Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`PTO/AIA/424 (03-13)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`First Named
`Inventor:
`Title of
`Invention:
`
`Kevin S. Warner
`
`I ~~~!~~~isional Application Number (if
`
`1191 O?US (AP)
`
`TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1 ), the prioritized examination fee set forth in
`37 CFR 1.17(c), and if not already paid, the publication fee set forth in 37 CFR 1.18(d) have
`been filed with the request. The basic filing fee, search fee, examination fee, and any required
`excess claims and application size fees are filed with the request or have been already been
`paid.
`
`2. The application contains or is amended to contain no more than four independent claims and no
`more than thirty total claims, and no multiple dependent claims.
`
`3. The applicable box is checked below:
`
`I.
`
`[?] Original Application (Track One)- Prioritized Examination under§ 1.102(e)(1)
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the utility application via EFS-Web.
`---OR---
`( b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the plant application in paper.
`
`ii. The executed inventor's oath or declaration is filed with the application. (37 CFR 1.63 and 1.64)
`0 Request for Continued Examination- Prioritized Examination under§ 1.102(e)(2)
`
`II.
`
`i. A request for continued examination has been filed with, or prior to, this form.
`ii.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.1 02( e )(2).
`
`siqnature/Krishna Banerjee/
`
`~p~~~Typed) Krishna Banerjee
`
`Date Nov. 18, 2013
`43 317
`'
`
`Practitioner
`Registration Number
`
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiple forms if more than one signature is required.*
`
`[] *Total of 1
`
`forms are submitted.
`
`1
`
`AMN1017
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`19107US (AP)
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`TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND
`
`METHODS FOR USE THEREOF
`
`By
`
`Kevin S. Warner, Ajay P. Parashar, Vijaya Swaminathan, and Varsha Bhatt
`
`CROSS REFERENCE TO RELATED APPLICATIONS
`
`[001] This application claims the benefit of U.S. Provisional Application Ser. No.
`
`611728,403 filed on November 20, 2012 and U.S. Provisional Application Ser. No.
`
`611770,768 filed on February 28, 2013, both of which are incorporated by reference herein in
`
`their entirety.
`
`FIELD
`
`[002] The present embodiments relate generally to compositions useful for treating a
`
`variety of dermatological conditions. In particular, some embodiments relate to dapsone and
`
`dapsone/adapalene compositions and methods for use thereof.
`
`BACKGROUND
`
`[003] Acne is a group of common skin conditions characterized by the so-called
`
`"acneiform" or acne-like skin eruptions, which can be contaminated with bacteria, such as
`
`Propionibacterium acnes, and can also be marked by inflammation. Acne tends to occur in
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`the areas of skin where the sebaceous glands are most active, such as the face. Acne is
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`associated with psychological trauma, and, if left untreated, can lead to scar formation and
`
`disfigurement.
`
`[004] Classification and the diagnosis of various acne conditions can be complex,
`
`and even contradictory. Given this complexity and unpredictability, medication and other
`
`therapies, are often developed on a trial-and-error basis in order to determine the most
`
`effective course of treatment for a particular patient. The outcome of any particular acne
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`treatment regimen greatly varies from patient to patient, as well as throughout treatment of a
`
`particular patient. In addition to the complexity and variability of acne conditions, treatment
`
`efficacy can be greatly affected by a patient's compliance with the treatment regimen.
`
`Patient compliance during acne treatment may be influenced by side effects, which, for
`
`topical medications, commonly include redness, itching, and skin peeling. The complexity of
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`the drug regimen can also negatively affect patient compliance, particularly where two or
`
`more different topical medications are prescribed simultaneously. Another factor that
`
`negatively affects patient compliance is the cost of a drug regiment, which is considerably
`
`higher when multiple medications are prescribed. In some countries, acne is considered a
`
`cosmetic problem, and acne treatments are not covered by insurance plans, thus further
`
`increasing patient's treatment costs. Certain compositions for treatment of acne are available.
