Maximizing Your Competitive Advantage

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1 Maximizing Your Competitive Advantage Nat Jones, RPh, FIACP Erin Michael, MBA, CPhT, Director of Outside Sales PCCA Marketing and Sales Symposium San Diego, CA May 12 14, PCCA. All Rights Reserved. 1

Base Focus MucoLox XemaTop Clarifying PracaSil

6 MucoLox Is a bio polymeric polysaccharide mucosal delivery system Unique synergy between Pullulan, Tamarind Xyloglucan, Zea Mays Starch, and Sodium Hyaluronate Polysaccharides are highly stable, safe, non toxic, hydrophilic, and biodegradable 2016 PCCA. All Rights Reserved. 6

7 Mucus X Polymers Mucins are high molecular weight, heavily glycosylated proteins produced by epithelial tissues, components of mucus by mucous membranes or are secreted to become a component of saliva * Brazilian Journal of Pharmaceutical Sciences vol. 46, n. 1, jan./mar., 2010 Mucoadhesive drug delivery systems. Flávia Chiva Carvalho 2016 PCCA. All Rights Reserved. 7

10 Technical Report Document #98928 Assessment of the Mucoadhesive Properties of MucoLox Using a 3D Model of the Human Oral Mucosa Oral tissue comprised of normal, human derived oral epithelial cells 2016 PCCA. All Rights Reserved. 10

13 MucoLox Safety Evaluation of the Safety and Toxicological Profile of MucoLox : Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa Document #98929 Oral Document #98933 Nasal Document #98930 Vaginal 2016 PCCA. All Rights Reserved. 13

14 Safety of This Mucoadhesive Polymer Is potentially as safe as distilled water following 4.5 hours of exposure, making it safe in the treatment of oral mucositis, candidiasis and mouth ulcers Safe mucoadhesive polymer that can offer increased retention of medication at the site of action without toxicity concerns (nasal) 2016 PCCA. All Rights Reserved. 14

15 Safety of This Mucoadhesive Polymer Compounded medicines prepared with MucoLox are then likely to remain at the site of action for a long period of time without causing damage to the vaginal tissue, potentially reducing the need for frequent dosing and increasing the effectiveness of each dose administration 2016 PCCA. All Rights Reserved. 15

16 Oral Mucosa All of the oral mucosa is made up of a thick stratified squamous epithelium, supported by a lamina propria Some is keratinized and some is not, but it doesn t matter All is moistened with mucus and saliva 2016 PCCA. All Rights Reserved. 16

Mucosa 1. Stratum basale 2. Stratum spinosum 3.

18 Three Kinds of Oral Mucosa 1. Masticatory mucosa, keratinized stratified squamous epithelium, found on the dorsum of the tongue, hard palate and attached gingiva 2. Lining mucosa, nonkeratinized stratified squamous epithelium: 1. Buccal mucosa, Labial mucosa, Alveolar mucosa 3. Specialized mucosa 2016 PCCA. All Rights Reserved. 18

20 Specialized Mucosa Found specifically in the regions of the taste buds on lingual papillae on the dorsal surface of the tongue that contains nerve endings for general sensory reception and taste perception Lingual papillae 2016 PCCA. All Rights Reserved. 20

22 MucoLox Loves Mucous Membranes Muco adhesive, Ionic attraction, Innovative coating effect Holds API in contact with mucosa tighter, longer Oral, nasal, vaginal, and rectal use 2016 PCCA. All Rights Reserved. 22

23 MucoLox Loves Mucous Membranes Water soluble for improved moisturization Outstanding stability Pleasant, neutral taste, easily flavored Free of gluten, casein, dye, and parabens, among other allergens (below detectable limits) 2016 PCCA. All Rights Reserved. 23

25 Lots of Causes Bacterial infections Viral infections (Herpes simplex, Varicella zoster) Fungal infections (Candida) Systemic disorders (Celiac disease, Vitamin B or C deficiency, IBS, Iron deficiency, Leukemia) Drugs (Chemo, NSAIDS) Physical irritation Irritants and allergies Misc. (burning mouth syndrome, Lichen planus, recurrent aphthous stomatitis, head and neck radiation) 2016 PCCA. All Rights Reserved. 25

