A Pilot Study on Pharmacists' Knowledge, Attitudes and Practices towards Medication Dysphagia via Asynchronous Online Focus Group Discussion.

Medication dysphagia (MD) refers to difficulty swallowing oral medications. To cope, patients may inappropriately modify or skip medications, leading to poorer outcomes. Little is known about healthcare professionals' (HCPs') perspectives in managing MD. This study investigated pharmacists' knowledge, attitudes, and practices (KAP) in caring for patients with MD. An asynchronous online focus group was pilot tested in seven pharmacists, with up to two questions posted daily on an online platform over 15 days. Thematic analysis of the transcripts revealed five interrelated themes: (1) knowledge about MD; (2) management of MD; (3) expectations of patient proactivity; (4) desire for objectivity; (5) professional roles. The findings provided insight into pharmacists' KAP and may be incorporated into a full-scale study involving various HCPs.

Development and validation of the INappropriate solid oral dosaGE form modification aSsessmenT (INGEST) Algorithm using data of patients with medication dysphagia from a neurology ward and nursing home in Singapore.

OBJECTIVES: This study aims to develop and validate a novel implicit tool to assist clinicians in resource-limited settings to promptly assess suitability for modification of solid oral dosage forms (SODFs) during medication prescribing, review and/or administration for patients with dysphagia. DESIGN: Literature review and a group discussion were conducted to elicit items for the construction of the INappropriate solid oral dosaGE form modification aSsessmenT (INGEST) algorithm. For its validation, inter-rater reliability among three independent users was evaluated. Accuracy of users' ratings was also evaluated against the screening results using the Don't Rush to Crush handbook. SETTING AND PARTICIPANTS: Three pharmacists were involved in the development and another three were involved in the validation of the INGEST algorithm using anonymised medication records of 50 patients in a nursing home and a hospital ward; only SODFs that were modified prior to administration were evaluated. RESULTS: Following literature review, considerations included by consensus in the INGEST algorithm were the presence of special coating or modified release characteristics of the SODF medications, hazardous nature and taste of the active ingredients, manufacturer's advice and use of tube feeding. Of the 381 SODF medications evaluated, 26 (6.8%) were identified by at least one pharmacist to be inappropriate for modification. Gwet's AC among the three pharmacists in identifying SODF medications inappropriate for modification was 0.75 (p<0.001, 95% CI 0.63 to 0.87), and 0.80 (p<0.001, 95% CI 0.71 to 0.89) in identifying SODF medications appropriate for modification, suggesting substantial inter-rater agreement. Overall accuracy of each pharmacist's ratings was high, ranging from 93.7% to 95.6%. CONCLUSIONS: The implicit INGEST algorithm has potential for use by clinicians in nursing home and hospital settings for determining suitability of SODF medications for modification. Further studies should be conducted to assess its external validity and utilisation in daily practice for improving clinical outcomes for patients with SODF dysphagia.

A Point Prevalence Study of Antimicrobial Use and Practice Among Nursing Homes in Singapore.

BACKGROUND: Inappropriate antimicrobial use is a major cause for the development of antimicrobial resistance in nursing homes (NHs); however, little is known about antimicrobial use at NHs in Singapore compared with NHs in other countries. OBJECTIVES: The aim of this study was to determine the prevalence, practice and challenges of antimicrobial prescribing in Singapore NHs compared with those in other countries. METHODS: A point prevalence survey (PPS) was conducted from August to October 2017. Data on antimicrobial use and the quality of documentation were retrieved from medical and/or medication records of NH residents. Informed consent was obtained from the NH management. RESULTS: Nine of 73 NHs in Singapore, with a total of 1760 residents, participated in the PPS. The prevalence of oral antibiotic and topical antimicrobial use was 2% and 11%, respectively, and the worldwide point prevalence of antimicrobial prescribing in NHs ranged from 1-17% (median 8%). The key challenges identified locally were different from those of overseas NHs, including incomplete documentation of antimicrobial duration and indication of use, as well as the high prevalence of topical antimicrobial use. CONCLUSIONS: The prevalence of oral antibiotic use in NHs in Singapore was lower, while topical antimicrobial use was higher, compared with NHs in other countries. Variability in antimicrobial prescribing and challenges in practice among local and overseas NHs implied that a comprehensive PPS could be beneficial to aid in the design of effective and practicable antimicrobial stewardship strategies appropriate for the NH.