`
`Many of the available compositions include one active agent known to have anti-acne
`
`activity. Stability of compositions with multiple anti-acne agents can be problematic. Also,
`
`these compositions can be difficult to manufacture.
`
`[005] The problems described above are not confined to the treatment or acne, but
`
`are also applicable to a variety of other skin conditions, including, but not limited, to
`
`conditions or classes of conditions with complex or unknown etiology and that are difficult to
`
`classify or diagnose, in which, nevertheless, topical application of agents are known to be
`
`effective at least in some cases. Examples of such conditions or classes of conditions include
`
`psoriasis, rosacea and ichthyosis.
`
`[006] Accordingly, there is a continuing need for compositions and methods used in
`
`a treatment of a variety of skin conditions, such as acne, in which topical application is
`
`potentially effective. The compositions and methods provided herein address these and other
`
`needs in the art.
`
`SUMMARY
`
`[007] Dapsone, ( 4,4'-diaminodiphenyl sulfone) is a medicament possessing several
`
`beneficial medicinal activities. Dapsone is typically administered as one of the medicinal
`
`agents used in the treatment of leprosy. Dapsone and its derivatives are also effective for
`
`treatment of bacterial infections, protozoal infections such as malaria, pneumocystis carinii,
`
`and plasmonic infections such as toxoplasmosis.
`
`[008] Dapsone is also useful as an anti-inflammatory agent. It has been used to treat
`
`skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis
`
`herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne
`
`vulgaris, and Sweet's Syndrome.
`
`[009] Use of topical compositions of dapsone can be problematic. Topical
`
`compositions may act as drying agents for the skin. They remove essential oils and natural
`
`skin softeners from the skin thus causing it to be dry, itch and crack. Inclusion of exogeneous
`
`skin emollients, oils and the like, however, causes phase separation and precipitation of
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`19107US (AP)
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`dapsone. Use of typical emulsifiers does not solve the dapsone precipitation owing to the
`
`lowered dapsone solubility and conflicting physical characteristics of the phases of the
`
`resulting composition. In particular, topical compositions including dapsone and methods are
`
`needed that would, for example, exhibit improved effectiveness, reduced side effects, or both,
`
`when used in a particular patient with a skin condition. Such improved topical compositions
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`including dapsone and methods of their uses are also needed to improve treatment of patients
`
`with acne or suspected acne. The present dapsone and dapsone/adapalene compositions can
`
`be useful for treating a variety of dermatological conditions. Some useful compositions
`
`include dapsone and/or adapalene in a polymeric viscosity builder. Some compositions can
`
`be adjusted to optimize the dermal delivery profile of dapsone to effectively treat
`
`dermatological conditions and improve the efficiency of pharmaceutical products applied to
`
`the skin. Diethylene glycol monoethyl ether is a solubilizer for dapsone, thereby allowing
`
`compositions to be prepared with increased solubilized concentrations of dapsone. As a
`
`result, the compositions described herein are effective in treating dermatological conditions in
`
`a subject in need thereof.
`
`[010] Moreover, it has been found that use of a polymeric viscosity builder
`
`minimizes the intensity of yellowing of the composition caused by the increased solubility of
`
`dapsone in diethylene glycol monoethyl ether. In addition, the polymeric viscosity builder
`
`influences dapsone crystallization. This, in turn, results in compositions with improved
`
`aesthetics (i.e., reduction in particle size which minimizes "gritty" feeling upon application).
`
`[011]
`
`In one embodiment, there are provided compositions including dapsone, a first
`
`solubilizing agent which is diethylene glycol monoethyl ether, optionally at least one second
`
`solubilizing agent, a polymeric viscosity builder, and water, wherein the dapsone is present at
`
`a concentration of about 5% w/w to about 10% w/w.
