A new approach to improve the yield in the production of slow release oral dosage forms

OBJECTIVE: The objectives of the study were to analyse a new improved method used for the production of pellets for the manufacture of solid oral dosage forms and to compare the new method with a method previously used and studied by Bartolo in 2011. METHOD: The parameters recorded during the production of slow release pellets were collected from the Batch Manufacturing and Instructions Record (BMIR). A total of eight batches were monitored and statistically analysed, using One Way Anova, to determine whether there is a statistically significant difference between the parameters of each batch. The mean surface rating of the pallets and the yield of the active pharmaceutical ingredient (API) obtained for the monitored batches, were statistically compared to those obtained in the previous study using the Independent Sample t-test. Statistical analysis was conducted using SPSS® version 20. KEY FINDINGS: Fine tuning in the control of all parameters during the manufacturing of different batches, even within established range, improves the yield of the final product. A statistically significant improvement in the mean pellets’ surface rating (p-value 0.004) and percentage yield of API (p-value 0.030) was observed in batches analysed in this study (4.75% and 94.09% respectively) when compared to batches analysed in the previous study (3.82% and 92.43% respectively) in 2011. The batches analysed during this study achieved the required dissolution rate after the application of the second slow release coating as opposed to the batches analysed in the earlier study, which required the application of a third slow release coating. CONCLUSION: The increase in the yield of API and improvement in the surface rating of the produced pellets implies that the new approach used for the production of slow release pellets is better and improved.peer-reviewe

A simple HPLC-UV method for the determination of clindamycin in human plasma

This study describes a simple high performance liquid chromatographic (HPLC) method for the determination of clindamycin in plasma. Analysis was carried out using a Varian® Pro Star HPLC unit equipped with an online degasser. A reversed-phase ACE® C18 column of dimensions 250x4.6mm, particle size 5μm was used. The mobile phase was made up of 0.02M disodiumhydrogen phosphate buffer (pH of 2.9) and acetonitrile at a ratio of 71:29 v/v, running through the column at a flow rate of 1.5ml/min and with ultraviolet (UV) detection set at a wavelength of 195nm. Clindamycin was separated from plasma proteins by protein precipitation with ice cold acetonitrile. Clindamycin and the internal standard phenobarbitone eluted after 3.96 and 7 minutes respectively. The method was validated for linearity in the working concentration range of 0.5-20μg/ml. Linearity was observed with a coefficient of determination (r2) of 0.990. The recoveries obtained were all above 82% and the limit of quantification and limit of detection were 0.2μg/ml and 0.1μg/ml respectively.peer-reviewe

The combined effects of pH and acetonitrile composition on the separation of two lincosamide antibiotics

Objective: Reversed-phase chromatography has become the method of choice to separate compounds that are similar in structure to each other. Selectivity, resolution and retention time can be improved by controlling different variants. The choice of the mobile phase for the analysis is important to achieve the best chromatographic results. The retention time, shape and width of chromatographic peaks are dependent on the buffer pH and also on the amount of organic modifier in the mobile phase. The aim of this study is to separate two lincosamide antibiotics-clindamycin phosphate and lincomycin hydrochloride using different mobile phases. Method: Each mobile phase was made up of a phosphate buffer and acetonitrile. The mobile phases had different buffer pHs and different percentage compositions of acetonitrile. Analysis was performed using nine different mobile phases to observe which of them gave the best results in terms of resolution, retention time, and peak shape. Results: The best results were given when using a mobile phase having 30% acetonitrile with a buffer pH of 3.0. Conclusion: This work shows the importance of adjusting the amount of the organic modifier in the mobile phase together with the buffer pH. The amount of organic modifier should not be too large as to cause loss of resolution between two neighboring peaks and not too small so as to result in too long of a retention time. The pH should be chosen to have the greatest percentage of ionized or unionized species of the analyte of interest present.peer-reviewe

IMPLICATIONS OF MOBILE PHASE COMPOSITION AND PH ON THE CHROMATOGRAPHIC SEPARATION OF AMITRIPTYLINE AND ITS METABOLITE NORTRIPTYLINE

Objective: Separation of tricyclic compounds sets the keystone for determining parent drug to metabolite concentration ratios and analysing impurities. The combined effects of acetonitrile composition and pH of the mobile phase on the separation of amitriptyline and nortriptyline by reversed-phase high-performance liquid chromatography (RP-HPLC) are presented.Methods: A series of RP-HPLC triplicate runs were carried out using acetonitrile and a phosphate buffer as the mobile phase and a Kinetex® C18 LC Column as the stationary phase using an Agilent 1260 Infinity Series® II liquid chromatography system with UV/visible detection. The stationary phase, column temperature, injection volume and flow rate were kept unchanged during analysis. Mobile phase composition and pH were varied to observe impact on peak shape, resolution and retention time, taking into consideration green analytical chemistry aspects.Results: Optimal chromatographic outcomes were achieved when using the mobile phase made up of 35% acetonitrile and 65% buffer at a pH of 5.6. These conditions resulted in nortriptyline and amitriptyline eluting at 4.66 min and 5.92 min respectively. Increasing the organic modifier content of the mobile phase to 40% completed separation within a run time of 4 min with comparable resolution. The 2 min gained by increasing 5% acetonitrile may not be justified due to potential implications on greening laboratory practices.Conclusion: Reversed-phase chromatography embodies a simple method for the separation of compounds that are similar in structure. Attuning the percentage of organic modifier and buffer pH provides acceptable retention times, without compromising resolution between neighbouring peaks

