Costa Juliana Souza Ribeiro, de Oliveira Cruvinel Karen, Oliveira-Nascimento Laura
Faculty of Pharmaceutical Sciences, University of Campinas, Rua Candido Portinari 200, 13083-871 Campinas, São Paulo, Brazil.
Institute of Biology, University of Campinas, Rua Monteiro Lobato 255, 13083-970 Campinas, São Paulo, Brazil.
J Adv Res. 2019 May 3;20:33-41. doi: 10.1016/j.jare.2019.04.010. eCollection 2019 Nov.
A great number of patients have difficulty swallowing or needle fear. Therefore, buccal and orodispersible dosage forms (ODFs) represent an important strategy to enhance patient compliance. Besides not requiring water intake, swallowing or needles, these dosage forms allow drug release modulation. ODFs include oral lyophilizates or wafers, which present even faster disintegration than its compressed counterparts. Lyophilization can also produce buccal wafers that adhere to mucosa for sustained drug release. Due to the subject relevance and recent research growth, this review focused on oral lyophilizate production technology, formulation features, and therapy gains. It includes Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) and discusses commercial and experimental examples. In sum, the available commercial products promote immediate drug release mainly based on biopolymeric matrixes and two production technologies. Therapy gains include substitution of traditional treatments depending on parenteral administration and patient preference over classical therapies. Experimental wafers show promising advantages as controlled release and drug enhanced stability. All compiled findings encourage the development of new wafers for several diseases and drug molecules.
大量患者存在吞咽困难或恐针问题。因此，口腔颊用和口腔速崩剂型（ODF）是提高患者依从性的重要策略。除了无需饮水、吞咽或打针外，这些剂型还能调节药物释放。ODF包括口服冻干制剂或薄片，其崩解速度比压制片更快。冻干还可制备能黏附于黏膜以实现药物持续释放的口腔薄片。鉴于该主题的相关性以及近期研究的增长，本综述聚焦于口服冻干制剂的生产技术、剂型特点和治疗优势。它涵盖关键质量属性（CQA）和关键工艺参数（CPP），并讨论了商业和实验实例。总之，现有的商业产品主要基于生物聚合物基质和两种生产技术促进药物立即释放。治疗优势包括替代依赖肠胃外给药的传统治疗方法以及患者对经典疗法的偏好。实验性薄片在控释和药物稳定性增强方面显示出有前景的数据增强。所有汇总结果都鼓励开发针对多种疾病和药物分子的新型薄片。
