Maximizing Your Competitive Advantage · Maximizing Your Competitive Advantage ... altered taste...

Maximizing Your Competitive Advantage

Nat Jones, RPh, FIACPErin Michael, MBA, CPhT, Director of Outside Sales

PCCA Marketing and Sales SymposiumSan Diego, CA

May 12‐14, 2016

© 2016 PCCA. All Rights Reserved. 1

What Advantage?• PCCA tools

– Bases, chemicals, equipment– R & D– Formulations– Marketing materials– Training & Education (C3, C4,

Seminars, Webinars), VOD– PCD


How Many?????

• Bases / Products / API’s– 60 + bases – 7000 + products– 3000 + API’s– Formulations (9000+)


Base Focus

• MucoLox™• XemaTop™• Clarifying™• PracaSil™‐Plus: Rx and OTC


MucoLox™

• For all mucous membranes– Oral – Nasal – Vaginal – Rectal

• Wounds too!


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


Mucus X PolymersMucins 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


Mucoadhesion process can be a consequence of interactions between the mucus layer and the mucoadhesive polymer


Rheological tests were performed using the rupture tensile strength test, most frequently used in studies on mucoadhesion

TM


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


Topical Application of Control Product

Showing disappearance of reference product after 5 min of incubation and washing


Topical Application of MucoLox™ Pilot

Gel retention after 40 min of incubation and washing


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


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)


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


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


Mucosa

1. Stratum basale 2. Stratum spinosum 3. Stratum granulosum 4. Stratum corneum


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


Masticatory Mucosa

Attached Gingiva


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


Mucosa

• The lip is thinly keratinized and has a high concentration of eleidin


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


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)


Mucositis… A Big Problem


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)


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. 2013 Nov;21(11):3233‐41. Emerging evidence on the pathobiology of

mucositis. Al‐Dasooqi N, et al.


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 non‐pharmacologic and pharmacologic methods.

* US Pharm. 2011;36(7)(Oncology suppl):12‐15. Oral Mucositis and Compounded Mouthwashes. Loyd V. Allen, Jr, PhD, RPh


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):12‐15. Oral Mucositis and Compounded Mouthwashes. Loyd V. Allen, Jr, PhD, RPh


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;120:1453–61. VC 2014. MASCC=ISOO Clinical Practice Guidelines for the

Management of Mucositis Secondary to Cancer Therapy. Rajesh V. Lalla, DDS, PhD1, et. al.


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


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


MucoLox™ Oral - Mucositis

• Formula #11144 ‐ Stanford Modified Mouthwash– Tetracycline Hydrochloride USP – Nystatin USP – Hydrocortisone USP Micronized – Diphenhydramine Hydrochloride USP

• Formula #11133 ‐Misoprostol 0.0024% / Diphenhydramine HCl 0.1% / Lidocaine HCl 1% Oral Rinse


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). 2013 Sep;22(5):564‐79. 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.


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.


The Nasal Cavity


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


Epistaxis


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. 2013 Jul 23;7:CD010562. Topical application of tranexamic acid

for the reduction of bleeding. Ker K1, Beecher D, Roberts I.

* Emerg Med J. 2014 May;31(5):436‐7. Best evidence topic reports. BET 3: Topical intranasal tranexamic acid for spontaneous epistaxis. Hilton L


Epistaxis

• Formula #11429 ‐ Tranexamic Acid 10% Nasal Drop (MucoLox™) – Dose: 2 sprays in affected nostril

• Formula #10618 ‐ Tranexamic Acid 10% Poloxamer Nasal Spray


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


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.


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. 2013 Nov‐Dec; 27(6): 473–478. Epidemiology and differential diagnosis of

nasal polyps. Chaaban MR, et al.

* Laryngoscope. 2003 Jul;113(7):1199‐205. The epidemiology of chronic rhinosinusitis in Canadians. Chen Y1, Dales R, Lin M.


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


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


Nasal Polyposis


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. 473‐478(6)


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


Sinus Anatomy


Ducts and Sinus Openings


Ciliary Mucous Flow


Sinusitis


Rhino-sinusitis


Sinusitis

• Acute– Symptoms lasting fewer than 8 weeks

• Chronic– Symptoms recurring or lasting longer than 8 weeks

• Recurrent– With three or more acute episodes a year


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)


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.