26 Oral Mucositis (OM) A profound negative effect Result in significant pain which affects patients ability to eat & take medicines, necessitates analgesic use, adversely affects nutritional status and quality of life * Support Care Cancer Nov;21(11): Emerging evidence on the pathobiology of mucositis. Al Dasooqi N, et al PCCA. All Rights Reserved. 26

27 Oral Mucositis ABSTRACT: OM is a widespread and potentially serious consequence of high dose chemotherapy and radiotherapy. Symptoms altered taste perception, sores, and varying degrees of pain, usually appear 4 to 5 days after treatment initiation. Treatment is mainly supportive, involving both nonpharmacologic and pharmacologic methods. * US Pharm. 2011;36(7)(Oncology suppl): Oral Mucositis and Compounded Mouthwashes. Loyd V. Allen, Jr, PhD, RPh 2016 PCCA. All Rights Reserved. 27

28 Oral Mucositis (cont d) ABSTRACT: For compounded preparations such as mouthwashes, there are various formulations that pharmacists can use based on the experience and needs of the individual physician and patient, respectively * US Pharm. 2011;36(7)(Oncology suppl): Oral Mucositis and Compounded Mouthwashes. Loyd V. Allen, Jr, PhD, RPh 2016 PCCA. All Rights Reserved. 28

29 Oral Mucositis (cont d) It occurs in approximately 20% to 40% of patients receiving conventional chemotherapy, 80% of those receiving high dose chemotherapy as conditioning for hematopoietic stem cell transplantation and nearly all patients receiving head and neck radiation therapy * Cancer 2014;120: VC MASCC=ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. Rajesh V. Lalla, DDS, PhD1, et. al PCCA. All Rights Reserved. 29

30 MASCC Recommendations for Oral Mucositis (partial list) Oral care protocols to prevent (cryotherapy) 0.5% doxepin mouthwash to treat pain 2% morphine mouthwash to treat pain Systemic zinc supplementation to help prevent 2016 PCCA. All Rights Reserved. 30

31 Cancer Mouth Pain Formula Formula #11431 Morphine Sulfate 2% Mouthwash (MucoLox ) 2.5ml rinse 4 to 6 times a day prn pain (spit or swallow decision up to practitioner) Formula #11128 Doxepin HCl 0.5% Mouthwash 2.5 ml rinse three to six times per day as needed (spit or swallow decision) Formula #11830 Zinc Sulfate 0.025% Mouth Rinse 2016 PCCA. All Rights Reserved. 31

32 MucoLox Oral - Mucositis Formula #11144 Stanford Modified Mouthwash Tetracycline Hydrochloride USP Nystatin USP Hydrocortisone USP Micronized Diphenhydramine Hydrochloride USP Formula #11133 Misoprostol % / Diphenhydramine HCl 0.1% / Lidocaine HCl 1% Oral Rinse 2016 PCCA. All Rights Reserved. 32

33 Preventative for Radiation Damage Calcium Phosphate (Supersaturated) Helps ionic and ph balance, dryness Use starting the day of chemo or radiation therapy * Eur J Cancer Care (Engl) Sep;22(5): Efficacy of a supersaturated calcium phosphate oral rinse for the prevention and treatment of oral mucositis in patients receiving high dose cancer therapy: a review of current data. Quinn B PCCA. All Rights Reserved. 33

34 MucoLox Oral - Mucositis Formula #11400 Supersaturated Calcium Phosphate Oral Rinse 2 to 3 ml 4 times per day from the onset of the cancer treatment (chemo or radiation). Up to 10 doses per day if pain from mucositis is experienced. Use for the duration of the treatment and beyond if needed PCCA. All Rights Reserved. 34

