The US Food and Drug Administration’s authorisation of Purdue’s controlled-release methylphenidate for adult ADHD: comments on the regulatory practice

2021 ◽  
pp. 014107682199453
Author(s):  
Kim Boesen ◽  
Karsten Juhl Jørgensen ◽  
Peter C Gøtzsche
Drug Research ◽  
2017 ◽  
Vol 67 (11) ◽  
pp. 653-660 ◽  
Author(s):  
Marilena Vlachou ◽  
Angeliki Siamidi ◽  
Dimitrios Spaneas ◽  
Dimitrios Lentzos ◽  
Polixeni Ladia ◽  
...  

AbstractThe aim of the present investigation was to develop matrix tablet formulations for the in vitro controlled release of two new tuberculocidal adamantane aminoethers (compounds III and IV), congeneric to the adamantane derivative SQ109, which is in final clinical trials, and aminoethers (I) and (II), using carefully selected excipients, such as polyvinylpyrrolidone, sodium alginate and lactose. The tablets were prepared using the direct compression method and dissolution experiments were conducted using the US Pharmacopoeia type II apparatus (paddle method) in gastric and intestinal fluids. The results suggest that both analogues, albeit more lipophilic than SQ109, and aminoethers (I) and (II), have the requisite in vitro release characteristics for oral administration. In conclusion, these formulations merit further assessment by conducting in vivo studies, at a later stage.


Drug Research ◽  
2017 ◽  
Vol 67 (08) ◽  
pp. 447-450 ◽  
Author(s):  
Marilena Vlachou ◽  
Angeliki Siamidi ◽  
Evanthia Diamantidi ◽  
Alexandra Iliopoulou ◽  
Ioannis Papanastasiou ◽  
...  

AbstractThe aim of the present investigation was to develop matrix tablet formulations for the in vitro controlled release of 2 new tuberculocidal adamantane aminoethers (compounds I and II), congeneric to the adamantane derivative SQ109, which is in final clinical trials, using carefully selected excipients, such as polyvinylpyrrolidone, sodium alginate and lactose. The tablets were prepared using the direct compression method and dissolution experiments were conducted using the US Pharmacopoeia type II apparatus (paddle method) in gastric and intestinal fluids. The results confirm that both analogues, albeit more lipophilic than SQ109, showed satisfactory in vitro release characteristics from solid pharmaceutical formulations. In conclusion, these formulations merit further assessment by conducting in the future bioavailability in vivo studies.


Author(s):  
Amarjit Salunke Salunke ◽  
Neeraj Upamanyu ◽  
Alka Singh ◽  
Ashish Jaiswal

The convenient and recent drug delivery system always likely to have some ideal and unique characters, particularly for safety, desired actions, accurate delivery, enrich with a therapeutic index with minimal adverse occurrence. In this regard, Nano sponges serve as a recent advance new drug delivery. Many researchers are attracted and concerned on Nano sponges presently. The present twofold objective of the review clarifies why Nano sponges are recent and advanced delivery system along with challenges related to solubility, stability and controlled release of Nano sponge and proven techniques to overcome. Since the nano-sized drug free carriers are recently formulated and suggested for drug delivery, which can be loaded with the numerous drugs, hence dealing with an appropriate technique for drug release is the need of the present time. This article states the most convenient method for drug release, and at concluding part gives awareness on recent work done and result obtained on Nano sponge worldwide along with the unique summary on the US granted patents for Nano sponges. Thus, a complete scenario on recent work, methods for evaluations, unique and multiple characters of Nano sponge has been discussed and summarized.


2019 ◽  
Vol 32 (4) ◽  
pp. 137-157
Author(s):  
Henri Boullier ◽  
David Demortain ◽  
Maurice Zeeman

In policies targeting environmental and health hazards, an effort is frequently made to anticipate and avert more or less probable adverse events. In this context, computerized models are frequently portrayed as superior knowledge tools, for their capacity to extrapolate from existing data and predict hazards. This paper looks at the historical development and use of such models in regulation, with the specific example of structure-activity relationships (SARs) in the regulation of new industrial chemicals at the US Environmental Protection Agency (EPA). It asks how evidential culture(s) in a regulatory organization change, in particular how new methods and forms of knowledge find their place alongside others to forge regulatory decisions. The development and application of, first, a qualitative approach to structure-activity relationships, and then of quantitative models, show that the EPA had the necessary autonomy to imagine and adjust a method emerging in the research environment to respond to regulatory needs. This can be understood from a coproductionist perspective, if adjusted to take into account the bureaucratic knowledge that mediates the imagining and application of prediction in regulatory practice.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1217-1217
Author(s):  
Anna Kirkland ◽  
Elizabeth Brandley ◽  
Kathleen Holton

Abstract Objectives The objective of this research was to investigate a novel low glutamate dietary intervention for Gulf War Illness (GWI), a chronic multi-symptom disorder that includes cognitive dysfunction. Methods Forty GW veterans with GWI were recruited from across the US. As part of a larger clinical trial, participants completed computerized cognitive testing and the Adult ADHD Self-Report Scale (ASRS) using CNS Vital Signs® (CNSVS) software. Before diet initiation, subjects received intensive dietary counseling. Post-diet assessments were completed after 1 month on the diet, and then participants were randomized to a 2-week double-blind placebo-controlled crossover challenge with glutamate (MSG)/placebo administered over 3 days of each week. The CNSVS battery was administered again on the 3rd day of each challenge week. The challenge data have not yet been un-blinded, and therefore will not be included in this abstract. Pre-post testing (t-test or Wilcoxon Signed Rank test) was conducted for each domain in the CNSVS battery, including an overall marker of neurocognitive function (NCI) and the ASRS. Results Several cognitive domains were significantly improved after 1-month on the low glutamate diet, including NCI (P < 0.01), executive functioning (P = 0.01), cognitive flexibility (P < 0.05), motor speed (P < 0.01), processing speed (P < 0.05), and psychomotor speed (P = 0.001). However, reaction time was slower at post-diet testing (P = 0.01). ADHD symptoms were also significantly improved at post-diet (P < 0.0001). Conclusions Veterans with GWI showed major improvements in cognitive function after 1-month on a low glutamate diet, including improvement in overall neurocognitive status. Upcoming analysis of the double-blind placebo-controlled crossover challenge data will provide additional information on which cognitive domains are directly affected by challenge with glutamate relative to placebo. Funding Sources The US Army Medical Research Acquisition Activity, 820 Chandler St, Fort Detrick MD 21,702–5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.


2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.


2005 ◽  
Vol 38 (22) ◽  
pp. 34
Author(s):  
ROBERT FINN
Keyword(s):  

2009 ◽  
Vol 00 (00) ◽  
pp. 090805050810080-8 ◽  
Author(s):  
Handoko Adi ◽  
Paul Michael Young ◽  
Hak-Kim Chan ◽  
Rania Salama ◽  
Daniela Traini

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