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.


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


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


XyliFos™

• Ingredients– Xylitol– Poloxamer 407– Hydroxypropyl betadex– Epigallocatechin Gallate


Base: PCCA XyliFos™patent-pending technology


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, anti‐inflammatory and antihistamines used in the formulations through a unique patent‐pending EGCg – Cyclodextrin complex

• Improving formulation substantivity (mucosal adhesiveness) as well as moisturization


XyliFos™/ LoxaSperse™ Combination

Optical Microscopy ‐ 100x Magnification


Nasal Nebulization and Irrigation Ingredients


Ingredients (cont’d)


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. 12 6432‐6433. Stability of

Colistimethate Sodium in Aqueous Solution. A. M. Healana, W. Grayb, E. J. Fuchsc, J. M. Griffissd, R. A. Salataa and J. Blumerb


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 #1


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 10/7/15


Materials Available to You

• Compounding ideas sheet for ENT– PCCA Document #99025

– Recently Requested Formulas


Comparing Formula Cost

$112.83With LoxaSperse™ (PCCA Formula #10341)Budesonide Micronized USP: 0.5mg $9.30Base, PCCA LoxaSperse™: 44.681gm $100.53PCCA Capsule Size #1: 100 ea. $3.00Cost per unit $1.13


Comparing Formula Cost

$56.33With LoxaSperse™ / XyliFos™ (PCCA Formula #11603)Budesonide Micronized USP: 0.5mg $9.30Base, PCCA LoxaSperse™: 4.48gm $10.08Base, PCCA XyliFos™: 39.946gm $33.95PCCA Capsule Size #1: 100 ea. $3.00Cost per unit $0.56


MucoLox™ Vaginal Possibilities

• Hormones• Dryness• Pain• Infections

• PCOS• Genital warts• Itching


MucoLox™: Vaginal Hormones

• Estrace® Vaginal Cream 42.5gm $285.55 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®)


MucoLox™: Vaginal Hormones

• Formula #11386 ‐ Dehydroepiandrosterone 13mg/Gm Vaginal Gel– Dosage range 3.5 to 13mg* Menopause. 2015 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.


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. 2011 Dec;17(4):120‐5. doi: 10.1258/mi.2011.011030. 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.


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. 2008 Sep;112(3):579‐85. Topical gabapentin in the treatment of localized and

generalized vulvodynia. Boardman LA, Cooper AS, Blais LR, Raker CA


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®


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?


MucoLox™: Vaginal Infections

• Formula #11413 ‐ Acyclovir 5% / Lidocaine HCl 5% / Deoxy‐D‐Glucose 2% Vaginal Gel– Apply 5 times a day– Herpes happens


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 (02‐14 + 11‐15 Apothagram)Formula #10871 ‐Metformin HCl 10% Topical Lipoderm®


Genital Warts

• Commercial 5FU Cream >$150/40gm– Formula Alternate #11111 ‐ Fluorouracil (5‐FU) 5% Topical Gel (MucoLox™ / VersaBase®)

• Vaginal or introital use

• Formula 11416 ‐ Deoxy‐D‐Glucose 0.2% / Acyclovir 5% / Imiquimod 2.5% / Tea Tree Oil 2.5% Vaginal Gel (MucoLox™ / VersaBase®)


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®)


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


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®)


GI / Rectal MucoLox™ Possibilities

• Radiation proctitis• Perianal Crohn's • Fissures• Gut recovery


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). 2014 Oct;239(10):1300‐9. 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). 2013 Oct;238(10):1127‐35. 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


Wound Gel

• Misoprostol decreases healing time of acute wounds• Formula #11953 ‐Misoprostol 0.0024% / Phenytoin 2% / Beta Glucan 0.5% Topical Gel (MucoLox™)– For shallow or deep wounds– 10 day BUD* Wounds. 2007 Dec;19(12):334‐9. Topical misoprostol and wound healing in rats. Mahoney J1,

Ponticello M, Nelson E, Ratz R.


