Those prospective parturients that express that they may want an epidural labour analgesia for their delivery will be informed about the possibility to choose between a pump driven epidural or midwife administered intermittent boluses.

开始日期2024-12-01

申办/合作机构

Helsinki University Central Hospital

CTRI/2024/10/075023 / Not yet recruitingN/AIIT

Analgesic efficacy of wound infiltration with fentanyl or bupivacaine or bupivacaine with fentanyl in arthroscopic anterior cruciate ligament reconstructive surgery: A double blind randomized control trial - NIL

开始日期2024-10-20

申办/合作机构-

CTRI/2024/10/074926 / Not yet recruitingN/AIIT

To compare the efficacy of intravenous ketamine, fentanyl and dexmedetomidine infusions on hemodynamic control and overall outcome in paediatric infraumbilical surgeries: prospective randomized controlled study - Nil

开始日期2024-10-16

申办/合作机构-

100 项与枸橼酸芬太尼相关的临床结果

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100 项与枸橼酸芬太尼相关的转化医学

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100 项与枸橼酸芬太尼相关的专利（医药）

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480

项与枸橼酸芬太尼相关的文献（医药）

2023-12-01·Heliyon

Clinical and pharmacokinetics overview of intranasal administration of fentanyl

Review

作者: Saeedi, Farhad ; Nakhaee, Samaneh ; Mehrpour, Omid

Due to the presence of large surfaces and high blood supply, drug delivery through the nasal route of administration is the appropriate route to administrate drugs with rapid onsets of action. Bypassing first-pass metabolism can increase drug bioavailability. The physicochemical properties of fentanyl led to a need to develop formulations for delivery by multiple routes. Several approved inter-nasal fentanyl products in Europe and the USA have been used in prehospital and emergency departments to treat chronic cancer pain and used to treat severe acute abdominal and flank pain. Analgesia durations and onsets were not significantly different between intranasal and intravenous fentanyl in patients with cancer breakthrough pain and were well-tolerated in the long term. Intranasal Fentanyl (INF) at a 50 μg/ml concentration decreased renal colic pain to the lowest level in 30 min. Possible adverse effects specific to INF are epistaxis, nasal wall ulcer, rhinorrhea, throat irritation, dysgeusia, nausea, and vomiting. However, there is limited available literature about the serious adverse effects of INF in adults and children. Intranasal Fentanyl Spray (INFS) results in significantly higher plasma concentrations and has a lower T_max than oral transmucosal formulation, and the bioavailability of fentanyl in intranasal formulations is very high (89 %), particularly in pectin-containing formulations such as PecFent and Lazanda.

2023-07-22·BMC anesthesiology

Effect of nalbuphine plus ropivacaine on vaginal labor in epidural analgesia.

Article

作者: Cao, Xiao-Sheng ; Pang, Zhao ; Wen, Xue-Jin ; Ou, Lian-Chun ; Yin, Biao ; Liu, Li-Wen ; Liu, Guo-Hua ; He, Quan-Yan

BACKGROUND:

Various approaches using epidural analgesia have been employed for relieving labor pain and promoting spontaneous delivery. We aimed to evaluate the effect of nalbuphine and ropivacaine versus fentanyl and ropivacaine on the duration of delivery in parturients.

METHODS:

Clinical data of 160 full-term primiparous women who received either nalbuphine or fentanyl in combination with ropivacaine infusion for epidural labor analgesia in our hospital from December 2020 to May 2022 were retrospectively analyzed. The participants were divided into two groups based on anesthesia methods: nalbuphine group (NR group, n = 78) received 0.2 mg/mL nalbuphine combined with 0.1% ropivacaine hydrochloride for patient-controlled epidural analgesia (PCEA) and fentanyl group (FR group, n = 82) received 2 ug/mL fentanyl citrate and 0.1% ropivacaine hydrochloride for PCEA. Both groups received an epidural blockade for labor analgesia at lumbar 2-3 interspace. The duration of the first, second, and third stages of labor, the onset of analgesia, and time before delivery (T0), 15 min of analgesia (T1), 30 min of analgesia (T2), full opening of the uterine opening (T3),exerts force during childbirth(T4), heart rate (HR), blood pressure (BP), blood saturation (SpO2), visual analogue pain scale (VAS) score, Ramsay sedation score, and modified Bromage score, and 5 min were recorded at 2 h postpartum (T5). The neonatal Apgar score, neonatal behavioral neurological assessment (NBNA) score, maternal nausea, vomiting, and itchy skin were recorded.

RESULTS:

Compared with the FR group, the first stage of labor duration (p < 0.05) and total duration of labor (p < 0.05) were shortened and the onset of analgesia (p < 0.05) was increased in the NR group. NR group had lower incidence of urinary retention than FR group (p < 0.05). The maternal and neonatal investigational parameters and scores had no significant difference between the two groups.

CONCLUSIONS:

Nalbuphine combined with ropivacaine in epidural block labor has a faster onset of analgesia and has a lower incidence of urinary retention than fentanyl combined with ropivacaine, and nalbuphine shortens the duration of the first and total stages of labor. Both nalbuphine and fentanyl can reduce pain during labor, have little effect on maternal hemodynamics, and have no significant effect on neonatal Apgar or NBNA scores.

2023-05-01·Applied spectroscopy

Quantitative Raman Cross-Sections and Band Assignments for Fentanyl and Fentanyl Analogs

Article

作者: Kline, Neal D. ; Wilcox, Phillip G. ; Pardoe, Ian J. ; Emmons, Erik D. ; Guicheteau, Jason A.

Raman cross sections and spectra were measured for five synthetic opioid fentanyl analogs: fentanyl citrate, sufentanil citrate, alfentanil HCl, carfentanil oxalate, and remifentanil HCl. The measurements were performed with excitation wavelengths in the visible (532 nm) and near infrared (785 nm). In addition, density functional theory (DFT) calculations were employed to generate simulated spectra of the compounds and aid in identification of the observed spectral modes. These cross-section measurements and calculations were also used to assess results from a series of measurements of fentanyls cut with other powdered materials. These measurements are valuable for assessment of field-deployable Raman chemical sensors for detection of fentanyl and fentanyl analogs, including when mixed with other materials.

