Cumulative Risks of Excipients in Pediatric Phytomucolytic Syrups: The Implications for Pharmacy Practice

Abstract

Expectorant phytomucolytic syrups are widely used pediatric OTC-medicines. Physicians, pediatricians, and pharmacists are traditionally concerned with the efficacy of the active ingredients in cough syrups, and rarely consider the safety aspects of excipients that however are not absolutely “inactive” and are proved to initiate some negative reactions and interactions with other drugs. This paper presents a review, categorization, and comparative analysis of the safety profile of excipients contained in the 22 best-selling OTC pediatric phytomucolytic syrups available in pharmaceutical markets in Ukraine and Germany and proposes an approach to the consideration of the excipients’ safety risks for a pharmacist in the process of pharmaceutical care. The study has revealed that only one of the twenty-two analyzed syrups does not contain any potentially harmful excipients. The results of this analysis were used for developing a specific decision tool for pharmacists that can be used for minimizing excipient-initiated reactions when delivering OTC phytomucolytic syrups for children.

Development of a Hydroxypropyl-β-Cyclodextrin-Based Liquid Formulation for the Oral Administration of Propranolol in Pediatric Therapy

“…Furthermore, the obtained products can result unpleasant in taste and appearance, leading to poor compliance in the pediatric population [ 6 , 7 ]. Moreover, the presence in such formulations of excipients such as preservatives, colorants, sweeteners, flavoring agents, or organic solvents, which could be potentially harmful to children, particularly for infants and neonates, should be considered [ 8 , 9 , 10 , 11 ]. In fact, safety concerns with some excipients may emerge when they are used in products intended for the pediatric population, particularly in infants [ 12 ], as has been reported, for example, for parabens [ 13 , 14 ], benzalkonium chloride [ 14 , 15 ], saccharin sodium [ 14 , 15 ], propylene glycol [ 14 , 16 , 17 ], and ethanol [ 14 , 18 ].…”

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

“…In addition, taste masking which often relies on sweeteners is important to improve palatability. Texture and viscosity are also key attributes for patient acceptability [ 10 , 11 , 12 , 13 , 14 ].…”

In-class Exercises Regarding the Roles of Excipients in a Pharmaceutics Course

“… 2 , 3 , 5 - 7 In general, the package insert, 5 as well as other professional resources, will identify the individual excipients used in the preparation of the dosage forms. A general understanding of the excipients and their roles in dosage forms are important for the compounding of medications and patient care, including consultation, 8 - 10 particularly as some excipients may exhibit adverse effects. 6 , 8 , 10 - 12 Moreover, compounding of dosage forms is part of the Entrustable Professional Activities Practice Manager Domain, 13 and dosage forms or delivery systems that by definition usually include excipients are mentioned in the North American Pharmacist Licensure Examination (NAPLEX) Competency Statements.…”

“…A general understanding of the excipients and their roles in dosage forms are important for the compounding of medications and patient care, including consultation, [8][9][10] particularly as some excipients may exhibit adverse effects. 6,8,[10][11][12] Moreover, compounding of dosage forms is part of the Entrustable Professional Activities Practice Manager Domain, 13 and dosage forms or delivery systems that by definition usually include excipients are mentioned in the North American Pharmacist Licensure Examination (NAPLEX) Competency Statements. 14 ___________________________________________________ Corresponding Author: Eytan A. Klausner, BPharm, PhD Department of Pharmaceutical Sciences South College School of Pharmacy, Knoxville, TN 37922 Phone number: 865-288-5835 Email: eklausner@south.edu Excipients and their roles are usually taught in foundational pharmaceutics courses 15 as well as non-sterile compounding courses.…”