Journal of pharmaceutical sciences
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Oral pediatric formulations are either ready-to-use or require manipulation and multiuse or single-use. Strong encouragement for preservative-free pediatric formulations has resulted in fewer multiuse solutions or suspensions in favor of single-use solid oral dosage forms. This updated review covering new pediatric formulations marketed in the United States of America, Europe, and Japan spanning the years 2007 to mid-2018 identified 16 types of pediatric oral formulations of which 7 are ready-to-use and 9 require manipulation, and 51 total new pediatric oral formulations of which 21 are ready-to-use and 30 require manipulation. ⋯ Formulations requiring manipulation include sprinkle capsule, powder for oral solution, powder for oral suspension, granules for oral suspension, oral powder, oral granules, tablet, dispersible tablet, dispersible scored tablet, tablet for oral suspension, and mini-tablets (oral granules). Significant advances in packaging technology include filling mini-tablets, granules, or powders into sachets, stick packets, blisters, and 2-piece capsules. The future of pediatric oral formulations will increasingly be with user-friendly, preservative-free, taste-masked formulations including multiparticulate single-use solid dosage forms including mini-tablets, orally disintegrating tablets, and sprinkle capsules with or without a specialized package configuration.
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Currently, biosimilar products are being actively developed around the world. One reason for this is the expiry of patents of original biopharmaceutical products with an extremely large market share because the biosimilar companies need to avoid infringing patents. A representative example of this is biosimilar versions of monoclonal antibodies. ⋯ However, no comparison of review systems for generics and biosimilars in Japan has been published. A more detailed understanding of review systems is important for using generic and biosimilar products. This article presents the current Japanese review systems for generic and biosimilar products and also the future challenges to facilitate the better regulation of both types of product.
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US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a major scientific priority area. This paper provides case studies and updates to describe the efforts by the FDA's Office of Clinical Pharmacology in its development and application of regulatory science, focusing on modeling and simulation. Key issues and challenges are identified that need to be addressed to promote the uptake of modeling and simulation approaches in drug regulation. ⋯ This article is a U. S. Government work and is in the public domain in the USA. 102:2912-2923, 2013.
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Neurontin®, an immediate-release (IR) formulation of gabapentin, was the first drug approved by the United States Food and Drug Administration for the treatment of postherpetic neuralgia (PHN). The effective dosing regimen of gabapentin IR (G-IR) for PHN is 1800 mg/day in three divided doses. In 2011, a gastroretentive (GR) formulation of gabapentin (G-GR, Gralise®) was approved for the treatment of PHN. ⋯ The GR formulation takes advantage of normal human gastrointestinal (GI) physiology and the unique pharmacokinetic properties of gabapentin. In this review, we compare the IR and GR formulations of gabapentin, overview the GI physiology and GR mechanism of G-GR, and describe the unique pharmacokinetic properties of gabapentin. The effect of GR formulation on efficacy and the incidence of adverse events that are commonly associated with G-IR treatment in PHN patients are also discussed.
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The acetaminophen dosage schedule in pediatric patients below 12 years of age for the over-the-counter (OTC) monograph is one of the many issues being evaluated and discussed in the development of the Proposed Rule for Internal Analgesic, Antipyretic, and Anti-rheumatic drug products. The dosage regimen based on age and weight, with instructions that weight-based dosage should be used if a child's weight is known, is currently being assessed by the agency. This review summarizes the available pharmacokinetic and pharmacodynamic (fever reduction) data of oral acetaminophen in pediatric patients of 6 months to 12 years of age. ⋯ The sulfation pathway plays a more important role in metabolizing acetaminophen than the glucuronidation pathway in younger children as compared with older children and adults. The pharmacokinetic exposure of acetaminophen in pediatric patients of 6 months to 12 years of age given oral administration of 10-15 mg/kg is within the adult exposure range given the OTC monograph dose. The antipyretic effect of acetaminophen is dose dependent and appears to be better than placebo at the dose range of 10-15 mg/kg in pediatric patients of 6 months to 12 years of age.