Spontaneous cutaneous adverse drug reaction reports-An analysis of a 10-year dataset in Singapore.

We analyzed the spontaneous adverse event database in Singapore to determine the types of cutaneous adverse drug reactions (CADRs) and causative drugs reported. We selected 10 CADRs-of-interest, and identified the suspected drugs and the characteristics of the at-risk population. ADR reports received from 2006 to 2015 of the system organ class "Skin and Appendages Disorders" were analyzed based on patient demographics, the types of CADRs, suspected drugs, outcome, and latency period. Of the 104 372 reports analyzed, 56.2% involved females and 72.5% involved Chinese patients. The mean age was 41.1 years old. The top CADRs reported were rash (including nonspecified rash, follicular rash, maculopapular rash, and vesicular rash) (67.2%) and angioedema (13.9%). The drugs frequently associated with the CADRs-of-interest include nonsteroidal antiinflammatory drugs and antibiotics with angioedema, iohexol with urticaria, and antiepileptics and allopurinol with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). A subgroup analysis based on age, sex, and race on the 10 CADRs-of-interest showed the following trends in reporting: Alopecia (reported more in females), drug hypersensitivity syndrome (more in males), angioedema (more in younger patients), and photosensitivity (more in older patients). In general, the racial distribution across each CADR-of-interest was consistent with that of Singapore's population, with slight deviations observed for SJS/TEN, photosensitivity and skin discoloration. We analyzed CADR reports from Singapore over 10 years, and identified the types of CADRs reported, and their associated drugs, latency periods and patient characteristics. Such information could add value to healthcare professionals as they assess CADR cases and evaluate suspected drugs.

Association between access to health-promoting facilities and participation in cardiovascular disease (CVD) risk screening among populations with low socioeconomic status (SES) in Singapore.

BACKGROUND: Low socioeconomic status (SES) is a barrier for cardiovascular disease (CVD) risk screening and a determinant of poor CVD outcomes. This study examined the associations between access to health-promoting facilities and participation in a CVD risk screening program among populations with low SES residing in public rental flats in Singapore. METHODS: Data from Health Mapping Exercises conducted from 2013 to 2015 were obtained, and screening participation rates of 66 blocks were calculated. Negative binomial regression was used to test for associations between distances to four nearest facilities (i.e., subsidized private clinics, healthy eateries, public polyclinics, and parks) and block participation rate in CVD screening. We also investigated potential heterogeneity in the association across regions with an interaction term between distance to each facility and region. RESULTS: The analysis consisted of 2069 participants. The associations were only evident in the North/North-East region for subsidized private clinic and park. Specifically, increasing distance to the nearest subsidized private clinic and park was significantly associated with lower [incidence rate ratio (IRR) = 0.88, 95% confidence interval (CI): 0.80-0.98] and higher (IRR = 1.93, 95%CI: 1.15-3.25) screening participation rates respectively. CONCLUSIONS: Our findings could potentially inform the planning of future door-to-door screenings in urban settings for optimal prioritization of resources. To increase participation rates in low SES populations, accessibility to subsidized private clinics and parks in a high population density region should be considered.

Antimicrobial use and drug-drug interactions among nursing home residents in Singapore: a multicentre prevalence study.