`
`[012]
`
`In one embodiment, there are provided compositions including dapsone, a first
`
`solubilizing agent which is diethylene glycol monoethyl ether, optionally at least one second
`
`solubilizing agent, a polymeric viscosity builder, and water, wherein the dapsone is present at
`
`a concentration of about 3% w/w to 8% w/w.
`
`[013]
`
`In another embodiment,
`
`there are provided methods
`
`for
`
`treating a
`
`dermatological condition. Such methods can be performed, for example, by administering to
`
`a subject in need thereof a therapeutically effective amount of a pharmaceutical composition
`
`described herein.
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`19107US (AP)
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`BRIEF DESCRIPTION OF THE FIGURES
`
`[014] Figure 1 presents the impact of an acrylamide/sodium acryloyldimethyltaurate
`
`copolymer emulsion viscosity builder on color change.
`
`[015] Figure 2 presents the impact of an acrylamide/sodium acryloyldimethyltaurate
`
`copolymer emulsion viscosity builder on dapsone crystal growth.
`
`[016] Figure 3 presents the impact of anti-oxidants and chelating agents on color
`
`change.
`
`DETAILED DESCRIPTION
`
`[017]
`
`It is to be understood that both the foregoing general description and the
`
`following detailed description are exemplary and explanatory only and do not restrict the
`
`claims. As used herein, the use of the singular includes the plural unless specifically stated
`
`otherwise. As used herein, "or" means "and/or" unless stated otherwise. Furthermore, use of
`
`the term "including" as well as other forms, such as "includes," and "included," is not
`
`limiting. The section headings used herein are for organizational purposes only and are not to
`
`be construed as limiting the subject matter described.
`
`[018] Some embodiments include compositions and products for treatment of skin
`
`conditions and methods of treating skin conditions. The term "skin condition" as used herein
`
`encompasses human and animal conditions, disorders, or diseases affecting skin. Such skin
`
`conditions include, but are not limited to, conditions involving skin inflammation, conditions
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`involving sebaceous glands and hair follicles, conditions characterized by acneiform
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`symptoms, and conditions involving skin dryness, skin thickening, skin scaling or skin
`
`flaking. Skin conditions that can be treated using some compositions, products and methods
`
`described herein include, but are not limited to, acne, rosacea, folliculitis, perioral dermatitis,
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`photodamage, skin aging, psoriasis, ichtiosis, atopic dermatitis, treatment of chronic wounds,
`
`bed sores, keratosis piralis, scars, including surgical and acne scars, sebaceous cysts,
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`inflammatory dermatoses, post inflammatory hyperpigmentation, eczema, xerosis, pruritis,
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`lichen planus, nodular prurigo, eczema, and miliaria.
`
`[019] The term "acne," as used herein, encompasses skin conditions involving
`
`acneiform or acne-like symptoms. For example, a skin condition characterized by follicular
`
`eruptions, such as papules and pustules resembling acne, can be categorized as acne. It is to
`
`be understood that the term "acne" is not to be limited to diseases and conditions
`
`characterized by papules and pustules, but can be characterized by a variety of symptoms. It
`
`is also to be understood that a particular patient having acne can be in remission, or the
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`patient's acne can be controlled by continuing treatments, and therefore the patient can
`
`exhibit reduced symptoms or be asymptomatic. Nevertheless, continuing treatment of acne
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`can be recommended in such a patient in order to reduce the probability of the return of the
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`acne symptoms.
