메뉴 건너뛰기




Volumn 2, Issue 7, 2011, Pages 949-956

Case studies with new excipients: Development, implementation and regulatory approval

Author keywords

[No Author keywords available]

Indexed keywords

BETA CYCLODEXTRIN SULFOBUTYL ETHER; ESCITALOPRAM; EXCIPIENT; LEVO T; LEVOTHYROXINE; NIFEDIPINE; POLYOXYL 15 HYDROXYSTEARATE; PROSTAGLANDIN E2; SILICALCIFIED MICROCRYSTALLINE CELLULOSE; UNCLASSIFIED DRUG; VFENDBETA; VORICONAZOLE;

EID: 79953239836     PISSN: 20415990     EISSN: 20416008     Source Type: Journal    
DOI: 10.4155/tde.11.62     Document Type: Review
Times cited : (16)

References (22)
  • 1
    • 79953238918 scopus 로고    scopus 로고
    • Advances and examples of new excipients in novel drug-delivery systems
    • Presented at: New Orleans LA USA 14-18 November
    • Koo OMY. Advances and examples of new excipients in novel drug-delivery systems. Presented at: Annual Meeting of the American Association of Pharmaceutical Scientists. New Orleans, LA, USA, 14-18 November 2010.
    • (2010) Annual Meeting of the American Association of Pharmaceutical Scientists
    • Koo, O.M.Y.1
  • 3
    • 1842556735 scopus 로고    scopus 로고
    • Synthetic excipients challenge all-natural organics
    • Russell R. Synthetic excipients challenge all-natural organics. Pharm. Technol. 27, 38-50 (2004).
    • (2004) Pharm. Technol. , vol.27 , pp. 38-50
    • Russell, R.1
  • 4
    • 77951990378 scopus 로고    scopus 로고
    • Functionality and performance of excipients in a quality-by-design world, part IX: New excipients
    • Moreton RC. Functionality and performance of excipients in a quality-by-design world, part IX: new excipients. Am. Pharm. Rev. 34-37 (2010).
    • (2010) Am. Pharm. Rev. , pp. 34-37
    • Moreton, R.C.1
  • 5
    • 79953236320 scopus 로고    scopus 로고
    • Application challenges and examples of new excipients in advanced drug delivery systems
    • Koo O. Application challenges and examples of new excipients in advanced drug delivery systems. Am. Pharm. Rev. 60-68 (2011).
    • (2011) Am. Pharm. Rev. , pp. 60-68
    • Koo, O.1
  • 6
    • 85157152003 scopus 로고    scopus 로고
    • Excipient innovation and regulatory acceptance for use in drug products - solubilizer solutol® HS 15 case study
    • Presented at: Los Angeles CA USA November
    • Velagaleti R. Excipient innovation and regulatory acceptance for use in drug products - solubilizer solutol® HS 15 case study. Presented at: Annual Meeting of the American Association of Pharmaceutical Scientists. Los Angeles, CA, USA, November 2009.
    • (2009) Annual Meeting of the American Association of Pharmaceutical Scientists
    • Velagaleti, R.1
  • 7
    • 85157150763 scopus 로고    scopus 로고
    • Polyoxyl 15 hydroxystearate
    • United States Pharmacopeia
    • United States Pharmacopeia. Polyoxyl 15 hydroxystearate. Pharmacopeial Forum 35(1), 128 (2009).
    • (2009) Pharmacopeial Forum , vol.35 , Issue.1 , pp. 128
  • 8
    • 77951498256 scopus 로고    scopus 로고
    • Characterization and stability of solid dispersions based on PEG polymer blends
    • Bley H, Fussnegger B, Bodmeier R. Characterization and stability of solid dispersions based on PEG/polymer blends. Intl J. Pharmaceutics 390, 165-173 (2010).
    • (2010) Intl J. Pharmaceutics , vol.390 , pp. 165-173
    • Bley, H.1    Fussnegger, B.2    Bodmeier, R.3
  • 10
    • 34548134519 scopus 로고    scopus 로고
    • Cyclodextrins as pharmaceutical solubilizers
    • DOI 10.1016/j.addr.2007.05.012, PII S0169409X07000841
    • Brewster ME, Loftsson T. Cyclodextrins as pharmaceutical solubilizers. Adv. Drug Deliv. Rev. 59, 645-666 (2007). (Pubitemid 47299263)
    • (2007) Advanced Drug Delivery Reviews , vol.59 , Issue.7 , pp. 645-666
    • Brewster, M.E.1    Loftsson, T.2
  • 11
    • 0033106029 scopus 로고    scopus 로고
    • Mechanisms of drug release from cyclodextrin complexes
    • DOI 10.1016/S0169-409X(98)00052-0, PII S0169409X98000520
    • Stella VJ, Rao VM, Zannou EA, Zia V. Mechanisms of drug release from cyclodextrin complexes. Adv. Drug Deliv. Rev. 36, 3-16 (1999). (Pubitemid 29074473)
    • (1999) Advanced Drug Delivery Reviews , vol.36 , Issue.1 , pp. 3-16
    • Stella, V.J.1    Rao, V.M.2    Zannou, E.A.3    Zia, V.4
  • 12
    • 21244492028 scopus 로고    scopus 로고
    • Cyclodextrin complexed generic drugs are generally not bio-equivalent with the reference products: Therefore the increase in number of marketed drug/cyclodextrin formulations is so slow
    • DOI 10.1007/s10847-004-7161-z
    • Szejtli J. Cyclodextrin complexed generic drugs are generally not bio-equivalent with the reference products: therefore the increase in number of marketed drug cyclodextrin formulations is so slow. J. Inclusion Phenomena Macrocyclic Chem. 52, 1-11 (2005). (Pubitemid 40897908)
