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Oral solid dosage formulations and/or tablets have remained the preferred route of administration by both patients and health care practitioners. Oral tablets are easy to administer, they are non-invasive and cause less risk adversity. Because of the lack of commercially available tablet dose options, tablets are being split or partitioned by users...
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The pharmaceutical tablet must meet specific standards to claim it as a standard drug approval. Pharmaceutical industries test the tablets for maintaining their accuracy following different standard parameters such as identity, strength, quality, purity, and stability, etc. For what why, it is essential to control pharmaceutical processes regardles...
Citations
... Thus, caregivers can be forced to manipulate prescribed medications to meet the needs of the patient [3,4]. Such manipulations (such as tablet crushing, capsule opening, dilution and administration via feeding tubes) could be performed multiple times per day and, when not specified in the summary of product characteristics (SmPC), are considerable as an off-label drug use and can lead to an alteration of the administered dose and a modification of the drug bioavailability [5,6]. The clinical impact for patients is the increasing risk of adverse effects and poor symptom control. ...
Background
In pediatric palliative care, the main caregiver is primarily responsible for managing pharmaceutical therapies. Few data are available regarding the influence of this burden on quality of life in terms of time, concerns as well as a considerable risk of administration errors and adverse effects. This study aims to investigate how caregivers prepared and administrated medication, including errors and associated expectations, to identify improvement interventions.
Methods
Between October 2022 and March 2023, a descriptive single-center survey study was carried out in the tertiary care pediatric palliative center of the Padova University Hospital. Participants were the caregivers of the patients followed by our center up to 23 years old, receiving at least one drug daily and who cannot self-administer their therapy. The questionnaire consisted of 18 multiple-choice and semi-closed questions, grouped into 4 main topics: therapy preparation, therapy administration, administration errors and therapy assessment.
Results
A total of 100 caregivers responded to the survey. Mothers represented the main caregiver (91%). The prevalence of polypharmacy was 67% across the patients. 52% of caregivers handled prescriptions at least three times per day and for 32% it took to prepare them more than 5 min each time. Only 59% reported to have been trained for preparing and administrating drugs. 14% reported having made at least a drug administration error due to the tiredness or the complexity of therapeutic regimens in the preceding three months. Nearly one caregiver out of three felt their child was using too many drugs. 73% positively welcomed the possibility of having clinical pharmacist-led counseling.
Conclusions
Many caregivers of pediatric palliative care patients frequently have trouble planning, preparing and delivering pharmacological therapy to their children. Attempting to simplify medication regimens, choosing formulations that are simpler to administer and measure, investing in improved caregiver training, talking about therapies with carers, and involving clinical pharmacists to clarify their doubts could be all potential strategies to improve this condition and reduce their burden.
... Pharmacotherapy in children necessitates medications in dosage forms and dose strengths suitable for their age [10][11][12][13]. Healthcare professionals often face challenges due to the lack of licensed and commercially available formulations, leading to the need to modify doses for administration [8,[13][14][15]. Such modifications, referred to as manipulated dosage forms, involve altering medications from their original forms and are considered off-label use. ...
... Such modifications, referred to as manipulated dosage forms, involve altering medications from their original forms and are considered off-label use. However, this manipulation can impact dosing accuracy, bioavailability, and the integrity of the medication to an uncertain degree [15][16][17][18]. To ensure adequate and safe pharmacotherapy in children, it is crucial to provide instructions from the patient information leaflet and evidence-based dosing guidelines. ...
Drug-resistant (DR) tuberculosis (TB) is a rising health concern that affects approximately 25 000 children annually. Nurses form much of the health care workforce in South Africa and play a crucial role in caring for children receiving DR-TB treatment. Explorations of the nurse’s experiences regarding the manipulation of dosage forms for DR-TB paediatric patients are also absent.
To determine attitude, knowledge, and practices of nurses on correct administration of DR-TB treatment to paediatric patients.
A qualitative method, utilising individual semi-structured interviews, was used to collect data in a specialised TB hospital. A semi-structured interview was developed and divided into three sections i.e. sociodemographic and professional data, perceptions about working with paediatric patients with DR-TB and knowledge regarding manipulation of dosage forms. The interviews were recorded and transcribed verbatim. The data was analysed using thematic analysis.