Background With the Ministry of Health's projected increase in nursing home beds and optimization of antimicrobial use in health care settings, it is therefore timely to consider baseline prevalence and patterns of antimicrobial use at nursing homes in Singapore as well as to evaluate the prevalence of potential clinically significant drug-drug interactions involving antimicrobials. Objective The primary objective was to determine the prevalence and patterns of antimicrobial use at nursing homes in Singapore. The secondary objective was to evaluate the prevalence of potential clinically significant drug-drug interactions involving antimicrobials. Setting Four nursing homes in Singapore. Method A retrospective cross-sectional study was conducted among nursing home residents. The antimicrobial prevalence, defined daily doses, days of therapy, and potential drug-drug interactions were determined using data from archived resident medication prescribing and administration records. Main outcome measure Prevalence and patterns of antimicrobial use, drug-drug interactions involving antimicrobials. Results Among 707 residents (mean age: 80.7 ± 8.8 years, female: 57.1%), 10% used antimicrobials during the study month, with a 1-day point prevalence of 3%. The utilization rates of antimicrobials were 28.9 defined daily doses/1000 resident-days and 24.8 days of therapy/1000 resident-days. Potential drug-drug interactions involving antimicrobials were identified among 32 of the 70 (46%) residents who were prescribed antimicrobials. Of these, 26 (81%) residents had 43 potential clinically significant drug-drug interactions. Conclusions The prevalence and utilization rates of antimicrobial use in Singapore nursing homes appear to be low. Yet, potential clinically significant drug-drug interactions are prevalent.

A novel unit-dose approach for the pharmaceutical compounding of an orodispersible film.

Orodispersible films (ODF) have clinical potential as extemporaneous pharmacy preparations for individualized pharmacotherapy. However, the conventional method of ODF preparation using a film applicator may limit its application, due to content uniformity challenges arising from viscosity changes of the casting solution and varied operator manipulation. This study proposes the unit-dose (UD) plate as an alternative to the film applicator for compounding individual ODFs. Using a design-of-experiments approach, we developed an extemporaneous ODF formulation for an antiemetic drug, ondansetron hydrochloride dihydrate (OND), at a clinically relevant dose. ODFs cast with the UD plate showed excellent content uniformity independent of the viscosity of the casting solution and drug concentration. Formulations were evaluated for performance with respect to patient acceptability and product quality. The effects of critical process parameters on critical quality attributes of the ODF were studied. HPMC concentration and volume of casting solution were the main factors affecting disintegration time and mechanical properties of the film, while drug concentration had no significant effect. However, further studies incorporating different drugs in larger concentration ranges are needed to investigate the impact of drug concentration and to establish a design space. Nevertheless, our results indicate the potential of using the UD plate to prepare ODFs with customized drug doses from a generic casting solution. Results from this study provide a framework for an extemporaneous ODF platform.

Application of miniaturized near-infrared spectroscopy for quality control of extemporaneous orodispersible films.

Extemporaneous oral preparations are routinely compounded in the pharmacy due to a lack of suitable formulations for special populations. Such small-scale pharmacy preparations also present an avenue for individualized pharmacotherapy. Orodispersible films (ODF) have increasingly been evaluated as a suitable dosage form for extemporaneous oral preparations. Nevertheless, as with all other extemporaneous preparations, safety and quality remain a concern. Although the United States Pharmacopeia (USP) recommends analytical testing of compounded preparations for quality assurance, pharmaceutical assays are typically not routinely performed for such non-sterile pharmacy preparations, due to the complexity and high cost of conventional assay methods such as high performance liquid chromatography (HPLC). Spectroscopic methods including Raman, infrared and near-infrared spectroscopy have been successfully applied as quality control tools in the industry. The state-of-art benchtop spectrometers used in those studies have the advantage of superior resolution and performance, but are not suitable for use in a small-scale pharmacy setting. In this study, we investigated the application of a miniaturized near infrared (NIR) spectrometer as a quality control tool for identification and quantification of drug content in extemporaneous ODFs. Miniaturized near infrared (NIR) spectroscopy is suitable for small-scale pharmacy applications in view of its small size, portability, simple user interface, rapid measurement and real-time prediction results. Nevertheless, the challenge with miniaturized NIR spectroscopy is its lower resolution compared to state-of-art benchtop equipment. We have successfully developed NIR spectroscopy calibration models for identification of ODFs containing five different drugs, and quantification of drug content in ODFs containing 2-10mg ondansetron (OND). The qualitative model for drug identification produced 100% prediction accuracy. The quantitative model to predict OND drug content in ODFs was divided into two calibrations for improved accuracy: Calibration I and II covered the 2-4mg and 4-10mg ranges respectively. Validation was performed for method accuracy, linearity and precision. In conclusion, this study demonstrates the feasibility of miniaturized NIR spectroscopy as a quality control tool for small-scale, pharmacy preparations. Due to its non-destructive nature, every dosage unit can be tested thus affording positive impact on patient safety.

