Development of meloxicam potassium-containing co-spray-dried inhalation powder with sodium stearate

Pulmonary drug delivery (PDD) has potential for both local and systemic therapy. Our research group is focus- ing on the development of dry powder inhalation (DPI) systems for PDD due to their beneficial properties. Although there is not yet a marketed inhalation product for non-steroidal anti-inflammatory drugs (NSAIDs), their therapeutic use in sev- eral lung diseases is well established and successful DPI developments have been performed with them. Sodium stearate (NaSt) is a promising excipient for DPI development, but its role in NSAIDs has not yet been investigated. Thus, the aim was to study DPI samples produced by co-spray-drying, applying meloxicam potassium (MXP) as an NSAID drug, and different concentrations (0-2 w/w%) of NaSt. Physicochemical investigations, in vitro lung deposition, and in vitro drug release measurements were performed. It can be stated that co-spray-drying of MXP with NaSt resulted in remarkable morphological differences by increasing the concentration of NaSt, which had a positive effect on cohesive work. Further- more, applying of NaSt accelerates the dissolution in simulated lung fluid (SLF). NaSt as excipient has a future for the formulation of the DPI systems because there are in the development focus the attaintment of the higher FPF values and improvement of dissolution in SLF

Stability study of nasal powder formulation containing nanosized lamotrigine

Drug administration through the nose offers great possibilities which have been discovered in the past few decades. Besides the most known local effect, systemic and central nervous system effect is also available, the administration is non-painful and the degradation effect of the gastrointestinal tract can be avoided. Amongst the nasal formulations, powders have become more popular as their stability is favorable compared to the liquid formulations and a higher doses can be administered in powder form. The quality insurance and stability of the products in the pharmaceutical field have gained considerable attention in the last decades. Due to this fact, the aim was to execute a long-term stability study of a previously developed, nanosized lamotrigine (LAM) containing nasal powder (NP) formulation. The results of the stability test showed that the NP formulation preserved its key properties (particle size, morphology, structure and in vitro drug release) after 6 months of storage

Electrospun nanofiber-based niflumic acid capsules with superior physicochemical properties

The aim of this study was to assess whether nanofibrous drug mats have potential as delivery systems for poorly water-soluble drugs. Amorphous nanofiber mats from a model poorly water-soluble active pharmaceutical ingredient (API), niflumic acid, together with the polymer excipient, polyvinyl pyrrolidine, were prepared by nozzle-free electrospinning. This technique offers a scalable way for drug formulation, and by increasing the surface area of the drug, the dissolution rate and therefore bioavailability of the API can be improved. In this study, both the amount of the dissolved active ingredient and the dissolution kinetics has been improved significantly when the nanofibrous mats were used in the drug formulation. A 15-fold increase in the dissolved amount of the produced amorphous niflumic acid nanofiber was observed compared to the dissolved amount of the raw drug within the first 15 minutes. Capsule formulation was made by mixing the electrospun nanofibers with a microcrystalline cellulose filler agent. When comparing the dissolution rate of the capsule formulation on the market with the nanofibrous capsules, a 14-fold increase was observed in the dissolved drug amount within the first 15 minutes