Neves Inês, Auxtero Maria D
CiiEM, Interdisciplinary Research Centre Egas Moniz, Instituto Universitário Egas Moniz, Quinta da Granja, Monte de Caparica, 2829-511 Caparica, Portugal.
Pharmaceutics. 2021 Apr 10;13(4):528. doi: 10.3390/pharmaceutics13040528.
Extemporaneous suspensions are often marketed with several administration devices that can be freely used by patients/caregivers. The homogeneity of suspensions requires shaking before use. Hence, it is crucial to assess the precision of all devices and the users' awareness of the shaking procedure. This study was conducted at University Institute Egas Moniz with 40 pharmacy students who were asked to measure 2.5 and 5 mL of two extemporaneous azithromycin suspensions. Formulation A is marketed with a double-dosing spoon and oral syringe, whereas B includes a transparent dosing spoon. Both have a reconstitution cup. The user's preference for administration devices, the degree of compliance with the 'shake before use' instruction and the accuracy of the manipulation were assessed. The double-dosing spoon was the preferred device. The "shake before use" instruction was overlooked by most volunteers. The average measured volumes obtained with the double-dosing spoon were significantly different from the ones obtained with the oral syringe ( < 0.001) and significantly lower than the reference dose ( < 0.001). The oral syringe originates significantly higher values than the reference dose ( < 0.001). The dosing spoons values were significantly different from each other ( < 0.001). Liquid medicines containing several administration devices may be a challenge since they are nonequivalent.
临时调配的混悬剂通常配有多种给药器具，患者/护理人员可自由使用。混悬剂的均匀性要求在使用前进行摇晃。因此，评估所有器具的精准度以及使用者对摇晃程序的认知至关重要。本研究在埃加斯·莫尼斯大学研究所开展，招募了40名药学专业学生，要求他们量取两种临时调配的阿奇霉素混悬剂，分别为2.5毫升和5毫升。制剂A配有双剂量勺和口服注射器，而制剂B配有透明剂量勺。两种制剂均配有复溶杯。评估了使用者对给药器具的偏好、对“使用前摇晃”说明的遵守程度以及操作的准确性。双剂量勺是首选器具。大多数志愿者忽略了“使用前摇晃”的说明。使用双剂量勺测得的平均体积与使用口服注射器测得的平均体积显著不同（<0.001），且显著低于参考剂量（<0.001）。口服注射器测得的值显著高于参考剂量（<0.001）。两种剂量勺测得的值彼此显著不同（<0.001）。含有多种给药器具的液体制剂可能是一项挑战，因为它们并不等效。
