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The aim of this study was to investigate the use of a three-fluid atomising nozzle in a lab-scale spray dryer for the production of dry powders intended for pulmonary delivery. Powders were composed of salbutamol sulphate and theophylline in different weight ratios. The three-fluid nozzle technology enabled powders containing a high theophylline content to be obtained, overcoming the problems associated with its relatively low solubility, by pumping two separate feed solutions (containing the two different active pharmaceutical ingredients (APIs)) into the spray dryer via two separate nozzle channels at different feed rates. The final spray-dried products were characterized in terms of morphology, solid-state properties and aerosolization performance, and were compared with an equivalent formulation prepared using a standard two-fluid atomising nozzle. Results confirmed that most of the powders made using the three-fluid atomising nozzle met the required standards for a dry powder inhaler formulation in terms of physical characteristics; however, aerosolization characteristics require improvement if the powders are to be considered suitable for pulmonary delivery.

[...]the present research was mainly focused on the development and evaluation of paediatric oral soft jellies of salbutamol sulphate that would be patient friendly and provide faster onset of action to relieve the symptoms of asthma immediately. [...]aspartame, sodium citrate, preservatives and orange flavour were added under continued stirring at 60 °C. The final weight was adjusted with purified water, mixed, transferred to polyethylene molds, sealed and allowed to cool at room temperature (25 °C ± 5 °C) to form a jelly like texture. The medicated jelly was squeezed out from the polyethylene plastic bag by making a cut of uniform size on the bag and viscosity had been measured using spindle number LV4 at the rotation of 50 RPM at 25 °C ± 1 °C. The viscosity measurements were made in triplicate using fresh samples each time. pH: In vitro dissolution was studied using type II USP dissolution test apparatus (Lab India Analytical Instruments Pvt. Ltd., Thane, India) in phosphate buffer solution, pH 6.8 (900 ml, 37 °C ± 0.5 °C) dissolution medium at 50 rpm. 5 ml samples were withdrawn at 5, 10, 15, 20, 25, 30, 40, 50 and 60 min using a pre-filter.

Purpose Demonstrate the applicability of a novel particle-based technology for the development of suspensions of small polar drugs and biomolecules in hydrofluoroalkane (HFA) propellants for pressurized metered-dose inhalers (pMDIs). Materials and Methods Emulsification diffusion was used to prepare core–shell particles. The shell consisted of oligo(lactide) grafts attached onto a short chitosan backbone. The active drug was arrested within the particle core. Colloidal Probe Microscopy (CPM) was used to determine the cohesive forces between particles in a model HFA propellant. The aerosol characteristics of the formulations were determined using an Anderson Cascade Impactor (ACI). Cytotoxicity studies were performed on lung epithelial and alveolar type II cells. Results CPM results indicate that particle cohesive forces in liquid HFA are significantly screened in the presence of the polymeric shell and correlate well with the physical stability of suspensions in propellant HFA. The proposed formulation showed little or no cytotoxic effects on both Calu-3 and A549 cells. Conclusions Core–shell particles with a shell containing the lactide moiety as the HFA-phile showed excellent dispersion stability and aerosol characteristics in HFA-based pMDIs. This is a general strategy that can be used for developing novel suspension pMDIs of both small polar drugs and large therapeutic molecules.