Preparation and Evaluation of Surface Modified Lactose Particles for Improved Performance of Fluticasone Propionate Dry Powder Inhaler
| Autor: | Samad Abdul, Rajesh R Jain, Mala D Menon, PS Soni, Hegde Darshana, DJ Singh, Rajiv V. Gaikwad |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Pulmonary and Respiratory Medicine
Time Factors Passivation Surface Properties Chemistry Pharmaceutical Pharmaceutical Science Lactose Polyethylene glycol Crystallography X-Ray Microscopy Atomic Force Fluticasone propionate Excipients chemistry.chemical_compound Drug Delivery Systems Drug Stability medicine Surface roughness Pharmacology (medical) Magnesium stearate Aerosols Drug Carriers Chromatography Calorimetry Differential Scanning Temperature Dry Powder Inhalers Humidity Equipment Design Poloxamer Dry-powder inhaler Bronchodilator Agents chemistry Chemical engineering Fluticasone Powders Rheology Powder Diffraction medicine.drug |
| Zdroj: | Journal of Aerosol Medicine and Pulmonary Drug Delivery. 28:254-267 |
| ISSN: | 1941-2703 1941-2711 |
| DOI: | 10.1089/jamp.2014.1146 |
| Popis: | Dry powder inhalers (DPI) are generally formulated by mixing micronized drug particles with coarse lactose carrier particles to assist powder handling during the manufacturing and powder aerosol delivery during patient use.In the present study, surface modified lactose (SML) particles were produced using force control agents, and their in vitro performance on dry powder inhaler (DPI) formulation of Fluticasone propionate was studied. With a view to reduce surface passivation of high surface free energy sites on the most commonly used DPI carrier, α- lactose monohydrate, effects of various force control agents such as Pluronic F-68, Cremophor RH 40, glyceryl monostearate, polyethylene glycol 6000, magnesium stearate, and soya lecithin were studied.DPI formulations prepared with SML showed improved flow properties, and atomic force microscopy (AFM) studies revealed decrease in surface roughness. The DSC and X-ray diffraction patterns of SML showed no change in the crystal structure and thermal behavior under the experimental conditions. The fine particle fraction (FPF) values of lactose modified with Pluronic F-68, Cremophor RH 40, glyceryl monostearate were improved, with increase in concentration up to 0.5%. Soya lecithin and PEG 6000 modified lactose showed decrease in FPF value with increase in concentration. Increase in FPF value was observed with increasing concentration of magnesium stearate. Two different DPI devices, Rotahaler(®) and Diskhaler(®), were compared to evaluate the performance of SML formulations. FPF value of all SML formulations were higher using both devices as compared to the same formulations prepared using untreated lactose. One month stability of SML formulations at 40°C/75% RH, in permeable polystyrene tubes did not reveal any significant changes in FPF values.SML particles can help in reducing product development hindrances and improve inhalational properties of DPI. |
| Databáze: | OpenAIRE |
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