Encapsulation of Black Seed Oil in Alginate Beads as a pH-Sensitive Carrier for Intestine-Targeted Drug Delivery: In Vitro, In Vivo and Ex Vivo Study.

Black seed oil (BSO) has been used for various therapeutic purposes around the world since ancient eras. It is one of the most prominent oils used in nutraceutical formulations and daily consumption for its significant therapeutic value is common phenomena. The main aim of this study was to develop alginate-BSO beads as a controlled release system designed to control drug release in the gastrointestinal tract (GIT). Electrospray technology facilitates formulation of small and uniform beads with higher diffusion and swelling rates resulting in process performance improvement. The effect of different formulation and process variables was evaluated on the internal and external bead morphology, size, shape, encapsulation efficiency, swelling rate, in vitro drug release, release mechanism, ex vivo mucoadhesive strength and gastrointestinal tract qualitative and quantitative distribution. All the formulated beads showed small sizes of 0.58 ± 0.01 mm (F8) and spherical shape of 0.03 ± 0.00 mm. The coefficient of weight variation (%) ranged from 1.37 (F8) to 3.93 (F5) ng. All formulations (F1-F9) were studied in vitro for release characteristics and swelling behaviour, then the release data were fitted to various equations to determine the exponent (ns), swelling kinetic constant (ks), swelling rate (%/h), correlation coefficient (r2) and release kinetic mechanism. The oil encapsulation efficiency was almost complete at 90.13% ± 0.93% in dried beads. The maximum bead swelling rate showed 982.23 (F8, r2 = 0.996) in pH 6.8 and the drug release exceeded 90% in simulated gastrointestinal fluid (pH 6.8). Moreover, the beads were well distributed throughout various parts of the intestine. This designed formulation could possibly be advantageous in terms of increased bioavailability and targeted drug delivery to the intestine region and thus may find applications in some diseases like irritable bowel syndrome.

Drug-drug Interaction-related Uncontrolled Glycemia.

CONTEXT: The literature of drug-drug interaction (DDI)-related uncontrolled causality, and preventability of DDI-induced UCG (HbA1c >7%) in outpatients glycemia (UCG) among outpatients with Type 2 diabetes mellitus is still limited. AIMS: The aim of this study is to identify the prevalence, mechanism, severity, with Type 2 diabetes. SETTINGS AND DESIGN: A cross-sectional study was conducted in Penang General Hospital. METHODS: A computerized system for DDI checking was used to assess the severity and mechanism of DDIs. Drug interaction probability scale was used to evaluate the likelihood of DDIs. Preventability of DDIs has been determined by the instrument of Hallas. The UCG prevalence related to DDIs was further assessed. STATISTICAL ANALYSIS USED: SPSS 21.00 was used in this study. RESULTS: From 425 outpatients with HbA1c% test, their mean age was 58.7 ± 12.8 years. Only 225 (52.9%) cases had controlled glycemia while 200 (47.1%) cases with UCG. They had multiple comorbidities, with a mean number of 3.8 ± 2.2/patient and often prescribed with multiple medications, with a mean number of 6.33 ± 4.67/patient. It has been detected that 86 DDIs causing UCG in 46 patients (23%) with range of (1 - 4) DDIs per patient. Drugs with DDI-induced UCG were as follows: diuretics (79%), salbutamol (9.2%), cortisones (5.8%), and others (6%). The majority of these DDIs were categorized as possible (77.9%) and preventable (37%). CONCLUSION: Nearly one-quarter of UCG was induced by DDIs; most of these DDIs are possible, and more than one-third are preventable. It was concluded that thiazide diuretics have the highest prevalence of DDI-related UCG.