Background: COVID-19 lockdown has forced pharmacy education to be conducted remotely for approximately half of the second semester in the year 2019/2020. This sudden shift to distance learning has put the pharmacy education system through an extraordinary experience that may impact its future. Objective: To investigate the effect emergency remote teaching has had on pharmacy education in Saudi Arabia, and to provide recommendations that may help set in place a contingency strategy. Methods: Two cross-sectional Likert-scale based questionnaires targeted at students and teachers separately, designed to explore stakeholders' satisfaction in three areas of emergency distance teaching/learning: The use of virtual classrooms, completion of course learning outcomes (CLOs) and assessment via alternative methods during the COVID-19 lockdown period. Furthermore, phone interviews were conducted with teachers and students to discuss results from both questionnaires for further clarity on teacher and student views. Results: Over 700 pharmacy students, from 19 different local colleges, and 74 faculty members from 10 different local colleges have participated in this study. While it was challenging for the majority of teachers (>60%) to delivery complex scientific concepts over virtual classrooms, >35% of students and 60% of teachers have expressed concerns on the lack of student–student and student–teacher interactions. A factor that has shown a significantly negative correlation with student overall satisfaction (p < 0.01). Emergency remote teaching has forced teachers to alternative assessment methods, which the majority (70%) believe had a positive effect on students' overall skills. Almost half of students (45%) were concerned by the lack of guidance accompanied by unfamiliar methods of assessments. Conclusions: Based on statistically analysed results from cross sectional Likert-scale questionnaires aimed at stakeholders of pharmaceutical education, this study concludes with a number of recommendations that may help pharmacy colleges seize this unique opportunity to further enhance the quality of pharmacy education in Saudi Arabia.
1 May 2019 in International Journal of Nanomedicine
Background and purpose: Conventional topical ophthalmic aqueous solutions and suspensions are often associated with low bioavailability and high administration frequency, pulsatile dose and poor exposure to certain ocular parts. The aim of this study was to develop an ophthalmic nanoparticles loaded gel, for delivering prednisolone acetate (PA), to increase dosing accuracy, bioavailability, and accordingly, efficiency of PA in treating inflammatory ocular diseases. Methods: A novel formulation of self-assembled nanoparticles was prepared by the complexation of chitosan (CS) and, the counter-ion, sodium deoxycholate (SD), loaded with the poorly-water-soluble PA. Particle size, zeta potential, encapsulation efficiency (EE) and drug loading content (LC) of prepared nanoparticles were assessed. Moreover, the nanoparticles were characterized using differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR). Drug release and eye anti-inflammatory potential of the prepared novel formulation was investigated. Results: Mean particle size of the nanoparticles have dropped from 976 nm ±43 (PDI 1.285) to 480 nm ±28 (PDI 1.396) when the ratio of CS-SD was decreased. The incorporation of 0.1-0.3% of polyvinyl alcohol (PVA), in the preparation stages, resulted in smaller nanoparticles: 462 nm ±19 (PDI 0.942) and 321 nm ±22 (PDI 0.454) respectively. DSC and FTIR results demonstrated the interaction between CS and SD, however, no interactions were detected between PA and CS or SD. Drug release of PA as received, in simulated tears fluid (pH 7.4), showed a twofold increase (reaching an average of 98.6% in 24 hours) when incorporated into an optimized nanoparticle gel formulation (1:5 CS-SD). Conclusion: The anti-inflammatory effect of PA nanoparticles loaded gel on female guinea pig eyes was significantly superior to that of the micronized drug loaded gel (P < 0.05).
Deaths from opioid overdose can be prevented through administration of the antagonist naloxone, which has been licensed for injection since the 1970s. To support wider availability of naloxone in community settings, novel non-injectable naloxone formulations are being developed, suitable for emergency use by non-medical personnel. 1) Identify candidate routes of injection-free naloxone administration potentially suitable for emergency overdose reversal; 2) consider pathways for developing and evaluating novel naloxone formulations. A three-stage analysis of candidate routes of administration was conducted: 1) assessment of all 112 routes of administration identified by FDA against exclusion criteria. 2) Scrutiny of empirical data for identified candidate routes, searching PubMed and WHO International Clinical Trials Registry Platform using search terms "naloxone AND [route of administration]". 3) Examination of routes for feasibility and against the inclusion criteria. Only three routes of administration met inclusion criteria: nasal, sublingual and buccal. Products are currently in development and being studied. Pharmacokinetic data exist only for nasal naloxone, for which product development is more advanced, and one concentrated nasal spray was granted licence in the US in 2015. However, buccal naloxone may also be viable and may have different characteristics. After 40 years of injection-based naloxone treatment, non-injectable routes are finally being developed. Nasal naloxone has recently been approved and will soon be field-tested, buccal naloxone holds promise, and it is unclear what sublingual naloxone will contribute. Development and approval of reliable non-injectable formulations will facilitate wider naloxone provision across the community internationally.