Wound Gel

• Formula #11975 ‐ Aloe Vera 0.2% / Arginine HCl 1% / Misoprostol 0.0024% / Naltrexone HCl 1% Topical Gel (MucoLox™)


Marketing Moment

• Target audience– Oncologists– Cancer Centers– ENTs– OB/GYNs– GPs– Dentists– Others??


Skin


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


Gut Repair Helps the Skin

• Digestive enzymes• Probiotics• Prebiotics

• Glutamine • Zinc‐carnosine• Sialic acid


Barrier


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


Skin Barrier

Structure of the outermost corneous layer of skin (SC). The structure of the lipid bilayer of SC

membrane is shown at the bottom.

Flattened, Dead, keratinized cells, without a nucleus

Corneocytes

CeramidesFatty acidsCholesterolCholesterol sulfate

Intracellular lipid matrixStratum corneum

Lipid bilayer


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


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


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, 949–963; Skin Barrier Disruption: A

Requirement for Allergen Sensitization? De Benedetto A, Kubo A, Beck LA


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, 949–963; Skin Barrier Disruption: A

Requirement for Allergen Sensitization? De Benedetto A, Kubo A, Beck LA


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


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


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


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


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


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


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


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


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


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


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


Hydroxyphenyl Propamidobenzoic Acid

• A synthetic avenanthramide• Avenanthramides are potent anti‐inflammatory agents that appear to mediate the anti‐irritant effects* Arch Dermatol Res. 2008 Nov;300(10):569‐74. Avenanthramides, polyphenols from oats,

exhibit anti‐inflammatory and anti‐itch activity. Sur R1, Nigam A, Grote D, Liebel F, Southall MD.


• An article by Rino and colleagues (2010) highlighted a substance called avenanthramide within the colloidal oatmeal that inhibit pro‐inflammatory factors p.368


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.


• 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

Paraphrased


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


Clarifying™ Base Ideal for…

• Teenage acne• Adult acne• Rosacea• Oily skin• Aging skin prone to acne


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


Clarifying™ Base Study• Stand alone cosmetic product that can be sold in your store with proper labeling

• Document #99071


Commonly Compounded With:

• Benzoyl peroxide• Salicylic acid• Tretinoin• Erythromycin

• Clindamycin• Niacinamide• Sulfacetamide• Metronidazole

Currently 48 formulas approved


Clarifying™ Base with Benzoyl Peroxide


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


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. 2006 May;154(5):977‐8. Clindamycin and rifampicin combination therapy for hidradenitis suppurativa. Mendonça CO1, Griffiths CE.


Fibroblast

• A type of cell in the dermal layer of the skin that synthesizes the extracellular matrix and collagen

• Collagen, is the main structural protein


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. 2008 Jan;32(1):82‐92. Epub 2007 Oct 30.


Sheet vs.Gel


PracaSil™-Plus

• Anhydrous silicone base with Pracaxi oil

• Designed for scar and cosmetic formulas

• OTC sales with proper label


General Post Surgical Formula

• Formula #10235– Dimethyl Sulfone 2%– Tranilast 1%– EGCg 1%– Ascorbic Acid 2%– PracaSil™‐Plus


Acne (no atrophy)

• No atrophy– Formula #10901 ‐Clindamycin 1% / Benzoyl Peroxide 3% PracaSil™‐Plus


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


Atrophic Scar

• Formula #10419 ‐ Tretinoin 0.1% PracaSil™‐Plus

• Expectation – Gradual improvement over 6‐12 months


Contracture

• Formula #10317 ‐ Pentoxifylline 0.3% / Caffeine 1% / EGCg 1% PracaSil™‐Plus

• Formula #10649 ‐ Pentoxifylline 1% / Caffeine 1% / Tranilast 1% PracaSil™‐Plus


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


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


PracaSil™-Plus OTC Labeling• PCCA PracaSil™‐Plus Marketing & Repackaging Guidelines (document #98678 on Members Only Website)


Marketing Moment

• Target market– Dermatologists– Cosmetic Surgeons– Vets(PracaSil™‐Plus)– GPs– Day spas– Others??


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