Alternative Routes of Drug Administration—Advantages and Disadvantages (Subject Review)

Berlin, Cheston M.; May-McCarver, D. G.; Notterman, Daniel A.; Ward, Robert M.; Weismann, Douglas N.; Wilson, Geraldine S.; Wilson, Jackie; Bennett, D. R.; Hoskins, Iffath A.; Kaufman, PharmD Michele B.; Mithani, Sabena Dawoodali; Mulinare, Joseph; Troendle, G.; March, John S.; Yaffe, S. J.; Szefler, Stanley J.; Coté, Charles J.

doi:10.1542/peds.100.1.143

Cited by 100 publications

(13 citation statements)

References 135 publications

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“…In general, drugs are not commonly administered rectally in neonates (term or preterm), as it is associated with erratic absorption as well as a risk of damage to the delicate rectal lining that could lead to infection (Jannin et al, 2014). Similarly, the risk of trauma and subsequent infection with rectal dosage forms is also high for immunocompromized patients (Berlin et al, 1997).…”

Section: Physiological Factors Influencing Rectal Drug Deliverymentioning

confidence: 99%

Physiological and Pharmaceutical Considerations for Rectal Drug Formulations

Hua

2019

Front. Pharmacol.

129

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Although the oral route is the most convenient route for drug administration, there are a number of circumstances where this is not possible from either a clinical or pharmaceutical perspective. In these cases, the rectal route may represent a practical alternative and can be used to administer drugs for both local and systemic actions. The environment in the rectum is considered relatively constant and stable and has low enzymatic activity in comparison to other sections of the gastrointestinal tract. In addition, drugs can partially bypass the liver following systemic absorption, which reduces the hepatic first-pass effect. Therefore, rectal drug delivery can provide significant local and systemic levels for various drugs, despite the relatively small surface area of the rectal mucosa. Further development and optimization of rectal drug formulations have led to improvements in drug bioavailability, formulation retention, and drug release kinetics. However, despite the pharmaceutical advances in rectal drug delivery, very few of them have translated to the clinical phase. This review will address the physiological and pharmaceutical considerations influencing rectal drug delivery as well as the conventional and novel drug delivery approaches. The translational challenges and development aspects of novel formulations will also be discussed.

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Section: Physiological Factors Influencing Rectal Drug Deliverymentioning

confidence: 99%

Physiological and Pharmaceutical Considerations for Rectal Drug Formulations

Hua

2019

Front. Pharmacol.

129

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“…A PIPP score of 0-6 suggests minimal or no pain, 7-12 indicates moderate pain and a score ≥ 13 is interpreted as severe pain (21). The physiological parameters of heart rate, respiratory rate, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) at baseline (just before IN fentanyl administration) and at prespecified intervals (15,30,45, and 60 min) after IN fentanyl administration were also recorded. Adverse events were defined as apnea (cessation of breathing for >20 s), bradycardia (heart rate < 100 beats/minute), desaturation (oxygen saturation < 80%), and chest wall rigidity and were monitored for 60 min after IN fentanyl administration.…”

Section: Methodsmentioning

confidence: 99%

Intranasal Fentanyl for Procedural Analgesia in Preterm Infants

et al. 2022

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BackgroundDespite the availability of evidence-based analgesic strategies, neonatal pain management continues to be suboptimal. Intranasal (IN) fentanyl is an alternative pharmacotherapy for procedural pain in neonatal units. The objective was to evaluate the effectiveness and safety of IN fentanyl for procedural pain in preterm infants.MethodsA retrospective cohort study was conducted in infants who received IN fentanyl between May 2019 and December 2020 at an academic neonatal intensive care unit. Main outcome measures were pain responses, physiological parameters before and up to 60 min after IN fentanyl administration, and adverse events. Paired t-test and analysis of variance were used to compare pain scores and physiological parameters, respectively.ResultsThirteen infants received IN fentanyl on 22 occasions. Median (interquartile range [IQR]) gestational age and birthweight were 27 (25, 27.6) weeks and 850 (530, 1,030) grams, while median (IQR) post-menstrual age and weight were 30.9 (28.9, 32.9) weeks and 1,280 (945, 1,623) grams at the time of IN fentanyl administration. IN fentanyl was most used for lumbar puncture (55%) followed by insertion of epicutaneo-caval catheters (27%). There was a difference between the mean pre- and post-procedure Premature Infant Pain Profile scores of 1.3 (95% CI = 0.07, 2.5; p = 0.04). Physiological parameters did not differ before and up to 60 min post IN fentanyl administration (p > 0.05). Two adverse events (one apnea and one desaturation) were noted.ConclusionIn our limited experience, IN fentanyl appears to be an alternative pharmacotherapy for procedural pain management in the absence of intravenous access in preterm infants.

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“…Sublingual fentanyl tablets (SFTs) are a fast-acting form of fentanyl, a potent and strongly lipophilic opioid, which provide a noninvasive mechanism for immediate drug absorption through the sublingual mucosa, avoiding the gastrointestinal tract and first pass hepatic metabolism [12–14]. SFTs have been shown to be a safe and effective option in controlling BTcP as well as improving QoL in cancer patients of all ages [15–19].…”

Section: Introductionmentioning

confidence: 99%

Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets

et al. 2019

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IntroductionSublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP). However, further examination is required to investigate the use of SFTs among the elderly. The aim of this study was to examine the influence of age in BTcP management with SFTs in the elderly population.MethodsWe performed subgroup analyses of a recently completed trial in two subsets of individuals: patients aged 65–74 years (low age group) and patients ≥ 75 years (high age group). Pain intensity (PI), onset of pain relief, frequency and duration of BTcP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health status instruments used were the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Short Form 12, version 2 (SF-12v2) questionnaire.ResultsLevels of PI at the end of the study improved significantly as compared with baseline in both the low and the high age groups (30.0% and 27.7% reduction, respectively). The onset of analgesia at the end of the study began in < 10 min in 85.0% of young–old subjects and in 62.5% of patients ≥ 75 years, but no significant differences were found. BTcP episodes lasted < 15 min in 75.0% of patients in the low age group and 58.3% in the high age group (p = 0.24). Most of patients in both groups experienced one to five BTcP daily episodes, at all assessment points. HADS-D decreased from 10.78 (± 4.33) to 8.21 (± 3.57) in the low age group, and from 10.96 (± 4.26) to 9.36 (± 3.35) in the high age group (p = 0.02). Significant differences in HADS-A scores from baseline to the end of the study were also observed in both subgroups (p < 0.05). Patients in the low age group had less favorable mental component summary (MCS) and physical component summary (PCS) scores than patients in the high age group. At the end of the study, 10.0% of young–old patients and 29.2% of patients aged ≥ 75 years reported AEs related to their treatment. The most commonly reported AEs included nausea, vomiting, constipation, somnolence, and skin disorders and they were generally mild to moderate in severity.ConclusionsThe results of this study showed that SFTs provided safe and clinically meaningful pain relief in both elderly subgroups. Clinical implications of these findings await validation in large, confirmatory studies to identify age subgroup divergences among elderly cancer patients treated with SFTs.

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Alternative Routes of Drug Administration—Advantages and Disadvantages (Subject Review)

Cited by 100 publications

References 135 publications

Physiological and Pharmaceutical Considerations for Rectal Drug Formulations

Physiological and Pharmaceutical Considerations for Rectal Drug Formulations

Intranasal Fentanyl for Procedural Analgesia in Preterm Infants

Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets

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