Exploring Product-Specific Attributes of a Community Cardiac Rehabilitation Program in an Asian Urban City.

BACKGROUND: Cardiac rehabilitation (CR) has been proven to improve long-term outcomes for patients. Despite its benefits, its uptake throughout the world is poor. Factors affecting the motivation and barriers impeding an individual from participating in a CR program have been extensively studied. Nevertheless, knowledge of product-specific factors in affecting participation is lacking. OBJECTIVES: To find out cultural-specific product attributes that are important to those contemplating participation in a community-based CR program using Consolidated criteria for Reporting Qualitative research (COREQ) as an anchor. METHODS: Participants were recruited from attendees of the CR program at the Singapore Heart Foundation. A literature review was done to identify product-specific attributes that affected participation in CR programs. An interview guide was developed on the basis of the list of product attributes. The analysis was done by two independent analysts using NVivo version 11 (QSR International, Melbourne, Australia) via an inductive approach. Data analysis was carried out with recruitment and interviews ongoing until thematic saturation was reached. RESULTS: In total, 13 male and 9 female participants (16 Chinese, 4 Indian, 1 Malay, and 1 Eurasian) aged between 47 and 89 years were interviewed. A total of 8 categories (System, Infrastructure, Environment, Monitoring, Activity, Program, Staff, and Companionship) with 30 subcategories were identified. New themes that have not been explored by previous studies were discovered under five different categories: System, Infrastructure, Environment, Program, and Companionship. CONCLUSIONS: This study allows a better understanding of product-specific factors affecting participation in CR programs and serves as a springboard for further research to improve participation in community-based CR programs.

Impact of Community-Based Cardiac Rehabilitation on Clinical Parameters of Patients with Cardiovascular Diseases.

BACKGROUND: Cardiac rehabilitation (CR) programmes have been shown to improve patient outcomes, but vary widely in their components. The impact of Singapore's CR programme on clinical outcomes is currently not known. OBJECTIVE: To evaluate the effects of a community-based CR programme on important clinical parameters in patients with cardiovascular disease in Singapore. METHOD: A retrospective cohort study was conducted. Cardiovascular patients who had completed a hospital-based CR programme were included. Patients who continued with community-based CR (n = 94) during the period of 2009-2013 were compared with patients who received regular care (n = 157). Changes in clinical and physical examination parameters between baseline and one-year post follow-up were analyzed. Within-group differences were compared using the paired t-test, while multivariate linear regression was used to compare the changes in the various parameters between the intervention and control groups. The primary outcome measure was low density lipoprotein (LDL) levels. RESULTS: Patients in the intervention group had significant lowering of LDL (2.5 to 2.2 mmol/L, p<0.01), while the control group's LDL increased (2.2 to 2.4 mmol/L, p<0.01). The intervention group had greater improvements in LDL (-0.3 vs. +0.2 mmol/L, p<0.01), triglycerides (-0.1 vs. +0.1 mmol/L, p=0.01), total cholesterol (-0.3 vs. +0.3 mmol/L, p<0.01), fasting blood glucose (-0.5 vs. +0.3 mmol/L, p<0.01), systolic blood pressure (-3.2 vs. +5 mmHg, p<0.01) and diastolic blood pressure (-2.6 vs. +2.8 mmHg, p<0.01). CONCLUSION: The community-based CR programme in Singapore is associated with improvements in several cardiovascular clinical parameters and may be of benefit to cardiovascular patients.

Drug-induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014.