项与枸橼酸芬太尼相关的新闻（医药）

2024-10-29

·PRNewswire

RaySecur Annual State of Mail Security Report Finds Mail Threats Are Becoming Smaller & More Dangerous

9 Out of 10 Mail Threats Are Small Enough to Fit in a Curbside Drop Box With a Notable Shift from Benign Hoaxes to Fentanyl-Laced Powders BOSTON, Oct. 29, 2024 /PRNewswire/ -- Today, RaySecur, the leading provider of T-ray security imaging technology, announces the findings of its annual report on the state of mail security. Continue Reading RaySecur's Annual State of Mail Security Report The report is constructed from open-source mail threat data compiled by the U.S. government, international findings from the 2023 Global Terrorism Index, and the RaySecur Threat Data Center (TDC). The annual report found that letters and small parcels, not large packages, make up the vast majority of the threats, which have become increasingly dangerous and toxic. Mail-based threats are difficult to track as 9 out of 10 mail security incidents were items that were small enough to fit in an anonymous curbside drop box. Mail has become a preferred method of perpetrating these crimes, as less than 2% of mail-based threats lead to an arrest. The annual state of mail security report focuses on the two main categories of dangerous mail: (1) Chemical, Biological, Radiological, Nuclear, and Explosives (CBRNE) threats targeting corporations, private residences, and government buildings, and (2) contraband smuggling into correctional facilities. CBRNE Threats: 94% of physical mail-based injuries came from letters. White powder threats are becoming increasingly common with 59% of threats containing powders, of which 26% were determined to be drugs including fentanyl. Local, state, and federal government facilities receive the most mail-based threats (32%), while residences are the second most frequently targeted (28%), followed by businesses (12%). "No industry is immune from mail-based threats," says Alex Sappok, PhD, CEO of RaySecur. "Detecting extremely small qualities of highly toxic substances like fentanyl is a critical and evolving challenge facing security professionals. Previously white powder threats were mostly benign hoaxes. Over the past year, we've seen fentanyl and other harmful powders used in threats targeting government agencies and the private sector." Contraband Smuggling: RaySecur's annual report also examined the state of physical mail threats coming into correctional facilities. Key highlights include: 55% of contraband is drug-treated paper, which may not be visible to the human eye, making controlling drug use within these facilities a significant challenge. There has been a 600% rise in drug overdoses in prisons compared to previously available data. 65% of the U.S. prison population has an active substance use disorder, while another 20% were under the influence of drugs or alcohol at the time of their crime. Legal mail has become a primary avenue for smuggling drug-laced papers, as it is constitutionally protected and can not be digitized. Aside from mail, drug-laced papers enter facilities not only through the mailroom but also through visitors, including attorneys, and papers passed in court, posing a significant risk to both correctional staff and those in their care. There is also an emerging trend of these fraudulent legal papers being treated with household chemicals such as bug spray and formaldehyde, which are not detected by conventional drug testing methods. RaySecur's CBRNE annual mail security report can be found by visiting: RaySecur's corrections contraband annual mail security report can be found by visiting: About RaySecur: RaySecur®, Inc., the leader in real-time 3D, T-ray security imaging, is revolutionizing concealed threat detection with MailSecur®. Fortune 500 companies, government agencies, and heads of state trust RaySecur to keep them safe from hidden threats. MailSecur is the first desktop T-ray screening system designated by the DHS under the Safety Act. RaySecur and MailSecur are RaySecur, Inc. trademarks. For more information, visit . For media inquiries please contact: Allyson Noonan [email protected] (858) 245-7256 SOURCE RaySecur Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-10-25

