Tramadol SR Formulations

Cnota, Peter J.; Nowak, H; Tagarro, Ignacio; Erb, Katharina; Schürer, Michael; Schulz, Hans–Ulrich; Maus, Joachim

doi:10.2165/00044011-200525070-00002

Cited by 17 publications

(3 citation statements)

References 9 publications

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“…Extended-release (ER) or controlled-release (CR) formulations may improve opioid tolerability in OA patients by preventing the high plasma peaks that are associated with the AEs observed with the immediate-release (IR) formulations [18]. A meta-analysis of four RCTs of patients with musculoskeletal pain found that ER tapentadol (100–250 mg/day) is associated with a reduction in pain intensity in comparison with placebo and oxycodone.…”

Section: Introductionmentioning

confidence: 99%

Safety of Opioids in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis

et al. 2019

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Objective We aimed to assess the safety of opioids in the management of osteoarthritis (OA) in a systematic review and meta-analysis of randomized, placebo-controlled trials. Methods A comprehensive literature search was undertaken in the MEDLINE, Cochrane Central Register of Controlled Trials (Ovid CENTRAL), and Scopus electronic databases. Randomized, double-blind, placebo-controlled, parallel-group trials that assessed adverse events (AEs) with opioids in patients with OA were eligible for inclusion. Two authors appraised titles, abstracts and full-text papers for suitability and then assessed the studies for random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data and selective outcomes reporting. The primary outcomes of interest were gastrointestinal (GI) disorders, cardiac disorders, vascular disorders, nervous system disorders, skin and subcutaneous tissue disorders, renal and urinary disorders, respiratory, thoracic and mediastinal disorders, as well as overall severe and serious AEs and drug-related AEs. Secondary outcomes were withdrawals due to AEs (i.e. the number of participants who stopped the treatment due to an AE) and total number of AEs (i.e. the number of patients who experienced any AE at least once). Results Database searches identified 2189 records, from which, after exclusions, 17 papers were included in the meta-analysis. More disorders of the lower GI tract (constipation, fecaloma) were reported with both immediate-release (IR) and extended-release (ER) formulations of opioids versus placebo: IR opioids (relative risk [RR] 5.20, 95% confidence interval [CI] 3.42–7.89); ER opioids (RR 4.22, 95% CI 3.44–5.17). The risk of upper GI AEs increased fourfold with ER opioids compared with placebo (RR 4.03, 95% CI 0.87–18.62), and the risk of nausea, vomiting or loss of appetite increased four- to fivefold with both formulations: IR opioids (RR 3.39, 95% CI 2.22–5.18); ER opioids (RR 4.03, 95% CI 3.37–4.83). An increased risk of dermatologic AEs (rash and pruritis; IR opioids: RR 3.60, 95% CI 1.74–7.43; ER opioids: RR 7.87, 95% CI 5.20–11.89) and central nervous system disorders (dizziness, headache, fatigue, somnolence, insomnia; IR opioids: RR 2.76, 95% CI 1.90–4.02; ER opioids: RR 2.76, 95% CI 2.19–3.47) was found with all opioid formulations versus placebo. Conclusions Our results confirm that there are considerable safety and tolerability issues surrounding the use of opioids in OA, and support the recommendation of international and national guidelines to use opioids in OA after other analgesic options, and for short time periods. Electronic supplementary material The online version of this article (10.1007/s40266-019-00666-9) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Safety of Opioids in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis

et al. 2019

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“…Лекарственные формы трамадола с замедленным высвобождением (ЗВ) предпочтительны, поскольку они связаны с меньшей частотой побочных эффектов [96]. Лекарственная форма трамадола в капсулах с микропеллетами на несколько единиц с ЗВ (Меда) обеспечивает длительное поддержание эффективного уровня трамадола в плазме с низкой вариабельностью скорости и степени абсорбции [97], таким образом предотвращая высокие пики концентрации в плазме, связанные с НР, которые отмечаются для лекарственных форм с немедленным высвобождением [96,97]. Кроме того, для повышения переносимости и минимизации случаев прекращения терапии по причине НР рекомендуется медленное повышение дозы трамадола с ЗВ от 50 до 100 мг 2 раза в день в течение 7 дней [98].…”

