Buccal Dosage Forms: General Considerations for Pediatric Patients

Abstract

The development of an appropriate dosage form for pediatric patients needs to take into account several aspects, since adult drug biodistribution differs from that of pediatrics. In recent years, buccal administration has become an attractive route, having different dosage forms under development including tablets, lozenges, films, and solutions among others. Furthermore, the buccal epithelium can allow quick access to systemic circulation, which could be used for a rapid onset of action. For pediatric patients, dosage forms to be placed in the oral cavity have higher requirements for palatability to increase acceptance and therapy compliance. Therefore, an understanding of the excipients required and their functions and properties needs to be particularly addressed. This review is focused on the differences and requirements relevant to buccal administration for pediatric patients (compared to adults) and how novel dosage forms can be less invasive and more acceptable alternatives.

Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System

“…Three different pediatric subgroups were considered [24,26,27]: neonate (0–1 month), infant (1–24 months) and child (2–12 years). For each group, the volume was estimated based on the volume of gastric fluids in fasted children, approximately 0.56 mL/kg [28,29,30], relative to the gastric volume of a 70 kg fasted adult (37.1 mL) [29,30] and BCS adult volume of 250 mL.…”

Development of Mucoadhesive Buccal Film for Rizatriptan: In Vitro and In Vivo Evaluation

“…In addition, the buccal route is most suitable for the non-invasive delivery of pharmaceutical actives generally used in acute therapy [ 13 ]. Buccal therapy has attained commercial status, and marketed products include soluble buccal films of buprenorphine hydrochloride (Belbuca), fentanyl buccal soluble film (Onsolis), fentanyl lozenges (Actiq), fentanyl buccal tablets (Fentora) and a combination of buprenorphine and naloxone (Bunavail) as well as the lidocaine patch (Dentipatch) [ 14 ]. The highly perfused oral mucosal membrane can provide a rapid permeation of drug molecules with low bioavailability as well as a short half-life into the blood circulation to deliver its therapeutic effect.…”

A mini-review on drug delivery through wafer technology: Formulation and manufacturing of buccal and oral lyophilizates

“…Buccal dosage forms include mucoadhesive tablets, films, patches, ointments, and hydrogels, each of which has limitations [6]. For instance, ointments and hydrogels are semi-solids that lack dosage precision or adequate hardness to resist tongue removal [4], [7].…”

“…For instance, ointments and hydrogels are semi-solids that lack dosage precision or adequate hardness to resist tongue removal [4], [7]. Although precision can be increased with mucoadhesive tablets, they are often uncomfortably large, limiting long-term residence and release time [6], [8]. These disadvantages can be overcome with the use of films, patches, and wafers [6], [9].…”

“…Although precision can be increased with mucoadhesive tablets, they are often uncomfortably large, limiting long-term residence and release time [6], [8]. These disadvantages can be overcome with the use of films, patches, and wafers [6], [9]. Buccal films are currently the preferred commercial dosage form for extended transmucosal delivery; their action depends on slow matrix erosion, high mucoadhesiveness, and adequate drug loading.…”