GlaxoSmithKline, New Frontiers Science Park, Third Avenue, Harlow, Essex CM19 5AW, UK.
Int J Pharm. 2012 Oct 5;435(2):124-30. doi: 10.1016/j.ijpharm.2012.05.070. Epub 2012 Jun 5.
There is some confusion about the types of paediatric pharmaceutical preparation (in a regulatory and pharmaceutical development context) that are acceptable for approval by medicines regulators. Some of the confusion relates to terminology which may mean different things to different stakeholders. It may not always be possible to provide authorised, commercially manufactured, age appropriate, ready-to-administer preparations. In terms of assurance of quality and bioavailability there is a continuum from this ideal through intermediate products through authorised compounding and manipulation of commercial dosage forms to ad hoc compounding using only the skills and experience of the individual pharmacist. Additionally, it is widely known that caregivers may manipulate medicines at home, for example by segmenting tablets and by addition to foods or liquids. The first intent of the manufacturer should be to provide for children an age appropriate, ready-to-administer preparation which is commercially manufactured and approved by the competent authorities. However, there will still be a place for providing other age appropriate preparations such as approved products that are 'intermediates' requiring reconstitution before use, or instructions for compounding or manipulation of a dosage form. If compounding or manipulation is likely to be required it is preferable that data are generated by Industry, approved by the competent authorities and provided in the Summary of Product Characteristics (SmPC). It is acknowledged however, that ad hoc compounding or manipulation may also take place in certain circumstances such as logistical difficulties or to satisfy the needs of the child who does not find the authorised product to be 'age appropriate'. This paper explores compounding and manipulation of medicines in relation to approval by medicines regulators and non-approved preparation to fulfil the needs of the individual patient. Definitions are proposed to provide a hierarchical classification based on assurances of quality and bioavailability.
在药品监管机构批准的范围内，对于儿科药物制剂（在监管和药物开发方面）的类型存在一些混淆。一些混淆与术语有关，这些术语可能对不同的利益相关者有不同的含义。并非总是能够提供经批准、商业化生产、适合年龄、可直接使用的制剂。在质量和生物利用度的保证方面，从这个理想状态到中间产品，再到经过授权的化合物制备和商业剂型的操作，再到仅依靠个别药剂师的技能和经验进行的临时化合物制备，存在一个连续体。此外，众所周知，护理人员可能会在家中对药物进行操作，例如将片剂分段并添加到食物或液体中。制造商的首要意图应该是为儿童提供适合年龄、可直接使用的制剂，该制剂应由商业生产并获得主管当局的批准。然而，仍然需要提供其他适合年龄的制剂，例如需要在使用前重新配制的已批准的“中间体”产品，或用于配制或操作剂型的说明。如果可能需要进行化合物制备或操作，则最好由行业生成数据，由主管当局批准，并在产品特性摘要（SmPC）中提供。然而，人们承认，在某些情况下，也可能会进行临时化合物制备或操作，例如物流困难或为了满足不认为授权产品适合“年龄”的儿童的需求。本文探讨了与药品监管机构批准和非批准制剂相关的药物化合物制备和操作，以满足个体患者的需求。本文提出了定义，以提供基于质量和生物利用度保证的分层分类。