Conversion into the amorphous form enhances the dissolution of poorly soluble drugs, however the barrier to market for medicines containing an amorphous drug is poor stability. The aim was to produce the amorphous form of a drug within a capsule, without thermal or mechanical stress during manufacture. To facilitate this aim, the mechanism for drug-polymer interaction was explored. Nifedipine and polyvinylpyrrolidone were dissolved in tert-butanol at different drug/polymer ratios. These solutions were dispensed into gelatin capsules and freeze-dried. Differential scanning calorimetry (DSC) & novel FT-IR analysis based on peak symmetry measurements confirmed the absence of crystallinity when polyvinylpyrrolidone exceeded 50%w/w. Capsules containing 10 mg of nifedipine were amorphous and stable for over 3 months at ≈40 °C. Evidence of hydrogen bonding between the N-H group of nifedipine and the C=O group of PVP was observed and this interaction inhibited nifedipine crystallisation. PVP’s high affinity for water and the nifedipine-polymer interaction lead to a significant dissolution rate enhancement. The freeze-dried capsule, 10%w/w nifedipine/PVP, had the highest dissolution rate constant of 0.37 ± 0.05 min−1, and the lowest time to achieve 50% dissolution or t1/2of 1.88 ± 0.05 min. This formulation reached 80% dissolved in less than 6 min whereas the equivalent marketed liquid filled nifedipine capsule took 3 times longer to reach 80% dissolution.
1 March 2019 in International Journal of Nanomedicine
Introduction: Presenting poorly water-soluble drugs as nanoparticles has shown to be an effective technique in enhancing drug dissolution rate, intrinsic solubility, and thus oral bioavailability. Nevertheless, working with nanoparticles introduces many challenges, one of which is their physical instability. Formulating nanoparticles into a solid dosage form may overcome such challenges and thus unlock the potential benefits of nanosizing. Methods: The current work investigates the possibility of developing a novel solid dosage form, with enhanced dissolution rate, whereby nanocrystals (~400 nm) of the class II Biopharmaceutical Classification System drug, glyburide (GBD) were fabricated through combined precipitation and homogenization procedures. Using a novel, but scalable, spraying technique, GBD nanocrystals were loaded onto commonly used tablet fillers, water-soluble lactose monohydrate (LAC), and water insoluble microcrystalline cellulose (MCC). Conventional tableting processes were then used to convert the powders generated into a tablet dosage form. Results: Studies of redispersibility showed considerable preservation of size characteristics of GBD nanocrystals during downstream processing with redispersibility indices of 105 and 118 for GBD–LAC and GBD–MCC, respectively. Characterization by differential scanning calorimetry, powder X-ray diffraction, and scanning electron microscopy showed that the powders generated powders contained nanosized crystals of GBD which adhered to carrier surfaces. Powder flowability was characterized using Hausner ratio (HR) and Carr’s index (CI). GBD–LAC-loaded particles exhibited poor flowability with CI and HR of 37.5% and 1.60, respectively, whilst GBD–MCC particles showed a slightly improved flowability with CI and HR of 26.47% and 1.36, respectively. The novel tablet dosage form met US Pharmacopeia specifications, including drug content, hardness, and friability. Conclusion: Higher dissolution rates were observed from the nanocrystal-based tablets compared to the microsized and commercial drug formulations. Moreover, the novel nanocrystal tablet dosage forms showed enhanced in vivo performance with area under the plasma concentration–time curve in the first 24 hours values 1.97 and 2.24 times greater than that of marketed tablets.
Limited information is known about the storage conditions of medicinal products post-dispensing in Saudi Arabia (SA). The particularly hot and humid climate in the region may lead to the loss of essential performance specifications. To investigate the conditions in which medications are held after being dispensed, and up until administration by households in SA. In addition, storage practices adopted by households in the region, as well as their knowledge and awareness are explored. This study also discusses the opportunity of utilising Time-Temperature Indicators (TTIs) in the pharmaceutical industry in SA as a quality-assurance enhancement solution. A cross-sectional questionnaire targeted at households in SA was designed to explore storage practices, background knowledge and awareness of factors that can influence drug stability. Additionally, temperature and relative humidity mapping of 35 different rooms in various homes and cities in SA, as well as car interiors, was performed. More than 1000 households have participated in this study from all regions of SA. Approximately, 95% have claimed to take part in storing medications at home. First-aid and supplemental purposes were two of the reasons 80.9% have claimed, while 43.2% claimed treatment for chronic conditions. Just over 35% claimed that not knowing how to dispose of medications, is the reason behind their storage. More than 35% of participants could not identify most suitable storage conditions, and >10% were unaware of the effect storage conditions may have on shelf-life. Many were found to store medication in inappropriate areas, liquid dosage forms for example were stored in freezers by more than 3%. Upon monitoring temperatures of all room types, 25ºC was exceeded throughout a 24-hour duration in bathrooms, kitchens and limited use rooms. Temperatures in parked car interiors exceeded 70ºC. A significant percentage of households in SA lacked knowledge and awareness of good storage practices. However, due to high temperatures observed in the region, increasing knowledge and awareness is not enough, as medicinal cabinets with basic temperature control (e.g. designated secure fridge) are needed. Additionally, the use of TTIs to provide consumers with accumulated thermal history may enhance quality-assurance of thermally sensitive products.