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Advanced Drug Delivery Reviews Jun 2014The rectal route can be considered a good alternative to the oral route for the paediatric population because these dosage forms are neither to be swallowed nor need to... (Review)
Review
The rectal route can be considered a good alternative to the oral route for the paediatric population because these dosage forms are neither to be swallowed nor need to be taste-masked. Rectal forms can also be administered in an emergency to unconscious or vomiting children. Their manufacturing cost is low with excipients generally regarded as safe. Some new formulation strategies, including mucoadhesive gels and suppositories, were introduced to increase patient acceptability. Even if recent paediatric clinical studies have demonstrated the equivalence of the rectal route with others, in order to enable the use of this promising route for the treatment of children in the 21st Century, some effort should be focused on informing and educating parents and care givers. This review is the first ever to address all the aforementioned items, and to list all drugs used in paediatric rectal forms in literature and marketed products in developed countries.
Topics: Administration, Rectal; Child; Humans; Pediatrics; Pharmaceutical Preparations
PubMed: 24871671
DOI: 10.1016/j.addr.2014.05.012 -
Biochemical Society Transactions Oct 1989
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The Cochrane Database of Systematic... Feb 2012Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Rectal administration may be preferable to oral for individuals experiencing nausea and/or vomiting.
OBJECTIVES
To determine the efficacy and tolerability of rectal sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.
SELECTION CRITERIA
We included randomised, double-blind, placebo- and/or active-controlled studies using rectally administered sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.
MAIN RESULTS
Three studies (866 participants) compared rectally administered sumatriptan with placebo or an active comparator. Most of the data were for the 12.5 mg and 25 mg doses. For the majority of efficacy outcomes, sumatriptan surpassed placebo. For sumatriptan 12.5 mg versus placebo the NNTs were 5.2 and 3.2 for headache relief at one and two hours, respectively. Results for the 25 mg dose were similar to the 12.5 mg dose, and there were no significant differences between the two doses for any of the outcomes analysed. The NNTs for sumatriptan 25 mg versus placebo were 4.2, 3.2, and 2.4 for pain-free at two hours, headache relief at one hour, and headache relief at two hours, respectively.Relief of functional disability was greater with sumatriptan than with placebo, with NNTs of 8.0 and 4.0 for the 12.5 mg and 25 mg doses, respectively. For the most part, adverse events were transient and mild and were more common with sumatriptan than with placebo, but there were insufficient data to perform any analyses.Direct comparison of sumatriptan with active treatments was limited to one study comparing sumatriptan 25 mg with ergotamine tartrate 2 mg + caffeine 100 mg.
AUTHORS' CONCLUSIONS
Based on limited amounts of data, sumatriptan 25 mg, administered rectally, is an effective treatment for acute migraine attacks, with participants in these studies experiencing a significant reduction in headache pain and functional disability within two hours of treatment. The lack of data on relief of headache-associated symptoms or incidence of adverse events limits any conclusions that can be drawn.
Topics: Acute Disease; Administration, Rectal; Adult; Caffeine; Ergotamine; Female; Humans; Male; Migraine Disorders; Pain Management; Randomized Controlled Trials as Topic; Serotonin 5-HT1 Receptor Agonists; Sumatriptan
PubMed: 22336868
DOI: 10.1002/14651858.CD009664 -
European Journal of Pharmaceutics and... Dec 2020Research around paediatric rectal drug delivery has previously been based on views of parents and healthcare workers. The aim of this exploratory study was to gauge...
AIMS
Research around paediatric rectal drug delivery has previously been based on views of parents and healthcare workers. The aim of this exploratory study was to gauge whether children and young adults in the UK were comfortable with the idea of rectal drug delivery.
METHODS
Eleven children from a pre-existing patient and public advisory group were involved in the session. Rectal drug delivery was explained and group participants were asked a series of questions. Responses were discussed in a group and recorded individually.
RESULTS
Of the group, 27% would consider the rectal route, while 64% said it depended on other options available. The primary concern focused on potential for abusive misuse by others. Participants thought this would be overcome if the child could self-administer, although there was also concern about the process of self-administration.
CONCLUSIONS
Not all children in the UK are against rectal drug delivery, but education is needed to teach children to self-administer medication in this way.
