Paediatric Formulation: Design and Development

Lopalco, Antonio; Denora, Nunzio

doi:10.3390/ijms21197118

Cited by 9 publications

(11 citation statements)

References 24 publications

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“…Because pediatric patients come in a wide range of ages and sensitivity levels, pediatric clinical trials should be cautious and properly designed. Pediatric kids may suffer from a variety of medical issues, unexpected side effects, and unforeseen bad effects if the procedure is not carried out appropriately [22].…”

Section: • Regulationmentioning

confidence: 99%

A Review of the Safety and Acceptability of Commercially-Available Pediatric Drug Formulations

Laluna¹,

Pedregosa²,

Abarca³

et al. 2023

Int.J.Res.Publ.Rev.

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Until now, drug formulations are still among the most important inventions, and ongoing research is being done to enhance their acceptability and efficacy in a variety of patient populations, as shown in both adults and pediatrics. Both age groups differ in a number of ways when it comes to the pharmacological element and therapy, including their aptitude for administering pharmaceuticals, how they respond to negative drug reactions, how they prefer to taste medications, and a host of other factors. Particularly, pediatrics and their pharmaceuticals require top priority due to the fact they must match and coincide with their age, size, physiological needs, and therapeutic requirements. This calls for addressing and elevating variations in these areas, particularly in pharmacokinetics, pharmacodynamics, formulation development, and regulation. This review explored these variations through a list of potentially-harmful medications for pediatrics presented in tables, as well as their uptake in adverse drug reactions than that of adults and pharmacodynamic differences, leading to the utilization of the physiologically-based Pharmacokinetic (PBPK) model for DDI prediction and evaluation model on pediatric-pharmacokinetic DDIs to assist in the safety and acceptability of commercially-available pediatric drug formulations.

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Section: • Regulationmentioning

confidence: 99%

A Review of the Safety and Acceptability of Commercially-Available Pediatric Drug Formulations

Laluna¹,

Pedregosa²,

Abarca³

et al. 2023

Int.J.Res.Publ.Rev.

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“…4 When designing and developing paediatric medicines, the route of administration, dosage form, and dose of the active ingredient (API) are decided on the basis of the expected duration of the therapy, the disease affecting a patient and his/her age, size, physio-pathological condition, API organoleptic and physicochemical properties (taste, aqueous solubility), its pharmacokinetic and pharmacodynamics properties, and stability during manufacture, storage, and use of the chosen formulation. 5 Irrational utilization of medicines in paediatrics become very common in clinical practice due to many factors. It explores various factors like paediatric ethics, unlicensed or off-label use of medicines, unavailability of suitable formulations, administration difficulties, etc that influence in the rational prescribing in the paediatric population.…”

Section: Research Articlementioning

confidence: 99%

Assessment of Prescribing Practices in Paediatric Patients in A Tertiary Level Referral Hospital