36 MucoLox Nasal Formula #11374 Nasal Spray General Formula (MucoLox ) Active Pharmaceutical Ingredient (API) BASE, PCCA MUCOLOX 15% Preserved Water (Parabens) qsad Medium spread spray >15%: stream Nostrils tacky for 2 hours 2016 PCCA. All Rights Reserved. 36

39 Tranexamic Acid for Epistaxis Reports vary as to efficacy of topical tranexamic acid use for epistaxis yes, no, maybe Still a requested compound * Cochrane Database Syst Rev Jul 23;7:CD Topical application of tranexamic acid for the reduction of bleeding. Ker K1, Beecher D, Roberts I. * Emerg Med J May;31(5): Best evidence topic reports. BET 3: Topical intranasal tranexamic acid for spontaneous epistaxis. Hilton L 2016 PCCA. All Rights Reserved. 39

41 Epistaxis Formula #10579 Aminocaproic Acid 250 mg/ml Nasal Spray Formula #10620 Aminocaproic Acid 250 mg/ml Poloxamer Nasal Spray Formula #0863 Phenylephrine HCl 0.094% / Tetracaine HCl 0.5% Nasal Pack Solution 2016 PCCA. All Rights Reserved. 41

42 Nasal Polyps Polypoidal masses arising mainly from the mucous membranes of the nose and paranasal sinuses. They are overgrowths of the mucosa that frequently accompany allergic rhinitis. They are freely movable and non tender PCCA. All Rights Reserved. 42

43 Nasal Polyps (NPs) Chronic rhinosinusitis (CRS) induction of NPs is common The prevalence of rhinosinusitis was higher in female (5.7%) than in male (3.4%) subjects * Am J Rhinol Allergy Nov Dec; 27(6): Epidemiology and differential diagnosis of nasal polyps. Chaaban MR, et al. * Laryngoscope Jul;113(7): The epidemiology of chronic rhinosinusitis in Canadians. Chen Y1, Dales R, Lin M PCCA. All Rights Reserved. 43

44 Nasal Polyps According to Mayo Clinic, there are more than 3 million annual cases in the U.S. Nasal polyps can affect anyone, but are more common in adults Surgery is sometimes needed to remove them, but even after treatment they often return 2016 PCCA. All Rights Reserved. 44

45 Nasal Polyps In the general population, the prevalence of nasal polyps is 4%. In patients with asthma, a prevalence of 7 to 15% has been noted whereas, in NSAID sensitivity, nasal polyps are found in 36 to 60% of patients 2016 PCCA. All Rights Reserved. 45

47 Nasal Polyps Symptoms of polyps include nasal congestion, sinusitis, loss of smell, and secondary infection leading to headache. They may be removed by surgery, but are found to recur in about 70% of cases. * Epidemiology and differential diagnosis of nasal polyps. Cahaba, Mohamad R.; Walsh, Erika M.; Woodworth, Bradford A. Source: American Journal of Rhinology & Allergy, Volume 27, Number 6, November/December 2013, pp (6) 2016 PCCA. All Rights Reserved. 47

48 Nasal Polyps Standard of care treatments usually include nasal steroids and antihistamines Intranasal steroid sprays may reduce or retard the growth of small nasal polyps, but they are relatively ineffective in massive nasal polyposis Steroid injections into polyps also a common office treatment 2016 PCCA. All Rights Reserved. 48

55 Sinusitis Symptoms Pain or pressure in your forehead, temples, cheeks, nose, and behind your eyes Nasal congestion Nasal discharge (yellow or green) Postnasal drip particularly at night or when lying down Toothache Cough, often worse at night Sore throat Fever Bad breath Loss of sense of smell Fatigue General sense of not feeling well (malaise) 2016 PCCA. All Rights Reserved. 55

56 Nasal Nebulization and Irrigation According to USP <797> and while compounded or manufactured aqueous solutions are sterile prior to administration, once the solution is opened and placed into a nebulizer cup or irrigation device it is no longer sterile, which means it s not actually administered sterile PCCA. All Rights Reserved. 56