BACKGROUND: The use of Complementary and Alternative Medicine (CAM) has been increasing over the years. A recent review of adverse event reports (AERs) associated with CAM in Singapore found a notable number of AERs submitted. The objectives of this study are to analyse hepatotoxicity cases associated with CAM in Singapore based on spontaneous adverse event reporting to the Health Sciences Authority (HSA), and to highlight safety signals for specific herbal ingredients. METHODS: AERs associated with CAM and hepatotoxicity submitted to the Vigilance and Compliance Branch (VCB) of the HSA from 2009 to 2014 were compiled. The following information was extracted and analysed: Demographic information; time to onset; hospitalisation status; outcome; type of hepatotoxicity; ingredients of CAM, and the total daily doses (TDD); concurrent western medicines and health supplements; and reporter details. RESULTS: Fifty-seven reports were eligible for analysis. Thirty-five (61.4 %) cases involved Traditional Chinese Medicine (TCM). The Roussel Uclaf Causality Assessment Method was applied in 29 (82.9 %) of these cases, and the median score was 4 (range: 1-8). Chai Hu (Radix bupleuri) was suspected in 11 (31.4 %) cases. TDDs of most ingredients were within recommended doses of the Chinese Pharmacopoeia. CONCLUSIONS: Drug-induced liver injury is still poorly understood and more objective assessments are warranted. Reporting of adverse events should be strongly advocated to facilitate future analyses and the understanding of risk-benefit profiles of CAM.

Complementary and alternative medicines use among pediatric patients with epilepsy in a multiethnic community.

OBJECTIVE: Prior studies highlighted that patients on chronic medications who used complementary and alternative medicines (CAMs) did not share this information with their healthcare providers. Furthermore, there might be potential adverse interactions between CAMs and antiepileptic drug (AED) therapy. However, there are no studies that investigate the effect of religion or race on CAM use in a multiethnic community. Therefore, we aimed to investigate CAM usage among pediatric patients with epilepsy (PPE) and identify predictors of CAM usage in our multiethnic setting. METHODS: This was a cross-sectional study where caregivers of recruited at an outpatient epilepsy clinic between September 2013 and July 2014 completed a self-administered survey. Those who declined participation, lacked understanding of English or Mandarin, or missed the clinic appointments were excluded. Those caring for more than one patient participated only once. RESULTS: Of the 195 surveys collected, 178 were used for analysis. The PPE used an average of 1.50 AEDs (range: 0-4). Forty-nine (27.5%) caregivers reported giving CAMs to their PPE. Commonly used CAMs were multivitamins (44.4%), traditional herbs (42.2%), and acupuncture (17.4%). Multivitamins were mostly given by Christian/Catholic caregivers while Buddhist caregivers mostly gave traditional herbs or acupuncture. The majority of the CAM users were Chinese. Univariate analysis showed that caregivers with secondary school (high school) education were 3.52 times more likely to use CAMs compared to those with primary school (elementary school) education. CONCLUSIONS: While some caregivers gave CAMs to their PPE, they had various misconceptions and did not discuss the usage with their healthcare providers. We propose that the predictors identified in this study can help to identify potential CAM users. Healthcare providers should routinely probe about the usage of CAMs by PPE, and thereafter, the suitability of CAM use could be evaluated. The caregivers will benefit from open discussion with healthcare professionals on the safe use of AEDs with or without CAMs.

Metabolic parameters in type 2 diabetic patients with varying degrees of glycemic control during Ramadan: An observational study.

