# US 8,783,451 B2 · Unit dose breakable vial with integrated brush applicator

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- Number: US 8,783,451 B2
- Document ID: US8783451B2
- Status: Granted
- Kind: B2
- Application number: 13/398,231
- Filed: 2012-02-16
- Published: 2012-08-30
- Granted: 2014-07-22
- Earliest claimed: 2011-02-18
- Assignees: Allergan, Inc.
- Applicants: Lorens F. Slokovic; Julie L. Gremal
- Inventors: Lorens F. Slokovic; Julie L. Gremal
- Web page: https://patentgrep.com/patent/US8783451B2

## CPC

- A61M 35/006: {using sponges, foams, absorbent pads or swabs as spreading means}
- A45D 34/04: Appliances specially adapted for applying liquid, e.g. using roller or ball
- A45D 34/042: {using a brush or the like}
- A45D 40/0087: {for samples}
- A46B 9/028: {Bristle profile, the end of the bristle defining a surface other than a single plane or deviating from a simple geometric form, e.g. cylinder, sphere or cone}
- A46D 1/0207: {Bristles characterised by the choice of material, e.g. metal}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/14: for baldness or alopecia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A45D: HAIRDRESSING OR SHAVING EQUIPMENT (wigs, toupees or the like A41G3/00, A41G5/00; hairdressers' chairs A47C1/04; hair cutting appliances, razors B26B); EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
- A46B: BRUSHES (handles not integral with brushware B25G)
- A46D: MANUFACTURE OF BRUSHES
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A disposable sterile breakable vial includes a handle section and a vial section which are completely separable in response to a manually applied separation force. The vial section includes a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. An elongated member comprises a proximal portion supported by the handle section and a distal portion provided with a sterile applicator element, such as a brush. At least the applicator element is completely enclosed within the vial section with the applicator element immersed within the therapeutic topical agent. A hermetic seal between the handle and vial sections maintains sterility of at least the vial section prior to handle and vial section separation. Complete separation of the handle section and the vial section exposes the elongated member and the applicator element for topical application of the therapeutic agent saturating the applicator element.

## Claims

### Claim 1

A disposable sterile or non-sterile apparatus containing a sterile therapeutic agent, comprising:
a breakable vial comprising a handle section and a vial section, the breakable vial completely separable into the handle section and the vial section in response to a manually applied separation force;
the vial section comprising a sterile void containing a unit dose of the sterile therapeutic topical agent, wherein the therapeutic topical agent comprises a prostaglandin analog;
a sterile applicator comprising a handle, a shaft, and a brush, the handle section supporting the handle, and at least a portion of the shaft and the brush completely enclosed within the breakable vial with the brush extending into the sterile void and immersed in the therapeutic topical agent, wherein the brush has a generally tapered shape comprising bristles of differing length that serves to trap the therapeutic topical agent using capillary action and comprises multiple bristles molded thereto; and
a hermetic seal between the vial section and the handle section that maintains sterility of the void, the therapeutic topical agent, the shaft, and the brush prior to separation of the handle section and vial section, wherein complete separation of the handle section and the vial section exposes the sterile shaft and the brush for topical application of the therapeutic agent saturating the brush.

### Claim 2 (depends on 1)

The apparatus according to claim 1, wherein the brush remains either immersed in or fully wetted with the therapeutic topical agent irrespective of an orientation of the disposable sterile apparatus.

### Claim 3 (depends on 1)

The apparatus according to claim 1, wherein the hermetic seal comprises a separation feature between the handle and vial sections.

### Claim 4 (depends on 1)

The apparatus according to claim 1, comprising a web of material between the vial and handle sections comprising a frangible separation feature.

### Claim 5 (depends on 1)

The apparatus according to claim 1, wherein the breakable vial and the applicator are formed from disparate materials.

### Claim 6 (depends on 1)

The apparatus according to claim 1, wherein the breakable vial and the applicator are formed from the same material.

### Claim 7 (depends on 1)

The apparatus according to claim 1, wherein:
the prostaglandin analog comprises a property of a tough extractable profile; and
the breakable vial and the applicator are formed from the same material.

### Claim 8 (depends on 7)

The apparatus according to claim 7, wherein the breakable vial and the applicator each are formed from low density polyethylene.

### Claim 9 (depends on 1)

The apparatus according to claim 1, comprising a plurality of the apparatuses connected together by frangible members to define a card of vials.

### Claim 10 (depends on 1)

The apparatus according to claim 1, wherein the prostaglandin analog comprises prostaglandin C-1 ethyl amides.

### Claim 11 (depends on 1)

The apparatus according to claim 1, wherein the prostaglandin analog is selected from the group consisting of bimatoprost, latanoprost, travaprost and mixtures thereof.

### Claim 12 (depends on 1)

The apparatus according to claim 1, wherein the bristles are coated with a coating designed to rapidly and evenly release prostaglandin analog to a surface of the skin or eyelid margin.

### Claim 13

A disposable sterile apparatus containing a therapeutic topical agent, comprising:
a breakable vial comprising a handle section and a vial section, the breakable vial completely separable into the handle section and the vial section in response to a manually applied separation force;
the vial section comprising a sterile void containing a unit dose of the sterile therapeutic topical agent, wherein the therapeutic topical agent comprises a prostaglandin analog;
an elongated member comprising a proximal portion supported by the handle section and a distal portion provided with a sterile applicator element, at least the applicator element completely enclosed within the vial section with the applicator element immersed within the therapeutic topical agent, wherein the applicator element comprises a brush with a generally tapered shape comprising bristles of differing length that serves to trap the therapeutic topical agent using capillary action and with multiple bristles molded thereto; and
a hermetic seal between the handle section and vial section, the hermetic seal maintaining sterility of at least the vial section prior to handle section and vial section separation, wherein complete separation of the handle section and the vial section exposes the elongated member and the applicator element for topical application of the therapeutic agent saturating the applicator element.

### Claim 14 (depends on 13)

The apparatus according to claim 13, wherein the prostaglandin analog comprises prostaglandin C-1 ethyl amides.

### Claim 15 (depends on 13)

The apparatus according to claim 13, wherein the prostaglandin analog comprises bimatoprost, latanoprost, or travoprost.