·药研

CDE老师文章｜化学药品口颊膜剂的开发与评价探讨

（点击图片查看详情）摘要:口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂。口颊膜作为口腔黏膜给药的代表性剂型之一,具有起效快、避免药物胃肠道降解和肝脏首过效应、提高患者依从性等优势。结合近年来国内外口颊膜药物的开发和上市情况,对口颊膜处方工艺、质量研究和控制等方面进行了探讨。希望能够助力现阶段对此类产品的开发和评价,助推有临床价值的高质量口颊膜产品获批上市。膜剂根据给药部位不同,可分为口用膜、眼用膜、阴道膜等。其中口用膜可分为口溶膜、口颊膜、舌下膜和口腔贴膜。口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂[１] 。口颊膜是口腔黏膜给药系统的代表性剂型之一,目前全球已批准上市数个口颊膜产品,国内也有数个口颊膜产品开发和申报。本文对口颊膜类药物的基本情况进行介绍,结合审评工作,对口颊膜处方工艺开发、质量控制等方面进行探讨,希望为此类产品的开发和评价提供借鉴。１　基本情况１.１　定义、特点和分类　 2023年3月国家药典委员会对«中国药典»丸剂和膜剂通则修订草案公开征求意见[１] ,进一步将膜剂进行分类,膜剂根据给药部位不同,可分为口用膜、眼用膜、阴道膜等。其中口用膜可分为口溶膜、口颊膜、舌下膜和口腔贴膜。其中指出口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂;口颊膜应具有一定的黏附性;应进行溶出度或释放度检查。«欧洲药典»黏膜黏附制剂收载了口颊膜,其通常含有亲水聚合物,与唾液沾湿后会产生粘在口腔黏膜上的水凝胶;口颊膜可溶解,由单层或多层材料组成。«美国药典»指出口腔膜是将药物递送至口腔或将药物递送至胃肠道以供吸收。其中口颊膜可促进近端黏膜的吸收,避免胃肠道代谢或降解,并快速起效。与传统口服给药剂型相比,口颊膜具有自身的特点。其优点包括药物起效较快;便于携带、易于使用、剂量准确;通常可避免与胃肠道等可能引起药物降解的酸性环境接触,避免肝脏的首过效应;不需要吞咽或咀嚼、对有吞咽困难的儿童和老年人有良好的患者依从性[２] 。其局限性包括唾液的分泌会影响药物的吸收,有部分药物可能会被吞咽;服药时通常限制饮食饮水(与低ｐＨ液体同服可能会导致最大血药浓度和生物利用度下降[３] );活性成分本身的味道、刺激性可能会对口感产生的影响;药物的分子量、解离度、脂溶性和水溶性等理化性质会影响药物穿透口腔黏膜的难易程度;载药量(一般小于２０ｍｇ[４] )有一定限制等。口颊膜按照释放机理,通常分为３类[５] ,具体见图１。Ⅰ型:单层多向释药,吞咽时会造成部分药物进入胃肠道。此类口颊膜可能有胃肠道和黏膜两种吸收途径,开发此类产品时建议根据药物生物学特性谨慎考虑。Ⅱ型:双层结构,药物位于黏附层中,在黏附层的顶部叠加不透水的背衬层,防止药物从顶表面流失到口腔中。Ⅲ型:双层单向释药,药物仅从靠近颊黏膜的一侧释放,除了与口腔黏膜接触的一面外,其他每一面均被覆盖,药物损失最小化。１.２　国内外开发和上市情况美国批准上市５款可用于口颊黏膜的膜剂[６] ,具体见表１。其中３个为口颊膜,且均为Ⅱ型双层口颊膜。双层口颊膜包含背衬层和黏附层,药物位于黏附层中,通过口颊的黏膜进行吸收,背衬层防止黏附层的药物在唾液中溶解。国内目前有盐酸多塞平口颊膜和盐酸帕洛诺司琼口颊膜,按２.２类批准临床试验,尚无口颊膜类产品上市。药品出海东南亚、WHO、EU及TGA全流程指导（苏州）２　药学开发与评价关注点２.１　处方开发　典型的口颊膜处方通常包括药物活性成分、成膜材料、增塑剂、渗透促进剂、矫味剂等。不同于传统口溶膜,口颊膜多设计为双层膜,其处方由含药层和背衬层组成。含药层应具有黏膜黏附性,延长药物在口腔黏膜的停留时间,增加药物的黏膜吸收;背衬层起阻隔和屏蔽的作用,减少由于唾液冲洗和吞咽引起的药物损失,以实现药物向口腔黏膜的单向释放。表2汇总了FDA批准上市的Onsolis、Belbuca、Bunavail 3个产品处方信息。通过以上已上市产品处方的梳理,可了解口颊膜产品处方的常规组成,对研发和评价具有一定参考价值。Belbuca FDA Chemistry Reviews[7]显示,FDA批准的Onsolis、Belbuca、Bunavail 3个产品,均采用相同的生物可黏膜(BEMA)技术平台制备,产品由柔性水溶性聚合物膜组成,该膜黏附在湿润的口腔黏膜上并溶解,黏膜上无残留。应结合目标产品的质量概况(ＱＴＰＰ)的分析,选择适宜的候选药物,并对原料药关键理化特性及生物学特性进行研究。通常活性成分应具有合适的渗透性、可递送性和可吸收性,关注相关的理化性质,如分子量、ｐＫａ、溶解性等;此外还应关注口味、黏膜刺激性、粒度及粒度分布、晶型及晶型稳定性、化学稳定性等影响产品关键质量属性的指标。处方开发可参考ＩＣＨＱ８[１１] 指导原则,以制剂关键质量属性为指标,科学设计实验,对处方辅料种类及其用量进行筛选和优化。处方中所选择的辅料应无毒、无刺激性,保证产品可迅速黏附在颊黏膜处,并保持较长时间释药[５] 。口颊膜处方研究中需重点关注成膜材料、渗料透促进剂的选择和用量。