57 797 - Dry Powder for Nasal Use According to USP <797>, compounded aqueous solutions for irrigation or nebulization are required to be sterile ( finished preparations that are stored by the patient or pharmacy). However dispersion powder formulations are dry powders. Commercially available dry powders for inhalation are manufactured as non sterile products PCCA. All Rights Reserved. 57

58 LoxaSperse Ingredients Xylitol NF Poloxamer 407 USP Poloxamer 188 USP Reduces particle size and increases the solubility and dispersibility of APIs, potentially enhancing drug delivery and absorption 2016 PCCA. All Rights Reserved. 58

59 LoxaSperse Ideal for multi API formulas Preservative free Prolonged beyond use date Easy to store and carry Antimicrobial synergy possible, as well as action against biofilms 25% minimum of total weight is required when used alone 2016 PCCA. All Rights Reserved. 59

62 XyliFos Allows for only 10% of LoxaSperse to be used in a formulation as compared to 25% minimum when used without XyliFos Supports the activity of antimicrobials, antiviral, antiinflammatory and antihistamines used in the formulations through a unique patent pending EGCg Cyclodextrin complex Improving formulation substantivity (mucosal adhesiveness) as well as moisturization 2016 PCCA. All Rights Reserved. 62

67 Colistimethate Sodium Spontaneously hydrolyzes to form colistin A (polymyxin E1) and B (polymyxin E2/B) when mixed with water. High levels of these active breakdown products at the time of administration have been associated with nephrotoxicity and even death. * Antimicrob. Agents Chemother. December 2012 vol. 56 no Stability of Colistimethate Sodium in Aqueous Solution. A. M. Healana, W. Grayb, E. J. Fuchsc, J. M. Griffissd, R. A. Salataa and J. Blumerb 2016 PCCA. All Rights Reserved. 67

71 LoxaSperse / XyliFos Formulas Approximately 105 LoxaSperse formulas in our database 37 LoxaSperse / XyliFos combination formulas available Formula #11607 (LoxaSperse /XyliFos ) Gentamicin 80 mg / Budesonide 0.6 mg Caps Size #1 Formula #11609 (LoxaSperse /XyliFos ) Tobramycin 100 mg / Budesonide 0.5 mg / Amphotericin B 5 mg Capsules Size # PCCA. All Rights Reserved. 71

72 LoxaSperse - XyliFos Ideal for multi API formulas Preservative free Prolonged beyond use date Easy to store and carry Antimicrobial synergy possible, as well as action against biofilms Technical Report: Antimicrobial Effectiveness Testing of a Gentamicin LoxaSperse Dispersion Online: accessed 10/7/ PCCA. All Rights Reserved. 72

74 Comparing Formula Cost $ With LoxaSperse (PCCA Formula #10341) Budesonide Micronized USP: 0.5mg $9.30 Base, PCCA LoxaSperse : gm $ PCCA Capsule Size #1: 100 ea. $3.00 Cost per unit $ PCCA. All Rights Reserved. 74

75 Comparing Formula Cost $56.33 With LoxaSperse / XyliFos (PCCA Formula #11603) Budesonide Micronized USP: 0.5mg $9.30 Base, PCCA LoxaSperse : 4.48gm $10.08 Base, PCCA XyliFos : gm $33.95 PCCA Capsule Size #1: 100 ea. $3.00 Cost per unit $ PCCA. All Rights Reserved. 75

77 MucoLox : Vaginal Hormones Estrace Vaginal Cream 42.5gm $ retail Formula #11116 Estriol 0.1% / Testosterone 0.1% Vaginal Gel (MucoLox /VersaBase Gel) (BUD Study) Formula #11115 Estriol 0.05% Vaginal Gel (MucoLox / VersaBase ) 2016 PCCA. All Rights Reserved. 77

78 MucoLox : Vaginal Hormones Formula #11386 Dehydroepiandrosterone 13mg/Gm Vaginal Gel Dosage range 3.5 to 13mg * Menopause Dec 28. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Labrie F et al PCCA. All Rights Reserved. 78

