摘要
对膜剂涂膜机的关键单元进行调试,考察了加料高度对空白膜厚和重量差异的影响、刮刀高度对膜厚和溶化时间的影响、送风风速和排风风速对干燥温度的影响,以及走带速度的稳定性。使用该设备在GMP生产车间制备了3批、每批10万片的他达拉非口溶膜,并进行了涂布工艺参数验证,评价该设备的涂布均匀性和稳定性。结果表明,该设备可在30~120℃范围内稳定地控制加热温度;走带速度在0.1~2.0 m/min内可调,实测值与设定值的误差在±1%以内;最大产量约为每8 h生产48万片。3批他达拉非口溶膜的厚度为60~64μm,重量差异分别为–2.06%~+1.37%、–3.34%~+2.68%和–1.89%~+2.05%;连续涂膜6 h,口溶膜的厚度和宽度均未发生明显变化,涂膜前、中和后段含量均匀度较好,A+2.2S为2.3~7.4。因此该设备可满足膜剂产业化生产的基本要求。
This research conducted a commissioning on the critical components of the film coating machine,by investigating the impact of the feeding height of casting mixture on thickness and weight variation of the blank films,the effect of casting height on film thickness and disintegration time,the influences of air flow rates at inlet and outlet on drying temperature,and the consistency of running speed.Three batches of tadalafil orodispersible films(ODFs)with 100000 pieces per batch were prepared with the machine in a GMP workshop,and the casting process parameters were verified to evaluate the casting uniformity and stability of the equipment.The results showed that the heating temperature could be steadily controlled within the range of 30-120℃,the running speed could be accurately set within the range of 0.1-2.0 m/min and the deviations between the measured and set values were within±1%.Additionally,the equipment offered a maximum output of approximately 480000 pieces per 8 hours.The thickness of the three batches of ODFs was 60-64μm,and weight variations of three batches were–2.06%to+1.37%,–3.34%to+2.68%,and–1.89%to+2.05%,respectively.There were no significant changes in the thickness and width of the films during the continuous operation of the equipment for 6 hours,and the films sampled from the front,middle and rear sections of the liner performed well on content uniformity with the values of A+2.2S ranging from 2.3 to 7.4.In conclusion,this equipment can basically meet the requirements of the industrial production for pharmaceutical films.
作者
王兵
吴王平
何军焘
袁春平
陈芳
WANG Bing;WU Wangping;HE Juntao;YUAN Chunping;CHEN Fang(National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203;Shanghai Sinopeak Pharmaceutical Co.,Ltd.,Shanghai 201506;Shanghai Huanghai Drug Control Instrument Co.,Ltd.,Shanghai 200070)
出处
《中国医药工业杂志》
EI
CAS
CSCD
2024年第3期397-405,共9页
Chinese Journal of Pharmaceuticals
关键词
涂膜机
膜剂
他达拉非
口溶膜
工艺参数
film coating machine
pharmaceutical film
tadalafil
orodispersible film
process parameter
