile condition, wherein the eye lotion is contained in at least one eye bath shaped for application to an eye and filled to an appropriate level for bathing an eye, the eye bath being closed by a sealed but removable membrane. The container may be formed, and aseptically filled in a blow moulding operation. Alternatively radioactive sterilization of the complete package may be employed. The eye bath may be formed at the rim with a flange portion which is bent outwardly and downwardly, and is sealed by a membrane which extends over the flange portion and is sealed to it at or adjacent to the edge.

Description

The present invention relates to preparations for the `
treatment of eyes especially eye lotions and eye washes and in -packaging and sterilising techniques to be adopted in dispensing ~-of such preparations.
Hereinafter the term "eye lotion" will be used to denote any liquid solution used for the treatment of eyes in quantities larger than individual drops, and to include for example eye ;
washes which need have little or no therapeutic properties but which may be used for washing out dirt and foreign bodies and also preparations which may have general or specific therapeutic pro-perties e.g. treatments as currently sold under the trade mark "OPTREX" Eye lotions of various kinds are well known. They ; normally consist of dilute aqueous solutions which are rendered isotonic with lachrymal secretions and are normally buffered e.g.
by the addition of borate or phosphate buffers to a specified range of pH, generally from 5 to 8, Sodium chloride ls most com-monly added for isotonicity Suitable preparations are listed for example in the British and United States Pharmacopaea.
Eye lotions are conventionally sold in multi-dose bot-tles and can be applied by means of eye baths. Although the lo-tions are sterile when prepared and sold, they can lose their sterility when the bottles are opened and the eye baths themselves require careful cleaning and are never wholly sterile.
Eye wash preparations have been used in single dose sterile flexible containers fitted with jet nozzles designed to allow a jet of liquid to be squirted into the eye. Although these are useful for emergency applications in cases of accident, where it is necessary to~wash our foreign bodies or liquids, the treat-ment is unpleasant and generally irritant and requires to be per-formed by a skilled second party. Such units are not normallysold for home use or for self-treatment.

It is an object of the invention to overcome these dis-.
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advantages and provide an eye lotion in a form which is economic, unobjectionable from the point of view of hygiene and sterility and at the same time pleasant and soothing to use, According to the invention there is provided a packaged assembly comprising an eye bath shaped for application to an eye and filled to an appropriate level for bathing an eye with ste-rile eye lotion, the eye bath having a rim portion formed so as to provide a smooth skin contacting surface area, and being sealed to a lid at a position removed from the skin contacting surface area.
Preferably the sealed packages are sterilised after their assembly, This can conveniently be done by irradiation with gamma or beta particles from a radioactive source, Methods of radioactive sterilisation are now becoming increasingly well known and are described in the British and United States Pharmacopaea.
The sealing of the lid at a portion removed from the eye-contacting surface portion of the rim avoids any irregularities in the rim (after opening) which might lead to discomfort or abra-sion in use.
In a preferred embodiment, the eye bath has been formed and filled by a blow moulding process, This allows a good quality sterile product to be produced economically.
In another embodiment, the eye bath is formed at the rim with a flange portion which is bent outwardly and downwardly, and is sealed by a membrane which extends over the flange portion and is sealed to it at or adjacent to the edge. In this embodiment, the part of the eye bath contacting the eye and the lotion remains sterile until use and no further sterile enclosure is needed.
Embodiments of the invention are hereinafter described with reference to the accompanying drawings, in which:
Figure 1 is a perspective view of a packaged dual eye bath and eye lotion assembly in accordance with the invention.

