Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain

Rauck, Richard; Tark, Marvin; Reyes, Eva; Hayes, Teresa G.; Bartkowiak, Anthony J; Hassman, David; Nalamachu, Srinivas; Derrick, Rob; Howell, Julian

doi:10.1185/03007990903368310

Cited by 129 publications

(99 citation statements)

References 10 publications

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“…SDs are dispersions of one or more active pharmaceutical ingredients (API) in an inert carrier or matrix such as biodegradable polymers in solid state, prepared by melting (fusion), solvent, or a melting-solvent method (Chiou, Riegelman, 1971). It has been suggested that orally disintegrating tablets (ODT) have a faster onset of action compared to conventional tablets, and are more appropriate for the treatment of acute pain (Rauck et al, 2009). In addition, ODTs could reduce dysphagia in older patients suffering from arthritis (Shen et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Preparation and physicochemical characterization of meloxicam orally fast disintegration tablet using its solid dispersion

Shoormeij

Taheri

Homayouni

2018

Braz. J. Pharm. Sci.

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Meloxicam (MLX) is a non-steroidal, anti-inflammatory drug that is prescribed in the treatment of rheumatoid arthritis and osteoarthritis. MLX is practically insoluble in water and exhibits a slow onset of action. In this study, MLX solid dispersions (MLX SDs) were prepared to improve the water solubility of this poorly water-soluble drug. Then orally disintegrating tablets (ODT) of MLX were developed using MLX SD to decrease the onset of action of this drug. MLX, poloxamer 188, and crospovidone of different ratios were melted in molten poloxamer 188 as a hydrophilic carrier. The optimum SD with the highest saturation solubility in water (13.09±0.34 microgram/mL) consisting of MLX: poloxamer 188: crospovidone in the ratio of 1:2:0 was used for the preparation of MLX ODTs. MLX ODTs were prepared by the direct compression method and optimized by the 2 3 factorial design. The effect of the superdisintegrant concentration, the mannitol-avicel ratio, and the level of compression force on the disintegration time, hardness, and percent of dissolved MLX from MLX ODTs after 30 min was evaluated. DSC and XRD analysis approved an amorphous form of MLX in SDs. The optimized ODT formulation containing 10% of superdisintegrant, and mannitol and avicel in the ratio of 4:1 respectively was compressed using a high level of compression force. The optimized ODT showed hardness (34.37±2.1 N) and friability (1.26±0.04%). This formulation showed a rapid disintegration in 12.66±2.5 seconds, which 82.66±5.1% of the MLX released within 30 min. MLX ODTs, prepared from MLX SD, could be introduced as a suitable dosage form of MLX with improved solubility and the onset of action.

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Section: Introductionmentioning

confidence: 99%

Preparation and physicochemical characterization of meloxicam orally fast disintegration tablet using its solid dispersion

Shoormeij

Taheri

Homayouni

2018

Braz. J. Pharm. Sci.

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“…Sublingual fentanyl (SLF) was assessed in cancer patients in a long-term safety phase of 12 months for the management of BTP. Only one patient dropped out for a serious adverse effect considered as possibly related to study medication [42].…”

Section: Discussionmentioning

confidence: 99%

“…Efficacy was based on a general impression regarding the efficacy of INFS with the following scale: 1 (poor), 2 (acceptable), 3 (good), 4 (very good), 5 (excellent). [42]. Quality of sleep was rated with the following scale: 0 (disturbed), 1 (frequent arousals), 2 (good), 3 (very good).…”

Section: Methodsmentioning

confidence: 99%

Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain

Mercadante

Vellucci²,

Cuomo

et al. 2014

Support Care Cancer

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Purpose The aim of the present study was to assess the longterm tolerability and efficacy of intranasal fentanyl (INFS) in opioid-tolerant patients with breakthrough cancer pain (BTP).Patients and methods A 6 months, observational, prospective, cohort study design was employed to follow advanced cancer patients with BTP receiving INFS under routine clinical practice. Eligible adult cancer patients suffering from BTP had been prescribed INFS at effective doses. Data were collected at T0 and at month intervals for six months. The principal outcomes were the evaluation of possible serious adverse effects with prolonged use of INFS, the efficacy of BTP treatment with INFS, the quality of sleep, the rate of INFS discontinuation, and reasons for that.Results Seventy-five patients were surveyed. Thirty-four patients (45.3 %) had a follow-up at 3 months, and twelve patients (16 %) were followed up at 6 months. The mean opioid doses, expressed as oral morphine equivalents, ranged 111-180 mg/day, while the mean INFS doses were 87-119 μg. Adverse effects were reported in a minority of patients and were considered to be associated with opioid therapy used for background pain. The quality of sleep significantly improved during the first 3-4 months. Finally, efficacy based on a general impression regarding the efficacy of INFS was good-excellent in most patients and statistically improved in time up to the third month. Conclusion The long-term use of INFS in advanced cancer patients is effective and safe. No serious adverse effects were found up to six months of assessment. The level of quality of sleep and patients' satisfaction was relatively good, considering the advanced stage of disease.

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“…Overall bioavailability is 54%. In a randomized placebo-controlled study of fentanyl sublingual tablets in 131 adult patients with btcp, use of the tablets resulted in significant improvements in pain intensity and relief compared with placebo 66 . In phase iii studies evaluating the long-term effectiveness of transmucosal immediate-release fentanyl, patients reported high levels of satisfaction with the formulation 65,67 .…”

Section: Contemporary Approaches To the Management Of Btcp With Rapidmentioning

confidence: 99%

“…It has a bioavailability of approximately 89% 68 . Its onset of action occurs within approximately 7 minutes, and its duration of analgesic effect is approximately 1 hour 66 . The efficacy of intranasal fentanyl spray 50-200 μg per spray was demonstrated in a phase iii randomized trial that included 120 opioid-tolerant patients with btcp 69 .…”

Section: Contemporary Approaches To the Management Of Btcp With Rapidmentioning

confidence: 99%

Canadian Recommendations for the Management of Breakthrough Cancer Pain

et al. 2016

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Breakthrough cancer pain (btcp) represents an important element in the spectrum of cancer pain management. Because most btcp episodes peak in intensity within a few minutes, speed of medication onset is crucial for proper control. In Canada, several current provincial guidelines for the management of cancer pain include a brief discussion about the treatment of btcp; however, there are no uniform national recommendations for the management of btcp. That lack, accompanied by unequal access to pain medication across the country, contributes to both regional and provincial variability in the management of btcp.Currently, immediate-release oral opioids are the treatment of choice for btcp. This approach might not always offer optimal speed for onset of action and duration to match the rapid nature of an episode of btcp. Novel transmucosal fentanyl formulations might be more appropriate for some types of btcp, but limited access to such drugs hinders their use. In addition, the recognition of btcp and its proper assessment, which are crucial steps toward appropriate treatment selection, remain challenging for many health care professionals.To facilitate appropriate management of btcp, a group of prominent Canadian specialists in palliative care, oncology, and anesthesiology convened to develop a set of recommendations and suggestions to assist Canadian health care providers in the treatment of btcp and the alleviation of the suffering and discomfort experienced by adult cancer patients.

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Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain

Cited by 129 publications

References 10 publications

Preparation and physicochemical characterization of meloxicam orally fast disintegration tablet using its solid dispersion

Preparation and physicochemical characterization of meloxicam orally fast disintegration tablet using its solid dispersion

Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain

Canadian Recommendations for the Management of Breakthrough Cancer Pain

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