Difficulty in instilling eyedrop is a concern for it may cause a progression of blindness in glaucoma patients. Early depletion of eyedrop before the next scheduled medication refill is a common issue faced by patients, resulting in poorer compliance to the therapy. Hence, we hypothesize that the lack of drop volume consistency is due to the eye drop bottle-related mechanics during drop instillation. This study aims to select the best bottle designs by examining drop volume consistency during drop instillation. Ten eyedrop bottles of different volumes were filled with 2.5 mL purified water. Next, the drop uniformity test was performed by expelling 10 droplets by holding the bottle vertically and weighing with an analytical balance. Based on the outcome, bottle C, which demonstrated high drop consistency with low percentage standard deviation and near-linear regression, was chosen as the eyedrop container for Latanost® 0.005% w/v eye drops. Using bottle C, the drop volume of Latanost® was estimated at 25.30 ± 1.87 μL. A 2.5 mL latanoprost solution can yield approximately 99.36 ± 7.52 drops per bottle. Besides that, the design of the eyedrop nozzle could determine the consistency of medication delivery. This report could better inform prescribers and patients in predicting the course of treatment. The selection of the right design of container closure system with a consistent drop delivery could significantly address the issue of early depletion of eyedrop before the next scheduled medication refill and difficulty in instilling eyedrop in glaucoma patients. This helps to improve medical treatment compliance in glaucoma patients

Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 mg tablet formulation. A dissolution study was conducted to optimize the formulation process before evaluating physical changes in the active pharmaceutical ingredient and the formulated product. Methods: This was a randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, two-way crossover, truncated bioequivalence study involving a washout period of ten days. A total of 26 healthy male volunteers were recruited. The pharmacokinetic profile of the test formulation was compared with the reference formulation. Results/Discussion: The pharmacokinetic parameters of ETO were calculated based on the plasma drug concentration-time profile using non-compartmental analysis to determine its safety profile and tolerability. The Test/Reference (T/R) ratio of ETO was 104.36% (90% confidence interval (CI): 98.30%–110.80%) for area under curve (AUC)0-72 while the T/R ratio of maximum concentration (Cmax) was 101.39% (92.15%–111.56%). The 90% CI of the Cmax and AUC0-72 of ETO were within acceptable bioequivalence limits of 80%–125%. All values were within the predetermined limits of the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines. Conclusion: The test formulation was found to be bioequivalent with respect to the reference drug, according to ASEAN bioequivalence guidelines.

In recent years there has been a rapid growth of the halal pharmaceutical industry, especially in the supply chain of solid oral dosage forms of medication. This article outlines aspects of the Halal Management System (HMS) in the development and production of halal pharmaceuticals. It explains the needs and requirements of HMS and identifies the challenges faced in implementation. The article outlines aspects of executions and hurdles encountered when standardizing halal certifi cation. The article also highlights the need for systematic traceability systems and effective product recall mechanisms to ensure adherence to halal requirements. It also highlights the grey areas for halal in terms of pharmaceutical manufacture that are brought about by use of non-halal raw materials, e.g. alcohol, gelatine, glycerin, lecithin, glutamic acid and stearates.