Tom Wynn, RPh
In 2011 the Census Bureau estimated that there were 16.4 million children in the United States. One thing we know about children is, as they build their immune system they tend to get sick. Of course, children can also be hard to reason with on the importance of compliance with medication regimens. Compounders have a unique opportunity to help customize therapies and ease medication delivery issues, which can lead to increased compliance.
Some medications can be delivered topically in lieu of oral dosing. This is a unique way to deliver active pharmaceutical ingredients while bypassing much of the metabolism that can occur with oral dosing. Promethazine is commonly prescribed for nausea but has also been shown to help with chronic pruritus.1 While promethazine suppositories have been a mainstay in pediatrics, promethazine can also be delivered topically and has historically produced very good therapeutic results. In vitro penetration studies have shown high flux potential through the skin.2 Topical promethazine formulations can be applied to thin skin areas such as wrists or shoulder blades.
Behavioral medications can also be delivered in a topical preparation. Selective serotonin inhibitors can cause many side effects including nausea and gastrointestinal distress. Feasibility studies have been preformed with topical fluoxetine, and show good suitability for topical delivery.3 In a case study topical sertraline was used successfully in a 6 yr old patient being treated for anxiety.4 In the study the child had been on a liquid formulation that caused mouth numbing and some GI disturbances. The topical sertraline formulation alleviated those side effects and worked well to control the anxiety.
Possible topical formulations:
Promethazine Hydrochloride 12.5 mg/ 0.1mL Cream (Lipopen)
Setraline 4 mg/ 0.1mL Cream (Pentravan)
Another unique dosing opportunity is the use of lollipop base. What child doesn’t like a lollipop? This form of delivery can have the appeal of providing both local and systemic delivery. Canker sores, strep throat, and dental procedures can all provide stress to a pediatric patient. A lollipop containing a numbing agent can help soothe the mucosal membranes and allow localized pain relief.5,6 Lollipops are typically made out of sorbitol, isomalt or sucrose. The bases are melted then reformed in lollipop molds after cooling.
When formulating lollipops with numbing agents, antifungals can be added for conditions involving thrush. Ingredients like sucralfate and hyaluronic acid may be added for patients receiving radiation treatments to soothe and promote healing.
Pharmaceutical round ball or rectangle lollipop molds are typically 6-9 grams. This size lollipop is not designed to be administered all at once. The lollipop is more likely to be used over the course of several days. Depending on the active ingredients being delivered a lollipop may be used 2-4 times per day. Duration of use is usually for 30 seconds to a minute.
Possible lollipop formulations:
Tetracaine Hydrochloride 0.5% lollipop (Freedom Lollipop Base)
Clotrimazole 1% / Lidocaine Hydrochloride 0.5% lollipop (Lollibase®)
Liquid suspensions are the most common dosage form used for pediatric patients. Liquids are typically easier for pediatrics patients since it takes some children quite a while to learn how to swallow a tablet or capsule. Suspensions can be made with various forms of suspending agents. Suspensions can be aqueous using cellulose thickening agents or anhydrous fixed oils suspensions. There are many commercially available suspending vehicles on the market. SyrSpend® is one such example, and has been studies with over 90 commonly prescribed Active Ingredients. SyrSpend® contains non-nutritive sweeteners and suspending agents, making it a simple one-step process for compounding.
The right addition of flavors and enhancers such as stevia, marshmallow, and chocolate can all help to effectively to mask bitterness. In addition, bitterness suppressor formulations in powders and liquids can be very useful in masking bitter taste.
Possible liquid formulations:
Metronidazole 50 mg/mL Oral Suspension (SyrSpend® SF)
Omeprazole 2 mg/mL Oral Suspension (SyrSpend® SF Alka)
There are many opportunities for compounding in pediatric medicine. If you have any questions regarding these or other compounding opportunities, feel free to contact a FACTS compounding consultant
- T. Patel and G. Yosipovitch. The management of chronic pruritus in the elderly. Skin Therapy Letter, vol. 15, no. 8, pp. 5–9, 2010.
- Babar A, Ray SD, Patel NK, Plakogiannis FM, Gogineni P. In vitro release and diffusion studies of promethazine hydrochloride from polymeric dermatological bases using cellulose membrane and hairless mouse skin. Drug Dev Ind Pharm. 1999;25(2):235-240.
- Parikh DK, Ghosh TK. Feasibility of transdermal delivery of fluoxetine. AAPS PharmSciTech. 2005;6(2):E144-E149.
- Wynn T. , D.Goetsch. Sertraline Cream for Transdermal Administration. IJCP 2011;15(3).
- Muller G, Case T, Deen GL. Tetracaine lollipops for the suppression of extreme gag reflex in dental patients. Int J Pharm Compd. 14(5):395-399. http://www.ncbi.nlm.nih.gov/pubmed/23965583. Accessed February 23, 2016.
- Ayoub C, Skoury A, Abdul-Baki H, Nasr V, Soweid A. Lidocaine lollipop as single-agent anesthesia in upper GI endoscopy. Gastrointest Endosc. 2007;66(4):786-793.
SyrSpend® SF is an innovative vehicle range for the compounding of oral liquid dosage forms. Based on food starch, SyrSpend® SF’s superior suspending properties provide consistent, individual dosing throughout treatment. The excellent compatibility with a broad range of active pharmaceutical ingredients (APIs) and meticulous ingredient safety make SyrSpend® SF highly suitable for compounding safe and stable customized medication for all patient groups, from neonates to the elderly.
Click here to download SyrSpend® BUD table.
Above are examples of some commonly prescribed formulations across a diverse array of specialties, and is not meant to encourage the use of any formula contained within. Fagron Academy, its owners, officers, agents, affiliates and employees make no representation or warranty whatsoever with respect to this Example Formula. Customer understands and agrees that Fagron Academy, its owners, officers, agents, affiliates and employees shall not be responsible for any claims, actions, liabilities, losses, expenses, damages, judgment or costs arising directly or indirectly or related in any way to any actual or alleged injury to any person (including death) resulting or claimed to result wholly or in part from any formulation that is the same or similar to any Example Formula. No compounded medication is reviewed by the FDA for safety or efficacy. References available upon request.