    • (2005) Journal of Inclusion Phenomena , vol.52 , Issue.1-2 , pp. 1-11
    • Szejtli, J.1
  • 13
    • 0033106020 scopus 로고    scopus 로고
    • Highly soluble cyclodextrin derivatives: Chemistry, properties, and trends in development
    • DOI 10.1016/S0169-409X(98)00092-1, PII S0169409X98000921
    • Szente L, Szejtli J. Highly soluble cyclodextrin derivatives: chemistry, properties, and trends in development. Adv. Drug Del. Rev. 36, 17-28 (1999). (Pubitemid 29074474)
    • (1999) Advanced Drug Delivery Reviews , vol.36 , Issue.1 , pp. 17-28
    • Szente, L.1    Szejtli, J.2
  • 14
    • 68849124197 scopus 로고    scopus 로고
    • Co-processed excipients
    • Block LH. Co-processed excipients. Pharmacopeial Forum 35(4), 1026-1028 (2009).
    • (2009) Pharmacopeial Forum , vol.35 , Issue.4 , pp. 1026-1028
    • Block, L.H.1
  • 15
    • 0032528373 scopus 로고    scopus 로고
    • Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose
    • DOI 10.1016/S0378-5173(98)00127-6, PII S0378517398001276
    • Tobyn MJ, McCarthy GP, Staniforth JN, Edge S. Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose. Int. J. Pharm. 169, 183-194 (1998). (Pubitemid 28345254)
    • (1998) International Journal of Pharmaceutics , vol.169 , Issue.2 , pp. 183-194
    • Tobyn, M.J.1    McCarthy, G.P.2    Staniforth, J.N.3    Edge, S.4
  • 16
    • 0028905996 scopus 로고
    • Coating of cellulose products with highly dispersed silicic acid: Investigations on the improvement of tabletting properties demonstrated in low dose tablets
    • Nurnberg E, Wunderlich J. Coating of cellulose products with highly dispersed silicic acid: investigations on the improvement of tabletting properties demonstrated in low dose tablets. Pharm. Ind. 57(3), 252-256 (1995).
    • (1995) Pharm. Ind. , vol.57 , Issue.3 , pp. 252-256
    • Nurnberg, E.1    Wunderlich, J.2
  • 17
    • 0034712809 scopus 로고    scopus 로고
    • The mechanical properties of compacts of microcrystalline cellulose and silicified microcrystalline cellulose
    • DOI 10.1016/S0378-5173(00)00343-4, PII S0378517300003434
    • Edge S, Steele DF, Chen A, Tobyn MJ, Staniforth JN. The mechanical properties of compacts of microcrystalline cellulose and silicified microcrystalline cellulose. Int. J. Pharm. 200, 67-72 (2000). (Pubitemid 30177251)
    • (2000) International Journal of Pharmaceutics , vol.200 , Issue.1 , pp. 67-72
    • Edge, S.1    Steele, D.F.2    Chen, A.3    Tobyn, M.J.4    Staniforth, J.N.5
  • 18
    • 70350668806 scopus 로고    scopus 로고
    • Functional performance of silicified microcyrtsalline cellulose versus microcrystalline cellulose: A case study
    • Aljaberi A, Chatterji A, Shah NH, Sandhu HK. Functional performance of silicified microcyrtsalline cellulose versus microcrystalline cellulose: a case study. Drug Dev. Ind. Pharm. 35(9), 1066-1071 (2009).
    • (2009) Drug Dev. Ind. Pharm. , vol.35 , Issue.9 , pp. 1066-1071
    • Aljaberi, A.1    Chatterji, A.2    Shah, N.H.3    Sandhu, H.K.4
  • 19
    • 0034960479 scopus 로고    scopus 로고
    • A study of the effects of the physical characteristics of microcrystalline cellulose on performance in extrusion spheronization
    • DOI 10.1023/A:1011054310895
    • Heng PWS, Koo OMY. A study of the effects of the physical characteristics of microcrystalline cellulose on performance in extrusion spheronization. Pharm. Res. 18(4), 480-487 (2001). (Pubitemid 32592580)
    • (2001) Pharmaceutical Research , vol.18 , Issue.4 , pp. 480-487
    • Heng, P.W.S.1    Koo, O.M.Y.2
  • 20
    • 85157221127 scopus 로고    scopus 로고
    • Excipient update: Silicified microcrystalline cellulose
    • Chaubal MV. Excipient update: silicified microcrystalline cellulose. Drug Development Delivery 3(1), 30-35 (2003).
    • (2003) Drug Development Delivery , vol.3 , Issue.1 , pp. 30-35
    • Chaubal, M.V.1
  • 21
    • 33750826855 scopus 로고    scopus 로고
    • High functionality excipients HFE - Prosolv® SMCC as an effective strategy for generic drug formulation
    • Zeleznik JA, Renak J. High functionality excipients (HFE) - Prosolv® SMCC as an effective strategy for generic drug formulation. Business Briefing: Pharmagenerics 1-4 (2004).
    • (2004) Business Briefing: Pharmagenerics , pp. 1-4
    • Zeleznik, J.A.1    Renak, J.2
  • 22
    • 68849096067 scopus 로고    scopus 로고
    • Silicified microcrystallaine cellulose
    • United States Pharmacopeia
    • United States Pharmacopeia. Silicified microcrystallaine cellulose. Pharmacopeial Forum 34(5), 1218 (2008).
    • (2008) Pharmacopeial Forum , vol.34 , Issue.5 , pp. 1218


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.