A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days. OBJECTIVE: The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. METHODS: The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. RESULTS: Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported. CONCLUSION: The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

A Novel Simulated Moving Plug Flow Crystallizer (SM-PFC) for Addressing the Encrustation Problem: Simulation-Based Studies on Cooling Crystallization.

The plug flow crystallizer (PFC) is a promising candidate in the move toward adoption of continuous manufacturing in the pharmaceutical industry. However, a major concern for the smooth running of PFCs is the encrustation or fouling which can result in blockage of the crystallizer or unplanned shutdown of the process. In order to address this problem, simulation studies are carried out to explore the feasibility of a novel simulated-moving PFC (SM-PFC) configuration that can run uninterrupted in the presence of heavy fouling without compromising the desired critical quality attributes of the product crystals. The key concept of the SM-PFC lies in the arrangement of the crystallizer segments where a fouled segment is isolated, while a clean segment is simultaneously brought online avoiding fouling-related issues and maintaining uninterrupted operation. The inlet and outlet ports are also changed appropriately so that the whole operation mimics the movement of the PFC. The simulation results suggest that the proposed PFC configuration could be a potential mitigating approach for the encrustation problem enabling continuous operation of the crystallizer in the presence of heavy fouling while maintaining the product specifications.

A Comparative Study of Coupled Preferential Crystallizers for the Efficient Resolution of Conglomerate-Forming Enantiomers.

The separation of enantiomers is of great importance due to their possible differences in therapeutic properties. Preferential crystallization in various configurations of coupled batch crystallizers is used as an attractive means to separate the conglomerate-forming enantiomers from racemic mixtures. However, the productivity of such batch processes can be limited by the nucleation of the counter enantiomer and consumption of the supersaturation. In this work, a recently proposed process configuration, which uses coupled mixed suspension mixed product removal (MSMPR) with liquid phase exchange, is investigated by simulation studies. A detailed study on the effect of process parameters (e.g., feed flow rate, seed mass, and liquid phase exchange) on the productivity and yield of the coupled MSMPR has been presented. Moreover, a comparison of various coupled crystallizer configurations is carried out. It is shown through simulation studies that the productivity of the enantiomeric separation can be significantly improved compared to the previously proposed batch modes when the continuous configuration is used. The effect of nucleation kinetic parameters on the performances of various crystallizer configurations is studied as well. A set of coupled population balance equations (PBEs) was used to describe the evolution of the crystal phase of the both enantiomers in each vessel. These equations were solved numerically using the quadrature method of moments. The insights obtained in this study will be useful in the process design of coupled crystallizer systems.

Haemangioma of cheek different presentation and management.

Though haemangioma of cheek is not a very uncommon entity, here we are presenting a case series of four such cases of haemangioma cheek of completely different presentation. One of which is classical maxillary haemangioma and the rest of the others have different and unusual presentations. They all have different radiological features and were managed successfully by different surgical approaches without any recurrence.

Endonasal dacryocystorhinostomy with mucosal flaps: our experience.

The endoscopic dacryocystorhinostomy (DCR) has distinct advantage over external DCR. There is no ugly scar on the face, less intraoperative bleeding, it is a daycare procedure and patient is discharged on the same day evening. Endoscopic DCR is considered to be a superior alternative technique to the conventional external DCR. Patients diagnosed with nasolacrimal duct obstruction between Jan 2009 and Jan 2011 were included in the study. One hundred and twenty endo DCR were performed with conventional 'cold steel' instruments. The technique involved complete exposure and marsupialization of the lacrimal sac. The surgical technique involved the creation of nasal mucosal and large posterior lacrimal flaps at the medial lacrimal sac wall and the two flaps were placed in close apposition. Success was defined as complete resolution of epiphora and a patent lacrimal system, evaluated by lacrimal irrigation and endoscopy, 1 year postoperatively.

Unusual clinical presentation of nasopharyngeal carcinoma--report of 3 cases.

Among head and neck cancers, nasopharyngeal carcinoma has the poorest prognosis because of the primary site's proximity to the base of the skull and multiple vital structures. The presenting symptoms are generally being nasal obstruction, epistaxis, painless cervical lymphadenopathy, etc. Some patients apart from these usual presentations, report with some unusual presentations. Here in this series, 3 patients were presented, one with distant metastasis, one with upper airway obstruction and another with complete visual loss and difficulty in swallowing. They all were treated with combination chemotherapy and external beam radiation.