AIMS/INTRODUCTION: The changes in metabolic parameters in type 2 diabetic patients who fast during Ramadan have not been studied in Singapore. This study aimed to examine the trends of glycated hemoglobin (HbA1c), systolic blood pressure, low-density lipoprotein cholesterol, and triglycerides in diabetic patients with varying degrees of glycemic control and different types of therapeutic approaches during Ramadan. METHODS: The present retrospective study used a national electronic database to examine the metabolic parameter of Malay patients with type 2 diabetes. Eligible patients were stratified into three groups based on their mean HbA1c control before Ramadan: group 1 (HbA1c ≥10%), group 2 (HbA1c 7.1-9.9%) and group 3 (HbA1c ≤7%). Patients with a glomerular filtration rate <15 mL/min were excluded. The trends of metabolic parameters were traced before, during and after Ramadan. RESULTS: Of 13,565 patients examined, 5,172 patients (38.1%) were eligible for this study. Mean change of HbA1c varied from -1.4% to +0.2% during Ramadan, with the greatest reduction observed in group 1 (P < 0.001). A minimal systolic blood pressure reduction was observed in groups 2 and 3 (2 mmHg; P < 0.01). Low-density lipoprotein cholesterol and triglycerides changes were insignificant. A small, 0.1%, reduction in mean HbA1c was observed in patients taking oral antidiabetic agents during Ramadan (P < 0.001). CONCLUSIONS: Blood glucose was most affected during Ramadan, particularly in patients with mean baseline HbA1c ≥10%. The type of antidiabetic agent used did not seem to contribute to glycemic changes.

Controlled Release Inhalable Polymeric Microspheres for Treatment of Pulmonary Arterial Hypertension.

Pulmonary arterial hypertension (PAH) is a chronic ailment of the lungs, exhibiting elevated arterial pressure and vascular resistance; with a mean arterial pressure above 25 mmHg at rest and above 30 mmHg during exercise. It is associated with poor prognosis, and its prevalence is estimated to be 15 cases per one million. The current treatment options for PAH are discussed with the prostanoid class of drugs being the most effective. The latter drugs act by dilating systemic and pulmonary arterial vascular beds and, with sustained long-term usage, altering pulmonary remodelling. They are administered as IV infusions or inhalation solutions. Despite their clinical effectiveness, prostanoids have short half-lives requiring frequent administration of 6-9 times daily and thus suffer from poor compliance. Controlled release inhalation delivery systems for treatment of PAH, ranging from liposomes, biodegradable nano- and microparticles, formation of co-precipitates and complexation with cyclodextrins, are explored. Arising from these formulation strategies, we developed novel polymeric microspheres for inhalation to reduce dosing frequency and improve medication compliance. These microspheres are designed with release modifiers, to reside in the lung which is the site of drug action for a longer duration so as to release the drug slowly and consistently over a prolonged period. This could lead to the development of the first commercially available controlled release inhalation product.

A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs.

Lipid Vesicles for the Skin Delivery of Diclofenac: Cerosomes vs. Other Lipid Suspensions.

PURPOSE: Lipid suspensions as drug carriers, including conventional liposomes, ethosomes, transferosomes, proniosomes, niosomes, PEG-PPG-PEG niosomes and stratum corneum liposomes (cerosomes), were formulated and compared. METHODS: Lipid vesicles were formulated and assessed with regards to enhancement of skin permeation of diclofenac and stability profiles of the formulations. Formulation-induced changes of the biophysical structure of excised human skin were monitored using the Fourier transform infrared spectroscopy. RESULTS: The stability profiles of these suspensions over 12 weeks did not show any significant drug leakage from the vesicles of interest (p > 0.05). FTIR observations indicated that the vesicles increased stratum corneum (SC) lipid fluidization and altered protein conformation. Skin permeability experiments showed that the free unencapsulated drug in the cerosomal formulations caused significant increase in drug permeation across the skin (p < 0.01). Low skin permeability of drug from the other lipid suspensions could be due to the entrapment of diclofenac within these vesicles which decreased the solubility of the hydrophilic drug in the skin lipids and the partition coefficient of the drug from these vesicles into the SC. CONCLUSION: Optimal drug entrapment in vesicles or alteration of the skin structure may not necessarily enhance the permeation of hydrophilic drugs across the human skin. These lipid vesicles may be further developed into carriers of both hydrophilic and hydrophobic drugs for topical and transdermal delivery, respectively.

Pharmaceutics, Drug Delivery and Pharmaceutical Technology: A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3893-3903, 2015.

