Rolenium50mcg/250mcg60ED粉吸入剂首个获批在欧盟与通用Salmeterolol /丙酸氟替卡松组合具有成本效益的选择。干燥粉末含有防潮60个单剂量在铝泡罩一个月的需求。呼吸激活在吸嘴允许活性成分的恒定剂量的施用,并确保在较宽范围的气流的一致的结果。 Rolenium应使用一个天(早晨和晚上)的2倍。
有效成分:
丙酸氟替卡松17
沙美特罗(特罗)
Rolenium50mcg/250mcg 60ED粉吸入剂
Rolenium不宜用于儿童和青少年18岁以下
技术特点
•呼吸激活,多单剂量DPI
•阻力位:高至中
•一致的性能(释放剂量,细颗粒剂)
•简单的建筑 - 内部无转动部件;
•尺寸:高度7.5厘米,6厘米长度,宽度3厘米
•可以在手掌很容易地举行
•形状和尺寸可以定做
•由三部分组成
◦mouthpiece与盖
◦supporting表面哈内斯剂量的包含条
◦storage隔室
•存储设备容量:服药60剂的
用药剂量
•用药的每个剂量包装作为粉末,在一个特殊设计的带材制成的
•ALU - ALU(单剂量泡罩带)
•根据药业的产品,带包含一个或两个
•每个填充有药物以粉末形式和吸入级乳糖;
•Formopen®条:一泡,充满了福莫特罗乳糖+
•Fluticapen®条:一泡,充满了氟替卡松+乳糖
•Rolenium®地带:2水疱,1泡罩填充有氟替卡松+乳糖,和其他与沙美特罗+乳糖
•Pulmoton®地带:一个水泡充满了布地奈德+福莫特罗+乳糖的混合物。
上市国家
德国
希腊
Elpen药业有限责任公司
ELPENHALER® Description
Operation
•Breath-activated
•Resistance: high to medium
•Consistent performance (Delivered Dose, Fine Particle Dose) over a wide range of airflow (30-90 L/min), storage conditions.
•No matter in which direction the device is rotated, the inhalation process and drug delivery are not affected.
Technical Characteristics
•Breath-Activated, Multi Single-Dose DPI
•Resistance: High to Medium
•Consistent performance (Delivered Dose, Fine Particle Dose)
•Simple Construction – no internal rotating parts;
•Dimensions: 7.5cm height, 6cm length, 3cm width
•Can be easily held in the palm
•Shape and dimensions can be custom-made
•Comprised of three parts (Fig. 1):
◦mouthpiece with cover (1)
◦supporting surface for the dose containing strip (2)
◦storage compartment (3)
•Device storage capacity: 60 doses of medication
Medication Doses
•Each dose of medication is packed as a powder, in a specially designed strip made of
•alu - alu (single-dose blister strip)
•Depending on the pharmaceutical product, the strip contains one (Fig. 2a) or two
•(Fig. 2b) blisters, each filled with medication in powdered form and inhalation grade lactose;
•Formopen® strip: one blister, filled with formoterol + lactose
•Fluticapen® strip: one blister, filled with fluticasone + lactose
•Rolenium® strip: two blisters, one blister is filled with fluticasone + lactose, and the other with salmeterol + lactose
•Pulmoton® strip: one blister filled with a mixture of budesonide +formoterol+lactose.
Supporting Surface for Blister Strip
•The supporting surface (Fig. 3, Fig. 4) is designed to securely attach the single dose blister strip
•For this purpose it contains:
◦An attachment point (2A)
◦One or two cavities (2B), depending on the product
◦Two strip guides (2C)
APIs and Excipients
•APIs include: formoterol, fluticasone, budesonide, tiotropium, and selected combinations
•Excipient used: lactose monohydrate inhalation grade
•Weight of blister: depending on the product 12 – 15 mg