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by Rudesha Sanders, PharmD Candidate, PCCA Clinical Services Intern, and Tricia Heitman, PharmD, PCCA Clinical Compounding Pharmacist
Developing pharmaceutical products for pediatric patients generally requires age appropriate, weight-based dosing or extensive formula considerations. Most commercially available drug products are not formulated with pediatric populations in mind; they are often generated using unsafe excipients or produced in inappropriate dosage forms.1
We should eliminate the use of these known excipients in compounds for neonatal (birth – 28 days) patients as much as possible due to toxicities:
Benzyl alcohol intoxication can lead to metabolic acidosis and possible respiratory depression; ethyl alcohol is known to cause neurotoxicity and cardiovascular problems in pediatric patients; and high doses of propylene glycol can affect the central nervous system.2
In addition, the above-mentioned excipients are known to accumulate more in a neonate’s system due to the baby’s premature and underdeveloped organs — exercise caution if including any of the excipients in a compounded preparation.
Caution should also be exercised with other excipients, including benzalkonium chloride; polysorbate; peanut oil or other known food-related allergens such as lactose, sorbitol, sucrose, aspartame, saccharin, artificial colors; as well as sulfites such as sodium metabisulfite and sodium bisulfite, which may cause allergy-like reactions.1-3
As infants (ages 29 days – < 2 years) and children (ages 2 years – < 12 years) grow, so do their organ systems; however, excipients remain a concern. Ethyl alcohol should be avoided in children under 2 years of age. Children 2 to 5 years of age should receive no more than a 6 mg/kg/dose of ethyl alcohol daily, with less than 0.5% percent volume in volume (v/v). Children 6 years and older should receive no more than 75 mg/kg/dose of ethyl alcohol daily; ages 6 to 12 years should receive less than 5% (v/v) of ethyl alcohol daily; and children ages 12 and older should receive less than 10% (v/v) of ethyl alcohol per day.1,3
Benzyl alcohol is contraindicated in children 3 years old and younger. Polyethylene glycol should be used with caution in infants. It is recommended to use propylene glycol with caution in children less than 4 years old.2
We should always be mindful of the types of dosage forms used when compounding preparations for children. Dosage forms should always be individualized to accommodate the child’s age, specific needs and preferences, as well as always dispensed in child-resistant packaging.
Oral suspensions, for example, are generally formulated in oil bases and pose a threat for aspiration, which can lead to lipoid pneumonia.3,4 To reduce this risk, children under 2 years of age or children at high risk for aspiration should have oral suspensions formulated with aqueous bases. SuspendIt® Anhydrous is a great base for pediatric patients: it’s preservative free; its anhydrous property allows for the potential of extended beyond-use dates (BUDs) and convenience for a parent or caregiver; its ability to mix easily with water, juice or other flavored liquids may possibly improve patient adherence; and its self-emulsifying drug delivery system allows use in nasogastric feeding tubes without clogging.6
Avoid using lollipops in children younger than 5 years of age due to the potential choking hazard — where the stick dislodges from the preparation — unless the child is closely supervised by a caregiver or medical personnel. Other challenges include flavoring issues and that lollipops must remain in the mouth for an extended period before they completely dissolve.
Like lollipops, hard troches should also be avoided in children under 5 years of age. In the event other dosage forms are not available or possible, ensure the child is closely monitored and supervised by a caregiver or medical personnel. Gelatin troches may be an option for children 2 years and older who have their primary teeth and can safely chew and swallow.7
Suppositories are generally a safe option in pediatric patients; just ensure use of the smallest size suitable for the dosage quantity.
Topical dosage forms are often a convenient and effective way to dose a child. The volume dispensed should be accurately measured and based on the patient’s age and weight. If a child has siblings, pets or attends school, instruct the child’s parents or caregivers to avoid placing the topical medication in an area where accidental transference to another child, caregiver or pet could occur.8
Remaining mindful and cautious of formulations and dosage forms used to compound preparations for neonates and infants will help reduce the accumulation of harmful toxicities. Applying the right dosage form with consideration toward the child’s age, specific needs and preferences, as well as their height and weight, will help ensure the safety and efficacy of compounded medications for pediatric patients.
These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.