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BMJ Open Aug 2019(1) Systematically assemble, analyse and synthesise published evidence on causes of prescribing error in children. (2) Present results to a multidisciplinary group of... (Review)
Review
OBJECTIVES
(1) Systematically assemble, analyse and synthesise published evidence on causes of prescribing error in children. (2) Present results to a multidisciplinary group of paediatric prescribing stakeholders to validate findings and establish how causative factors lead to errors in practice.
DESIGN
Scoping review using Arksey and O'Malley's framework, including stakeholder consultation; qualitative evidence synthesis.
METHODS
We followed the six scoping review stages. (1) Research question-the research question was 'What is known about causes of prescribing error in children?' (2) Search strategy-we searched MEDLINE, EMBASE, CINAHL (from inception to February 2018), grey literature and reference lists of included studies. (3) Article selection-all published evidence contributing information on the causes of prescribing error in children was eligible for inclusion. We included review articles as secondary evidence to broaden understanding. (4) Charting data-results were collated in a custom data charting form. (5) Reporting results-we summarised article characteristics, extracted causal evidence and thematically synthesised findings. (6) Stakeholder consultation-results were presented to a multidisciplinary focus group of six prescribing stakeholders to establish validity, relevance and mechanisms by which causes lead to errors in practice.
RESULTS
68 articles were included. We identified six main causes of prescribing errors: led to ; and . Primary evidence clarifying causes was lacking.
CONCLUSIONS
Specific factors complicate prescribing for children and increase risk of errors. Primary research is needed to confirm and elaborate these causes of error. In the meantime, this review uses existing evidence to make provisional paediatric-specific recommendations for policy, practice and education.
Topics: Child; Dosage Forms; Drug Dosage Calculations; Humans; Medication Errors; Off-Label Use
PubMed: 31401597
DOI: 10.1136/bmjopen-2018-028680 -
Acta Pharmaceutica (Zagreb, Croatia) Jun 2024Pediatric patients often require individualized dosing of medicine due to their unique pharmacokinetic and developmental characteristics. Current methods for tailoring... (Review)
Review
Pediatric patients often require individualized dosing of medicine due to their unique pharmacokinetic and developmental characteristics. Current methods for tailoring the dose of pediatric medications, such as tablet splitting or compounding liquid formulations, have limitations in terms of dosing accuracy and palatability. This paper explores the potential of 3D printing as a solution to address the challenges and provide tailored doses of medication for each pediatric patient. The technological overview of 3D printing is discussed, highlighting various 3D printing technologies and their suitability for pharmaceutical applications. Several individualization options with the potential to improve adherence are discussed, such as individualized dosage, custom release kinetics, tablet shape, and palatability. To integrate the preparation of 3D printed medication at the point of care, a decentralized manufacturing model is proposed. In this setup, pharmaceutical companies would routinely provide materials and instructions for 3D printing, while specialized compounding centers or hospital pharmacies perform the printing of medication. In addition, clinical opportunities of 3D printing for dose-finding trials are emphasized. On the other hand, current challenges in adequate dosing, regulatory compliance, adherence to quality standards, and maintenance of intellectual property need to be addressed for 3D printing to close the gap in personalized oral medication.
Topics: Printing, Three-Dimensional; Humans; Administration, Oral; Child; Tablets; Drug Compounding; Technology, Pharmaceutical; Precision Medicine; Dosage Forms; Chemistry, Pharmaceutical; Pharmaceutical Preparations
PubMed: 38815205
DOI: 10.2478/acph-2024-0012 -
Journal of Pharmacy & Pharmaceutical... 2020A joint Canadian Society for Pharmaceutical Sciences and Health Canada workshop entitled "Biowaiver for Immediate and Modified Release Dosage forms" was held in Ottawa,...
A joint Canadian Society for Pharmaceutical Sciences and Health Canada workshop entitled "Biowaiver for Immediate and Modified Release Dosage forms" was held in Ottawa, November 19th 2015. A summary of all presentations is included.
Topics: Biological Availability; Biopharmaceutics; Canada; Chemistry, Pharmaceutical; Congresses as Topic; Delayed-Action Preparations; Drug Liberation; Humans; Pharmaceutical Preparations; Therapeutic Equivalency
PubMed: 32877636
DOI: 10.18433/jpps31424 -
Journal of Pharmaceutical Sciences Jul 2024The production of paediatric pharmaceutical forms represents a unique challenge within the pharmaceutical industry. The primary goal of these formulations is to ensure... (Review)
Review
The production of paediatric pharmaceutical forms represents a unique challenge within the pharmaceutical industry. The primary goal of these formulations is to ensure therapeutic efficacy, safety, and tolerability in paediatric patients, who have specific physiological needs and characteristics. In recent years, there has been a significant increase in attention towards this area, driven by the need to improve drug administration to children and ensure optimal and specific treatments. Technological innovation has played a crucial role in meeting these requirements, opening new frontiers in the design and production of paediatric pharmaceutical forms. In particular, three emerging technologies have garnered considerable interest and attention within the scientific and industrial community: 3D printing, prilling/vibration, and microfluidics. These technologies offer advanced approaches for the design, production, and customization of paediatric pharmaceutical forms, allowing for more precise dosage modulation, improved solubility, and greater drug acceptability. In this review, we delve into these cutting-edge technologies and their impact on the production of paediatric pharmaceutical forms. We analyse their potential, associated challenges, and recent developments, providing a comprehensive overview of the opportunities that these innovative methodologies offer to the pharmaceutical sector. We examine different pharmaceutical forms generated using these techniques, evaluating their advantages and disadvantages.