`
`[020] Symptoms of acne or acne-like conditions include, but are not limited to, the
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`appearance of various skin lesions. The term "lesion" is generally used to denote an infected
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`or diseased patch of skin. A lesion can involve an infected sebaceous gland. Some lesions
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`are more severe than others. Examples of skin lesions are comedones, macules, papules,
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`pustules, nodules and cysts. The term "comedo" (plural "comedones") is used to describe a
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`sebaceous follicle plugged with dirt, other cells, tiny hairs, or bacteria. Comedones include
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`the so-called "blackheads," which can also refer to as "open comedones," which have a spot
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`or a surface that appears black. Comedones also include slightly inflamed, skin colored
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`bumps, as well as "whiteheads," which have a spot or a surface that appears white. The term
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`"macule" generally refers to a flat spot or area of the skin with a changed color, such as a red
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`spot. The term "pustule" is generally used to refer to an inflamed, pus-filled lesion, or a
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`small inflamed elevation of the skin that is filled with pus. The term "papule" is generally
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`used to refer to a small, solid, usually inflammatory elevation of the skin that does not contain
`
`pus. The term "nodule" is generally used to refer to an elevation of a skin that is similar to a
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`papule but is white and dome-shaped. Colloquially, a papule, a pustule or a nodule can be
`
`referred to as "a pimple" or "a zit." The term "cyst" generally refers to an abnormal
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`membranous sac containing a liquid or semi-liquid substance containing white blood cells,
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`dead cells, and bacteria. Cysts can be painful and extend to deeper layers of skin.
`
`[021]
`
`In dermatological science and dermatological and cosmetology practice, acne
`
`can be classified or categorized into one or more types or categories, according to one or
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`more lines of categorization, such as a predominantly observed type of symptoms, severity of
`
`condition or predominant localization. It is to be understood that classification of acne into
`
`one of the subtypes does not mean that the characteristics of the classified condition are
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`limited to the symptoms associated with the specific type.
`
`[022] Comedonal acne is characterized by the appearance of non-inflammatory
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`lesions, such as blackheads and whiteheads. Localized cystic acne is characterized by
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`appearance of a few cysts on face, chest and back. Diffuse cystic acne is characterized by
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`the appearance of cysts on wide areas of face, chest and back. Nodular acne is characterized
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`by the appearance of nodules. Nodulocystic acne is characterized by appearance of nodules
`
`and cysts. Acne vulgaris is a common form of acne characterized by the appearance of
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`several types of lesions, which may appear together or separately. Individual acne lesions
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`usually last less than two weeks but the deeper papules and nodules may persist for months.
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`Acne vulgaris commonly affects adolescents, but it may also appear, persist or become more
`
`severe in adulthood. Acne vulgaris may occur on the face, chest, back and sometimes even
`
`more extensively.
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`[023] Depending on severity, acne can be mild, moderate or severe. Mild acne is
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`generally categorized by the appearance of with blackheads and whiteheads, but can also
`
`include papules and pustules. Moderate acne is generally characterized by appearance of
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`more painful, deep-rooted, inflamed lesions, which can result in scarring. Severe acne is
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`characterized by the appearance of deep-rooted inflammatory lesions, including cysts and
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`nodules which can be painful and can produce scarring. Acne conglobata is a category of
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`acne characterized by highly inflammatory cysts that communicate under the skin with
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`abscesses and burrowing sinus tracts.
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`[024] Some other skin conditions exhibiting acne-like symptoms which can be
`
`treated by the compositions and methods described herein are discussed below. Pyoderma
`
`faciale, also known as rosacea fulminans, is a condition that appears in females and is
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`characterized by abrupt appearance of inflamed cysts and nodules localized on the face.
`
`Rosacea, which can be referred to as acne rosacea, is a condition that can affects both the skin
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`and the eyes and is characterized by redness, bumps, pimples, and, in advanced stages,
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`thickened skin on the nose. In some classification systems, rosacea and acne are considered
`
`as separate conditions. Rosacea usually occurs on the face, although the neck and upper
`
`chest are also sometimes involved. A mild degree of eye (ocular) involvement occurs in more
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`than fifty percent of people with rosacea. Perioral dermatitis is characterized by the
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`appearance of small tiny papules, pustules, red bumps and scaling with intense itching. It is
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`usually localized to the surrounding area of the mouth and on the chin, or extends to involve
`
`the eyelids and the forehead. Gram-negative folliculitis is a bacterial infection characterized
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`by the appearance of pustules and cysts, possibly occurring as a complication resulting from a
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`long term antibiotic treatment of acne vulgaris.