A total of 10 nurses were interviewed using the semi-structured interview guide that was developed. The saturation point was reached after 8 interviews were conducted. Two additional interviews were conducted. From the interviews conducted, 4 major themes and 16 sub-themes were identified.
Manipulation of dosage forms to achieve the required dose is common practice in the paediatric population. The interviewees presented generally favourable attitudes towards working with DR-TB children and were experienced with manipulation of available dosage forms to administer to children. Based on the practice of manipulation of dosage forms, continuous education is necessary to ensure patient safety.
... The packaging and storage conditions can affect the stability and quality of the tablet. Improper storage conditions, such as exposure to moisture, heat, or light, can cause degradation of the API and affect the tablet properties [46]. ...
In Southeast Asia and Sub-Saharan Africa, approximately 35% of antimalarial drugs are of substandard quality. Counterfeit and substandard medications constitute 10% of the global pharmaceutical trade. The World Health Organization (WHO) recommends artemether-lumefantrine (AL) as the first-line treatment for acute falciparum malaria in endemic regions. However, there is a lack of validated analytical methods to simultaneously determine the content of artemether and lumefantrine in these formulations, particularly in resource-limited settings. This paper focuses on quality concepts related to AL tablets and suspensions. It provides an overview of quality assessment techniques, including visual inspection, weight uniformity, content assay, and dissolution tests. Regulatory requirements and case studies are also discussed. By rigorously assessing AL quality, regulatory agencies, pharmaceutical companies, and healthcare professionals can ensure compliance with established standards and regulations.
... Caregivers may lack appropriate and standardized training for the correct preparation and administration of pharmacological therapy and this aspect contributes to the risk of medication preparation and administration errors with potential risks to the patient [2]. Due to the lack of many commercially available drugs in formulations and doses suitable for pediatric patients, caregivers are often forced to manipulate prescribed medications to meet the needs of the patient [3,4] Such manipulations (tablet crushing, capsule opening, dilution and administration via feeding tubes), often performed multiple times a day, when not speci ed in the summary of product characteristics (SmPC), are considered as an off-label drug use and can lead to adverse events, alteration in the administered dosage and a modi cation of drug bioavailability [5,6]. This can lead to both an increased risk of adverse effects and poor symptom control. ...
BACKGROUND
In pediatric palliative care, the primary caregiver is primarily responsible for managing pharmaceutical therapies. Few data are available regarding the influence of this burden on quality of life in terms of time, concerns as well as a considerable risk of administration errors and adverse effects.
OBJECTIVES
The aim of this survey was to look at how the caregiver prepared and administered pharmacological therapy, including any delivery problems, as well as how the caregiver assessed the treatment.
METHODS
Between October 2022 and March 2023, a descriptive single-center survey study was carried out in the tertiary care pediatric palliative center of the Padova University Hospital. Participants are all the people who provide care for children in charge of our center who are younger than 23 years old, receiving at least one drug daily and who cannot self-administer their therapy. The questionnaire consisted of 18 multiple-choice and semi-closed questions, grouped into 4 main topics: therapy preparation, therapy administration, administration errors, and therapy assessment.
RESULTS
A total of 100 survey responses were collected. The most challenging categories have been identified as being therapy preparation and medication dose measurement. 52% of caregivers handle prescriptions at least three times each day, with 32% preparing them for more than 5 minutes. Only 59% of respondents reported enough training. Due to tiredness or the complexity of therapeutic regimens, 14% of respondents reported making a drug mistake in administration in the preceding three months.
Nearly one caregiver in three believed their child "always" used too many drugs. 39% of patients had issues or questions about the prescription and wanted to discuss them with medical experts; 79% of patients believed that seeking assistance from a clinical pharmacist about the prescribed medicaments.
DISCUSSION
Many caregivers of pediatric palliative care patients frequently had trouble planning, preparing and delivering pharmacological therapy to their children. Attempting to simplify medications regimen, choosing formulations that are simple to administer and measure, investing in improved caregiver training, talking about therapies with carers, and involving clinical pharmacists in this process are all potential strategies to improve this condition and reduce their burden.