79 MucoLox : Vaginal Atrophy Formula #11117 Sodium Hyaluronate 5 mg/gm Compound Vaginal Gel (MucoLox / VersaBase Gel) Formula #11724 Oxytocin 120 U/Gm Vaginal Gel Formula #11119 Vitamin E 200 U/Gm Vaginal Gel (MucoLox / VersaBase ) * Menopause Int Dec;17(4): doi: /mi Epub 2011 Nov 25. Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double blind randomized pilot study. Jonasson AF, Edwall L, Uvnäs Moberg K PCCA. All Rights Reserved. 79

80 MucoLox : Vaginal Pain Formula #11108 Amitriptyline HCl 2% / Baclofen 2% Vaginal Gel [Carboxymethylcellulose Sodium 1.75% Gel (MucoLox )] Formula #11110 Gabapentin 6% Vaginal Gel * Obstet Gynecol Sep;112(3): Topical gabapentin in the treatment of localized and generalized vulvodynia. Boardman LA, Cooper AS, Blais LR, Raker CA 2016 PCCA. All Rights Reserved. 80

81 Pelvic Pain Sometimes using a topical pain gel to the dermatome can enhance pain relief Lower cost formulations include: Formula #9874 Ketoprofen 10% / Cyclobenzaprine HCl 2% Topical Lipoderm (BUD Study) Formula #9377 Amitriptyline HCl 2% / Baclofen 2% Topical Lipoderm 2016 PCCA. All Rights Reserved. 81

82 MucoLox : Vaginal Infections Infection MetroGel Vaginal #70 grams cost to pharmacy is around $273 Mucoadhesive!!!! Formula #11994 Metronidazole 0.75% Vaginal Gel (MucoLox / VersaBase Add acidophilus or clindamycin? 2016 PCCA. All Rights Reserved. 82

84 MucoLox : PCOS Metformin GI side effects when taken orally; patients are often unable to tolerate it Formula #11542 Metformin HCl 10% Vaginal Gel (MucoLox ) Document #98749 Transdermal Metformin Consultant's Corner by Jane Jones ( Apothagram) Formula #10871 Metformin HCl 10% Topical Lipoderm 2016 PCCA. All Rights Reserved. 84

85 Genital Warts Commercial 5FU Cream >$150/40gm Formula Alternate #11111 Fluorouracil (5 FU) 5% Topical Gel (MucoLox / VersaBase ) Vaginal or introital use Formula Deoxy D Glucose 0.2% / Acyclovir 5% / Imiquimod 2.5% / Tea Tree Oil 2.5% Vaginal Gel (MucoLox / VersaBase ) 2016 PCCA. All Rights Reserved. 85

86 Genital Warts Imiquimod commercial product 5% comes only as packets; varying prices 2.5% cream (7.5g size; brand name only $1K) 3.75% cream (7.5g size; Brand name only $1K) Formula #11112 Imiquimod 0.5% Vaginal Gel (MucoLox / VersaBase ) 2016 PCCA. All Rights Reserved. 86

87 MucoLox : Vaginal Itching Skyrocketing topical steroid prices Combinations Crotamiton + betamethasone is sometimes prescribed, but commercial crotamiton often unavailable to patients A 60 gram tube of crotamiton cost to the pharmacy is close to $mid high 400 s 2016 PCCA. All Rights Reserved. 87

88 MucoLox : Vaginal Itching Compounded alternatives: Formula #11887 Tranilast 1% / Betamethasone 0.05% Topical Gel (MucoLox / VersaBase ) Formula #11575 Ketotifen 0.4% Vaginal Gel (MucoLox / VersaBase ) 2016 PCCA. All Rights Reserved. 88

90 Wounds Fibroblast Increased proliferation and faster migration of fibroblast could potentially result in early collagen deposition and lead to faster wound healing * Exp Biol Med (Maywood) Oct;239(10): Selective blockade of the OGF OGFr pathway by naltrexone accelerates fibroblast proliferation and wound healing. Immonen JA1, Zagon IS1, McLaughlin PJ2. * Exp Biol Med (Maywood) Oct;238(10): Topical treatment with the opioid antagonist naltrexone accelerates the remodeling phase of full thickness wound healing in type 1 diabetic rats. Immonen JA1, Zagon IS, Lewis GS, McLaughlin PJ 2016 PCCA. All Rights Reserved. 90