`
`[025] As used herein, the terms "treatment" or "treating" in reference to a skin
`
`condition generally mean "having positive effect on a skin condition" and encompass
`
`alleviation of at least one symptom of a skin condition, a reduction in the severity of the skin
`
`conditions, or delay, prevention, or inhibition of the progression of the skin condition.
`
`Treatment need not mean that the condition is totally cured. A composition or a product
`
`useful for treatment of a skin condition, or a method of treating a skin condition, needs only
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`to reduce the severity of a skin condition, reduce the severity of symptoms associated
`
`therewith, provide improvement to a patient's quality of life, or delay, prevent, or inhibit the
`
`onset of symptoms of a skin condition.
`
`[026]
`
`In one embodiment, there are provided compositions including dapsone, a first
`
`solubilizing agent which is diethylene glycol monoethyl ether, optionally at least one second
`
`solubilizing agent, a polymeric viscosity builder, and water, wherein the dapsone is present at
`
`a concentration of about 5% w/w to about 10% w/w, about 1% w/w to about 10% w/w, about
`
`3% w/w to about 10% w/w, about 3% w/w to about 8% w/w, about 4% w/w to about 6%
`
`w/w, or about 5%. In certain embodiments, dapsone is present in the composition at 5.0%,
`
`5.5%, 6.0%, 6.5%, 7.0%, 7.5%, 8.0%, 8.5%, 9.0%, 9.5%, or 10.0% w/w.
`
`[027]
`
`In
`
`some
`
`embodiments,
`
`the
`
`polymeric viscosity builder
`
`IS
`
`an
`
`acrylamide/sodium acryloyldimethyltaurate copolymer, and further includes isohexadecane,
`
`sorbitan oleate, water, and Polysorbate 80.
`
`In some embodiments, the polymeric viscosity
`
`builder is present at a concentration of about 2% w/w to about 6% w/w.
`
`In some
`
`embodiments, the polymeric viscosity builder is present at a concentration of about 3% w/w
`
`to about 5% w/w. In some embodiments, the polymeric viscosity builder is present in the
`
`composition at about 4% w/w.
`
`[028]
`
`In some embodiments, diethylene glycol monoethyl ether is present at a
`
`concentration of about 25% w/w to about 40% w/w. In some embodiments, diethylene glycol
`
`monoethyl ether is present at a concentration of about 30% w/w to about 40% w/w. In some
`
`embodiments, diethylene glycol monoethyl ether is present at a concentration of about 35%
`
`w/w to about 40% w/w.
`
`[029]
`
`In some embodiments, diethylene glycol monoethyl ether is present at a
`
`concentration of about 10% w/w to about 40% w/w, about 20% w/w to about 30% w/w, or
`
`about 25%.
`
`[030]
`
`In another embodiment, there are provided compositions further including
`
`adapalene. In some embodiments, adapalene is present at a concentration of about 0.1% w/w
`
`to about 0.3% w/w.
`
`[031]
`
`In some embodiments, the second solubilizing agent is selected from alcohols,
`
`glycols, esters, ethers, or silicones. Such second solubilizing agents include, but are not
`
`limited to, PEG 400, lactic acid, dimethyl isosorbide, propylene glycol, propylene carbonate,
`
`hexylene glycol, isostearyl alcohol, benzyl alcohol, diethyl sebacate, and ethanol.
`
`[032]
`
`In certain embodiments, the second solubilizing agent is propylene glycol. In
`
`some embodiments, propylene glycol is present at a concentration of about 2% w/w to 8%
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`w/w.
`
`In some embodiments, propylene glycol is present at a concentration of about 3% w/w
`
`to 7% w/w. In some embodiments, propylene glycol is present in the composition at about
`
`5%w/w.