, -2-~068S71 Figure 2 is a vertical longitudinal cross-sectional view of a dual eye bath and eye lotion assembly manufactured by a blow moulding and injection filling process;, Figure 3 is a section along the line VI-VI of Figure 2;
Figure 4 is a vertical cross-sectional view of a stack of packaged individual filled eye baths; and Figure 5 is a vertical section perpendicular to the section of Figure 4, of one of the eye baths of Figure 4;
Figures 6a and 6b show stages in the manufacture of ;-another embodiment, in side elevation;
Figure 7 shows diagrammatically in side elevation a mo-dification of the embodiment of Figures 6a and 6b; and Figure 8 shows in perspective a detail of a further modification.
The packaged assembly of Figure 1 comprises an eye bath unit 1 consisting of a single moulding formed with two baths 2,

2' having a common base or bottom 3. Naturally the baths can be formed separately if desired. Both the baths 2 and 2' are filled ; with eye lotion as indicated and sealed by membranes 4, 4' at a level below the rims 5, 5'.
Although the rims 5, 5' are shown of planar configura-tion, they may be of a concave or boat shaped configuration (i.e.
dished in one or both dimensions) more suitable for application to the skin contour around the eye. Such a configuration is shown in Figure 2.
The membranes 4, 4' are provided below or internally of the rims in order that their removal will not cause discomfort when the bath is applied to the eye, The memhranes may, if desired, be attached at the position of the rims 5, 5', But this is less desirable for the reason stated.
The eye bath unit is preferably moulded from a mouldable synthetic plastics material e.g. PVC, polystyrene, polycarbonate,

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or acrylic resin. The membrane 4 is preferably of the same mate-rial as the rest of the bath. It may be adhered in place with a suitable adhesive or line-welded e.g. by a high-fre~uency welding process. For this purpose the membranes may be formed with flanges which abut the interior surfaces of the eye baths to which they are welded. The eye bath may be filled prior to welding the mem-brane in place or afterwards through~attube as shown at 9 which is afterwards heat sealed. The material used in the eye bath should obviously be a material which does not shatter e.g. upon removal of the lid or membrane so as to deposit solid matter in the exposed lotion. The material should again be cmmpatible with the lotion and non-toxic.
The package may be prepared and sold without any outer envelope, but the rim area of the two eye baths will then not remain wholly sterile, Therefore the sealed eye bath unit is preferably surrounded by a sealed envelope 6 so that the whole of the unit inside remains sterile after terminal sterilisation until the envelope 6 is broken.
The envelope~ should be imperviaus to microbial infection and may be of flexible plastics sheeting e.g. polyethylene. The envelope is conveniently formed from a tube of such sheet sealed along the lines indicated at 7, 7'.
The membranes 4, 4' may be formed with lines of weakness and with projecting tabs or rings e.g. as shown at ~ so that they can be removed by tearing.
The eye bath assembly of Figures 2 and 3 generally re- -; sembles that of Figure 1 but is designed for manufacture by a pro-cess of blow moulding with injection filling. Although a dual bath unit is described, naturally the baths can be made separately and individually. This type of blow moulding process is now well known for the manufacture of sealed filled bottles, ampules and other containers and has the particular advantage of allowing such 1068S7~ ` -containers to be formed in a sterile condition and filled with sterile liquid under aseptic conditions. It may therefore not be necessary to further subject the package after filling to a -steri;isation procedure such as radiation although of course this can be done if necessary or desired, For details of a typical blow moulding and filling process attention is directed to British Patents 1,054,597 in the name of Shell International Research Maatschappij N,V, pub~ished January 11, 1967 and 1J059~454 in the name of Shell International Research Maatschappij N,V, published February 22, 1967 and the literature and brochures of Rommelag SA
of Switzerland, e.g, brochures for machines sold under the trade names TYP 301 and TYP 302, Reference may also be made to "Blow Moulding of Plastics"-,by E.G, Fisher and E.D, Clark (Butterworth Co,, London, 1971), especially pages 136 - 138, These publications describe a blow moulding machine in which the plastic is first extruded into a semi-molten tube which is fed between the two blow moulds with the interposition of a mandrel for moulding the ~nterior of the neck and al~lowing filling, After closure of the jaws around the mandrel compressed air is injected through the hollow mandrel to form the main part of the ves~el, The filling liquid can then be injected through the hollow mandrel or through a separate filling mandrel after sever-ing of the tube, after which separate mould halves are closed to form a knub which seals the top of the vessel, The dual eye bath unit of Figures 2 and 3 is an inte-gral moulded unit 40 formed with two baths 41, 41' having a co~-mon bottom 42, The eye bath 41' is formed identically with the bath 41 which is shown in full, This comprises a beaded rim 43 having a boat-shaped configuration as illustrated for convenient fitment around the eye and is generally oval in plan view with straight wall sections 44 and a tapered bowl section 45. The bath is sealed with a lid 46 which is connected to the interior ~ A