91 Wound Gel Misoprostol decreases healing time of acute wounds Formula #11953 Misoprostol % / Phenytoin 2% / Beta Glucan 0.5% Topical Gel (MucoLox ) For shallow or deep wounds 10 day BUD * Wounds Dec;19(12): Topical misoprostol and wound healing in rats. Mahoney J1, Ponticello M, Nelson E, Ratz R PCCA. All Rights Reserved. 91

95 The Skin is One of the 5 Detox Organs Skin, lungs, kidney, colon, and liver The skin is sometimes called the third kidney. A lot of toxins come out through perspiration, and in dead skin cells that flake off Alternatively a lot of toxins also go in through the skin though toiletries and cosmetics 2016 PCCA. All Rights Reserved. 95

98 Barrier The lipids that make up this matrix mortar consist of ceramides, free fatty acids, cholesterol, and cholesterol sulfate The lipid matrix of the skin's stratum corneum plays a key role in the barrier function, which protects the body from water loss 2016 PCCA. All Rights Reserved. 98

Skin Barrier Corneocytes Intracellular lipid matrix Stratum corneum Flattened, Dead, keratinized cells, without a nucleus Lipid bilayer Ceramides Fatty acids Cholesterol

99 Skin Barrier Corneocytes Intracellular lipid matrix Stratum corneum Flattened, Dead, keratinized cells, without a nucleus Lipid bilayer Ceramides Fatty acids Cholesterol Cholesterol sulfate Structure of the outermost corneous layer of skin (SC). The structure of the lipid bilayer of SC membrane is shown at the bottom PCCA. All Rights Reserved. 99

100 Ceramide Latin cera (wax) so ceramides are a family of waxy lipid molecules Are found in high concentrations within the cell membrane Ceramide is the main component of the stratum corneum of the epidermis, up to 47% of the weight 2016 PCCA. All Rights Reserved. 100

101 Lipid Bilayer Not only prevents excessive water loss due to evaporation but also functions as a barrier against the entry of microorganisms With aging there is a decline in ceramide and cholesterol in the stratum corneum There is also less sebum produced with age 2016 PCCA. All Rights Reserved. 101

103 Inflammation and Barrier Dermatologic conditions arise from the dynamic crosstalk that occurs between skin barrier and the immune system. * Journal of Investigative Dermatology (2012) 132, ; Skin Barrier Disruption: A Requirement for Allergen Sensitization? De Benedetto A, Kubo A, Beck LA 2016 PCCA. All Rights Reserved. 103

104 Inflammation and Barrier Examples are atopic dermatitis and / or eczema along with a number of allergy driven disorders for which skin barrier is at least transiently compromised, such as psoriasis, allergic contact dermatitis, and blistering disorders * Journal of Investigative Dermatology (2012) 132, ; Skin Barrier Disruption: A Requirement for Allergen Sensitization? De Benedetto A, Kubo A, Beck LA 2016 PCCA. All Rights Reserved. 104

105 Cytokines Are a broad and loose category of small proteins that are important in cell signaling and affect the behavior of other cells They include chemokines, interferons, interleukins, lymphokines, tumor necrosis factor Signal inflammation up or down depending on the cytokine 2016 PCCA. All Rights Reserved. 105

106 Cytokines Are produced by a broad range of White Blood Cells, such as: Macrophages, Lymphocytes and mast cells As well as skin cells (keratinocytes, fibroblasts) The same cytokine may be produced by more than one type of cell 2016 PCCA. All Rights Reserved. 106

107 Interleukins A sub group of cytokines that mediate cellular communication Particularly important in stimulating immune responses, such as inflammation There are 36 known interleukins at the present time 2016 PCCA. All Rights Reserved. 107

