Telmisartan Tablets Repackaged into Dose Administration Aids: Physicochemical Stability under Tropical Conditions

Dose administration aids (DAAs) are commonly used to assist patients with chronic disease to manage multiple medications and thus improve adherence. Several brands of telmisartan, commonly prescribed for hypertension, are available in Australia. Manufacturer’s storage advice is to leave tablets in the blister strip until administered to patients. This study aimed to investigate the stability of telmisartan tablets when repackaged and stored in DAAs, to identify a brand, which is sufficiently stable to be repackaged. All available brands of telmisartan tablets in Australia, which contain different excipients, were repackaged into DAAs and stored at 30 °C, 75% RH for 28 days before screening, using visual inspection and physical testing. A candidate brand was then selected for physicochemical and photostability testing using pharmacopoeial methods. Repackaged Mizart® tablets were shown to be sufficiently stable, when repackaged and stored under tropical conditions (30 °C, 75% RH) for 28 days. Several of the other brands were deemed inappropriate for repackaging, due to physical instability, highlighting the importance of considering not only the drug, but also excipients to ensure the stability of repackaged medicines. Although the repackaging of telmisartan tablets is not advised, this study provides evidence to support the Mizart® brand as an option for pharmacists to recommend for repackaging

Does acute exercise affect the performance of whole-body, psychomotor skills in an inverted-U fashion?:a meta-analytic investigation

The primary purpose of this study was to examine, using meta-analytical measures, whether research into the performance of whole-body, psychomotor tasks following moderate and heavy exercise demonstrates an inverted-U effect. A secondary purpose was to compare the effects of acute exercise on tasks requiring static maintenance of posture versus dynamic, ballistic skills. Moderate intensity exercise was determined as being between 40% and 79% maximum power output (ẆMAX) or equivalent, while ≥ 80% ẆMAX was considered to be heavy. There was a significant difference (Zdiff = 4.29, p = 0.001, R2 = 0.42) between the mean effect size for moderate intensity exercise (g = 0.15) and that for heavy exercise size (g = − 0.86). These data suggest a catastrophe effect during heavy exercise. Mean effect size for static tasks (g = − 1.24) was significantly different (Zdiff = 3.24, p = 0.001, R2 = 0.90) to those for dynamic/ballistic tasks (g = − 0.30). The result for the static versus dynamic tasks moderating variables point to perception being more of an issue than peripheral fatigue for maintenance of static posture. The difference between this result and those found in meta-analyses examining the effects of acute exercise on cognition shows that, when perception and action are combined, the complexity of the interaction induces different effects to when cognition is detached from motor performance

Prevalence of substandard amoxicillin oral dosage forms in the National Capital District of Papua New Guinea

Antibiotics are commonly reported as being substandard or falsified in low- to middle-income countries, having potential to contribute to the development of antimicrobial resistance and drug-resistant infections. Amoxicillin, used to treat a number of infections and listed by the WHO as an essential medicine, presented as a good drug candidate for this study. We aimed to measure the prevalence of substandard and falsified amoxicillin oral products (tablets, capsules, and suspensions) in the National Capital District of Papua New Guinea (PNG). These oral products were surveyed in 2018 and 2019 from retail pharmacies, private and public health facilities, and the Area Medical Store, representing more than 90% of licensed medicine outlets. The product packaging was visually inspected, and the samples were analyzed for amoxicillin content using a validated high-performance liquid chromatography method. Although no falsified products were identified, 15% of the 190 products analyzed contained substandard amounts of amoxicillin. Quality varied with the dosage form (P = 0.002), with capsules exhibiting the lowest incidence of substandard content (4% in 2019) and tablets collected in 2018 experiencing the highest failure rate (50%). Suspension (40%) quality was compromised by failure to achieve homogeneity on reconstitution. A higher incidence of substandard content (P = 0.002) was associated with one major retail group. Routine testing of medicines by resource-poor countries is often unachievable, leading to the circulation of poor quality drugs, which is a global public health concern. Our study highlighted that substandard amoxicillin oral products are indeed prevalent in the NCD of PNG

Addressing varenicline adherence through repackaging in a dose administration aid

Background: Ensuring adherence to prescribed smoking cessation medications, such as Champix® (varenicline), is essential during a quit attempt as non-adherence can significantly reduce the likelihood of achieving prolonged smoking abstinence. The use of dose administration aids may improve adherence, though medication stability on repackaging is not guaranteed, due to a lack of available data from manufacturers supporting this practice. Objective: To determine the suitability for repackaging varenicline tartrate tablets into a dose administration aid, by assessing its physical and chemical stability after being repackaged and stored at ambient conditions for 6 weeks. Methods: Varenicline tartrate (1.0 mg) tablets were repackaged into commercially available Webster-pak® blister compartments and stored for 42 days at ambient conditions characteristic of a Zone IVB climate (30 ± 2°C and 75 ± 5% relative humidity) according to the World Health Organization (WHO) guidelines on pharmaceutical stability testing. Physical and chemical tests were performed on the repackaged and control tablets, including an assessment of: tablet thickness, hardness, weight uniformity, friability, dissolution, disintegration, and content uniformity after exposure to ambient conditions and light according to International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use guideline Q1B. Results: Weight, friability, and thickness of the tablets complied with compendial standards. A validated high performance liquid chromatography method was used to confirm that after exposure to light, and repackaging at 30°C/75% relative humidity, the tablets remained within the required 95%–105% of the stated drug content. However, tablet hardness and disintegration decreased over time, with tablets becoming softer and undergoing more rapid disintegration in water. Conclusion: Repackaging 1.0 mg varenicline tartrate tablets into a dose administration aid can be undertaken to improve adherence rates and therefore smoking abstinence rates. This can be performed without compromising either the physical or chemical stability of the tablets