of the wall 44 at a line of weakness 47, the lid 46 being integral with a longitudinal reinforcing rib 48 which extends as shown along the centre line of the lid 46 to the longitudinal extremities of the lid 46 and is formed with a pair of ring structures 49 which allow convenient gripping by the thumb and forefinger in order to tear off the membrane when it is desired to use the bath.
To produce the embodiment of Figures 2 and 3 the main moulding jaws of the blow moulding machine are closed in the direc-tion of the arrows in Figure 3, the position of the filling man-drel being indicated by the bore 50 at the centre of the rib 48which is formed between the jaws. The bore 50 is sealed at the top of the knub 51 sealing jaws in a later operation. The dual eye bath unit may be formed through the use of two separate blow heads in opposition or by using an invertion step after forming and filling the upright bath. It may be convenient or desirable to extend the central portion of the mould in the vicinity of the bottom wall 42 to provide a narrow neck region allowing more con-venient sealing of the unblown tube in this vicinity. This may provide a further advantage that the two eye baths may be twisted apart into separate units so that one can be thrown away after - use and the other retained temporarily, Naturally single eye bath units could be so formed instead of dual units, the single units having the appearance of the unit 40.
The blow moulding and injection process is suitable for a variety of thermoplastics including soft and hard polyethylene, polypropylene, polystyrene, polycarbonate, polyacetate among others.
In Figure 4 there is shown a stack o-f individually in-~jection moulded or vacuum formed eye baths 60, one of which is shown in Figure 5. The eye baths are oval in plan view and have a rim surface 61 which is arcuate in longitudinal section as shown in Figure 5 and horizontal in the opposite vertical cross-section ~068571- ~ ~
as shown in Figure 4 to allow convenient sealing by a separate membrane 62 which may be formed with tabs 63 facilitating its removal, Each eye bath is formed with a bath portion 64 which extends inwardly and downwardly from the rim section 61. The exterior of the rim section terminates in a vertical surrounding wall section 64 which is open at the bottom 65, Each unsealed bath unit can therefore be formed between two closing dyes which are brought together vertically, forming a flashpoint conveniently 10 at the bottom of the wall portion 64. This allows a slight cham-fer at the exterior edge 66 of the rim section 61, so thât a sharp surface is not presented to the skin around the eye, The bottom edge 67 of the wall section 64 conforms to the shape of the rim section 61 so that the edge 67 of an upper bath firmly abuts against the membrane 62 of the underneath bath, This allows a series of sealed and filled baths shown in Figure 4 to be packaged firmly in a single package without fear of rupture of the membrane, Ic' desired a separator sheet may be inserted between each pair of baths, The membrane 62 may comprise a sheet of plastics mate-rial which is heat sealable to the rim 61 or, conveniently alumi-nium foil which may be coated with a sealable plastics material.
This form of sealing is conventional in the packaging of small , containers of foodstuffs, The coating is normally softened by heat to allow it to be sealed over the rim effectively to prevent any leakage inward or outward but at the same time allowing the membrane to be pealed off when it is desired to expose the contents, The eye baths may be filled in the conventional manner as for foodstuffs and subsequent~y the filled package sterilised 30 e,g, by radiation, If desired the upper and lower rims of each unit can be planar, This would allow the eye bath to be supported more ~,ii - . , .:.:. .
:. . . ~ . .. .. , .. . . . .. -conveniently on a shelf. On the other hand the configuration shown is preferred as being adaptable to the surface of the eye and also discourages the user from re-using the eye bath after it has lost its sterility.
The shape of the eye bath of Figures 4 and 5 and its ~ethod of manufacture are cheap and convenient and the invention is inclusive of an unfilled and unsealed eye bath as shown in Figures 4 and 5. Individually inventive features are the formation of the bath section by dishing the bottom of an inverted cup-shaped structure, which allows a smooth rim to be formed withoutflash regions or sharp edges; the conformation of the bottom edge to the upper rim to allow stacking; the boat-shaped bottom edge, preferably with curvature in one plane and not the other.
The eye baths of Figures 4 and 5 can be cheaply manu-factured from thin walled PVC, polystyrene or other suitable ther-moplastics material capable of being formed by injection moulding or vacuum forming, Figures 6a and 6b show another embodiment of packaged ,' eye lotion which has the advantage of great simplicity and main-tenance of sterility without the need for a surrounding envelope or other sealed impervious enclosure. Figure 6b shows a single completed eye bath unit which may be sold separately or with others, e.g. nested together in a column. The bath 70 is shown as a single cup-shaped bath with straight sides and preferably an , oval cross-section although other shapes may be used. The rim 71 ' is formed as a flange which is bent over and downwardly. A lid or sealing membrane 73 extends over the flange and is sealed thereto at the edge or close to the edge, The bath may be opened by cutting around the edge of the ~lange e.g. with scissors at the position of the double arrows to separate the lid.
; If desired, a line of weakness (75 Fig. 8) can be formed immediately inside the seal (e,g, as shown by the broken line .

