CFDA has recently announced new classification guidance for drug product application. Under this new guidance, drug product with modified dosage regimen, dosage forms etc. (second generation products) are defined as new drugs. Comparing with first generation NCE based drug products, these second generation tend to have less adverse effect, longer effective time and better patient compliance. Although Chinese companies have launched quite few NCE based drug products domestically no NDA product has gained approval from FDA. Developing products with modified dosage regimen, dosage forms etc. could be an alternative way for innovative drug products to be recognized internationally because these types of product development will have less financial requirement, higher success rate and shorter development time. Using solid oral modified release products as examples, this article has reviewed a variety of modified release technologies and their application in product development. Sales data are used to show the importance of these products. It has also indicated different aspects and considerations to develop modified release products.
WEN Xiaoguang
,
XI Fengde
,
LU Ping
,
ZHANG Chenliang
,
YUAN Juyong
. New drug products development and innovation by oral controlled release technologies[J]. Science & Technology Review, 2016
, 34(11)
: 65
-75
.
DOI: 10.3981/j.issn.1000-7857.2016.11.011
[1] 刘昌孝.创新释药技术, 领引高端制剂发展[J].科技导报, 2011, 29(27): 3.
[2] Mandal A S, Biswas N, Karim K M, et al.Drug delivery system based on chronobiology-A review[J].Journal of Controlled Release, 2010, 147: 314-325.
[3] Maroni A, Zema L, Del Curto M D, et al.Oral pulsatile delivery: Ratio-nale and chronopharmaceutical formulations[J].International Journal of Pharmaceutics.2010, 398: 1-8.
[4] Lee Y L, Zhang S, Lin J, et al.A janus mucoadhesive and omniphobic device for gastrointestinal retention[J].Advanced Healthcare Materials, 2016, 5(17): 745-862.
[5] Gonçalves L M, Maestrelli F, DiCesareManelli L, et al.Development of solid lipid nanoparticles as carriers for improving oral bioavailability of glibenclamide[J].European Journal of Pharmaceutics and Biopharma-ceutics, 2016, 102: 41-50.
[6] Muñoz de Escalona M, Sáez-Fernández E, Prados J C, et al.Magnetic solid lipid nanoparticles in hyperthermia against colon cancer[J].Inter-national Journal of Pharmaceutics, 2016, 506: 11-19.
[7] You J, Wang Z, Du Y, et al.Specific tumor delivery of paclitaxel using glycolipid-like polymer micelles containing gold nanospheres[J].Bioma-terial, 2013, 34: 4510-4519.
[8] Du Y Z, Wang L, Yuan H, et al.Linoleic acid-grafted chitosan oligo-saccharide micelles for intracellular drug delivery and reverse drug re-sistance of tumor cells[J].International Journal of Biological Macromole-cules, 2011, 48: 215-222.
[9] Franiak-Pietryga I, Maciejewski H, Ostrowska K, et al.Dendrimerbased nanoparticles for potential personalized therapy in chronic lym-phocytic leukemia: Targeting the BCR-signaling pathway[J].Internation-al Journal of Biological Macromolecules, 2016, 88: 156-161.
[10] You J, Wang Z, Du Y, et al.Specific tumor delivery of paclitaxel us-ing glycolipid-like polymer micelles containing gold nanospheres[J].Biomaterial, 2013, 34: 4510-4519.
[11] Mittal A, Chitkara D, Behrman S W, et al.Efficacy of gemcitabine conjugated and miRNA-205 complexed micelles for treatment of ad-vanced pancreatic cancer[J].Biomaterials, 2014, 35: 7077-7087.
[12] Zhang L, Lu J, Jin Y, et al.Folate-conjugated beta-cyclodextrinbased polymeric micelles with enhanced doxorubicin antitumor efficacy [J].Colloids and Surfaces B: Biointerfaces, 2014, 122: 260-269.
[13] Chen H, Zhang T, Zhou Z, et al.Enhanced uptake and cytotoxity of fo-late-conjugated mitoxantrone-loaded micelles via receptor up-regula-tion by dexamethasone[J].International Journal of Pharmaceutics, 2013, 448: 142-149.
[14] Nam K, Nam H Y, Kim P H, et al.Paclitaxel-conjugated PEG and ar-ginine-grafted bioreducible poly (disulfide amine) micelles for co-de-livery of drug and gene[J].Biomaterials, 2012, 33: 8122-8130.
[15] Shaat H, Mostafa A, Moustafa M, et al.Modified gold nanoparticles for intracellular delivery of anti-liver cancer siRNA[J].International Journal of Pharmaceutics, 2016, 504: 125-133.
[16] Shukla R S, Jain A, Zhao Z, et al.Intracellular trafficking and exocyto-sis of a multi-component siRNA nanocomplex[J].Nanomedicine: Nano-technology, Biology and Medicine, 2016, 12: 1323-1334.
[17] Brambilla D, Luciani P, Leroux J C.Breakthrough discoveries in drug delivery technologies: The next 30 years[J].Journal of Controlled Re-lease, 2014, 190: 9-14.
[18] Rowe C W, Katstra W E, Palazzolo R D, et al.Multimechanism oral dosage forms fabricated by three dimensional printingTM[J].Journal of Controlled Release, 2000, 66: 11-17.
[19] Katstra W E, Palazzolo R D, Rowe C W, et al.Oral dosage forms fabri-cated by Three Dimensional PrintingTM[J].Journal of Controlled Re-lease, 2000, 66: 1-9.
[20] 任瑾, 杜倩, 艾凤伟, 等.药物新剂型与新技术在中药制剂中的应用开发[J].中成药, 2015, 37(2): 392-396.
[21] 梅兴国.把握创新制剂推动我国药业发展新机遇[J].国际药学研究杂志, 2010, 37(2): 89-91.
[22] 张强.药物制剂研究开发现状与未来发展趋势[J].全球药讯, 2013(1): 11-15.
[23] 魏际刚.中国医药体制改革与发展[N].医药经济报, 2010(A08).
[24] 刘兰茹, 刘佳明.新药研发中的风险控制[J].中国卫生经济, 2007, 26(8): 724.
[25] 周建平.现代药物制剂技术研究进展[J].中国兽药杂志, 2009, 43(10): 2033.