Addressing varenicline adherence through repackaging in a dose administration aid

Background: Ensuring adherence to prescribed smoking cessation medications, such as Champix® (varenicline), is essential during a quit attempt as non-adherence can significantly reduce the likelihood of achieving prolonged smoking abstinence. The use of dose administration aids may improve adherence, though medication stability on repackaging is not guaranteed, due to a lack of available data from manufacturers supporting this practice. Objective: To determine the suitability for repackaging varenicline tartrate tablets into a dose administration aid, by assessing its physical and chemical stability after being repackaged and stored at ambient conditions for 6 weeks. Methods: Varenicline tartrate (1.0 mg) tablets were repackaged into commercially available Webster-pak® blister compartments and stored for 42 days at ambient conditions characteristic of a Zone IVB climate (30 ± 2°C and 75 ± 5% relative humidity) according to the World Health Organization (WHO) guidelines on pharmaceutical stability testing. Physical and chemical tests were performed on the repackaged and control tablets, including an assessment of: tablet thickness, hardness, weight uniformity, friability, dissolution, disintegration, and content uniformity after exposure to ambient conditions and light according to International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use guideline Q1B. Results: Weight, friability, and thickness of the tablets complied with compendial standards. A validated high performance liquid chromatography method was used to confirm that after exposure to light, and repackaging at 30°C/75% relative humidity, the tablets remained within the required 95%–105% of the stated drug content. However, tablet hardness and disintegration decreased over time, with tablets becoming softer and undergoing more rapid disintegration in water. Conclusion: Repackaging 1.0 mg varenicline tartrate tablets into a dose administration aid can be undertaken to improve adherence rates and therefore smoking abstinence rates. This can be performed without compromising either the physical or chemical stability of the tablets

Dose Administration Aids: Pharmacists’ Role in Improving Patient Care

Dose administration aid (DAA) usage has become increasingly prevalent among populations worldwide and as such has become an important part of pharmacy practice. The evidence for the use of these aids has been favourable in Australia resulting in 2006 in a community based DAA program being considered by the Professional Programs and Services Advisory Committee and the first phase of this program implemented in October 2007. The program was established under the Better Community Health Initiative of the 4th Community Pharmacy Agreement with the Government. The aim of this program is to reduce medication-related hospitalizations and adverse events through improved medication management and adherence for people in the community. The most common patient groups that access this service include the elderly, who are often on several different medications and patients with cognitive disabilities who may have trouble understanding or remembering their dosage regimes. Repackaging of a medication, involving removal from its primary packaging invalidates the stability guarantee of the manufacturer. It is in fact the role of the health team to ensure patient care by making an informed judgment as to the effect on the quality and safety of this repackaging process. Drug manufacturers, on the whole, tend to discourage repackaging of medications and as there is little quality data available to support this process. Indeed, only a small number of medications have been investigated for their stability following repackaging into DAAs, namely atenolol, paracetamol, frusemide, prochlorperazine, sodium valproate, aspirin (dosette boxes) and clozapine. This paper will review the repackaging of medications into DAAs and the role that the pharmacist plays in this process to improve patient care, in addition to presenting the Australian research that has contributed substantially to the body of information available internationally on the quality implications, relating to the stability of repackaging medicines into DAAs

Red blood cell mannoses as phagocytic ligands mediating both sickle cell anaemia and malaria resistance

Acknowledgements We are grateful for the assistance provided by both the Microscopy and Histology Core Facility, and the Iain Fraser Cytometry Centre, at the University of Aberdeen. We thank Ann Wheeler and Matt Pearson from Edinburgh Super-Resolution Imaging Consortium for technical support with 3D SIM microscopy. We also thank Janet A. Willment and Bernard Kerscher, supervised by G.D.B., for providing the Fc fusion proteins, Jeanette A. Wagener, supervised by Neil A.R.G. Gow, for providing high purity chitin, Jan Westland for obtaining blood samples and Paul Crocker for useful discussions. Principal funding for this project was provided by Wellcome Trust grant 094847 (R.N.B., L.P.E., M.A.V.). In addition, support was provided by Biotechnology and Biological Sciences Research Council grants BBF0083091 (A.D. and S.M.H.) and BBK0161641 (A.D. and S.M.H.), Wellcome Trust grant 082098 (A.D.), Wellcome Trust grants 97377, 102705 (G.D.B.), and funding for the MRC Centre for Medical Mycology at the University of Aberdeen MR/N006364/1 (G.D.B.).Peer reviewedPublisher PD