Topics: Printing, Three-Dimensional; Humans; Child; Microfluidics; Dosage Forms; Technology, Pharmaceutical; Pediatrics; Pharmaceutical Preparations; Drug Compounding; Chemistry, Pharmaceutical; Solubility
PubMed: 38582283
DOI: 10.1016/j.xphs.2024.04.001 -
Yakugaku Zasshi : Journal of the... 2015Children generally reject taking medicine which does not have a favorable shape, taste, flavor, etc. However, if a child who needs to take a medicine, rejects taking it,...
Children generally reject taking medicine which does not have a favorable shape, taste, flavor, etc. However, if a child who needs to take a medicine, rejects taking it, he might never recover from his condition. When a child is unable to take medicine orally, it is intravenously administered, and he and his caregivers then may experience stress. Syrups and suspensions are considered as favorable types of dosage forms in which to orally administer medicine to infants and children. However, they may have disadvantages such as solubility, a bad taste, portability problems or required refrigerator storage. World Health Organization (WHO) currently favors that infants and children be treated with oral solid medicines. New oral solid tablets, such as a mini-tablet, instead of liquid medicines are proposed for this group, however, there are a few reports that mini-tablets are suitable for infants and children. Palatability is one of the main elements of patient acceptability of an oral pediatric medicine. Palatability is defined as the overall appreciation of an oral medicinal product in relation to its smell, taste, aftertaste and feeling in the mouth. Design of the formulation of an oral pediatric medicine should be considered together with its palatability.
Topics: Administration, Oral; Child; Drug Design; Humans; Powders; Solubility; Suspensions; Tablets; Taste
PubMed: 25747220
DOI: 10.1248/yakushi.14-00228-4 -
Clinical Interventions in Aging 2017Demographic indicators forecast that by 2050, the elderly will account for about one-third of the global population. Geriatric patients require a large number of... (Review)
Review
Demographic indicators forecast that by 2050, the elderly will account for about one-third of the global population. Geriatric patients require a large number of medicines, and in most cases, these products are administered as solid oral solid dosage forms, as they are by far the most common formulations on the market. However, this population tends to suffer difficulties with swallowing. Caregivers in hospital geriatric units routinely compound in solid oral dosage forms for dysphagic patients by crushing the tablets or opening the capsules to facilitate administration. The manipulation of a tablet or a capsule, if not clearly indicated in the product labeling, is an off-label use of the medicine, and must be supported by documented scientific evidence and requires the patient's informed consent. Compounding of marketed products has been recognized as being responsible for an increased number of adverse events and medical errors. Since extemporaneous compounding is the rule and not the exception in geriatrics departments, the seriousness and scope of issues caused by this daily practice are probably underestimated. In this article, the potential problems associated with the manipulation of authorized solid oral dosage forms are discussed.
Topics: Administration, Oral; Aged; Deglutition Disorders; Humans; Tablets
PubMed: 28203065
DOI: 10.2147/CIA.S121905 -
European Review For Medical and... Jun 2022Nausea and vomiting of pregnancy is a common disease that affects many women suffering from mild to severe symptoms. Amongst the different treatments, a fixed dose...
OBJECTIVE
Nausea and vomiting of pregnancy is a common disease that affects many women suffering from mild to severe symptoms. Amongst the different treatments, a fixed dose combination of doxylamine and pyridoxine has been proven safe and effective although the mechanism of action is not well established. There are different pharmaceutical dosage forms in the European market. The objective of this study was to compare the characteristics of a capsule formulation, Cariban® and a tablet formulation, Xonvea® to evaluate the potential impact of their release profiles on their onset of action.
MATERIALS AND METHODS
10 mg/10 mg of doxylamine succinate/pyridoxine hydrochloride capsules (Cariban®) and tablets (Xonvea®) were used as reference materials. Appearance, mass, composition, and in vitro dissolution profiles were compared. Bibliographic data from 4 pharmacokinetic studies of Xonvea® and 1 pharmacokinetic study of Cariban® was reviewed.