A comparison of European and Japanese pharmaceutical regulations : drug information and over the counter products perspective

Japan and EU regulatory bodies historically have in principle accepted regulations issued by each other and mutually agreed on the requirements and regulatory processes to provide drugs in a timely manner while ensuring safety, quality, and efficacy. However, there are still a number of pharmaceutical regulations in Japan and the EU which are different.peer-reviewe

Knowledge and application of green practices within community pharmacy

The leaching of active pharmaceutical ingredients within the environment can be reduced if greener practices are adopted throughout the lifecycle of pharmaceutical products. Being at the forefront of healthcare systems, pharmacists and the pharmaceutical workforce have an important role in reducing the impact of pharmaceutical related activities.peer-reviewe

Evaluation of virtual pharmacy students' research symposium

The Annual Pharmacy Symposium organised by the Department of Pharmacy, University of Malta brings together academic staff, undergraduate and postgraduate students, collaborators and stakeholders to discuss outcomes of student research projects as oral and poster presentations. The 2021 Pharmacy Symposium was held online for the first time via the Zoom platform due to restrictions brought about by the COVID-19 pandemic.peer-reviewe

Evaluation of educational seminar on the analysis of pesticides in cannabis

There is a need for sensitive, accurate and efficient methods of analysis to determine amounts of pesticides in herbal products intended for medicinal use, such as cannabis. An educational seminar on the analysis of pesticides in cannabis was organised for scientists and healthcare professionals involved in pharmaceutical analysis, evaluation of herbal medicinal products and patient care. During the seminar, reflections on standardised methods of analysis of pesticides that could be adopted by the industry were discussed to support services development that ensure quality, efficacy and safety of herbal medicinal products.peer-reviewe

A three-year post-graduate Doctorate in Pharmacy course incorporating professional, experiential and research activities : a collaborative innovative approach

Background A three-year post-graduate international Doctorate in Pharmacy collaborative course, was launched by the Department of Pharmacy, University of Malta in collaboration with the College of Pharmacy, University of Illinois at Chicago.Aim and rationale To demonstrate that the professional Doctorate in Pharmacy (i) fits the requirements of a Level 8 degree according to the Bologna process, (ii) helps graduates develop competencies and attributes in proficiency in clinical and professional aspects, (iii) has a research component that provides the right level of abilities to participate in research initiatives and to interpret research outcomes, (iv) enables graduates to obtain leadership characteristics.Approach The unique characteristics of the course were evaluated through an outcomes result-oriented measurement. Leadership aspects were measured through policies and strategies presented by students and graduates.Outcomes i) course is in line with the Bologna declaration, ii) research work shown in the dissertation satisfied competencies required iii) research abilities have been examined through a third party and found to be compliant with acquiring of concepts in the design, carrying out, assessment of outcomes and interpretation of results of the research study carried out by each student, and iv) leadership characteristics were shown by the positions taken up by the graduates and early outcomes from these positions.Conclusion Learning activities enable development of professionals able to merge scientific and practice aspects in the evaluation of innovative therapies, the use of medicines and patient monitoring, and in pharmaceutical policy development and regulation. Leadership positions taken up by graduates point to the acquisition of leadership skills by graduates.Next Steps The authors are happy to extend collaboration for this model to be adapted by other institutions for the curricular development entailed in this programme to enhance and improve an innovative aspect in the evolvement of the pharmacy profession on the international scenario.peer-reviewe

Influenza and COVID-19 vaccine hesitancy in pharmacists and pharmacy students

BACKGROUND: In the COVID-19 pandemic, vaccination was identified as being of significant importance to prevent virus spread and to move towards re-introducing normality in everyday life. As the influenza season approached in autumn 2020, the importance of the influenza vaccine was highlighted as a mitigation strategy to limit the consequences and risk of co-infection with the influenza virus and COVID-19. The aim of the study was to evaluate the degree of hesitancy of pharmacists and pharmacy students towards influenza and COVID-19 vaccines in autumn 2020.METHODS: A questionnaire was developed and disseminated online to Maltese pharmacists and pharmacy students to evaluate influenza and COVID-19 vaccine hesitancy.RESULTS AND CONCLUSION: A total of 136 participants took part in the study where 54% (n=73) were pharmacists and 46% (n=63) were students. A statistically significant increase in the number of participants who intended to take the influenza vaccine in the current year compared to the number of participants who took the vaccine in the previous year was observed in both student and pharmacist cohorts. Fifty-seven percent (n=78) of participants were likely to take the COVID-19 vaccineonce available. Reasons for COVID-19 vaccine hesitancy at baseline (prior to COVID-19 vaccines being available) included potential long term side-effects (77%), lack of knowledge (54%) and accelerated process used for the approval of the vaccine (69%).peer-reviewe