PubMed · 3112894
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M Radermecker. 1987-05-15. [Aerosol therapy].. https://pubmed.ncbi.nlm.nih.gov/3112894/
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Using high sensitivity differential scanning calorimetry (HSDSC), the phase transitions of dimyristoylphosphatidylcholine (DMPC) liposomal bilayers and their interaction with the model steroid beclomethasone dipropionate (BDP) were found to be dependent on the method of liposome manufacture. Ethanol-based proliposomes produced liposomes having no phospholipid pretransition, a main transition of high enthalpy and a low onset temperature, and a very low incorporation of the steroid (maximum 1 mol%). This was attributed to an alcohol-induced interdigitation of the bilayers, which was not apparently reversed by flushing the liposome dispersion with nitrogen in an attempt to remove ethanol. For liposomes manufactured by thin film or particulate-based proliposome methods, 1-2.5 mol% steroid was optimal for incorporation within bilayers, although the nature of the steroid interaction with the bilayers differed between the two methods. For liposomes manufactured by the thin film method, a higher steroid concentration resulted in a broadened main transition and a reduced melting cooperativity. This suggests that BDP formed separate domains within the bilayers which caused non-ideal mixing and phase separation at 5 mol% steroid. This observation was absent for liposomes generated from particulate-based proliposomes, indicating separate steroid domains were not formed and subsequent non-ideal mixing and phase separation did not occur. In addition, liposomes generated from particulate-based proliposomes showed reduced pretransition and main transition enthalpies. These differences were attributed to the employment of sucrose to manufacture the particulate-based proliposomes. This study has shown that the thermal behaviour of liposomes and their interaction with beclomethasone dipropionate were dependent on the method of liposome manufacture. Moreover, particulate-based proliposomes may provide a reasonable alternative to the conventional thin film method in producing liposomes incorporating this steroid.
This study compared the in vitro performance of two inhaled corticosteroid products for nebulisation, Pulmicort Respules(budesonide 0.5 mg/mL) and Clenil) per Aerosol (beclomethasone dipropionate (BDP) 0.4 mg/mL). Each product was used in combination with three different nebulisers (2 mL/test, 5 min run time) and the dose to the lungs was determined according to standard methods. The shape of the suspended particles in each product was studied using scanning electron microscopy (SEM). Overall, a higher fine particle dose was achieved with Pulmicort Respules versus Clenil per Aerosol, with estimated dose to the lungs of 8-14 and 3-6% of nominal dose, respectively. SEM showed that budesonide particles were small, typically approximately 2-3 microm in diameter, whereas those of BDP were needle-shaped and up to approximately 10 microm long. The more favourable particle shape and size of suspended budesonide may explain the higher fine particle dose with Pulmicort Respules versus Clenil per Aerosol.
The product performance of a series of solution Metered Dose Inhalers (MDIs) were evaluated using the TSI Model 3306 Impactor Inlet and the Andersen Cascade Impactor (ACI). The goal of the study was to test whether the fine particle and coarse particle depositions obtained using the Model 3306 were comparable to those results obtained by ACI testing. The analysis using the Model 3306 was performed as supplied by the manufacturer as well as with 20 cm and 40 cm vertical extensions that were inserted between the Model 3306 and the USP Inlet. Nine different solution formulations were evaluated. The drug concentrations ranged from 0.08 to 0.8% w/w and the ethanol cosolvent concentration varied between 5 and 20% w/w. In general, it was found that good correlations between the two instruments were obtained. However, for formulations containing 10-20% w/w ethanol it is shown that an extension fitted to the Model 3306 yielded an improved correlation to those obtained from the ACI.