RESULTS
In vitro dissolution studies showed significant differences in dissolution profiles of tablets and capsules. The later exhibiting some release of both drug substances in acid conditions followed by a non-complete release after a total of 3 hours while the tablets demonstrated gastro-resistant properties and rapid API release in about 20-30 minutes after the acid stage. Comparison of PK data showed greater Cmax for pyridoxine.
CONCLUSIONS
At pH 6.8, complete and faster release of the fixed dose combination for Xonvea® gastro-resistant tablets compared to Cariban® capsules could possibly explain the greater Cmax observed in vivo for the tablet's formulation. This could translate into faster onset of action and relief of nausea for pregnant women taking the tablets vs. the capsules.
Topics: Antiemetics; Doxylamine; Female; Gastrointestinal Agents; Humans; Nausea; Pregnancy; Pyridoxine; Solubility; Tablets
PubMed: 35776043
DOI: 10.26355/eurrev_202206_29081 -
Discovery Medicine Dec 2012Parkinson's disease (PD) is a neurodegenerative disorder characterized by a multifactorial nature due to the reduction in dopamine level in the brain. The projected... (Review)
Review
Parkinson's disease (PD) is a neurodegenerative disorder characterized by a multifactorial nature due to the reduction in dopamine level in the brain. The projected number of people with Parkinson's disease is expected to increase mostly due to a greater aging population. Clinicians often face challenges in controlling the effective drug concentration in a patient's body to achieve therapeutic response throughout various stages of Parkinson's disease. To meet the therapeutic goals at different levels of Parkinson's progression, various dosage form approaches are used to enhance the delivery of anti-Parkinson's disease drugs into the brain. This review provides a summary on the available anti-Parkinson's disease drug dosage forms as well as the prototypes that are still under investigation through oral, transmucosal, transdermal, intranasal, pulmonary, rectal, and parenteral routes. These novel delivery systems will be extremely important in increasing therapeutic efficacy and reducing unwanted complications in the treatment of Parkinson's disease.
Topics: Animals; Dosage Forms; Drug Administration Routes; Humans; Neuroprotective Agents; Parkinson Disease
PubMed: 23272689
DOI: No ID Found -
The Journal of Pharmacy and Pharmacology Jul 2012This review highlights current methods and strategies for accelerated in-vitro drug release testing of extended-release parenteral dosage forms such as polymeric... (Review)
Review
OBJECTIVES
This review highlights current methods and strategies for accelerated in-vitro drug release testing of extended-release parenteral dosage forms such as polymeric microparticulate systems, lipid microparticulate systems, in-situ depot-forming systems and implants.
KEY FINDINGS
Extended-release parenteral dosage forms are typically designed to maintain the effective drug concentration over periods of weeks, months or even years. Consequently, 'real-time' in-vitro release tests for these dosage forms are often run over a long time period. Accelerated in-vitro release methods can provide rapid evaluation and therefore are desirable for quality control purposes. To this end, different accelerated in-vitro release methods using United States Pharmacopeia (USP) apparatus have been developed. Different mechanisms of accelerating drug release from extended-release parenteral dosage forms, along with the accelerated in-vitro release testing methods currently employed are discussed.
SUMMARY
Accelerated in-vitro release testing methods with good discriminatory ability are critical for quality control of extended-release parenteral products. Methods that can be used in the development of in-vitro-in-vivo correlation (IVIVC) are desirable; however, for complex parenteral products this may not always be achievable.
Topics: Chemistry, Pharmaceutical; Delayed-Action Preparations; Humans; Infusions, Parenteral; Pharmaceutical Preparations; Quality Control
PubMed: 22686344
DOI: 10.1111/j.2042-7158.2012.01482.x -
British Journal of Clinical Pharmacology Mar 2015Paediatric formulation design is complex as there is a need to understand the developmental physiological changes that occur during childhood and their impact on the... (Review)
Review
Paediatric formulation design is complex as there is a need to understand the developmental physiological changes that occur during childhood and their impact on the absorption of drugs. Paediatric dose adjustments are usually based on achieving pharmacokinetic or pharmacodynamic profiles equivalent to those achieved in adult populations. However, differences in the way in which children handle adult products or the use of bespoke paediatric formulations can result in unexpected pharmacokinetic drug profiles with altered clinical efficacy. Differences in drug formulations need to be understood by healthcare professionals involved in the prescribing, administration or dispensing of drugs to children such that appropriate advice is given to ensure that therapeutic outcomes are achieved. This issue is not confined to oral medicines but is applicable for all routes of administration encountered in paediatric therapy.
Topics: Child; Dosage Forms; Drug Delivery Systems; Drug Design; Humans; Pharmaceutical Preparations; Therapeutic Equivalency
PubMed: 25855822
DOI: 10.1111/bcp.12268