... Poor pourability can lead to inaccurate dosing due to inconsistent volume or a difcult-to-pour suspension. A suspension with good pourability facilitates accurate measurement and dosage administration, especially for children or elderly patients who may struggle with viscous or poorly fowing suspensions [47]. Te specifc gravity values of the suspensions, which varied from 1.07 to 1.14, may shed light on the absence of pourability issues observed across all the samples. ...
Artemether-lumefantrine (AL) is a highly effective and commonly used Artemisinin-based Combination Therapy (ACT) for treating uncomplicated malaria caused by Plasmodium falciparum, including drug-resistant strains. However, ineffective regulatory systems in resource-limited settings can lead to the infiltration of poor-quality and counterfeit antimalarial medicines into the pharmaceutical supply chain, causing treatment failures, prolonged illness, and disease progression. The objective of the study was to assess the quality of selected brands of fixed-dose combination (FDC) AL tablets and suspensions marketed in Kumasi, Ghana. A total of fourteen brands of FDC AL medicines, comprising eight tablets and six suspensions were purchased from various retail pharmacy outlets in Kumasi, Ghana. All samples were subjected to thorough visual inspection as a quick means of checking quality through meticulous observation of the packaging or dosage form. The quality parameters of the tablets were determined using uniformity of weight, hardness, friability, and disintegration tests. Suspensions were assessed based on pH and compared with the British Pharmacopeia (BP) standard. The samples were then analyzed for drug content (assay) using reverse-phase high-performance liquid chromatography (RP-HPLC). All the tablet samples conformed to BP specification limits for uniformity of weight (deviation of less than ± 5%), hardness (4.0–10 kg/mm2), friability (<1%), and disintegration time (<15 minutes). The active pharmaceutical ingredients’ quantitative assay demonstrated that all the tablets met the BP specifications (90–110%). The results of the pH studies showed that out of the six brands of suspension investigated, five (83.3%) were compliant with the official specification for pH, while one (16.7%) failed the requirement. Unlike the tablet brands, drug content analysis of the six suspensions showed that two (33.3%) were substandard. The artemether and lumefantrine contents in these failed suspensions were variable (artemether: 81.31%–116.76%; lumefantrine: 80.35%–99.71%). The study results indicate that most of the tested products met the required quality standards, demonstrating satisfactory drug content and other quality specifications. The presence of substandard drugs underscores the necessity for robust pharmacovigilance and surveillance systems to eliminate counterfeit and substandard drugs from the Ghanaian market.
... Consequently, the SODFs are preferred by patients and healthcare professionals (Jacques & Alexandridis, 2019) and are usual in primary and secondary care (Drumond & Stegemann, 2021). ...
Aim
To appraise and synthesize research investigating optimizing the administration of solid oral dosage forms (SODFs) to adults with swallowing difficulties.
Design
An integrative review.
Methods
An electronic search was conducted on Medical Literature Analysis and Retrieval System Online (Public Medline interface), Elsevier SciVerse Scopus and Scientific Electronic Library Online (updated February 2023). Restriction regarding the publication date was not considered for the inclusion of records. Studies addressing risks, general aspects, recommendations about patient postural adjustments, swallowing techniques, swallowing aids and aspects of concealment of SODFs were included.
Results
Fifty‐three records published between 2002 and 2021 were included. The main administration risks were aspiration, asphyxia and solid oral dosage form‐induced oral/oesophageal mucosal lesions. The most frequent general aspect reported was administering one oral dosage form at a time. The sitting position was the most patient postural adjustment mentioned. The most frequently reported solid oral dosage form swallowing technique was the lean‐forward method for capsules. Solid oral dosage form swallowing aids cited: tongue and throat lubricant and solid oral dosage form coating device, swallowing cup and swallowing straw.
Conclusion
The literature data on administering SODFs for adults with swallowing difficulties were appraised and synthesized. Some aspects, for example, not administering SODFs simultaneously, can make swallowing safer. Postural adjustments and solid oral dosage form swallowing aids are important to avoid administration risks. Swallowing SODFs can be easier if learned by techniques. Liquid and food are helpful as vehicles, and several of these have been listed.
Implications for the Profession and/or Patient Care
By optimizing the contributing factors of administering oral pharmacotherapy, the nurse can use appropriate practices to improve patient safety. Additionally, knowing and establishing the administration aspects are reasonable steps for standardizing care for patients with swallowing oral dosage form difficulties.