`
`[033]
`
`In certain embodiments, the second solubilizing agent is propylene carbonate.
`
`In some embodiments, propylene carbonate is present at a concentration of about 2% w/w to
`
`8% w/w.
`
`In some embodiments, propylene carbonate is present at a concentration of about
`
`3% w/w to 7% w/w.
`
`In some embodiments, propylene carbonate is present in the
`
`composition at about 5% w/w.
`
`[034]
`
`In certain embodiments, the second solubilizing agent is ethanol.
`
`In some
`
`embodiments, ethanol is present at a concentration of about 1% w/w to about 5% w/w.
`
`In
`
`some embodiments, ethanol is present at a concentration of about 2% w/w to about 4% w/w.
`
`In some embodiments, ethanol is present in the composition at about 3% w/w.
`
`[035]
`
`[036]
`
`In some embodiments, the compositions further include methylparaben.
`
`In other embodiments,
`
`the compositions
`
`further
`
`include carbomer
`
`homopolymer type C. In some embodiments, carbomer homopolymer type C is present at a
`
`concentration of about 0. 7% w/w to about 1.5% w/w.
`
`In other embodiments, carbomer
`
`homopolymer type Cis present at a concentration of about 0.85% w/w to about 1.0% w/w.
`
`[037]
`
`In some embodiments, the compositions further include a neutralizing agent.
`
`In certain embodiments, the neutralizing agent is an ionic or amine buffer.
`
`In certain
`
`embodiments, the neutralizing agent is sodium hydroxide or triethanolamine. Use of a
`
`neutralizing agent results in compositions typically having a pH from 5.5 to 6.5.
`
`[038]
`
`In some embodiments, the compositions further include a chelating agent. In
`
`some embodiments, the chelating agent is ethylenediamine tetraacetic acid (EDTA). EDTA
`
`is typically present in the compositions from about 0.02% w/w to about 0.04% w/w.
`
`In
`
`certain embodiments, EDTA is present in the compositions at about 0.03% w/w.
`
`[039] Compositions described herein are typically in the form of a gel, an emulsion,
`
`a cream, a liquid, a paste, a lotion, a nanoemulsion, a microemulsion, a reverse emulsion, or a
`
`liposomal cream.
`
`EMBODIMENTS
`
`[040] The following embodiments are specifically contemplated herein.
`
`Embodiment 1.
`
`A composition comprising dapsone, a first solubilizing agent
`
`which is diethylene glycol monoethyl ether, optionally at least one second solubilizing
`
`agent, a polymeric viscosity builder, and water, wherein the dapsone is present in the
`
`composition at a concentration of about 3% w/w to about 10% w/w.
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`8
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`10
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`19107US (AP)
`
`Embodiment 2.
`
`The composition of embodiment 1, wherein the diethylene
`
`glycol monoethyl ether is present at a concentration of about 10% w/w to about 40%
`
`w/w.
`
`Embodiment 3.
`
`The composition of embodiment 1, wherein the diethylene
`
`glycol monoethyl ether is present at a concentration of about 20% w/w to about 30%
`
`w/w.
`
`Embodiment 4.
`
`The composition of embodiment 1, wherein the diethylene
`
`glycol monoethyl ether is present in the composition at a concentration of about 25%
`
`w/w.
`
`Embodiment 5.
`
`The composition of embodiment 1,
`
`further compnsmg
`
`adapalene.
`
`Embodiment 6.
`
`The composition of embodiment 5, wherein the adapalene is
`
`present at a concentration of about 0.1% w/w to about 0.3% w/w.
`
`Embodiment 7.
`
`The composition of embodiment 1 wherein
`
`the second
`
`solubilizing agent is selected an alcohol, a glycol, an ester, or an ether.
`
`Embodiment 8.
