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JAMA Apr 2023
Topics: Cannabidiol; Cannabis; Melatonin; Administration, Oral; United States; Dosage Forms
PubMed: 37097362
DOI: 10.1001/jama.2023.2296 -
International Journal of Pharmaceutics Mar 2022The total number of paediatric formulations available only account for a small proportion of the full therapeutic plethora required to effectively treat paediatrics and,... (Review)
Review
The total number of paediatric formulations available only account for a small proportion of the full therapeutic plethora required to effectively treat paediatrics and, therefore, the availability of high quality medicines designed specifically for children remains an ongoing challenge. Currently, the World Health Organisation (WHO) report that around 50% of medication issued for long-term conditions are not taken as advised, whilst it has also been established that, in general practice, around one tenth of medicines prescribed for children are either off-label or unlicensed. Such off-label and unlicensed use is owing to the considerable anatomical and physiological differences observed between paediatric subsets. Identifying such differences, is essential for better informing paediatric drug development and assisting regulatory reviews, whilst ensuring safe and effective therapeutic concentrations of pharmacological substances. Points covered: The review discusses factors affecting the safety, toxicity and efficacy of paediatric drug delivery systems. The research highlights features of the gastrointestinal tract and reports anatomical and physiological differences between paediatrics and adults. Additionally, differences observed in paediatric pharmacokinetic profiles (absorption, distribution, metabolism and elimination) due to physiological differences are also discussed. Furthermore, this review considers the advantages and limitations of current paediatric specific dosage forms available and assesses the acceptability of innovative small flexible solid oral dosage forms. Lastly, this review highlights factors affecting paediatric medicine adherence and acceptability and discusses the techniques available to overcome barriers associated with non-adherence.
Topics: Adult; Child; Dosage Forms; Humans; Off-Label Use; Pediatrics; Pharmaceutical Preparations
PubMed: 35092832
DOI: 10.1016/j.ijpharm.2022.121501 -
BioMed Research International 2020Oleanolic acid is a pentacyclic triterpenoid compound that exists widely in medicinal herbs and other plants. Because of the extensive pharmacological activity,... (Review)
Review
Oleanolic acid is a pentacyclic triterpenoid compound that exists widely in medicinal herbs and other plants. Because of the extensive pharmacological activity, oleanolic acid has attracted more and more attention. However, the structural characteristics of oleanolic acid prevent it from being directly made into new drugs, which limits the application of oleanolic acid. Through the application of modern preparation techniques and methods, different oleanolic acid dosage forms and derivatives have been designed and synthesized. These techniques can improve the water solubility and bioavailability of oleanolic acid and lay a foundation for the new drug development. In this review, the recent progress in understanding the oleanolic acid dosage forms and its derivatives are discussed. Furthermore, these products were evaluated comprehensively from the perspective of characterization and pharmacokinetics, and this work may provide ideas and references for the development of oleanolic acid preparations.
Topics: Animals; Anti-Inflammatory Agents; Antineoplastic Agents; Antioxidants; Cell Line, Tumor; Cyclodextrins; Dosage Forms; Drug Screening Assays, Antitumor; HeLa Cells; Humans; Inhibitory Concentration 50; Liposomes; Liver; Mice; Micelles; Nanoparticles; Oleanolic Acid; Phospholipids; Plants; Solubility; Structure-Activity Relationship
PubMed: 33299854
DOI: 10.1155/2020/1308749 -
AAPS PharmSciTech Apr 2015Oral drug delivery is a non-invasive and therefore a very convenient route of administration. Orally disintegrating dosage forms, like soluble films and (mini-)tablets,... (Review)
Review
Oral drug delivery is a non-invasive and therefore a very convenient route of administration. Orally disintegrating dosage forms, like soluble films and (mini-)tablets, appear promising for use in the pediatric population. New guidance for the development of pediatric medicines has been published, which provides considerations on how pediatric products should be designed. However, most of the considerations leave a lot of room for interpretations. Bearing in mind the different aspects discussed in the latest guideline, the use of orally disintegrating films and tablets, in particular, small-sized tablets, is discussed and reflected upon by providing evidence from the scientific literature. The available dosage forms for children are various and examples of currently licensed products for use in the pediatric population were compiled. Aspects such as the appropriateness for pediatrics, the choice of excipients, the opportunities for modified drug release preparations or fixed-dose combinations, the acceptability and palatability, and also limitations were discussed with respect to the new dosage forms of orally disintegrating films and mini-tablets. This paper points out that innovation in pediatric medicines are planned and should be encouraged; however, supported by the regulatory guidance, only general considerations are provided. Nevertheless, the guideline summarizes multiple points to consider during the development of medicines for pediatric use. Considering the scientific evidence and the regulatory guidance, orally disintegrating dosage forms, like soluble films and (mini-)tablets, offer an innovative solution for pediatric drug delivery.