Impact
This study addressed administering SODFs to adult patients with swallowing difficulties.
The administration of SODFs to adult patients with swallowing difficulties can be optimized if only one oral dosage form at a time is administrated and if patient postural adjustments, swallowing techniques and swallowing aids are used.
This investigation will impact the care of patients with swallowing difficulties.
Reporting Method
The authors declare they adhered to the relevant EQUATOR guidelines and report following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) 2020 Statement.
Patient or Public Contribution
No patient or public contribution.
... Handling ease and dividing uniformity are critical characteristics of scored tablets. [29][30][31] It has been reported that more than 10% of the weight devia-* To whom correspondence should be addressed. e-mail: kz-tkym@josai.ac.jp ...
... These findings indicate that score depth is more important than score angle for ease of subdivision and halving equality of score tablets. 29,30) ...
Various stresses and strains are generated on the surface and inside of pharmaceutical tablets when an external force is applied. In addition, stresses in various directions can remain on the surface and inside the tablets because they are generally prepared by compaction of pharmaceutical powders using dies and punches. As it is difficult to measure the stress and strain generation in the tablets experimentally, a numerical simulation was applied by employing a finite element method (FEM). An elastic model is often used to represent stress and strain generation after loading an external force to tablets, and the Drucker–Prager cap (DPC) model has been widely recognized for representing the remaining stress distributions during the compaction of powder to tablet form. Firstly, this article describes an FEM simulation of the stress generation on the surface of the scored tablets after loading the bending force from the back side of the tablets. Next, the FEM simulation was introduced to determine the effect of diametrical compression on the stress and strain generation in the tablets by comparing the results measured experimentally. Furthermore, the residual stresses remaining inside the tablets were simulated using FEM, in which powder compaction was represented as the DPC model. A clear difference was observed in the residual stress distributions between the flat and convex tablets. This indicates that FEM simulation is useful for achieving a science-based understanding of critical quality attributes in various types of tablets.
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... Tablet dosage forms may not needed at all in some situations, especially for neonates and paediatrics with the presence of naso-gastric tube, as they are unable to take whole tablets or capsules [3]. Consequently, the off-label manipulation of medicinal products to extract a part of the whole dosage form, to facilitate administration or to improve acceptability is a common practice in paediatric drug therapy setting where limited dosage regimens are available [4][5][6]. As a result, the practice remains an important public health issue in both developed and developing countries [2] and seems to increase, if responsible bodies do not give attention. ...
Unlabelled:
Tablet manipulation (modification) is a practice where the licensed tablet product is customized into reduced fractions of doses or changed into dispersions using solvents because of suitable dose for paediatrics and neonates are frequently unavailable. As a result, unlicensed dosage form frequently used after manipulation, outside what is approved by drug regulatory authorities.
Objective:
To assess the practice of off-label tablet manipulation in pediatric and neonatal wards at selected public hospitals in Ethiopia.
Methods:
A prospective, direct observational approach was used to investigate the frequency, nature and appropriateness of tablet manipulations in neonatal and pediatrics patients of two public hospitals of Ethiopia from April 12, to June 30, 2021.
Results:
During the study period a total of 303 tablet manipulations were observed. Two hundred nine (69%) of tablets were dispensed to pediatric patients to be taken after split into lower strengths. The remaining nighty four (31%) tablets were manipulated into dispersion using 0.9% normal saline as a main solvent. Interestingly, 48 (15.8%) of tablet manipulations into dispersions involved practically insoluble drugs whose manipulation may probably affect their bioavailability. In 12.5% (12/94) dispersion manipulations, large undissolved fractions were observed during administration through naso-gastric tubes. The most commonly manipulated tablets were drugs for central nervous system (n = 135, 44.6%) followed by cardiovascular drugs (n = 85, 28%).
Conclusions:
and recommendations: The study revealed the off-label use of tablets for pediatrics age groups is very common in Ethiopia. Evidence-based guidelines for tablet manipulations should be practiced to improve the safety of paediatric drug use. As for policy implication, this study concurs with previous scientific recommendations that manufacturers introduce a wide range of dosage forms to reduce the need for manipulations.