108 XemaTop XemaTop is a proprietary base developed to be applied topically for the management of psoriasis, either alone or as a compounding base for the incorporation of different active pharmaceutical ingredients Formulations have been created targeting patients with eczema, psoriasis and xerosis 2016 PCCA. All Rights Reserved. 108

109 XemaTop It uses the power and synergy of several natural ingredients and elegant film formers to deliver and improve the action of common active pharmaceutical ingredients (APIs) used in formulations for these patients 2016 PCCA. All Rights Reserved. 109

110 XemaTop Cream Water Cyclopentasiloxane Glyceryl Stearate PEG 100 Stearate Polyglyceryl 3 Cetearyl Ether Olivate Propanediol Carapa Guaianensis Seed Oil Dimethicone Hexyldecanol Lactobacillus Ferment Polyacrylate Crosspolymer 11 Butylene Glycol Pentylene Glycol Glycerin Theanine Cholecalciferol Beta Glucan Phosphatidylcholine 2016 PCCA. All Rights Reserved. 110

111 XemaTop Cream Phosphatidylglycerol Brassica Campestris (Rapeseed) Sterols Vitis Vinifera (Grape) Seed Extract Boswellia Serrata Resin Extract Bisabolol Xylitol Anhydroxylitol Xylitylglucoside Tocopheryl Acetate Cetylhydroxyproline Palmitamide Hydroxyphenyl Propamidobenzoic Acid Maltodextrin Stearic Acid Polysilicone 11 Microcrystalline Cellulose Silica Disodium EDTA 2016 PCCA. All Rights Reserved. 111

112 XemaTop Cream Water Cyclopentasiloxane Glyceryl Stearate PEG 100 Stearate Polyglyceryl 3 Cetearyl Ether Olivate Propanediol Carapa Guaianensis Seed Oil Dimethicone Hexyldecanol Lactobacillus Ferment Polyacrylate Crosspolymer 11 Butylene Glycol Pentylene Glycol Glycerin Theanine Cholecalciferol Beta Glucan Phosphatidylcholine 2016 PCCA. All Rights Reserved. 112

113 XemaTop Cream Phosphatidylglycerol Brassica Campestris (Rapeseed) Sterols Vitis Vinifera (Grape) Seed Extract Boswellia Serrata Resin Extract Bisabolol Xylitol Anhydroxylitol Xylitylglucoside Tocopheryl Acetate Cetylhydroxyproline Palmitamide Hydroxyphenyl Propamidobenzoic Acid Maltodextrin Stearic Acid Polysilicone 11 Microcrystalline Cellulose Silica Disodium EDTA 2016 PCCA. All Rights Reserved. 113

114 Ingredient Discussion Cyclopentasiloxane a silicone Boswellic acid anti inflammatory Cetylhydroxyproline Palmitamide Ceramide Hydroxyphenyl Propamidobenzoic Acid avenanthramide (from oats) anti inflammatory, antioxidant, anti itch, and anti irritant 2016 PCCA. All Rights Reserved. 114

115 Phosphatidylglycerol (PG) PG is a unique lipid which occurs in skin It regulates specific human genes and pathways which act on skin cells affecting growth, inflammation and hydration Regulating water channels (Aquaporins) that selectively move water molecules in and out of cells 2016 PCCA. All Rights Reserved. 115

116 Hydroxyphenyl Propamidobenzoic Acid A synthetic avenanthramide Avenanthramides are potent anti inflammatory agents that appear to mediate the anti irritant effects * Arch Dermatol Res Nov;300(10): Avenanthramides, polyphenols from oats, exhibit anti inflammatory and anti itch activity. Sur R1, Nigam A, Grote D, Liebel F, Southall MD PCCA. All Rights Reserved. 116

An article by Rino and colleagues (2010) highlighted a substance called avenanthramide within the

118 IL-6 study data The anti inflammatory and antiproliferative properties of XemaTop and the reference product were assessed and compared using the following test formulations: XemaTop, mometasone furoate in XemaTop, calcitriol in XemaTop, mometasone furoate in reference product, and calcitriol in reference product PCCA. All Rights Reserved. 118

