【国外标准】 Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs

4.1 The European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) describe several dissolution and drug release setups for tablets, capsules, transdermal patches and suppositories (USP <711>, USP <724>, Ph. Eur. 2.9.3, Ph. Eur. 2.9.4). However, up to this point no pharmacopoeia standardized in-vitro release test has been established for parenteral dosage forms which provide sustained drug release, for example, implants.4.2 An appropriately designed in-vitro release test would be favorable in the early stage of development of biomolecule-releasing scaffolds for TEMPs, as well as in quality control, and may help to reduce the number of animal experiments.4.3 Appendix X1 provides a tabulated overview of published in-vitro release studies performed with biomaterial scaffolds loaded with biomolecules.4.4 One goal of in-vitro release studies is to simulate the in-vivo conditions as closely as possible, but with sufficiently simplifying abstraction. The simplification comprises two general aspects: the amount of fluid or release medium in contact with the implant to simulate the physiological environment, and the composition of that release medium.1.1 To describe general principles of developing and/or using an in vitro assay to evaluate biomolecule release from biomaterials scaffolds for TEMPs, with examples from the literature1.2 The guide will address scaffolds that do not contain seeded cells; general principles may still apply but may need to be modified if cells are part of the TEMPs.1.3 In vitro release assessment of biomolecules from matrices is a valuable tool for screening biomolecule-scaffold interactions, as well as characterization, and/or quality control.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.