Archives of Pharmacy

Parenteral preparations for administration in the pediatric population: The challenges of excipients selection

2025-10-26T17:25:51+01:00

The need for the development of age-appropriate preparations for patients under 18 years of age is important to ensure appropriate therapy for all children via different routes of administration. Parenteral administration of medicinal products in the pediatric population is common in hospitalized patients, in emergency situations or when the (per)oral route of administration is not possible. The development of a drug formulation for parenteral administration in children requires the consideration of the route of administration (related to physiological differences between children and adults), the site of action and the duration of the pharmacological action of the active substance, the volume of the preparation and the general health condition of the patient. A major challenge in the formulation of these preparations is the selection of excipients that should ensure adequate product quality and patient tolerability.The paper presents an overview of considerations related to the formulation of parenteral preparations for the pediatric population. The regulatory requirements regarding the use of excipients with confirmed effects and the labeling of preparations containing them are listed. Also, modern approaches (databases and tools) that can be useful for the selection of appropriate excipients were considered.

Innovations in pediatric dosage forms via 3D printing: Chewing lozenges as an example

2025-10-26T17:25:51+01:00

Three-dimensional (3D) printing offers a versatile platform for producing personalized, age-appropriate dosage forms that address the specific therapeutic and administration needs of the pediatric population. Among several oral dosage forms that can be prepared by 3D printing, chewing lozenges offer numerous advantages, especially for the pediatric population. This study illustrates a formulation development and selection of process parameters for 3D-printed chewing lozenges containing propranolol hydrochloride as a model drug, with potential application in the pediatric population. It also highlights the advantages of 3D printing using the semi-solid material extrusion method. Gelatin and sodium alginate were used as carriers for 3D printing. Immersion time in the calcium chloride solution (t_im) and lozenges shape were varied, while the following tests were performed: the assessment of organoleptic properties, mass and thickness variations, melting and disintegration time, drug content and dissolution rate. Initially, the key 3D printing parameters for lozenge production were identified, and then the appropriate formulation was selected. Subsequent testing demonstrated that the shape of lozenges, along with variations in t_im, influenced the pharmaceutical-technological characteristics. A formulation based on the combination of gelatin and sodium alginate in 1:3 ratio, immersed for 60 seconds in a calcium chloride solution, was found to be suitable for 3D printing of chewable lozenges.

Preparation of orodispersible films using semisolid extrusion 3D printing: A versatile manufacturing approach

2025-10-26T17:25:51+01:00

Orodispersible films (ODFs) emerged as a patient-friendly dosage form that is particularly suitable for pediatric therapy, where swallowing difficulties often interfere with adherence to therapy. In this study, the preparation of ODFs using semi-solid extrusion (SSE) 3D printing was investigated as an alternative to the conventional solvent casting method. Four hydrophilic polymers – hydroxypropyl cellulose (HPC), polyethylene glycol-polyvinyl alcohol graft copolymer (PVA-PEG), maltodextrin (MDX) and sodium alginate (SA) – were used either individually or in binary blends, with caffeine selected as the model active ingredient. Films were printed on an Ultimaker 2+ system and evaluated for uniformity, thickness, porosity, moisture content, mechanical strength, disintegration and drug release. Formulations containing only MDX or PVA-PEG exhibited poor printability due to leakage and spreading, while other systems showed reproducible film deposition and satisfactory dimensional stability. Binary blends generally resulted in increased film thickness. SA-based films showed the lowest porosity and moisture absorption, while HPC films exhibited favorable mechanical properties. The investigated samples achieved rapid disintegration and complete release of the caffeine. These results confirm the potential of SSE 3D printing as a versatile manufacturing platform for customizable ODFs that enable precise dosing and patient-centric design for pediatric drugs.

