School of Pharmacy, Temple University, Philadelphia, PA 19140, USA.
Curr Med Chem. 2013;20(13):1635-8. doi: 10.2174/0929867311320130003.
The history of Fixed Dose Combination (FDC) oral drug products has been tumultuous over its history. Some FDCs were prepared for marketing purposes and others for clinical improvements. Often, the products prepared for marketing advantage ended up causing negative outcomes. However, in recent years, there has been a resurgence of FDCs as clinicians have found them adventitious for treatment of AIDS/HIV and for oral contraceptives, just to name two examples. International regulatory Agencies and most major drug regulatory agencies have established guidelines along with regulations concerning preparation, labeling and marketing for FDCs. The advantages of FDCs are said to be in the clinical realm where simplified therapy regimens are thought to enhance patient's medication taking compliance. On the financial side, health insurers and other payers normally save money from a decreased number of dispensing fees, the use of fewer bottles, labels, etc., and from the possible situation where the price of the FDC is less than the medication price of the two separate ingredients dispensed individually. Overall, there is a great deal of evidence in favor of appropriate FDCs.
固定剂量复方（FDC）口服药物制剂的历史可谓跌宕起伏。有些 FDC 是为了营销目的而制备的，而有些则是为了临床改善。通常，为营销优势而制备的产品最终会导致负面结果。然而，近年来，随着临床医生发现 FDC 对艾滋病/艾滋病和口服避孕药的治疗有意外的效果，FDC 又重新流行起来，仅举两个例子。国际监管机构和大多数主要药物监管机构已经制定了关于 FDC 的制备、标签和营销的指导方针和规定。据说 FDC 的优势在于临床领域，简化治疗方案被认为可以提高患者的用药依从性。在财务方面，健康保险公司和其他支付方通常会从减少配药费用、使用更少的瓶子、标签等方面节省资金，并且在 FDC 的价格低于单独配药的两种成分的药物价格的情况下也会节省资金。总的来说，有大量证据支持适当的 FDC。