120 Paraphrased The highest inhibition of IL 6 was achieved with the XemaTop formulations, suggesting that the delivery of active ingredients was better than the commercial reference products This inhibition of IL 6 is likely to decrease the inflammation and skin thickening associated with psoriasis XemaTop may be considered a valuable base for the incorporation of active substances when compounding topical formulations for psoriasis 2016 PCCA. All Rights Reserved. 120

121 Clarifying Base An emulsion created for acne or problem skin Easily accommodate a variety of active ingredients such as: Antimicrobials, benzoyl peroxide, tretinoin, alpha hydroxy acids, beta hydroxy acids, and many more 2016 PCCA. All Rights Reserved. 121

123 Clarifying Base Decreases oil formation because of its unique avocado extract Reduces the chances of irritation often seen with acne medications, because of its phospholipid emulsifiers that are mild and mimic skin lipids Inhibits the growth of P. acnes at a concentration of 15% by itself and 10% with benzoyl peroxide 2016 PCCA. All Rights Reserved. 123

125 Commonly Compounded With: Benzoyl peroxide Salicylic acid Tretinoin Erythromycin Clindamycin Niacinamide Sulfacetamide Metronidazole Currently 48 formulas approved 2016 PCCA. All Rights Reserved. 125

128 Hidradenitis Suppurativa (HS) Is a chronic disfiguring stubborn skin condition that features pea to marble sized lumps, boils AKA acne inversa Centered on inflammation of the large apocrine sweat glands Armpits, groin, between the buttocks and under the breasts 2016 PCCA. All Rights Reserved. 128

129 HS - Clarifying Base Formula #11899 Rifampin 2% / Clindamycin 1% / Pentoxifylline 5% / Glycolic Acid 3% Topical Cream (Clarifying ) Patient instructed to apply to affected areas bid Reddish orange color may discolor skin & stain clothing * Br J Dermatol May;154(5): Clindamycin and rifampicin combination therapy for hidradenitis suppurativa. Mendonça CO1, Griffiths CE PCCA. All Rights Reserved. 129

131 Silicone Decreases Trans Epidermal Water Loss (TEWL) Acts on the epidermis to normalize signaling * Evolution of silicone therapy and mechanism of action in scar management. Aesthetic Plast Surg Jan;32(1): Epub 2007 Oct PCCA. All Rights Reserved. 131

Acne (no atrophy) No atrophy Formula #10901 Clindamycin 1% /

137 Atrophic Acne Formula #11057 Erythromycin 3% / Tretinoin 0.05% PracaSil Plus Formula #11083 Niacinamide 4% / Glycolic Acid 2.5% / Tretinoin 0.05% / Ascorbic Acid 1% / Lactic Acid 2.5% PracaSil Plus 2016 PCCA. All Rights Reserved. 137

Atrophic Scar Formula #10419 Tretinoin 0.

Contracture Formula #10317 Pentoxifylline 0.

140 Hypertrophic / Keloid Formula #10233 Betamethasone Valerate 0.1% / Tranilast 1% PracaSil Plus Formula #10234 Tamoxifen 0.1% / Tranilast 1% / Caffeine 0.1% / Lipoic Acid 0.5% PracaSil Plus 2016 PCCA. All Rights Reserved. 140

141 Straie (stretch marks) Formula #10419 Tretinoin 0.1% PracaSil Plus Formula #10719 Aloe Vera 0.5% PracaSil Plus Formula #10976 Beta Glucan 0.25% / Vitamin E Acetate 2% / Vitamin D3 0.5% PracaSil Plus 2016 PCCA. All Rights Reserved. 141

Compounding Options for Female and Male Patients

Compounding Options for Female and Male Patients Bruce Biundo, RPh and Andrea Branvold, RPh 2016 Las Vegas Hormone Replacement Therapy Symposium Las Vegas, NV February 11 13, 2016 Men s Health: Treating