Section: трамадолunclassified

The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (Esceo) Algorithm for the Management of Knee Osteoarthritis Is Applicable to Russian Clinical Practice: A Consensus Statement of Leading Russian and Esceo Osteoarthritis Experts

Denisov¹,

Цветкова²,

Голубев³

et al. 2017

Naučno-praktičeskaâ revmatologiâ

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The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) treatment algorithm for the management of knee osteoarthritis (OA), published in December 2014, provides practical guidance for the prioritization of interventions. This current paper represents an assessment and endorsement of the algorithm by Russian experts in OA for use in Russian clinical practice, with the aim of providing easy-to-follow advice on how to establish a treatment flow in patients with knee OA, in support of the clinicians’ individualized assessment of the patient. Medications recommended by the ESCEO algorithm are available in Russia. In step 1, background maintenance therapy with symptomatic slow-acting drugs for osteoarthritis (SYSADOA) is advised, for which high-quality evidence is provided only for the formulations of patented crystalline glucosamine sulphate (pCGS) (Rottapharm/Meda) and prescription chondroitin sulfate. Paracetamol may be added for rescue analgesia only, due to limited efficacy and increasing safety signals. Topical non-steroidal anti-inflammatory drugs (NSAIDs) may provide additional symptomatic treatment with the same degree of efficacy as oral NSAIDs but without the systemic safety concerns. To be effective, topical NSAIDs must have high bioavailability, and among NSAIDs molecules like etofenamate have high absorption and bioavailability alongside evidence for accumulation in synovial tissues. Oral NSAIDs maintain a central role in step 2 advanced management of persistent symptoms. However, oral NSAIDs are highly heterogeneous in terms of gastrointestinal and cardiovascular safety profile, and patient stratification with careful treatment selection is advocated to maximize the risk: benefit ratio. Intra-articular hyaluronic acid as a next step provides sustained clinical benefit with effects lasting up to 6 months after a short-course of weekly injections. As a last step before surgery, the slow titration of sustained-release tramadol, a weak opioid, affords sustained analgesia with improved tolerability.

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“…The multi-unit drug delivery system (MUDDS) had unique advantages over the single pellet system in the treatment of some diseases (Cnota 2005). Studies had shown that the double-release pellets MUDDS made by the mixture of immediate-release and sustained-release pellets according to a certain proportion not only could a 1547357926@qq.com b 930520491@qq.com c 1592974052@qq.com ensure the initial effect of the drug in vivo, but also make the stable release of MUDDS in vivo so that the efficacy and safety of the drug were significantly improved (Dong 2018, Shan 2022).…”

Section: Introdutionmentioning

confidence: 99%

Optimization of Preparation Process and Pharmacokinetics of APAP Double-Release Pellet Capsules

Song

Gao

et al. 2023

BIO Web Conf.

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In order to develop a kind of APAP double-release pellet capsules, which was prepared with the manual filling method, the immediate and sustained release pellets of a certain proportion were prepared by the fluidized bed coating and the extrusion spheroidization process, respectively. It was founded that both the prepared immediate-release pellets and sustained-release pellets had smooth and round surfaces. The particle size distribution ranged evenly from 16 to 35 mesh. Response surface plots showed that the optimal preparation prescription for immediate-release pellets were that ethanol concentration (X1) 70%, APAP 20%, MCC (X2) 40%, PVP K30 (X3) 20%, and sucrose pellet core 20%; and the optimal preparation prescription for sustained-release pellets were that HPMC concentration (X*3) 6.5%, APAP 30%, EC (X*1) 20%, MCC (X*2) 40%, PVP K30 4%, and lactose 6%. The results of pharmacokinetic analysis revealed that, after the APAP double-release pellet was orally administered, compared with that of conventional tablets, the plasma APAP levels in the blood circulation dramatically rose to significant peaks as a result of the quick and slow release of APAP from the capsules, which significantly prolonged the effective time of drugs in blood. Finally, immediate and sustained antipyretic-analgesic effects were obtained.

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Tramadol SR Formulations

Cited by 17 publications

References 9 publications

Safety of Opioids in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis

Safety of Opioids in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis

The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (Esceo) Algorithm for the Management of Knee Osteoarthritis Is Applicable to Russian Clinical Practice: A Consensus Statement of Leading Russian and Esceo Osteoarthritis Experts

Optimization of Preparation Process and Pharmacokinetics of APAP Double-Release Pellet Capsules

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