Pembentukan granul berasaskan asid mefenamik dan polietilena glikol (PEG) menggunakan teknik pengranulan tekanan terayun dalam turus terbendalir

Ab Ghani Salinda, Noor Fitrah Abu Bakar, M. R. A. Bakar, Y. Yusof, Norazah Abd Rahman
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Abstract

Granulation of mefenamic acid particles was conducted to produce spherical shape, narrow size distribution of granules, high granule strength and good content uniformity by using Pressure Swing Granulation (PSG) technique in a fluidized bed. Two types (binderless and with binder) of granules namely lactose-mefenamic acid (MA) and lactose-polyethylene glycol (PEG)-(MA) with mass ratio of 30:70 and 25:5:70 were produced respectively. The later type of granules was heated for 80 ˚C, above the PEG melting point. Results indicated that all granules were uniform, spherical and narrow size distribution with the average granules size was less than 500 μm. The tensile strength of the lactose-PEG-MA was higher than the lactose-MA due to heating process. The tensile strength of lactose-PEG-MA and lactose-MA with average granules size of 500 μm were 0.42 MPa and 0.33 MPa, respectively. The drug contents in both types of granules were uniform i.e. around 70 ± 0.3 wt.%.
采用变压造粒(PSG)技术在流化床中对甲氨酰胺颗粒进行造粒,制备出球形、粒径分布窄、颗粒强度高、含量均匀性好的颗粒。制备了两种颗粒(无粘结剂和有粘结剂),即乳糖-甲氨酰胺(MA)和乳糖-聚乙二醇(PEG)-(MA),质量比分别为30:70和25:5:70。后一种类型的颗粒加热到80℃,高于PEG的熔点。结果表明:颗粒呈均匀球形,粒径分布窄,平均粒径小于500 μm;由于加热过程的原因,乳糖- peg - ma的拉伸强度高于乳糖- ma。平均粒径为500 μm的乳糖- peg - ma和乳糖- ma的抗拉强度分别为0.42 MPa和0.33 MPa。两种颗粒剂的药物含量均匀,均在70±0.3 wt.%左右。
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