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arrows in Fig. 6a) to allow the sealed rim of the flange to be torn off. This may be assisted by providing a tab and a radial line of weakness 76 around one side of the tab between the cir-cumferential line of weakness and the edge.
The opened eye bath then terminates with a smooth rim at the position 72 which in use contacts the skin near the eye.
This portion remains sterile until immediately before use and the point of contact of the scissors is at a position removed from the part of the bath touching the eye or the eye lotion.
Therefore no further sterile enclosure is necessary.
Figure 6a shows how the lid can conveniently be sealed by high frequency welding along a line in a plane as indicated by the arrows. The curve of the flange and lid can be made in a subsequent forming operation. If desired the lid and flange in Figure 6a can be dished or boat-shaped, preferably in a single plane in the lengthwise direction as in Figure 5. The sealing and forming can be performed immediately successively in a single operation.
Figure 7 shows a modification of Figures 6a and 6b in which the floor 74 of one bath A forms the sealing membrane or lid of another bath B of an assembly of integrated baths, A, B, C.
(A and B are shown separated for clarity).
The baths can be sealed as already described with refe-rence to Figures 6a and 6b.
In figures 6b and 7 the curved flanges amy be formed before sealing if desired. The baths may be injection moulded or preferably vacuum formed from any suitable termoplastics ma-terial such as PVC.
The baths can be filled before sealing. The filled and sealed baths are sterilised after being sealed preferably by a radioactive technique as already described.
It will be apparent that the invention allows eye baths _g_ .

~068571 to be used in a sterile form. In general eye baths are more com- -~
fortable and convenient to use than either drops or jets o~ eye wash and bathing the eye provides a more prolonged treatment which is lacking in other forms of eye treatment which are otherwise tending to be preferred since they are more readily adaptable to modern sterility requirements, .

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Claims (7)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A packaged assembly comprising an eye bath shaped for application to an eye and filled to an appropriate level for bathing an eye with sterile eye lotion, the eye bath being formed with a flanged rim portion which is curved over and downwardly, in cross sectional view so as to provide a smooth skin-contacting sur-face area, and weld-sealed at or adjacent its edge to a lid which extends over the flange portion, whereby the lid can be separated from the bath at a position remote from the skin-contacting surfa-ce area.

2. An assembly according to claim 1 wherein a line of weakness is formed between the weld-seal and the skin-contacting surface area.

3. An assembly according to claim 1 wherein the eye bath has been formed and filled by a flow-moulding process,

4. An assembly according to claim 1 wherein the eye bath has been formed in a sterile condition and aseptically fil-led with sterile lotion by a blow moulding process.

5. An assembly according to claim 1 or claim 2 wherein the lid forms the floor of another eye bath.

6. An assembly according to claim 1 wherein the interior of the eye bath and the contained eye lotion are sterilized after weld-sealing the lid.

7. An assembly according to claim 6 wherein the steri-lization is carried out by radioactive sterilization.