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.

Peppermint oil (PO) is the most prominent oil using in pharmaceutical formulations with its significant therapeutic value. In this sense, this oil is attracting considerable attention from the scientific community due to its traditional therapeutic claim, biological and pharmacological potential in recent research. An organic solvent-free and environment-friendly electrohydrodynamic assisted (EHDA) technique was employed to prepared PO-loaded alginate microbeads. The current study deals with the development, optimization, in vitro characterization, in vivo gastrointestinal tract drug distribution and ex-vivo mucoadhesive properties, antioxidant, and anti-inflammatory effects of PO-loaded alginate microbeads. The optimization results indicated the voltage and flow rate have a significant influence on microbeads size and sphericity factor and encapsulation efficiency. All these optimized microbeads showed a better drug release profile in simulated intestinal fluid (pH 6.8) at 2 h. However, a minor release was found in acidic media (pH 1.2) at 2 h. The optimized formulation showed excellent mucoadhesive properties in ex-vivo and good swelling characterization in intestine media. The microbeads were found to be well distributed in various parts of the intestine in in vivo study. PO-loaded alginate microbeads similarly showed potential antioxidant effects with drug release. The formulation exhibited possible improvement of irritable bowel syndrome (IBS) in MO-induced rats. It significantly suppressed proinflammatory cytokines, i.e., interleukin-IL-1β, and upregulated antiinflammatory cytokine expression, i.e., IL-10. It would be a promising approach for targeted drug release after oral administration and could be considered an anti-inflammatory therapeutic strategy for treating IBS.

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This study aimed to develop a carbamazepine (CBZ) sustained release formulation suitable for pediatric use with a lower risk of precipitation. The CBZ was first prepared as sustained release microparticles, and then the microparticles were embedded in alginate beads, and finally, the beads were suspended in a gel vehicle. The microparticles were prepared by a solvent evaporation method utilizing ethyl cellulose as a sustained release polymer and were evaluated for particle size, encapsulation efficiency, and release profile. The beads were fabricated by the dropwise addition of sodium alginate in calcium chloride solution and characterized for size, shape, and release properties. The gel was prepared using iota carrageenan as the gelling agent and evaluated for appearance, syneresis, drug content uniformity, rheology, release profile, and stability. The microparticles exhibited a particle size of 135.01 ± 0.61 µm with a monodisperse distribution and an encapsulation efficiency of 83.89 ± 3.98%. The beads were monodispersed with an average size of 1.4 ± 0.05 mm and a sphericity factor of less than 0.05. The gel was prepared using a 1:1 ratio (gel vehicle to beads) and exhibited no syneresis, good homogeneity, and good shear-thinning properties. The release profile from the beads and from the gel was not significantly affected, maintaining similarity to the tablet form. The gel properties were maintained for one month real time stability, but the accelerated stability showed reduced viscosity and pH with time. In conclusion, CBZ in a gel sustained release dosage form combines the advantages of the suspension form in terms of dosing flexibility, and the advantages of the tablet form in regards to the sustained release profile. This dosage form should be further investigated in vivo in animal models before being considered in clinical trials.

Objective: The principal aim of this study was to identify factors influencing the severity of peripheral diabetic neuropathy pain (PDNP), a symptom of the common neurological complication of diabetes mellitus, and peripheral diabetic neuropathy. Methods:A cross-sectional study was performed using two self-administered questionnaires among subjects recruited from outpatient clinics at Hospital Tengku Ampuan Afzan, Kuantan, Malaysia. The Neuropathic Pain-4 tool was used to evaluate the presence of PDNP, and the Short-Form McGill Pain Questionnaire (MPQ) was used to characterize and determine the severity of PDNP. Sociodemographic and clinical data were collected from the patients.Results: The MPQ indicated that most patients reported experiencing mild pain for all sensory pain descriptors other than throbbing and aching (mostly reported to be moderate) and hot-burning (mostly reported to be no pain). The severity of pain was found to be significantly related to the length of time for which the patients had suffered from diabetes in those patients who had been diagnosed over 10 years previously (p=0.04). Indian patients reported a higher severity of pain overall (p=0.04). No significant relationship was found between pain severity and any of the following factors: Type of diabetes (I or II), gender, smoking status, alcohol consumption, obesity, medication taken, or presence of other diseases. Conclusion:In this study, most patients with PDNP reported the severity of the pain to be "mild." The pain severity may be influenced by a patient's ethnicity and the length of time for which they have suffered from diabetes.

Purpose: To evaluate synergy in the analgesic effects of a combination therapy of carbamazepine (CBZ)

Objective: This study aimed to develop a new, rapid, robust, effective, inexpensive, and accurate UV-Vis method for the quantification analysis of carbamazepine (CBZ) in the carbamazepine-loaded microparticles.Methods: CBZ was encapsulated in ethyl cellulose microparticles by a solvent evaporation method using polyvinyl alcohol (PVA) as a stabilizer. Methanol was used to dissolve CBZ followed by dilution with distilled water as diluent. CBZ drug, excipients, and microparticles were subjected to specificity, solution stability, linearity, precision and accuracy to confirm and ensure the validity of this method.Results: The results showed no interference from the excipients in the selected wavelength 286 nm. It was exhibited linearity in the range 2-12 μg/ml with R2 = 0.9992. CBZ solution was stable during 24 h. Accuracy and precision were within the accepted limits (100±2%). All results were in accordance to the ICH-Q2 guideline.Conclusion: As a conclusion, CBZ could be quantified from loaded EC microparticles using UV-Vis spectrophotometer at 286 nm. Therefore, this method can be used for the quantification analysis of CBZ in CBZ-loaded microparticles can be utilized also as an alternative method to calculate CBZ in different dosage forms.

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