CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Rua Central de Gandra, 1317, 4585-116, Gandra, PRD, Portugal.
UCIBIO, REQUIMTE, Laboratório de Tecnologia Farmacêutica, Departamento de Ciências do Medicamento, Faculdade de Farmácia da Universidade do Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313, Porto, Portugal.
AAPS PharmSciTech. 2019 Jan 2;20(1):36. doi: 10.1208/s12249-018-1246-2.
Different types of topical preparations are available as anti-psoriatic medicines, semisolid formulations being the preferred dosage forms for the treatment of body lesions. The mechanical characterization of these semisolid formulations is seldom reported, although mechanical features have been recognized to play an important role in treatment acceptability and adherence. The aim of this study was to characterize the mechanical properties of semisolid topical formulations commercially available for psoriasis treatment. One complementary aim was to evaluate patient satisfaction with topical treatment and discuss the results according to the mechanical features of the dosage form. Eight ointments (O 1-8), five creams (C 1-5), one oleogel (G1), and one excipient (E1-petrolatum) were characterized for textural properties (spreadability and penetration tests) and flow behavior. Power law model was fitted to the results. A questionnaire for the assessment of satisfaction with topical medicines used for psoriasis treatment over 6 months was developed and applied to 79 psoriasis patients. All the tested formulations presented a shear-thinning behavior with power law indexes (n) lower than 1. Ointments were distinct from the other dosage forms, since they presented higher consistency coefficients (K), firmness, and adhesiveness and this was evidenced by hierarchical cluster analysis, which identified two clusters based on the mechanical properties. Cluster 1 included the ointments and petrolatum and the cluster 2 enclosed the creams and the gel. The clusters were associated with several attributes classified by patients as analyzed with Fisher's exact test. In all cases, higher satisfaction was observed for cluster 2. The knowledge obtained regarding the influence of the dosage form on the degree of satisfaction with the treatment could be helpful in supporting the selection of the dosage form in clinical practice and thus improve treatment adherence and clinical outcomes. The differences observed between the mechanical properties of the formulations studied may be also relevant to the industry, as guidance to the development of new medicines.
有不同类型的局部制剂可用作抗银屑病药物，半固体制剂是治疗身体损伤的首选剂型。这些半固体制剂的机械特性很少有报道，尽管机械特性已被认为在治疗可接受性和依从性方面起着重要作用。本研究的目的是表征市售用于治疗银屑病的半固体制剂的机械性能。另一个目的是评估患者对局部治疗的满意度，并根据剂型的机械特性讨论结果。对 8 种软膏（O1-8）、5 种乳膏（C1-5）、1 种油凝胶（G1）和 1 种赋形剂（E1-凡士林）进行了质地特性（铺展性和渗透性测试）和流动行为的表征。用幂律模型拟合结果。开发了一种用于评估银屑病患者使用 6 个月以上的局部药物满意度的问卷，并对 79 名银屑病患者进行了调查。所有测试的制剂均表现出剪切稀化行为，幂律指数（n）小于 1。软膏与其他剂型明显不同，因为它们表现出更高的稠度系数（K）、硬度和粘性，这一点通过层次聚类分析得到了证实，该分析根据机械性能将制剂分为两个簇。簇 1 包括软膏和凡士林，簇 2 包括乳膏和凝胶。使用 Fisher 精确检验对患者分类的几个属性进行了聚类分析。在所有情况下，簇 2 的满意度更高。关于剂型对治疗满意度的影响的知识可以帮助在临床实践中选择剂型，从而提高治疗依从性和临床效果。观察到的制剂机械性能之间的差异对于行业也可能是相关的，为开发新药提供指导。