... In the case of breaking force, the measured values were in the range of 80-474 N (Table 3); thus, they differed significantly between manufacturers. There are several factors that influence the final hardness of the obtained tablets, such as the characteristics of the powders/granules to be compressed, the type and amount of excipients used (e.g., lubricants, glidants, anti-adherents), and compression force [52]. It is well-known that the desired values of breaking force should be repeatable to provide good quality of the final product. ...
Our aim was to assess the mineral composition as well as the physicochemical quality of green tea-based dietary supplements (capsules and tablets) with respect to average weight, size and shape, friability, breaking force and disintegration time. Products were analysed by flame atomic absorption spectrometry for Ca, K, Mg, Na, Cr, Cu, Fe, Zn, Mn, Pb and Cd. Approximately 60% of the analysed supplements met the requirements of European and Polish regulations. The dietary supplements passed weight variation tests, but not all products had compliant capsule sizes. One product in tablet form failed the friability test, and eleven dietary supplements in tablet form failed the disintegration test. The supplements were characterised by a varied elemental composition, with the highest values found for Ca, Fe, Zn and Mn. The recommended daily allowance realisation for Fe and Zn in two dietary supplements (capsule form) exceeded 100%. As a result of the estimation of the monthly intake of toxic metals, it was concluded that the tested products do not pose a risk to consumer health. Significant relationships (p < 0.001) were found for K, Mg, Na, Cu, Fe, Mn and Zn. The application of factor and cluster analyses allowed the verification of the similarity of green tea extracts contained in dietary supplements to the natural raw material, green tea leaves, used as a reference material.
... One of the essential objectives for the manufacturing of the tablets is to ensure the free flow of the material, which in turn determines: (i) the uniform loading of machine molds, (ii) the uniformity of mass and of the physical-mechanical properties of the tablets, (iii) avoiding the air incorporation into the powder bed and thereby avoiding undesirable phenomena that may occur in the preparation of tablets, such as pickling or lamination, and (iv) limiting the formation of fine particles in the powder mass, which could lead to increased friction with the walls of the mold, preventing proper lubrication [40][41][42]. ...
The present study aims to demonstrate the influence of the polymer-carrier type and proportion on the quality performance of newly developed oral immediate-release tablets containing amiodarone solid dispersions obtained by hot-melt extrusion. Twelve solid dispersions including amiodarone and different polymers (PEG 1500, PEG 4000; PEG 8000, Soluplus®, and Kolliphor® 188) were developed and prepared by hot-melt extrusion using a horizontal extruder realized by the authors in their own laboratory. Only eleven of the dispersions presented suitable physical characteristics and they were used as active ingredients in eleven tablet formulations that contain the same amounts of the same excipients, varying only in solid dispersion type. The solid dispersions’ properties were established by optical microscopy with reflected light, volumetric controls and particle size evaluation. In order to prove that the complex powders have appropriate physical characteristics for the direct compression process, they were subjected to different analyses regarding their flowability and compressibility behavior. Additionally, the Fourier transform infrared spectroscopy and X-ray diffraction analysis were performed on the obtained solid dispersions. After confirming the proper physical attributes for all blends, they were processed into the form of tablets by direct compression technology. The manufactured tablets were evaluated for pharmacotechnical (dimensions–diameter and thickness, mass uniformity, hardness and friability) and in vitro biopharmaceutical (disintegration time and drug release) performances. Furthermore, the influence of the polymer matrix on their quality was determined. The high differences in flow and compression performances of the solid dispersions prove the relevant influence of the polymer type and their concentration-dependent plasticizing properties. The increase in flowability and compressibility characteristics of the solid dispersions could be noticed after combining them with direct compression excipients owning superior mechanical qualities. The influence of the polymer type is best detected in the disintegration test, where the obtained values are quite different between the studied formulations. The use of PEG 1500 alone or combined in various proportions with Soluplus® leads to rapid disintegration. In contrast, the mixture of PEG 4000 and Poloxamer 188 in equal proportions determined the increase in disintegration time to 120 s. The use of Poloxamer 188 alone and a 3:1 combination of PEG 4000 and Soluplus® also generates a prolonged disintegration time for the tablets.