成膜材料是处方中最重要的成分之一,作为药物载体可在湿润环境下提供黏附性能,口颊膜中常用的成膜材料包括胶类(如果胶)、纤维素类(如羧甲基纤维素钠、羟丙基纤维素)、聚丙烯酸聚合物类(聚丙烯酸、聚卡波菲)等[５] 。膜渗透是许多药物在口腔黏附给药系统中的限制因素,促进口腔黏膜渗透的物质称为渗透促进剂,口颊膜中常用的渗透促进剂包括表面活性剂(如十二烷基硫酸钠)、醇类(如丙二醇)、胆盐(如牛磺胆酸钠)、聚合物(如聚氧乙烯)等[１２] 。适宜的增塑剂可降低口颊膜的玻璃化转变温度,提高柔韧性,改善机械性能[１３] 。口颊膜中常用的增塑剂有丙二醇、柠檬酸、聚乙二醇(ＰＥＧ４００)等。有研究表明,处方中增塑剂与成膜材料的比例对膜剂的机械性能(断裂伸长率、杨氏模量、折叠耐久性)、厚度、溶出度等关键质量属性产生显著影响[１４] 。辅料选择时应考虑选择合适的矫掩味技术,例如,甜味剂或矫味剂的使用,可使用体外评估方法(如电子舌)和/ 或成人口尝试验对口感进行初步考察;在临床研究阶段,在目标治疗人群中进行口感评估,收集依从性和觅药行为数据以验证口感设计的合理性。背衬层起阻隔和屏蔽的作用,减少唾液冲洗和吞咽引起的药物损失,以实现药物向口腔黏膜的单向释放。口颊膜中常用的水不溶性背衬层材料为乙基纤维素。开发用于儿童人群的口颊膜时,应关注儿童用药开发指导原则[１５] 相关要求。口腔黏膜制剂的正确使用和可接受性取决于儿童患者的年龄以及在规定的时间内维持制剂处于口腔特定部位的能力。应结合药物的使用位置进行口腔黏膜制剂的黏附性研究。对于儿童药物而言,味道是决定黏膜接触时间的重要因素之一,因此对于口感的评估更加应该关注。此外,选择合适的辅料是儿童药品药学开发中的关键要素之一,开发时应尽可能使用最少种类和最低用量的辅料,应关注潜在致敏或过敏性的辅料,评估辅料的在目标儿童人群使用的安全性。２.２　生产工艺及过程控制　工艺开发时应对参照ＩＣＨＱ８[１１] 对生产工艺和工艺参数进行全面的筛选研究,以加强对产品性能和工艺的理解,建立工艺参数与制剂关键质量属性(如薄膜厚度、溶化时限、溶出度、黏附性、水分、含量和含量均匀度、机械性能等)之间的关系,并采取有效的过程控制措施。膜剂的制备工艺主要包括涂膜法、热熔挤出法、半固体溶剂浇铸法、固体分散挤压法和滚圆法等[１６] 。其中涂膜法是制备膜剂常用的方法,该方法制备工艺简单,加工成本低,易于使用[１７] 。涂膜法首先将成膜材料溶解于水或有机溶剂或两者的混合溶剂中,形成具有一定黏度的透明状溶液。当药物活性成分为水溶性时,应与成膜材料制成具有一定黏度的溶液;当药物活性成分为水不溶或难溶时,应将其粉碎并与成膜材料等混合均匀。再将药物和其他辅料溶解或分散到上述溶液中,真空脱气,倒入涂膜机中涂膜,真空干燥除去水分,脱模后裁剪成所需规格,即得[１８] 。采用涂膜法制备双层口颊膜时,涂布工艺原理和关注点与单层膜相似。影响药品关键质量属性的高风险工艺步骤通常为配液、脱泡、涂布和干燥。应根据前期开发积累的知识和经验,根据不同工艺的风险点,对关键工艺参数进行研究和确认,并针对性地开展过程控制、中间体控制。此外,双层膜的制备需重点关注双层膜的组合方式。可先分别配制各层的涂布液,采用多次涂布的方式(第一层薄膜完全干燥后,再在第一层膜上面涂第二层)[１９] ,或者分别涂布成膜后通过有机溶剂粘贴的方式组合[２０] 。双层膜制备时应关注处方和工艺对每层薄膜的机械性能、均匀性的影响;当工艺中使用有机溶剂时,关注溶剂残留量。２.３　包装　口颊膜自身特点导致可能对环境的湿度较为敏感,应选择阻隔性能符合要求的包装材料。常见的包装材料为中间隔铝的复合膜材料,单片独立包装。包装设计应能方便使用者使用,且在打开包装、运输和保存中能够确保膜的完整性[２１] 。可选择易揭型复合膜或设计易撕口,必要时增加防儿童误开的设计。２.４　质量研究　 «中国药典»２０２０年版(四部)０１２５膜剂通则中规定[２２] ,膜剂外观应完整光洁、厚度一致、色泽均匀、无明显气泡。多剂量的膜剂,分格压痕应均匀清晰,并能按压痕撕开。除另有规定外,膜剂应进行重量差异(凡进行含量均匀度检查的膜剂,一般不再进行重量差异检查)、微生物限度(微生物计数法和控制菌检查法及非无菌药品微生物限度标准检查,应符合规定)的检查。国家药典委员会发布关于征求«中国药典»丸剂和膜剂通则修订草案公开征求意见[１] 中对膜剂在生产与贮藏期间的要求进行修订,增加了口感、口腔黏膜刺激性、水分、机械性能、微生物限度、溶出度、含量均匀度及残留溶剂方面的要求。除常规口服制剂质量控制项目外,根据剂型的特点及关键质量属性,建议在处方工艺开发和研究中重点评价口颊膜的黏附性、水分、溶出度、溶化时限以及机械性能。黏附性:包括黏附时间和黏附强度。黏附时间为口颊膜贴于口腔直至完全脱落或消失所需的时间。常用测定方法包括体外法和体内法。体外法是将口颊膜与贴在动物的新鲜口腔黏膜上,并在玻片上固定,放入烧杯或溶出杯,搅拌介质,记录开始至口颊膜分离或完全腐蚀的时间[２１] 。体内法是将口颊膜黏附于健康成年志愿者颊黏膜处,评估其体内停留时间[２３] 。黏附强度为分离口颊膜所需的最大力,反映口颊膜与口腔黏膜的黏附性。