Technical Research and Development, Novartis Pharma AG, Basel, Switzerland.
Novartis Institute for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.
Expert Opin Drug Deliv. 2022 Oct;19(10):1265-1283. doi: 10.1080/17425247.2022.2106213. Epub 2022 Aug 2.
We see a development in the field of long-acting products to serve patients with chronic diseases by providing benefits in adherence, efficacy, and safety of the treatment. This review investigates features of long-acting products on the market/pipeline to understand which drug substance (DS) and drug product (DP) characteristics likely enable a successful patient-centric, low-dosing frequency product.
This review evaluates marketed/pipeline long-acting products with greater than 1 week release of small molecules and peptides by oral and injectable route of administration (RoA), with particular focus on patient centricity, adherence impact, health outcomes, market trends, and the match of DS/DP technologies which lead to market success.
Emerging trends are expected to change the field of long-acting products in the upcoming years by increasing capability in engineered molecules (low solubility, long half-life, high potency, etc.), directly developing DP as long-acting oral/injectable, increasing the proportion of products for local drug delivery, and a direction toward more subcutaneous, self-administered products. Among long-acting injectable products, nanosuspensions show a superiority in dose per administration and dosing interval, overwhelming the field of infectious diseases with the recently marketed products.
我们看到长效产品领域的发展，通过提供在治疗的依从性、疗效和安全性方面的益处，为慢性病患者服务。本综述研究了市场/研发管线中长效产品的特点，以了解哪些药物物质（DS）和药物产品（DP）特性可能使以患者为中心、低频率给药的产品取得成功。
本综述评估了通过口服和注射途径（RoA）上市/研发管线中具有超过 1 周释放小分子和肽的长效产品，特别关注以患者为中心、对依从性的影响、健康结果、市场趋势以及导致市场成功的 DS/DP 技术的匹配。
预计未来几年，通过提高工程分子（低溶解度、长半衰期、高效力等）的能力、直接开发长效口服/注射 DP、增加局部药物递送产品的比例以及朝着更偏向皮下、自我给药的产品方向发展，将改变长效产品领域。在长效注射产品中，纳米混悬剂在每次给药和给药间隔的剂量方面表现出优势，最近上市的产品在传染病领域占据主导地位。