Topics: Administration, Oral; Animals; Drug Delivery Systems; Excipients; Humans; Pediatrics; Tablets
PubMed: 25739913
DOI: 10.1208/s12249-015-0313-1 -
International Journal of Pharmaceutics Jul 2023A correlative, multiscale imaging methodology for visualising and quantifying the morphology of solid dosage forms by combining ptychographic X-ray computed...
A correlative, multiscale imaging methodology for visualising and quantifying the morphology of solid dosage forms by combining ptychographic X-ray computed nanotomography (PXCT) and scanning small- and wide-angle X-ray scattering (S/WAXS) is presented. The methodology presents a workflow for multiscale analysis, where structures are characterised from the nanometre to millimetre regime. Here, the method is demonstrated by characterising a hot-melt extruded, partly crystalline, solid dispersion of carbamazepine in ethyl cellulose. Characterisation of the morphology and solid-state phase of the drug in solid dosage forms is central as this affects the performance of the final formulation. The 3D morphology was visualised at a resolution of 80 nm over an extended volume through PXCT, revealing an oriented structure of crystalline drug domains aligned in the direction of extrusion. Scanning S/WAXS showed that the nanostructure is similar over the cross section of the extruded filament, with minor radial changes in domain sizes and degree of orientation. The polymorphic forms of carbamazepine were qualified with WAXS, showing a heterogeneous distribution of the metastable forms I and II. This demonstrates the methodology for multiscale structural characterization and imaging to enable a better understanding of the relationships between morphology, performance, and processing conditions of solid dosage forms.
Topics: X-Rays; Radiography; Carbamazepine; Pharmaceutical Preparations; X-Ray Diffraction; Dosage Forms
PubMed: 37414373
DOI: 10.1016/j.ijpharm.2023.123200 -
Pharmaceutical Research May 2017
Topics: Chemistry, Pharmaceutical; Dosage Forms; Drug Compounding; Drug Liberation; Excipients; Humans; Pharmaceutical Preparations; Solubility
PubMed: 28299534
DOI: 10.1007/s11095-017-2137-z -
European Journal of Pharmaceutical... Mar 2023Non-compliance, dosing inaccuracy, choking risk, flavour, and instability, are some of the issues associated with paediatric, oral dosage forms - tablets, capsules,... (Review)
Review
Non-compliance, dosing inaccuracy, choking risk, flavour, and instability, are some of the issues associated with paediatric, oral dosage forms - tablets, capsules, solutions, and suspensions. Orally disintegrating drug carriers, a dosage form with growing interest, are thought to overcome several of the challenges associated with these conventional formulations by rapidly disintegrating within the buccal cavity without the need for water. This review serves as an up-to-date report on the various types of orodispersible delivery systems, currently being developed or commercialized, by detailing their characteristics, manufacturing processes, and applications in the paediatric population. Mentioned are orodispersible tablets, films, wafers and lyophilisates, mini-tablets, capsules, granules, electrospun fibers and webs. Also highlighted are the choice of excipients, quality control requirements, and expected pharmacokinetics of orally disintegrating drug carriers concerning the paediatric population. Overall, orodispersible formulations, particularly tablets, films, and lyophilisates/wafers, have shown to be a valuable addition to medication administration in minors, thus the execution of more targeted research and development activities is expected to lead to enhanced paediatric care and outcomes.