Evaluating the Effect of Ramadan Fasting on Muslim Patients with Diabetes in relation to Use of Medication and Lifestyle Patterns: A Prospective Study.

Objectives. This study aimed to examine the effect of Ramadan fasting on HbA1c in Muslim patients with type 2 diabetes. The incidence of hypoglycemia and glycemic changes in relation to the adjustment of doses of antidiabetic agents, diet, and physical activity during Ramadan was also evaluated. Methods. This was a prospective study conducted in an outpatient endocrine clinic. A set of questionnaires was administered to Muslim patients with diabetes who fasted for ≥10 days. Those who were hospitalized for diabetic ketoacidosis or severe hypoglycemia a month prior to Ramadan or were given short-term corticosteroid therapy were excluded. The patients' responses and clinical outcomes from the clinic database were collected before, during, and after Ramadan. Results. A total of 153 participants completed the study. The mean HbA1c improved from 8.9% before Ramadan to 8.6% during Ramadan (P < 0.05). Although diet and physical activity did not contribute to changes in glycemia, a significant improvement in HbA1c was observed in patients who had adjustments made to their doses of antidiabetic agents during Ramadan (P < 0.001). In addition, their rate of hypoglycemia was minimal. Conclusions. Ramadan fasting appeared to improve glycemic control, especially in those whose doses of antidiabetic agents were adjusted during Ramadan.

Novel nanofiltration membranes consisting of a sulfonated pentablock copolymer rejection layer for heavy metal removal.

Facing stringent regulations on wastewater discharge containing heavy metal ions, various industries are demanding more efficient and effective treatment methods. Among the methods available, nanofiltration (NF) is a feasible and promising option. However, the development of new membrane materials is constantly required for the advancement of this technology. This is a report of the first attempt to develop a composite NF membrane comprising a molecularly designed pentablock copolymer selective layer for the removal of heavy metal ions. The resultant NF membrane has a mean effective pore diameter of 0.50 nm, a molecular weight cutoff of 255 Da, and a reasonably high pure water permeability (A) of 2.4 LMH/bar. The newly developed NF membrane can effectively remove heavy metal cations such as Pb(2+), Cd(2+), Zn(2+), and Ni(2+) with a rejection of >98.0%. On the other hand, the membrane also shows reasonably high rejections toward anions such as HAsO4(2-) (99.9%) and HCrO4(-) (92.3%). This performance can be attributed to (1) the pentablock copolymer's unique ability to form a continuous water transport passageway with a defined pore size and (2) the incorporation of polyethylenimine as a gutter layer between the selective layer and the substrate. To the best of our knowledge, this is the first reported NF membrane comprising this pentablock copolymer as the selective material. The promising preliminary results achieved in this study provide a useful platform for the development of new NF membranes for heavy metal removal.

Effect of type and ratio of solubilising polymer on characteristics of hot-melt extruded orodispersible films.

In formulating an orodispersible film (ODF), it is important for polymer choice to strike a balance between mechanical properties and release rates. Studies have been done to study polymer combinations. However, there is a lack of a systematic study to determine key factors affecting these properties. We studied the effect of varying the ratios of a solubilising polymer (Kollidon(®) VA 64 or Soluplus(®)) to a film forming polymer, hydroxypropyl cellulose (HPC), on mechanical properties and release rates of hot-melt extruded ODFs using a 2(3) factorial design. The two drugs evaluated were chlorpheniramine and indomethacin. The main effects impacting mechanical properties were the drug and two-way interaction between drug and solubilising polymer. For dissolution, the main effects were the solubilising polymer; the drug; and the two-way interaction between solubilising polymer and ratio of solubilising to film forming polymer. Both drugs exhibited plasticising effects on the polymer matrix and had higher film ductility and lower film stiffness. Kollidon(®) VA 64-containing films performed better in terms of drug release whereas Soluplus(®)-containing films had better mechanical properties. The dissolution rate can be improved by decreasing film thickness. The findings of our study will be crucial to forming a robust ODF formulation.