Topics: Administration, Rectal; Adolescent; Adolescent Behavior; Age Factors; Child; Child Behavior; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Patient Acceptance of Health Care; Patient Education as Topic; Patient Preference; Pharmaceutical Preparations; Self Administration
PubMed: 33022390
DOI: 10.1016/j.ejpb.2020.09.015 -
International Journal of Molecular... May 2021Rectal drug delivery is an effective alternative to oral and parenteral treatments. This route allows for both local and systemic drug therapy. Traditional rectal dosage... (Review)
Review
Rectal drug delivery is an effective alternative to oral and parenteral treatments. This route allows for both local and systemic drug therapy. Traditional rectal dosage formulations have historically been used for localised treatments, including laxatives, hemorrhoid therapy and antipyretics. However, this form of drug dosage often feels alien and uncomfortable to a patient, encouraging refusal. The limitations of conventional solid suppositories can be overcome by creating a thermosensitive liquid suppository. Unfortunately, there are currently only a few studies describing their use in therapy. However, recent trends indicate an increase in the development of this modern therapeutic system. This review introduces a novel rectal drug delivery system with the goal of summarising recent developments in thermosensitive liquid suppositories for analgesic, anticancer, antiemetic, antihypertensive, psychiatric, antiallergic, anaesthetic, antimalarial drugs and insulin. The report also presents the impact of various types of components and their concentration on the properties of this rectal dosage form. Further research into such formulations is certainly needed in order to meet the high demand for modern, efficient rectal gelling systems. Continued research and development in this field would undoubtedly further reveal the hidden potential of rectal drug delivery systems.
Topics: Acrylic Resins; Administration, Rectal; Alginates; Body Temperature; Drug Compounding; Drug Delivery Systems; Forecasting; Gels; Hot Temperature; Humans; Intestinal Absorption; Methylcellulose; Pharmaceutical Preparations; Poloxamer; Povidone; Suppositories
PubMed: 34071110
DOI: 10.3390/ijms22115500 -
International Journal of Pharmaceutical... 2022Suppositories have not gained the level of acceptability, respect, and usage as most other dosage forms. Rectal administration is not often the first route of... (Review)
Review
Suppositories have not gained the level of acceptability, respect, and usage as most other dosage forms. Rectal administration is not often the first route of choice, but it becomes a good alternative when the oral route is inadvisable. Much work has been conducted in recent years on suppositories as a dosage form, as evidenced by the literature citations on suppository or suppositories. Although suppositories are not very popular as a mode of administering drugs, this dosage form will probably always have a place in medicine. Newer specialty suppository dosage forms have been developed to introduce drugs into the body, including the hollow-type suppository. Hollow-type suppositories have been investigated as a new dosage form that can be used for various purposes including but not limited to 1) enhancing the bioavailability of a drug, 2) slowing down or speeding up its onset of action, and 3) increasing or decreasing its duration of action. The flexibility of hollow-type suppositories may provide compounding pharmacists additional options for patients in the future. The purpose of this article is to provide a review of the characteristics and applications of hollow-type suppositories in both research and clinical situations.
Topics: Administration, Oral; Administration, Rectal; Biological Availability; Humans; Suppositories
PubMed: 35820136
DOI: No ID Found -
Epilepsy & Behavior : E&B Aug 2015The intramuscular (IM) and rectal routes are alternative routes of delivery for antiepileptic drugs (AEDs) when the intravenous route is not practical or possible. For... (Review)
Review
The intramuscular (IM) and rectal routes are alternative routes of delivery for antiepileptic drugs (AEDs) when the intravenous route is not practical or possible. For treatment of acute seizures, the AED used should have a short time to maximum concentration (Tmax). Some AEDs have preparations that may be given intramuscularly. These include the benzodiazepines (diazepam, lorazepam, and midazolam) and others (fosphenytoin, levetiracetam). Although phenytoin and valproate have parenteral preparations, these should not be given intramuscularly. A recent study of prehospital treatment of status epilepticus evaluated a midazolam (MDZ) autoinjector delivering IM drug compared to IV lorazepam (LZP). Seizures were absent on arrival to the emergency department in 73.4% of the IM MDZ compared to a 63.4% response in LZP-treated subjects (p < 0.001 for superiority). Almost all AEDs have been evaluated for rectal administration as solutions, gels, and suppositories. In a placebo-controlled study, diazepam (DZP) was administered at home by caregivers in doses that ranged from 0.2 to 0.5 mg/kg. Diazepam was superior to placebo in reduced seizure frequency in children (p < 0.001) and in adults (p = 0.02) and time to recurrent seizures after an initial treatment (p < 0.001). Thus, at this time, only MZD given intramuscularly and DZP given rectally appear to have the properties required for rapid enough absorption to be useful when intravenous routes are not possible. Some drugs cannot be administered rectally owing to factors such as poor absorption or poor solubility in aqueous solutions. The relative rectal bioavailability of gabapentin, oxcarbazepine, and phenytoin is so low that the current formulations are not considered to be suitable for administration by this route. When administered as a solution, diazepam is rapidly absorbed rectally, reaching the Tmax within 5-20 min in children. By contrast, rectal administration of lorazepam is relatively slow, with a Tmax of 1-2h. The dependence of gabapentin on an active transport system, and the much-reduced surface area of the rectum compared with the small intestine, may be responsible for its lack of absorption from the rectum. This article is part of a Special Issue entitled "Status Epilepticus".
