Aditya Narayan, Ben Teasdale, A J Hudspeth, David Y Light, Jill K Nailor, Kevin Schulman
{"title":"哌甲酯产品的价格和质量。","authors":"Aditya Narayan, Ben Teasdale, A J Hudspeth, David Y Light, Jill K Nailor, Kevin Schulman","doi":"10.1016/j.jaac.2025.05.002","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>For many products, generic markets are very mature, with aggressive competition driving down the price of products for manufacturers. Under these conditions, manufacturers may not have an ability to invest in high-quality manufacturing processes.</p><p><strong>Method: </strong>We acquired samples of all available methylphenidate products in immediate-release tablet (IR), extended-release tablet (ERT), and extended-release capsule (ERC) formulations in all available doses from all available labelers listed at one major wholesaler in February 2023. Products were analyzed for variations in dissolution parameters and for the presence of N-nitroso-methylphenidate. Finally, we examined the cost and quality of tested products.</p><p><strong>Results: </strong>All immediate-release methylphenidate products had similar dissolution profiles. For extended-release products, the confidence intervals of the difference factors for 12 of the 24 generic extended-release tablets sampled did not contain the null value, indicating a statistically significant difference in dissolution from the branded product. N-nitroso-methylphenidate, a probable human carcinogen, was detected above regulatory thresholds in generic immediate-release products for 7 of the 15 unique products sampled. N-nitroso-methlyphenidate was detected below regulatory thresholds in extended-release tablets and was not detected above the limit of quantification in extended-release capsules. The average prices for products with and without elevated N-nitroso-methlyphenidate were not significantly different.</p><p><strong>Conclusion: </strong>Independent laboratory testing of generic methylphenidate products found significant product quality concerns. Making product quality transparent could offer the potential to dramatically improve the quality of generic drugs at no additional cost.</p>","PeriodicalId":17186,"journal":{"name":"Journal of the American Academy of Child and Adolescent Psychiatry","volume":" ","pages":""},"PeriodicalIF":9.5000,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Price and Quality of Methylphenidate Products.\",\"authors\":\"Aditya Narayan, Ben Teasdale, A J Hudspeth, David Y Light, Jill K Nailor, Kevin Schulman\",\"doi\":\"10.1016/j.jaac.2025.05.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>For many products, generic markets are very mature, with aggressive competition driving down the price of products for manufacturers. Under these conditions, manufacturers may not have an ability to invest in high-quality manufacturing processes.</p><p><strong>Method: </strong>We acquired samples of all available methylphenidate products in immediate-release tablet (IR), extended-release tablet (ERT), and extended-release capsule (ERC) formulations in all available doses from all available labelers listed at one major wholesaler in February 2023. Products were analyzed for variations in dissolution parameters and for the presence of N-nitroso-methylphenidate. Finally, we examined the cost and quality of tested products.</p><p><strong>Results: </strong>All immediate-release methylphenidate products had similar dissolution profiles. For extended-release products, the confidence intervals of the difference factors for 12 of the 24 generic extended-release tablets sampled did not contain the null value, indicating a statistically significant difference in dissolution from the branded product. N-nitroso-methylphenidate, a probable human carcinogen, was detected above regulatory thresholds in generic immediate-release products for 7 of the 15 unique products sampled. N-nitroso-methlyphenidate was detected below regulatory thresholds in extended-release tablets and was not detected above the limit of quantification in extended-release capsules. The average prices for products with and without elevated N-nitroso-methlyphenidate were not significantly different.</p><p><strong>Conclusion: </strong>Independent laboratory testing of generic methylphenidate products found significant product quality concerns. Making product quality transparent could offer the potential to dramatically improve the quality of generic drugs at no additional cost.</p>\",\"PeriodicalId\":17186,\"journal\":{\"name\":\"Journal of the American Academy of Child and Adolescent Psychiatry\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":9.5000,\"publicationDate\":\"2025-05-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American Academy of Child and Adolescent Psychiatry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jaac.2025.05.002\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Academy of Child and Adolescent Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaac.2025.05.002","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
The Price and Quality of Methylphenidate Products.
Objective: For many products, generic markets are very mature, with aggressive competition driving down the price of products for manufacturers. Under these conditions, manufacturers may not have an ability to invest in high-quality manufacturing processes.
Method: We acquired samples of all available methylphenidate products in immediate-release tablet (IR), extended-release tablet (ERT), and extended-release capsule (ERC) formulations in all available doses from all available labelers listed at one major wholesaler in February 2023. Products were analyzed for variations in dissolution parameters and for the presence of N-nitroso-methylphenidate. Finally, we examined the cost and quality of tested products.
Results: All immediate-release methylphenidate products had similar dissolution profiles. For extended-release products, the confidence intervals of the difference factors for 12 of the 24 generic extended-release tablets sampled did not contain the null value, indicating a statistically significant difference in dissolution from the branded product. N-nitroso-methylphenidate, a probable human carcinogen, was detected above regulatory thresholds in generic immediate-release products for 7 of the 15 unique products sampled. N-nitroso-methlyphenidate was detected below regulatory thresholds in extended-release tablets and was not detected above the limit of quantification in extended-release capsules. The average prices for products with and without elevated N-nitroso-methlyphenidate were not significantly different.
Conclusion: Independent laboratory testing of generic methylphenidate products found significant product quality concerns. Making product quality transparent could offer the potential to dramatically improve the quality of generic drugs at no additional cost.
期刊介绍：
The Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) is dedicated to advancing the field of child and adolescent psychiatry through the publication of original research and papers of theoretical, scientific, and clinical significance. Our primary focus is on the mental health of children, adolescents, and families.
We welcome unpublished manuscripts that explore various perspectives, ranging from genetic, epidemiological, neurobiological, and psychopathological research, to cognitive, behavioral, psychodynamic, and other psychotherapeutic investigations. We also encourage submissions that delve into parent-child, interpersonal, and family research, as well as clinical and empirical studies conducted in inpatient, outpatient, consultation-liaison, and school-based settings.
In addition to publishing research, we aim to promote the well-being of children and families by featuring scholarly papers on topics such as health policy, legislation, advocacy, culture, society, and service provision in relation to mental health.
At JAACAP, we strive to foster collaboration and dialogue among researchers, clinicians, and policy-makers in order to enhance our understanding and approach to child and adolescent mental health.
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