Dissertation > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > General issues > Pharmaceutical Process

Preparation and Evaluation of Nebulizer of Betamethasone Dipropionate Nanosuspension

Author SongShuang
Tutor JinQiFeng
School Liaoning Normal University
Course Polymer Chemistry and Physics
Keywords Nanosuspension Betamethasone dipropionate High Pressure Microfluidization Pulmonary drug delivery
CLC TQ460.6
Type Master's thesis
Year 2013
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Pulmonary delivery has shown to be a promising non-invasive approach for thetreatment of local and systemic diseases. The deposition site of inhaled particles isdetermined by their aerodynamic diameters, and only those particles less than2microns canbe delivered to the alveolar regions. The traditional micronization methods of jet millinggenerate big particles and strong particulate cohesion, which bring about poor aerosolisationperformance and reduced deposition in the lower respiratory tract.This paper reported a novelapproach of high pressure microfluidization(HPM) to prepare betamethasonedipropionate(BDP) nanosuspension for inhalation. The suspension of HPM-treated BDPnanosuspension were subsequently aerosolized using ultrasonication for inhalation, and thein-vitro deposition was further investigated.Objective: Preparation of betamethasone dipropionate nanosuspension with optimumformulation and process conditions for pulmonary delivery by HPM.Method:1.The choice of surfactant,treatment pressures and treatment numbers were evaluated bythe particle morphology,particle size and polydispersity index with single influence factor.Sooptimum formulation and process conditions of betamethasone dipropionate nanosuspensionwill be determined.2.The quality evaluation of betamethasone dipropionate nanosuspension: the particlemorphology of nanosuspension were observed by a scanning electron microscopy (SEM,Hitachi S-4700, Japan).For further particle size distribution and Zeta potential were measured3. The stability test of betamethasone dipropionate nanosuspension: the variation ofparticle size distribution of different betamethasone dipropionate nanosuspensions weremeasured by particle size analyzer after placed in room temperature for20days.4. Pulmonary deposition efficiency of betamethasone dipropionate nanosuspension: Toinvestigate the property in vitro deposition, the next generation pharmaceutical impactor(NGI)was used to simulate lung and concentration of betamethasone dipropionate nanosuspensionwere determined by high performance liquid chromatography (HPLC).Result:1. Optimum formulation and process conditions: the concentration of pre-treatedbetamethasone dipropionate suspension was120μg/mL containing0.5‰w/v SLS.Pre-treated suspension was treated under pressure of180MPa and repeated30numbers by high pressure microfluidization, in order to prepara betamethasone dipropionatenanosuspension.2.The mean particle size of betamethasone dipropionate nanosuspension was a value of(644±3.4) nm,and the value of polydispersity index was0.26,and the value of zeta potentialwas (-59.3±0.38) mV.3. Betamethasone dipropionate nanosuspensions were placed for20days with a valueof the Mean particle size of betamethasone dipropionate nanosuspension was (699.1±28.1)nm after placed in room temperature for20days,4. The results of the deposion rate in NGI was61.39%.The percentage of each part inNGI was35.78%,1.69%,1.14%,5.59%,0.96%,2.53%,50.53%,0.85%,0.49%,0.44%.Conclusion: The prepared BDP nanosuspension showed small particle size with uniformpolydispersity index, and can form a stable suspension for20days. The BDP suspension wasnebulized to generate aerosols for the in vitro deposition in the Next Generation Impactorand the results showed a great deposition rate suggesting the nanoparticles were great suitablefor inhalation. Using high pressure microfluidization preparation two betamethasonedipropionate nanosuspension small particle size, polydispersity index is smaller, place20days remained stable. Be used for inhalation can get better lung deposition efficiency. Theadvantages of The technique are simple operation, short duration of action, and is suitable forindustrial production. Moreover, it provides the basis for the preparation of other insolubledrugs.

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