Suriyaprakash¹,

Basheera²,

Kurian³

et al. 2022

IJPSRR

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Paediatrics differs from adult in many aspects of which body size and maturational changes plays an important role. Effective medical treatment of paediatric patient is based upon an accurate diagnosis and optimum course of therapy. Irrational drug prescription leads to ineffective treatment, occurrence of adverse effects, prolonged duration of illness and suffering to patient, and an increased economic burden to society. Therefore the aim of our study is to analyse prescribing practices in paediatric department of KIMS Al Shifa Hospital to identify the prevailing disease traits, ADRs, dosage form, route of administration and potential drug interactions among children over 6 months study period. The aim of the study is to assess the prescribing patterns of paediatric patients in a tertiary level referral hospital. A Prospective observational study was conducted for a period of 6 months that focus on Assessment of prescribing practices in paediatric patients. The study was carried out in Paediatric department of KIMS AL SHIFA SUPER SPECIALITY HOSPITAL, Perinthalmanna, Malappuram. The patients were selected based on Inclusion and Exclusion criteria. Out of 87 prescriptions analysed, we found a predominance of male patients as compared to female paediatric patients. The analysed prescriptions were contributed mainly by paediatric age group of 1-3 years (34.5%). LRTI (24.1%) was identified as the most prevailing disease. A total of 466 drugs were retrieved from the study, contributed mainly by antibiotics (24.2%) and antipyretics (11.2%). Among antibiotics cephalosporins (38.1%) were the most common ones. Bronchodilators (45.8%) were the most often used respiratory system drug and proton pump inhibitors (44.9%) were most repeatedly used GI drug. Branded drugs were most commonly prescribed as compared to generic drugs. Among dosage forms, injectable (36.1%) were most frequently prescribed over syrups (32.6%) and tablets (10.1%). Oral route was the most commonly used route of administration of drugs contributing (51.1%) followed by parenteral route (36.1%) and nasal route (10.3%) respectively. In our study of assessment of prescribing practices in paediatric patients in a tertiary level referral hospital in south Malabar region of Kerala, we analysed over 87 prescriptions. According to the results procured from the study, a total of 466 drugs were identified. LRTI was the most prevalent disease and was found to be the primary cause for hospitalisation in paediatric patients. Antibiotics were the most commonly prescribed class, contributed mainly by Cephalosporins. Most enrolled patients stayed in hospital for 3-5 days and majority of the prescriptions had 4 drugs. Among all available routes for administration, oral route was preferred over others, because it is not invasive and carries a low risk of pain. By using NFI, rationality and safety of prescribing pattern were analysed and using Medscape potential drug interactions were identified.

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“…Owing to the bitter taste of brompheniramine, there is a patient compliance issue similar to that with many other drugs with an unpleasant taste, especially in children. Noncompliance owing to an unpleasant taste is one of the top reasons for unsuccessful pharmacotherapy (Arima et al, 2012;D'Sa, 1995;Lopalco & Denora, 2020;Strickley, 2019).…”

Section: Introductionmentioning

confidence: 99%

“…Taste has been reported to be a critical attribute to ensure adequate adherence to a pediatric formulation as a palatable taste can minimize medication loss owing to spitting to help ensure therapeutic dosing (D'Sa, 1995;Faisal et al, 2018;Ivanovska et al, 2014;Lopalco & Denora, 2020;Pein et al, 2014;Sohi et al, 2004;Strickley, 2019; Disclaimer: This publication reflects the views of the authors and should not be construed to represent the FDA's views or policies. Thabet et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

Bioavailability assessment of a brompheniramine taste‐masked pediatric formulation in a juvenile porcine model

Wang,

Shakleya,

Giacoia

et al. 2024

Biomedical Chromatography

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A brompheniramine taste‐masked pediatric formulation was developed as part of the National Institutes of Health Pediatric Formulation Initiative to help address low patient compliance caused by the bitter taste of many adult formulations. To confirm that the taste‐masked formulation can provide a similar pharmacological effect to the previous marketed adult formulations, a juvenile porcine model was used to screen the model pediatric formulation to compare the bioavailability between the marketed brompheniramine maleate and the taste‐masked maleate/tannate formulation. Pigs were dosed orally with both formulations and blood samples were obtained from 0 to 48 h. Plasma samples were prepared and extracted using solid‐phase extraction. The mass spectrometer was operated under selected ion monitoring mode. The selected ion monitoring channels were set to m/z 319.1 for brompheniramine and m/z 275.2 for the internal standard chlorpheniramine. Calibration curves were linear over the analytical range 0.2–20 ng/ml (r2 > 0.995) for brompheniramine in plasma. The intra‐ and inter‐day accuracies were between 98.0 and 105% with 5.73% RSD precision. The bioanalytical method was successfully applied to a preclinical bioavailability study. The bioavailability profiles were not significantly different between the two formulations, which demonstrates that taste‐masking with tannic acid is a promising approach for formulation modification for pediatric patients.

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Paediatric Formulation: Design and Development

Cited by 9 publications

References 24 publications

A Review of the Safety and Acceptability of Commercially-Available Pediatric Drug Formulations

A Review of the Safety and Acceptability of Commercially-Available Pediatric Drug Formulations

Assessment of Prescribing Practices in Paediatric Patients in A Tertiary Level Referral Hospital

Bioavailability assessment of a brompheniramine taste‐masked pediatric formulation in a juvenile porcine model

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