Topics: Humans; Child; Drug Carriers; Administration, Oral; Tablets; Drug Compounding; Excipients; Solubility
PubMed: 36634740
DOI: 10.1016/j.ejps.2023.106377 -
Current Drug Delivery 2019Medicated foams and film forming systems are dosage forms formulated to undergo a controlled metamorphosis when applied on the skin. Indeed, due to the presence of... (Review)
Review
Medicated foams and film forming systems are dosage forms formulated to undergo a controlled metamorphosis when applied on the skin. Indeed, due to the presence of propellant or a particular air-spray foam pump, a liquid can generate foam when applied on the stratum corneum, or a liquid or conventional dosage form can form on the skin a continuous film as a consequence of the solvent evaporation. Thanks to these controlled modifications, the drug thermodynamic activity increases favoring the skin penetration and, therefore, the bioavailability with respect to conventional semi-solid and liquid dosage forms. Furthermore, the available clinical data also evidence that these dosage forms improve the patient's compliance. The main formulative aspects of medicated foams and film forming systems are reviewed with the aim to underline the possible advantages in terms of biopharmaceutical performances and patient's adherence.
Topics: Administration, Cutaneous; Biopharmaceutics; Dosage Forms; Drug Delivery Systems; Humans; Medication Adherence; Skin; Skin Absorption; Thermodynamics
PubMed: 30657040
DOI: 10.2174/1567201816666190118124439 -
International Journal of Pharmaceutics Jun 2021Nanosizing of pharmaceutical drug particles is one of the most important drug delivery platforms approaches for the commercial development of poorly water-soluble drug... (Review)
Review
Nanosizing of pharmaceutical drug particles is one of the most important drug delivery platforms approaches for the commercial development of poorly water-soluble drug molecules. Though nanosizing of drug particles has been proven to greatly enhance drugs dissolution rate and apparent solubility, nanosized materials have presented significant challenges for their formulation as solid dosage forms (e.g. tablets, capsules). This is due to the strong Van der Waals attraction forces between dry nanoparticles leading to aggregation, cohesion, and consequently poor flowability. In this review, the broad area of nanomedicines is overviewed with the primary focus on drug nanocrystals and the top-down and bottom-up methods used in their fabrication. The review also looks at how nanosuspensions of pharmaceutical drugs are generated and stabilised, followed by subsequent strategies for isolation of the nanoparticles. A perspective on the future outlook for drug nanocrystals is also presented.
Topics: Chemistry, Pharmaceutical; Drug Delivery Systems; Nanoparticles; Pharmaceutical Preparations; Solubility; Tablets; Technology, Pharmaceutical
PubMed: 33992712
DOI: 10.1016/j.ijpharm.2021.120708 -
International Journal of Molecular... Dec 2019Safe and effective delivery of therapeutics at the target site is the key to successful therapy. Nanocarriers can offer significant advantages over conventional dosage...
Safe and effective delivery of therapeutics at the target site is the key to successful therapy. Nanocarriers can offer significant advantages over conventional dosage forms. Over the decades, nanoparticles have been extensively used to increase bioavailability, improve solubility and stability, reduce toxicities, and facilitate the controlled release of therapeutics. Further, nanoparticles have often been surface-functionalized with a variety of ligands to enhance circulation half-life and increase target-specificity. Although nanotechnology has shown significant therapeutic benefits for multiple biomedical applications, limited nanoparticle-based formulations have progressed to clinical trials, and only a few have reached the pharmaceutical market. This editorial is an introduction to the special issue entitled Surface-Functionalized Nanoparticles as Drug Carriers. We outline the scope of the special issue, summarize the results and conclusions of the nine articles published in this issue, and provide perspective on the application of surface-functionalized nanoparticles in the drug delivery field.
Topics: Biological Availability; Delayed-Action Preparations; Drug Carriers; Drug Compounding; Drug Delivery Systems; Drug Liberation; Humans; Nanoparticles; Nanotechnology
PubMed: 31861113
DOI: 10.3390/ijms20246352