Topics: Acute Disease; Administration, Rectal; Anticonvulsants; Humans; Injections, Intramuscular; Seizures; Status Epilepticus
PubMed: 26071998
DOI: 10.1016/j.yebeh.2015.05.001 -
Expert Review of Medical Devices Jun 2018Health care providers are increasingly challenged to balance cost considerations for devices, drugs, and staffing all while continuing to provide excellent care.... (Review)
Review
Health care providers are increasingly challenged to balance cost considerations for devices, drugs, and staffing all while continuing to provide excellent care. Patients in both the post-acute and acute care settings often require fluid and/or medication when their oral route is compromised and vascular access may not be warranted or immediately accessible. The rectum is an underutilized administration point that can be accessed with speed and relative ease. Areas Covered: Literature reviews of pharmaceutical, medical, and nursing references reveal current and historical science that validates the rectal route as a means of alternative administration for fluids and medications. Expert Commentary: Historically the rectum has been used for medication and fluid delivery but in more recent times, use has waned due to many factors. The physiology of the rectum allows for rapid and reliable administration of a variety of medications as well as hydration. This serves as an introduction to a novel, simple, cost effective device that allows for discreet and painless rectal administration of fluids and medications when the oral route is compromised and/or intravenous access is difficult or unnecessary. This device is used in a variety of patients in many care settings.
Topics: Administration, Rectal; Catheters; Costs and Cost Analysis; Fluid Therapy; Humans; Product Surveillance, Postmarketing; Rectum
PubMed: 29846093
DOI: 10.1080/17434440.2018.1481744 -
Journal of Pharmaceutical Sciences Feb 2020Neonatal infections are a major cause of newborn mortality in low- and middle-income countries, particularly in areas without access to inpatient care. To address this,...
Neonatal infections are a major cause of newborn mortality in low- and middle-income countries, particularly in areas without access to inpatient care. To address this, the World Health Organization developed guidelines for delivering simplified antibiotic regimens (oral amoxicillin and intramuscular gentamicin) in outpatient settings to young infants with suspected serious bacterial infection when referral is not feasible. However, there are still limitations to access, as the regimen requires a health care provider trained in giving intramuscular injections to infants. To provide a needle-free, simplified alternate to intramuscular delivery, PATH investigated the feasibility of the rectal administration of gentamicin. Potential formulations were screened by in vitro testing, and 2 liquid enema formulations and a cocoa butter suppository were developed and evaluated in a preclinical study of the rectal uptake of gentamicin in a neonatal minipig model. Sera samples from the control group, dosed by intramuscular injection, resulted in expected sera concentrations of gentamicin, but no gentamicin was detected in the sera of groups rectally dosed with the test formulations. The results of this study did not provide evidence to support the therapeutic feasibility of rectally absorbed gentamicin.
Topics: Administration, Rectal; Amoxicillin; Animals; Anti-Bacterial Agents; Feasibility Studies; Gentamicins; Humans; Infant; Injections, Intramuscular; Swine; Swine, Miniature
PubMed: 31404543
DOI: 10.1016/j.xphs.2019.08.003 -
Pediatric Neurology 1988
Topics: Administration, Rectal; Child; Diazepam; Epilepsy; Humans
PubMed: 3242523
DOI: 10.1016/0887-8994(88)90013-6