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Paediatric
Application of biorelevant in vitro assays for the assessment and optimization of ASD-based…
Amorphous solid dispersions (ASD) have been a successful formulation strategy to overcome the poor aqueous solubility of many novel drugs, but the development of pediatric formulations presents a special challenge due to variable gastrointestinal conditions in children. It was the aim of this work…
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Pediatric Mini-Tablets: Predicting the Hidden Risk of Fill Errors
Compressed mini-tablets in sachets or capsules are an increasingly prevalent oral solid dosage form for pediatric products. While resembling adult tablets, additional care is required to control weight and potency (blend uniformity) variation due to their small size (≤2.5 mm average diameter).…
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Enhancing the oral drug delivery through hot melt extrusion techniques
Hot melt extrusion has been developed as a fresh technique for taste masking, in recent years. This method provides many aids as compared to traditional methods like avoiding the use of solvents, continuous manufacturing, ease to scale up, and adaptability to meet the goals of FDA for quality…
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Formulation and stability study of an oral paediatric phenobarbital 1% solution containing…
Abstract
Objectives
Phenobarbital is a barbiturate, used to treat focal and generalised epilepsy. Since the end of marketing of the oral solution KANEURON in 2017, phenobarbital tablets remain the only available dosage form. Development of an oral phenobarbital solution for paediatric use is…
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Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple…
Nicardipine hydrochloride is an anti-hypertensive drug that is used off-label to treat hypertension in children. A previous oral formulation of nicardipine hydrochloride was developed using a commercial vehicle as an excipient. However, ready-to-use vehicles are prone to supply shortages, and their…
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Paediatric Solid Oral Dosage Forms for Combination Products: Improving In Vitro Swallowability of…
There is a growing interest in determining and improving the acceptability of solid oral dosage forms (SODF) in paediatric populations. Combination products can be an interesting solution to combine two active pharmaceutical ingredients. This study shows that binary mixture of paediatric SODF could…
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Orally disintegrating drug carriers for paediatric pharmacotherapy
Non-compliance, dosing inaccuracy, choking risk, flavour, and instability, are some of the issues associated with paediatric, oral dosage forms — tablets, capsules, solutions, and suspensions. Orally disintegrating drug carriers, a dosage form with growing interest, are thought to overcome several…
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Excipients in pediatric dosage forms and related regulatory aspects with review to propylene glycol
Pediatric formulations often contain excipients with lack of safety and toxicity data based on a unique and daily exposure, duration of treatment and patient acceptability. In the 1980s, US set up regulatory initiatives for the development of pediatric drugs. In 2007, pediatric regulation focused on…
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Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for…
Abstract
One of the main challenges to paediatric drug administration is swallowing difficulties, hindering the acceptability of the medicine and hence clinical outcomes. This study aims at developing a child-appropriate dosage form, the orodispersible mini-tablet (ODMT), using the model drug…
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Particle-Based therapies for antigen specific treatment of type 1 diabetes
Type 1 diabetes mellitus (T1D) is the leading metabolic disorder in children worldwide. Over time, incidence rates have continued to rise with 20 million individuals affected globally by the autoimmune disease. The current standard of care is costly and time-consuming requiring daily injections of…
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