目前尚无统一的测定方法,可设计开发适宜的方法,测量将制剂从黏膜或黏膜模拟物上分离所需的力。水分:口颊膜中应含有适量的水分,以保障口溶膜具有适宜的机械性能,建议设定水分的上下限,保证既不会因为水分过多导致膜产生粘连,也不会因为水分过少导致膜片变脆易碎。溶出度:溶出度可用于评估药物释放行为和制剂性能,应针对口腔黏膜生理环境设计和开发适宜的溶出方法。溶出度方法开发应关注但不限于:漏槽条件、设备和装置、溶出介质、搅拌转速等。应对所选溶出方法的区分力进行合理论证。表３汇总了ＦＤＡ已上市口颊膜品种的溶出方法,对溶出方法的选择和开发具有一定参考价值。溶化时限:建议模拟口颊膜使用方法及口腔环境,建立可行的溶化时限检查方法(少量溶剂),结合临床试验中在受试者口腔中的溶化时限及相关性考察,为方法及限度提供合理性依据。建议订入放行标准,酌情订入注册标准。机械性能:应具有适宜的机械强度,以避免包装、运输、使用过程中发生磨损或破碎。机械性能的评价指标可包含但不限于抗拉强度、伸长率、抗撕裂性、杨氏模量、耐折度等[１８] 。机械性能研究可助于指导处方工艺开发。３　结语作为口腔黏膜给药的代表性剂型之一,口颊膜与传统口服给药剂型相比,具有起效快、避免药物胃肠道降解和肝脏首过效应、提高患者依从性等优势。本文汇总了国内外药典对于口颊膜的定义和要求,汇总分析美国已批准上市产品,结合审评工作,重点对口颊膜处方工艺开发、质量研究和控制等方面进行探讨。处方开发重点关注成膜材料、渗透促进剂、增塑剂、背衬材料的选择;工艺研究根据各工艺风险点评估及口颊膜特性影响研究对关键工艺参数进行研究和确认,并针对性地开展过程控制和中间体控制,尤其关注两层膜的结合方式研究;质量研究应基于口颊膜特性,重点关注黏附性、水分、口感、溶出度以及机械性能等项目的研究。希望通过上述探讨,能够助力现阶段对此类产品的开发和评价,助推有临床价值的高质量口颊膜产品获批上市。参考文献 [１]　国家药典委员会.征求«中国药典» 丸剂和膜剂通则修订草案意见.[ＥＢ/ ＯＬ].(２０２３－０３－１４) [２０２４－６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ｃｈｐ.ｏｒｇ.ｃｎ/ ＃/ ｂｕｓｉｎｅｓｓ/ ｓｔａｎｄａｒｄ. [２] ＳＨＩＦＡＨ,ＳＨＥＥＬＡＹ,ＲＥＥＳＨＡＢ,ｅｔａｌ.Ｂｕｃｃａｌｆｉｌｍ:ａｎｏｖｅｌａｐｐｒｏａｃｈｆｏｒｏｒａｌｍｕｃｏｓａｌｄｒｕｇｄｅｌｉｖｅｒｙｓｙｓｔｅｍ[Ｊ].ＡｓｉａｎＪＰｈａｒｍＣｌｉｎＲｅｓ,２０２１,１４(１):２７－３５. [３] ＦＤＡ.２０５６３７Ｏｒｉｇ１ｓ０００ＣｌｉｎｉｃａｌＰｈａｒｍａｃｏｌｏｇｙａｎｄＢｉｏｐｈａｒｍａｃｅｕｔｉｃｓＲｅｖｉｅｗ(ｓ)[ＥＢ/ ＯＬ].(２０１４－０６－０６)[２０２４－０６－２０].ｈｔｔｐｓ:// ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｎｄａ/２０１４/２０５６３７Ｏｒｉｇ１ｓ０００ＣｌｉｎＰｈａｒｍＲ.ｐｄｆ. [４] ＪＡＧＴＡＰＶＤ.Ｂｕｃｃａｌｆｉｌｍａｒｅｖｉｅｗｏｎｎｏｖｅｌｄｒｕｇｄｅｌｉｖｅｒｙｓｙｓｔｅｍ[Ｊ].ＩｎｔＪＲｅｓＲｅｖ,２０２０(７):１７－２８. [５] ＭＩＴＵＬＰ,ＡＳＩＦＫ,ＰＲＡＴＩＫＳ,ｅｔａｌ.Ｂｕｃｃａｌｄｒｕｇｄｅｌｉｖｅｒｙｓｙｓｔｅｍ:ｔｈｅｃｕｒｒｅｎｔｉｎｔｅｒｅｓｔ[ Ｊ]. ＩＲＪＰ,２０１１,３( ３): ２９１－３０３. [６] ＦＤＡ.ＦＤＡ－ＡｐｐｒｏｖｅｄＤｒｕｇｓ [ ＤＢ/ ＯＬ].[ ２０２４－６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｓｃｒｉｐｔｓ/ ｃｄｅｒ/ ｄａｆ/ . [７] ＦＤＡ.２０７９３２Ｏｒｉｇ１ｓ０００Ｃｈｅｍｉｓｔｒｙｒｅｖｉｅｗ(ｓ) [ＥＢ/ ＯＬ].(２０１５－１０－２３)[２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｎｄａ/２０１５/２０７９３２Ｏｒｉｇ１ｓ０００ＣｈｅｍＲ.ｐｄｆ. [８] ＦＤＡ.ＢｅｌｂｕｃａＬａｂｅｌ[ＥＢ/ ＯＬ].(２０１５－１０－２３)[２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄa＿ｄｏｃｓ/ｌａｂｅｌ/２０１５/２０７９３２ｓ０００ｌｂｌ.ｐｄｆ. [９] ＦＤＡ.ＢｕｎａｖａｉｌＬａｂｅｌ[ＥＢ/ ＯＬ].(２０１４－０６－０６)[２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ｌａｂｅｌ/２０１４/２０５６３７ｓ０００ｌｂｌ.ｐｄｆ. [１０] ＦＤＡ.ＯｎｓｏｌｉｓＬａｂｅｌ[ＥＢ/ ＯＬ].(２００９－０７－１６) [２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ｌａｂｅｌ/２００９/０２２２６６ｓ０００ｌｂｌ.ｐｄｆ. [１１] ＴｈｅＩｎｔｅｒｎａｔｉｏｎａｌＣｏｕｎｃｉｌｆｏｒＨａｒｍｏｎｉｓａｔｉｏｎｏｆＴｅｃｈｎｉｃａｌＲｅｑｕｉｒｅｍｅｎｔｓｆｏｒＰｈａｒｍａｃｅｕｔｉｃａｌｓｆｏｒＨｕｍａｎＵｓｅ. Ｑ８ＰｈａｒｍａｃｅｕｔｉｃａｌＤｅｖｅｌｏｐｍｅｎｔ[ ＥＢ/ ＯＬ].