Formulas for Pediatric and Specialty Populations

Saad Dinno, BSPharm, RPh, FIACP, FACA

President, Co-Owner

Acton Pharmacy

Disclosures

“I, Saad Dinno, declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.”

These are formulas that we have utilized and examined for our patients and prescribers. We strongly encourage you to do your own BUD studies and research. The information provided below is for reference purposes only.

Disclaimer

Learning Objectives

• Identify innovative practice techniques not currently being utilized in attendees’ own pharmacy practice

• Discuss implementation of these techniques

• Discuss recent developments in pharmacy practice and how to take advantage of several new opportunities

Eosinophilic Esophagitis

• Inflammation of the esophagus

– “contact dermatitis” of the esophagus

– Results from food allergen exposure

• May be chronic, despite allergen avoidance

• May be acute (commonly), avoidance of allergen sufficient

• Seen in both children and adults

– Children have shorter esophagus – usually up to 5mL/dose

– Adults have longer esophagus – 5-10mL/dose

Eosinophilic EsophagitisMometasone

• 750mcg/5mL– 5-10mL PO QD-BID

• Lower-cost API• Tastes less bitter

Budesonide

• 1-3mg/5-10mL

– 5-10mL PO BID

• More expensive

• Both work well, depends on the preference of the MD• Both can be made in a 2% Methylcellulose suspension

or in other thick vehicles• 2% flavor, 0.2% Steviol, 0.1% Acesulfame

• Recommend refrigeration, mostly for flavor.

Eosinophilic Esophagitis, continue

• Do not eat/drink for 30 minutes after swallowing med. Can brush teeth/mouth to reduce bitterness. Pina Colada flavoring ideal, masks the bitterness best.

• Both are charged corticosteroids which have a low absorption profile in the GIT

• There are multiple clinical trials currently underway (clinicaltrials.gov), ORBIT2 being the more prominent study• Chan, L. J., Tan, L., Dhaliwal, J., Briglia, F., Clarkson, C. and Krishnan, U. (2016), Treatment outcomes for eosinophilic esophagitis in

children with esophageal atresia. Dis Esophagus, 29: 563–571. doi:10.1111/dote.12368• A prospective open clinical trial of a proton pump inhibitor, elimination diet and/or budesonide for eosinophilic oesophagitis.

Alimentary Pharmacology & Therapeutics [Aliment Pharmacol Ther] 2016 May; Vol. 43 (9), pp. 985-93. Date of Electronic Publication: 2016 Mar 04

• Dysphagia and quality of life may improve with mometasone treatment in patients with eosinophilic esophagitis: a pilot study. Otolaryngology-Head & Neck Surgery (OTOLARYNGOL HEAD NECK SURG), Oct2011; 145(4): 551-556.

Autism

• No one specific drug that is used to “treat” autism

• Medications prescribed are usually for mood, anxiety, hyperactivity, aggressive behavior, or GIT fungal infections.

• Myriad of different medications, ranging from mirtazapine to atomoxetine for mood/behavior

• Formulations depend on stability of medication

AutismGuanfacine

• Can make 1mg/5mL suspension

• In Oil or Ora Plus:Ora Sweet

• Oil

• 2% silica gel, 0.2% steviol, 2% flavor

• BUD 90 days (USP <795> non-aqueous formulation)

• Ora Plus:Ora Sweet

• 2% flavor

• BUD 14 days (USP <795> aqueous systemic formulation)

Clonidine• Can make into 0.1mg/mL or 0.1mg/5mL

solution

• Depending on how small of a dose prescriber wants

• HIGH ALERT – dose warning

• Clonidine 1:100mg aliquot utilized for safety

• Never use the straight powder – hard to weigh and can cause damage/death if wrong amount used

• Wet aliquot with water, QS with simple syrup

• Stability 28 days refrigerated per Trissel’s & IJPC

AutismNystatin 1MU/5mL Susp

• Nystatin powder

• Water-based formulation, sugar free

• Steviol 0.2%, Sodium benzoate 0.2%, xanthan gum 0.2%, glycerin 8%, Tutti-frutti 1.6%, water base

• Make a paste of powders w/ glycerin

• Add in flavor, slowly work up to volume with water in 30mL increments

Atomoxetine 10mg/mL Susp

• Atomoxetine capsules

• Oil-based suspension

• 0.05% Saccharin Sodium, 0.1% BHT, 0.5% Steviol, 2% silica gel, 2% Flavor

• Well tolerated

Smith-Lemli-Opitz (SLO) Syndrome• Genetic disorder, can be diagnosed in utero (amniocentesis for Down’s has sensitivity for

SLO), at birth, or later in life

– Is an inability (or decreased) production of cholesterol by the body

– Leads to decreased membrane fluidity, lack of or diminished vitamin D, Coenzyme Q10, neurotransmitters, hormones, and other cholesterol-based molecules synthesized by the body

• Characterized by: webbing in fingers/toes, growth and mental development delays, mental retardation, death at early age

• May be severe (diagnosed at birth), or mild (diagnosed later in life)

• Only treatment is cholesterol supplementation

– Either through egg-yolk (each yolk contains 200mg Cholesterol, symbol of SLO), or compounded medications

Smith-Lemli-Opitz (SLO) Syndrome• Cholesterol 200mg/mL suspension

• Cholesterol powder, oil base

• Oil can be whatever patient can tolerate (allergies)

• Thicker oils – Soybean, Almond – are ideal

• Use either a hand blender or GM300 (a Cuisinart™ blender on steroids – made by Retsch) to mix

• Leads to a better suspension

• Will settle, but re-suspends easily with shaking. Thicker oils yield better suspendibility, as well as using the GM300 since it creates smaller particles and settling occurs less rapidly

• BUD 90 days (per USP <795> non-aqueous formulation)

Ketogenic Diet• Is a high-fat, low carb diet, designed by a nutritionist for each patient to help with seizure

control

– MOA: 1) theorized that blood alkalinizes to a certain extent because of the ketones produced in fat catabolism in the absence of sugars 2) ketone bodies cross the BBB and enter the CNS, having a stimulatory effect on GABA-receptors (more current evidence)

• Was the first-ever therapy for seizure control, developed in the 1920’s

– Now is considered a supplement to seizure medications, or last-line for seizure control

• Many seizure medications (valproic acid, levetiracetam, clobazam, etc.) are either syrup-based, or contain sugar alcohols, glycerin, or other non-keto-friendly components

• Many seizure medications can be compounded to be ketogenic friendly

• Can use Methylcellulose 1% as a base, or an oil

– Both are keto-friendly

Ketogenic Diet

Levetiracetam 100mg/mL SuspValproic Acid 250mg/5mL Susp

• Valproic Acid powder• Contains: 0.2% sodium

benzoate, 1:1 water:methylcellulose 1% base– Dissolve powders in water,

QS with Methlycellulose1% susp

• No flavor, all of our patients who have been/are on this medication are G-tube

• Levetiracetam powder• Contains: 0.3% steviol, 2%

strawberry flavor, 1% marshmallow flavor, 0.6% Bitter-Stop™, methylcellulose 1% base– Dissolve powders in

Methylcellulose 1% base, add in flavors

• Leave out flavors/sweeteners in G-tube patients

Additional Info

• There are many niches in GI, Neurology, Pediatrics, and other specific fields that allow for specific compounds.

• Quality, above all else, is necessary to create a good relationship with providers

– Once established, can use the compound formulas developed with other physicians and grow the niche

• Trissel’s, IJPC, Nationwide Children’s, your local children’s hospital, and others will have resources for formulas and stability

– Follow formula based on stability studies performed by the reference

Questions?