Abstract：
Pharmaceutical products represent a meaningful target for sustainability improvement and emissions reduction. It is proposed here that rethinking the standard, and often linear, approach to the synthesis of Active Pharmaceutical Ingredients (API) and subsequent formulation and drug product processing will deliver transformational sustainability opportunities. The greatest potential arguably involves API that have challenging physico-chemical properties. These can require the addition of excipients that can significantly exceed the weight of the API in the final dosage unit, require multiple manufacturing steps to achieve materials amenable to delivering final dosage units, and need highly protective packaging for final product stability. Co-processed API are defined as materials generated via addition of non-covalently bonded, non-active components during drug substance manufacturing steps, differing from salts, solvates and co-crystals. They are an impactful example of provocative re-thinking of historical regulatory and quality precedents, blurring drug substance and drug product operations, with sustainability opportunities. Successful examples utilizing co-processed API can modify properties with use of less excipient, while simultaneously reducing processing requirements by delivering material amenable to continuous manufacturing. There are also opportunities for co-processed API to reduce the need for highly protective packaging. This commentary will detail the array of sustainability impacts that can be delivered, inclusive of business, regulatory, and quality considerations, with discussion on potential routes to more comprehensively commercialize co-processed API technologies.
摘要：
药品是改善可持续性和减少排放的有意义的目标。这里建议重新考虑标准，通常是线性的，活性药物成分（API）的合成方法以及随后的配方和药物产品加工将提供转型的可持续性机会。可以说，最大的潜力涉及具有挑战性的物理化学性质的API。这些可能需要添加赋形剂，这些赋形剂可能会大大超过最终剂量单位中API的重量，需要多个制造步骤来获得适合于输送最终剂量单位的材料，并且需要高度保护性的包装以确保最终产品的稳定性。共加工API定义为通过添加非共价键合产生的材料，在原料药制造步骤中的非活性成分，不同于盐，溶剂化物和共晶。它们是对历史监管和质量先例进行挑衅性重新思考的一个有影响力的例子，模糊药物和药物产品操作，可持续发展的机会。使用共处理API的成功实例可以使用较少的赋形剂来修改特性，同时通过提供适合连续制造的材料来降低加工要求。共处理API也有机会减少对高度保护性包装的需求。本评论将详细说明一系列可实现的可持续性影响，包括商业，监管,和质量方面的考虑，讨论了将协同处理API技术更全面地商业化的潜在途径。