`
`The composition of embodiment 1, wherein the second
`
`solubilizing agent is PEG 400, lactic acid, dimethyl isosorbide, propylene glycol,
`
`propylene carbonate, hexylene glycol, isostearyl alcohol, diethyl sebacate, or ethanol.
`
`Embodiment 9.
`
`The composition of embodiment 8, wherein the second
`
`solubilizing agent is propylene glycol.
`
`Embodiment 10.
`
`The composition of embodiment 9, wherein the propylene
`
`glycol is present in the composition at a concentration of about 5% w/w.
`
`Embodiment 11.
`
`The composition of embodiment 8, wherein the second
`
`solubilizing agent is propylene carbonate.
`
`Embodiment 12.
`
`The composition of embodiment 11, wherein the propylene
`
`carbonate is present in the composition at a concentration of about 5% w/w.
`
`Embodiment 13.
`
`The composition of embodiment 8, wherein the second
`
`solubilizing agent is ethanol.
`
`Embodiment 14.
`
`The composition of embodiment 13, wherein the ethanol IS
`
`present in the composition at a concentration of about 3% w/w.
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`9
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`19107US (AP)
`
`Embodiment 15.
`
`The composition of embodiment 1, wherein the polymeric
`
`viscosity builder
`
`compnses
`
`an
`
`acrylamide/sodium
`
`acryloyldimethyltaurate
`
`copolymer.
`
`Embodiment 16.
`
`The composition of embodiment 1, wherein the polymeric
`
`viscosity builder is present at a concentration of about 2% w/w to about 6% w/w.
`
`Embodiment 1 7.
`
`The composition of embodiment 1, wherein the polymeric
`
`viscosity builder is present at a concentration of about 4% w/w.
`
`Embodiment 18.
`
`The composition of embodiment 1, further comprising methyl
`
`paraben.
`
`Embodiment 19.
`
`The composition of embodiment 1,
`
`further compnsmg
`
`Carbomer interpolymer type A, Carbomer interpolymer type B, or Carbomer
`
`Homopolymer Type C.
`
`Embodiment 20.
`
`The composition of embodiment 19, wherein the Carbomer
`
`Homopolymer Type C is present at a concentration of about 0. 7% w/w to about 1.5%
`
`w/w.
`
`Embodiment 21.
`
`The composition of embodiment 19, wherein the Carbomer
`
`Homopolymer Type C is present at a concentration of about 0.85% w/w to about
`
`1.5%w/w.
`
`Embodiment 22.
`
`The composition of embodiment 19, wherein the Carbomer
`
`interpolymer Type A is present at a concentration of about 1% w/w to 2% w/w.
`
`Embodiment 23.
`
`The composition of embodiment 19, wherein the Carbomer
`
`interpolymer Type B is present at a concentration of about 0.1% w/w to about 0.5%
`
`w/w.
`
`Embodiment 24.
`
`The composition of embodiment 1, further compnsmg a
`
`neutralizing agent.
`
`Embodiment 25.
`
`The composition of embodiment 24 wherein the neutralizing
`
`agent is NaOH or triethanolamine.
`
`Embodiment 26.
`
`The composition of embodiment 1 further compnsmg a
`
`chelating agent.
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`19107US (AP)
`
`Embodiment 27.
`
`The composition of embodiment 26, wherein the chelating
`
`agent is ethylenediamine tetraacetic acid.
`
`Embodiment 28.
`
`The composition of embodiment 27, wherein the ethylene
`
`diamine tetraacetic acid is present at a concentration of about 0.02% w/w to about
`
`0.04%w/w.
`
`Embodiment 29.
`
`The composition of embodiment 27, wherein the ethylene
`
`diamine tetraacetic acid is present in the composition at about 0.03% w/w.
`
`Embodiment 30.
`
`The composition of embodiment 1 wherein the composition is
`
`in the form of a gel, a suspension, an emulsion, a cream, a liquid, a paste, a lotion, a
`
`nanoe