Food supplements in the pediatric population of Serbia: A review of commonly used products

2025-10-26T17:25:52+01:00

Food supplements (FS) are products intended to provide additional nutrients to the normal diet. They contain concentrated amounts of nutritive and non-nutritive compounds with a nutritional or physiological effects and are available in various dosage forms for ingestion in small, defined quantities. In recent decades, FS have become increasingly popular among children. When developing pediatric products, both the nutritional needs and the safety aspects specific to this population group are considered. This report analyzes dietary supplements used by children in Serbia, focusing on dosage, safety and the existence of official guidelines. The analysis includes vitamins (D, K and B-complex), probiotics, omega-3 fatty acids, beta-glucans and various herbal products. Although these supplements are widely used in Serbia, there are official pediatric guidelines only for vitamin D, vitamin K, probiotics and omega-3 fatty acids. Herbal supplements are particularly problematic due to insufficient data on safety, interactions and possible side effects. Therefore, increased education of both parents and healthcare professionals is essential to ensure appropriate intake, maximize health benefits and support the proper and safe use of supplements in the pediatric population.

Herbal medicinal products for respiratory infections in the pediatric population

2025-10-26T17:25:52+01:00

Cough and cold represent some of the most prevalent indications for using herbal medicinal products in pediatric care across European countries. These herbal medicines are generally regarded as safe, with their efficacy predominantly classified as good to very good. Traditional herbal medicinal products based on mucilaginous herbal drugs like Althaeae radix, Malvae folium, Lichen islandicus and Plantaginis lanceolatae folium are used in the treatment of oral and pharyngeal inflammations and associated dry cough. For productive coughs, herbal medicinal products with well-established use, based on Hederae folium, or a range of traditional herbal medicinal products containing Primulae radix, Thymi herba, and other aromatic drugs and essential oils are administered. It is important to note that products containing essential oils and certain aromatic herbal drugs are contraindicated in children under 2 to 2.5 years of age due to the risk of laryngospasm. In the pediatric population, products derived from Matricariae flos, Pelargonii radix, Tiliae flos and Sambuci flos are used to relieve various cold symptoms. Use is restricted to children over a certain age, mostly due to lack of safety data, and in some cases due to the possibility of certain adverse effects.

Practical aspects of antiseizure medication treatment in pediatric patients: A helpful guide for pharmacists counseling young patients with epilepsy and their parents

2025-10-26T17:25:53+01:00

Epilepsy is a common brain disorder which frequently affects pediatric patients (from newborns to adolescents). The cornerstone of epilepsy treatment for most patients is the use of antiseizure medicines (ASM). These medications, when used as monotherapy or in combination, can achieve seizure control in up to 70% of patients with epilepsy. However, despite the availability of effective ASMs, adherence to these medicines in pediatric epilepsy tends to be suboptimal, which may adversely affect the long-term prognosis of pediatric patients. In this regard, pharmacist-led interventions, aimed at increasing the health literacy of patients and their family members regarding epilepsy treatment, have been shown to increase adherence to the prescribed ASMs. These interventions focus on educating patients and parents on the nature of epilepsy and practical aspects related to appropriate ASM use. In this article, we aimed to provide a useful source of information for pharmacists (and other healthcare workers) on how to counsel patients and parents on issues related to starting/using ASM treatment (e.g. appropriate dose titration, managing skipped doses), additional measures that may improve treatment outcomes (e.g. monitoring seizure frequency, avoidance of seizure triggers) and safety risks associated with ASMs (and how to control/mitigate these risks).

A clinical perspective of therapeutic drug monitoring of cyclosporine in pediatric patients with kidney transplant

2025-10-26T17:25:53+01:00

Cyclosporine A (CsA) is an immunosuppressive used in both children and adult transplant recipients, as well as patients with autoimmune diseases such as nephrotic syndrome. Therapeutic drug monitoring (TDM) of CsA is essential due to its significant interindividual and intraindividual pharmacokinetic variability, narrow therapeutic index and the risk of organ rejection or autoimmune disease relapse at subtherapeutic levels, as well as the potential for serious adverse effects with overexposure. In pediatric patients, CsA pharmacokinetics can be significantly influenced by developmental physiological factors, necessitating even greater attention to TDM in this vulnerable population. This paper explores the key challenges associated with TDM in children, the clinical rationale for its use, clinical settings where it is applied and future perspectives, including the potential of model-informed precision dosing (MIPD).