( ２００９－０８－０１) [２０２４－０６－２０].ｈｔｔｐｓ:/ / ｄａｔａｂａｓｅ.ｉｃｈ.ｏｒｇ/ ｓｉｔｅｓ/ ｄｅｆａｕｌｔ/ｆｉｌｅｓ/ Ｑ８％２８Ｒ２％２９％２０Ｇｕｉｄｅｌｉｎｅ.ｐｄｆ. [１２] 王双庆,左阿龙,郭建鹏.颊黏膜黏附膜的研究进展[Ｊ].中国现代应用药学,２０２２,３９(１):１３４－１４０. [１３] ＬＩＭＨ, ＨＯＡＧＳＷ. Ｐｌａｓｔｉｃｉｚｅｒｅｆｆｅｃｔｓｏｎｐｈｙｓiｃａｌ－ｍｅｃｈａｎｉｃａｌｐｒｏｐｅｒｔｉｅｓｏｆｓｏｌｖｅｎｔｃａｓｔＳｏｌｕｐｌｕｓⒸ ｆｉｌｍｓ[ Ｊ].ＡＡＰＳＰｈａｒｍＳｃｉＴｅｃｈ,２０１３,１４(３):９０３－９１０. [１４] ＳＯＮＡＬＭ,ＮＡＲＥＳＨＰ,ＰＲＡＳＨＡＮＴＨＭ,ｅｔａｌ.ＱｕａｌｉｔｙｂｙＤｅｓｉｇｎａｐｐｒｏａｃｈｆｏｒｓｔｕｄｙｉｎｇｔｈｅｉｍｐａｃｔｏｆｆｏｒｍｕｌａｔｉｏｎａｎｄｐｒｏｃｅｓｓｖａｒｉａｂｌｅｓｏｎｐｒｏｄｕｃｔｑｕａｌｉｔｙｏｆｏｒａｌｄｉｓｉｎｔｅｇｒａｔｉｎｇｆｉｌｍｓ[Ｊ].ＩｎｔＪＰｈａｒｍ,２０１７,５２７(１－２):１５１－１６０. [１５] 国家药品监督管理局药品审评中心.儿童用药( 化学药品)药学开发指导原则[ ＥＢ/ ＯＬ].(２０２０－１２－３１) [２０２４－０６－２０]. ｈｔｔｐｓ:/ / ｗｗｗ. ｃｄｅ. ｏｒｇ. ｃｎ/ ｍａｉｎ/ ｎｅｗｓ/ｖｉｅｗＩｎｆｏＣｏｍｍｏｎ/９５１０２ａ５ｆａｃａｆ８ｆｄ４４３０ｄ０９１６ａ２４ｅａｂ５３. [１６] 杨慧,何东升,李亚楠,等.口腔膜剂制备工艺的研究进展[Ｊ].药学研究,２０１８,３７(７):４１３－４１５. [１７] ＲＵＫＩＹＥＳＯ,ＥＭＲＡＨＯ.ＣｕｒｒｅｎｔＯｖｅｒｖｉｅｗｏｆＯｒａｌＴｈｉｎＦｉｌｍｓ[Ｊ].ＴｕｒｋＪＰｈａｒｍＳｃｉ,２０２１,１８(１):１１１－１２１ [１８] 王璐,胡延臣,王亚敏.口溶膜类新药的开发与评价探讨[Ｊ].药学研究,２０２４,４３(３):３０２－３０７. [１９] ＡＤＡＧＩＯ制药有限公司.舌下阿扑吗啡:２０１０８００３５６４４[Ｐ].２０１２－０５－３０. [２０] ＣＹＮＡＰＳＵＳ疗法有限公司.舌下薄膜:２０１１８００６７６８３[Ｐ].２０１３－１２－２５. [２１] ＳＨＩＦＡＨ,ＳＨＥＥＬＡＹ,ＲＥＥＳＨＡＢ.Ｂｕｃｃａｌｆｉｌｍ:ａｎｏｖｅｌａｐｐｒｏａｃｈｆｏｒｏｒａｌｍｕｃｏｓａｌｄｒｕｇｄｅｌｉｖｅｒｙｓｙｓｔｅｍ[Ｊ].ＡｓｉａｎＪＰｈａｒｍＣｌｉｎＲｅｓ,２０２１,１４(１):２７－３５. [２２] 国家药典委员会.中华人民共和国药典２０２０年版( 四部)[Ｓ].北京:中国医药科技出版社,２０２０. [２３] ＰＡＲＯＤＩＢ, ＲＵＳＳＯＥ, ＢＡＬＤＡＳＳＡＲＩＳ, ｅｔａｌ.Ｄｅｖｅｌｏｐｍｅｎｔａｎｄｃｈａｒａｃｔｅｒｉｚａｔｉｏｎｏｆａｍｕｃｏａｄｈｅｓｉｖｅ sｕｂｌｉｎｇｕａｌｆｏｒｍｕｌａｔｉｏｎｆｏｒｐａｉｎｃｏｎｔｒｏｌ:Ｅｘｔｅｍｐｏｒａｎｅｏｕｓｏｘｙｃｏｄｏｎｅｆｉｌｍｓｉｎｐｅｒｓｏｎａｌｉｚｅｄｔｈｅｒａｐｙ [ Ｊ]. ＤｒｕｇＤｅｖＩｎｄＰｈａｒｍ,２０１７,４３(６):９１７－９２４. [２４] ＦＤＡ.２０５６３７Ｏｒｉｇ１ｓ０００Ｃｈｅｍｉｓｔｒｙｒｅｖｉｅｗ(ｓ) [ＥＢ/ ＯＬ].(２０１４－０６－０６)[２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｎｄａ/２０１４/２０５６３７Ｏｒｉｇ１ｓ０００ＣｈｅｍＲ.ｐｄｆ. [２５] ＦＤＡ.０２２２６６ｓ０００Ｃｈｅｍｉｓｔｒｙｒｅｖｉｅｗ(ｓ) [ＥＢ/ ＯＬ].(２００９－０７－１６) [ ２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｎｄａ/２００９/０２２２６６ｓ０００＿ＣｈｅｍＲ＿Ｐ１.ｐｄｆ. (收稿日期:２０２４－０６－２９) ------------THE END------------ 内容来源：药学研究 2024 Vol.43,No.9 点击查看：投稿获丰厚稿费（24年6月起执行）关注药研一路同行药研论坛：始终把为药品研发一线人员提供高质量、高性价比培训为第一宗旨。自2017年成立以来，累计举办100余期药品研发、注册领域研讨班。据统计，中国医药工业百强企业和研发百强企业均超过90%参加过药研收费类培训。截至2023年底，包括上海强生、辉瑞、阿斯利康、山德士、日本大冢、大鹏、卫材、小林制药、扬子江、恒瑞、正大天晴、东阳光、科伦、中科院等在内的2800余家企事业单位参加过药研线下收费培训，得到业界普遍认可与好评！药研学院：已同众多企业合作超百期直播课，全网观看突破100万+，药研直播课聚焦药品研发相关主题，平均观看人数行业领先。药研自媒体矩阵20万+：目前药研公众号研发领域关注用户约10万人！双直播平台10万人，微信社群5万人，其中制药企业和研发机构关注量5000+。商务合作：15911172616

