Formulas for Pediatric and Specialty Populations. Saad Dinno, BSPharm, RPh, FIACP, FACA President, Co-Owner Acton Pharmacy

Transcription

1 Formulas for Pediatric and Specialty Populations Saad Dinno, BSPharm, RPh, FIACP, FACA President, Co-Owner Acton Pharmacy

2 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.

3 Disclaimer 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.

4 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

5 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

6 Eosinophilic Esophagitis Budesonide 1-3mg/5-10mL 5-10mL PO BID More expensive Mometasone 750mcg/5mL 5-10mL PO QD-BID Lower-cost API Tastes less bitter 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.

7 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: doi: /dote 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 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):

8 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

9 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 Autism 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 Guanfacine 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)

10 Atomoxetine 10mg/mL Susp Atomoxetine capsules Oil-based suspension Autism 0.05% Saccharin Sodium, 0.1% BHT, 0.5% Steviol, 2% silica gel, 2% Flavor Well tolerated Nystatin 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

11 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

12 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)

13 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

14 Ketogenic Diet Valproic Acid 250mg/5mL Susp Valproic Acid powder Contains: 0.2% sodium benzoate, 1:1 water:methylcellulose 1% base Dissolve powders in water, QS with Methlycellulose 1% susp No flavor, all of our patients who have been/are on this medication are G-tube Levetiracetam 100mg/mL Susp 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

15 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

16 Questions?