Joanneum Research HEALTH - Institute for Biomedical Research and Technologies, Graz, Austria.
RaDes GmbH, Hamburg, Germany.
Eur J Pharm Sci. 2024 Dec 1;203:106913. doi: 10.1016/j.ejps.2024.106913. Epub 2024 Sep 17.
Despite the prevalence and the impact on quality of life of dermatological indications, drug products to treat such conditions have rarely been blockbusters. The prevailing perception of a limited commercial potential of dermatological drug products has restricted innovation and encouraged a more conservative development approach. For example, the focus was on repurposing/reformulation of existing active pharmaceutical ingredients (APIs) specifically for the topical delivery route. However, the situation is quite different today catalyzed in part by the blockbuster success of Dupixent (dupilumab), the first monoclonal antibody treatment for atopic dermatitis which has been approved by the US Food and Drug Administration (US FDA) in 2017. Dupixent's success not only encouraged the development of other biologics but also inspired the (re-)development of new dermal drug products that can reap the many benefits of topical administration. We have also witnessed a shift toward outsourcing development efforts (and associated risks) towards small- to mid-size pharmaceutical companies which often require support of contract research and development/manufacturing organizations (CRO and CDMO). Such trends also emphasize the need of greater expertise in topical formulation design, as well as associated commercial and regulatory considerations. Today, we believe that topical drug products remain not only an essential but also commercially viable class of dermatological therapeutics. In this opinion article, we will address the challenges as well as opportunities of coherent development strategies in the current market environment, formulation innovations of topical drug products and technological advances to facilitate rational topical drug formulation development.
尽管皮肤科适应症普遍存在且对生活质量有影响，但用于治疗这些疾病的药物产品却很少成为重磅炸弹药物。人们普遍认为皮肤科药物产品的商业潜力有限，这限制了创新，并鼓励采取更为保守的开发方法。例如，重点是针对特定的局部递药途径对现有活性药物成分 (API) 进行再利用/重新配方。然而，今天的情况已大不相同，部分原因是 Dupixent（度普利尤单抗）的重磅成功，Dupixent 是首款获美国食品和药物管理局 (US FDA) 批准用于特应性皮炎的单克隆抗体治疗药物，于 2017 年获得批准。Dupixent 的成功不仅鼓励了其他生物制剂的开发，也激发了（重新）开发可从局部给药中获得诸多益处的新型皮肤药物产品。我们还见证了向小型到中型制药公司外包开发工作（及相关风险）的转变，这些公司通常需要合同研究和开发/制造组织 (CRO 和 CDMO) 的支持。此类趋势也强调了需要在局部制剂设计方面具备更专业的知识，以及相关的商业和监管考虑因素。如今，我们认为局部药物产品不仅仍然是皮肤科治疗的重要组成部分，而且在商业上也是可行的。在这篇观点文章中，我们将讨论在当前市场环境下，局部药物产品的一致性开发策略、制剂创新以及技术进步所面临的挑战和机遇，这些进步有助于合理的局部药物制剂开发。