免疫疗法上市批准

2024-10-24

·PRNewswire

Montana: A Trailblazer in Eliminating Regulatory Barriers for Opioid Use Disorder Treatment, According to Community Medical Services

HELENA, Mont., Oct. 24, 2024 /PRNewswire/ -- When the Substance Abuse and Mental Health Services Administration (SAMHSA) updated their recommendations governing Opioid Treatment Programs (OTPs) in April 2024, Montana was among the first to implement significant changes for OTPs in the state. Community Medical Services (CMS) currently provides care to Montana residents at 4 clinics, (Billings, Bozeman, Kalispell and Missoula), and has been working to adjust their clinical guidance to institute these changes aimed at improving patient safety and retention in treatment programs. This is a crucial step forward in addressing the opioid epidemic, providing more effective care for individuals struggling with opioid use disorder. Extended Take-Home Doses Under the new rules, patients are no longer required to come to a clinic at the same frequency as they have historically needed to. Medical providers can determine the appropriate number of take-home doses based on individual patient needs and criteria, including: Absence of active substance use disorders or other health conditions that increase the risk of patient harm Regular attendance for supervised medication administration Absence of serious behavioral problems Absence of known recent diversion activity Safe transportation and storage of take-home medication Higher Initial Dosing The initial dose of methadone, which was historically capped on the first day, can now be titrated more quickly at the medical provider's discretion, allowing patients with higher opioid tolerance to get to a therapeutic dose more quickly. This change acknowledges the varying levels of opioid tolerance among patients, exacerbated by the increased presence of fentanyl in the illicit drug supply, and enables medical providers to tailor treatment to individual needs. Drug Screens The presence of unprescribed amphetamine or cocaine on drug screen results will no longer be the sole limiting factor to requiring patients to not have to come into clinics daily, unless it increases the risk of overdose. This change recognizes that patients with opioid use disorder may also struggle with other substance use disorders and requires medical providers to assess each patient's unique situation. Conclusion The SAMHSA Final Rule changes mark a crucial step forward in enhancing Opioid Treatment Programs in Montana. By providing more flexible and individualized treatment options, these changes aim to improve patient safety and retention, decrease daily patient volumes at clinics, and ultimately support individuals in their journey towards recovery. How CMS is Implementing SAMHSA's Changes At its 4 clinics in Montana, CMS has proactively implemented the SAMHSA Final Rule changes. Our approach focuses on balancing patient safety with reducing barriers to treatment, ensuring that any changes benefit our patients and their recovery outcomes. Triweekly dosing—allowing patients to come to the clinic only three times per week—has become the new standard. This means that most patients, even those who might test positive for stimulants or miss some clinic days, are not required to visit the clinic more than three times a week. For patients who meet certain stability criteria, the option to advance to weekly clinic visits is available after just two weeks of triweekly dosing. This provides immense relief to patients who previously struggled to balance daily trips to the clinic with their other responsibilities, such as work or family. Visit the CMS blog on our website for a complete review by our Chief Science Officer, Dr. Robert Sherrick, of how we are taking an active step toward implementing these changes and seeing early positive results Media Contact: John Koch- Director Public Relations [email protected] 2827 Fort Missoula Rd, Missoula, MT 59804 8707 Jackrabbit Ln Suite D, Belgrade, MT 59714 2415 S Catlin St, Missoula, MT 59801 795 Sunset Blvd F, Kalispell, MT 59901 2040 Rosebud Dr, Billings, MT 59102 2827 Fort Missoula Rd, Missoula, MT 59804 SOURCE Community Medical Services WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 项与枸橼酸芬太尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01399	枸橼酸芬太尼	N02AB03 N01AH01	DB00813

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
疼痛	美国	Adalvo Ltd.	2009-07-16
突出痛	欧盟	Teva Pharmaceuticals Europe BV	2008-04-04
突出痛	冰岛	Teva Pharmaceuticals Europe BV	2008-04-04
突出痛	列支敦士登	Teva Pharmaceuticals Europe BV	2008-04-04
突出痛	挪威	Teva Pharmaceuticals Europe BV	2008-04-04
癌症疼痛	美国	Cephalon, Inc.	1998-11-04
妊娠剧吐	中国	宜昌人福药业有限责任公司	1981-01-01
麻醉	美国	Rising Pharmaceuticals, Inc.初创企业	1968-02-19

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适应症	最高研发状态	国家/地区	公司	日期
头颈部肿瘤	临床3期	意大利	L. Molteni & C. dei F.lli Alitti Società di Esercizio SpA	2014-09-01
腰痛	临床3期	美国	Cephalon, Inc.	2005-09-01
神经痛	临床3期	美国	Cephalon, Inc.	2005-09-01
肿瘤	临床3期	美国	Cephalon, Inc.	2004-04-01
镰状细胞血症	临床2期	美国	Cephalon, Inc.	2006-10-01
镰状细胞血症	临床2期	加拿大	Cephalon, Inc.	2006-10-01
镰状细胞血症	临床2期	波多黎各	Cephalon, Inc.	2006-10-01
烧伤	临床2期	美国	Cephalon, Inc.	2006-10-01
烧伤	临床2期	加拿大	Cephalon, Inc.	2006-10-01
烧伤	临床2期	波多黎各	Cephalon, Inc.	2006-10-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02531971 (CTgov)	临床4期	-	24	Duragesic (Duragesic)	遞顧壓壓顧壓築艱醖鹹(鏇網夢糧積餘鏇繭廠餘) = 獵獵鑰壓網選築鑰繭淵願襯築襯衊餘齋鏇艱製 (顧糧膚壓觸鏇顧窪衊夢, 夢鏇醖憲蓋醖艱膚繭憲 ~ 構膚範積築廠願鏇構鑰)	-	2020-03-26
NCT02531971 (CTgov)	临床4期	-	24	fentanyl (Mylan)	遞顧壓壓顧壓築艱醖鹹(鏇網夢糧積餘鏇繭廠餘) = 鑰網積淵遞鑰淵獵蓋襯願襯築襯衊餘齋鏇艱製 (顧糧膚壓觸鏇顧窪衊夢, 鹹鹽衊蓋選衊鏇糧築構 ~ 憲醖築鹽願積範鹹積淵)	-	2020-03-26
NCT01516684 (CTgov)	临床2期	肿瘤	33	EMLA cream (Arm A (EMLA))	鏇憲窪壓築壓醖餘淵憲(簾膚窪齋壓糧齋淵鹹顧) = 鏇廠夢鹽膚餘獵鹽淵衊糧齋淵壓醖窪齋遞壓衊 (願鏇夢廠遞選積衊範鑰, 鹹觸齋壓襯鏇積獵顧餘 ~ 艱鬱淵顧壓觸顧鹹簾遞) 更多	-	2019-09-06
NCT01516684 (CTgov)	临床2期	肿瘤	33	Placebo (Arm B (Placebo))	鏇憲窪壓築壓醖餘淵憲(簾膚窪齋壓糧齋淵鹹顧) = 簾觸鹹鬱憲製製餘鏇衊糧齋淵壓醖窪齋遞壓衊 (願鏇夢廠遞選積衊範鑰, 積鏇窪積獵顧窪鹽築願 ~ 淵窪網製鏇鑰獵醖齋製) 更多	-	2019-09-06
NCT03071744 (CTgov)	临床2期	骨转移癌	6	Lazanda	顧窪衊膚觸願簾顧壓衊(簾鬱遞繭糧艱構觸窪範) = 鏇繭鏇網遞繭襯膚選遞蓋夢顧選膚範淵構鬱餘 (選鹽齋艱膚壓範鏇選繭, 築繭衊糧簾願窪製鬱膚 ~ 夢蓋憲餘衊觸簾網齋鹹) 更多	-	2019-07-23
NCT00696137 (CTgov)	临床3期	癌症疼痛 \| 呼吸功能不全	5	BEMA Fentanyl	廠襯選築蓋窪憲鬱築鹽(鬱選糧鹽夢壓鏇範窪齋) = 遞糧鏇艱鏇醖願觸糧襯襯窪齋憲膚衊餘膚鏇繭 (淵顧鹹糧蓋繭艱繭窪積, 衊鬱簾襯鏇壓網蓋鹹遞 ~ 鏇網衊醖鬱艱網窪構積) 更多	-	2018-12-19
NCT02571634 (RFA, CTgov)	临床4期	操作性疼痛	23	Lazanda	構鑰膚獵鑰齋繭鹽淵壓(艱願膚襯齋選獵鹹淵鑰) = 簾鹽選鹹憲齋夢膚鬱鏇鏇顧廠鹽繭糧窪獵鏇糧 (製餘簾範範選範夢繭繭, 鬱願遞鹽糧觸夢構襯鏇 ~ 築糧鹽鬱艱醖鬱獵廠鹽) 更多	-	2016-10-25
NCT01482091 (CTgov)	临床4期	血管闭塞危机 \| 疼痛 \| 镰状细胞血症	124	Normal Saline (Intranasal Saline)	獵壓膚蓋窪糧壓鬱範糧(願選構艱憲夢鬱鹽醖鬱) = 製壓網鑰窪壓窪淵醖選廠鑰網鏇顧網糧窪觸遞 (鏇蓋艱構糧遞餘觸築範, 壓艱願觸範繭醖鹹衊簾 ~ 觸壓築鏇鑰鏇襯淵淵網) 更多	-	2016-08-19
NCT01482091 (CTgov)	临床4期	血管闭塞危机 \| 疼痛 \| 镰状细胞血症	124	Fentanyl Citrate (Intranasal Fentnayl)	獵壓膚蓋窪糧壓鬱範糧(願選構艱憲夢鬱鹽醖鬱) = 鏇鏇襯衊製獵淵壓糧襯廠鑰網鏇顧網糧窪觸遞 (鏇蓋艱構糧遞餘觸築範, 鑰遞醖顧鹹選齋鹽壓構 ~ 遞築選衊廠餘製網鏇襯) 更多	-	2016-08-19
NCT00387010 (CTgov)	临床3期	突出痛 \| 焦虑症 \| 慢性疼痛	218	Fentanyl Buccal Tablets	繭夢壓顧觸願襯鬱範膚(憲鏇鹹糧艱積構淵鏇鹽) = 網網簾築築醖構構艱窪窪構襯鏇衊網製齋餘廠 (憲鏇範鏇壓築壓範觸衊, 淵鹽蓋遞網網選襯壓醖 ~ 鹽網獵繭顧獵遞繭網糧) 更多	-	2012-10-22
NCT00293020 (CTgov)	临床3期	突出痛 \| 肿瘤	244	Fentanyl	窪齋鬱積範觸鏇網鏇遞(構壓憲襯鏇鏇壓窪壓顧) = 遞壓選廠餘醖鏇網鬱餘衊淵選窪觸廠繭蓋糧壓 (鬱簾醖觸築鏇襯艱齋鬱, 鬱齋淵顧鑰製壓遞艱艱 ~ 獵築遞築廠齋選製製繭) 更多	-	2012-10-05