메뉴 건너뛰기




Volumn 398, Issue 1-2, 2010, Pages 9-13

Critical factors in manufacturing multi-layer tablets-Assessing material attributes, in-process controls, manufacturing process and product performance

Author keywords

Bi layer tablets; Compaction; Material attributes; Multi layer tablets; Process parameter; Tablet breaking force; Tensile strength

Indexed keywords

DISSOLUTION; DRUG COATING; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; IN VITRO STUDY; PRIORITY JOURNAL; SHORT SURVEY; TABLET; TABLET COMPRESSION; TABLET FORMULATION; TENSILE STRENGTH;

EID: 77956225785     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2010.07.025     Document Type: Short Survey
Times cited : (51)

References (32)
  • 1
    • 53549110237 scopus 로고    scopus 로고
    • Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types
    • Aryal S., Skalko-Basnet N. Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types. Acta Pharm. 2008, 58:299-308.
    • (2008) Acta Pharm. , vol.58 , pp. 299-308
    • Aryal, S.1    Skalko-Basnet, N.2
  • 2
    • 34250179723 scopus 로고    scopus 로고
    • Fixed-dose combinations improve medication compliance: a meta-analysis
    • Bangalore S., Kamalakkannan G., Parkar S., Messerli F.H. Fixed-dose combinations improve medication compliance: a meta-analysis. Am. J. Med. 2007, 120:713-719.
    • (2007) Am. J. Med. , vol.120 , pp. 713-719
    • Bangalore, S.1    Kamalakkannan, G.2    Parkar, S.3    Messerli, F.H.4
  • 3
    • 56149123504 scopus 로고    scopus 로고
    • Treatment options for insomnia-pharmacodynamics of zolpidem extended-release to benefit next-day performance
    • Bogan R.K. Treatment options for insomnia-pharmacodynamics of zolpidem extended-release to benefit next-day performance. Postgrad. Med. 2008, 120:161-171.
    • (2008) Postgrad. Med. , vol.120 , pp. 161-171
    • Bogan, R.K.1
  • 4
    • 0023915030 scopus 로고
    • Investigation into substrate cracking of a film-coated bi-layered tablets
    • Breech J.A., Lucisano L.J., Franz R.M. Investigation into substrate cracking of a film-coated bi-layered tablets. J. Pharm. Pharmcol. 1988, 40:282-283.
    • (1988) J. Pharm. Pharmcol. , vol.40 , pp. 282-283
    • Breech, J.A.1    Lucisano, L.J.2    Franz, R.M.3
  • 5
    • 33746768780 scopus 로고    scopus 로고
    • Compaction behaviour and new predictive approach to the compressibility of binary mixtures of pharmaceutical excipients
    • Busignies V., Leclerc B., Porion P., Evesque P., Couarraze G., Tchoreloff P. Compaction behaviour and new predictive approach to the compressibility of binary mixtures of pharmaceutical excipients. Eur. J. Pharm. Biophar. 2006, 64:66-74.
    • (2006) Eur. J. Pharm. Biophar. , vol.64 , pp. 66-74
    • Busignies, V.1    Leclerc, B.2    Porion, P.3    Evesque, P.4    Couarraze, G.5    Tchoreloff, P.6
  • 6
    • 0020717271 scopus 로고
    • The tensile strengths of single powders and binary mixtures
    • Chan S.Y., Pilpel N., Cheng D.C.-H. The tensile strengths of single powders and binary mixtures. Powder Technol. 1983, 34:173-189.
    • (1983) Powder Technol. , vol.34 , pp. 173-189
    • Chan, S.Y.1    Pilpel, N.2    Cheng, D.C.-H.3
  • 7
    • 0020574226 scopus 로고
    • Unloading and post compression viscoelasitc stess versus strain behaviour of pharmaceutical solids
    • Danielson D.W., Morehead W.T., Rippie E.G. Unloading and post compression viscoelasitc stess versus strain behaviour of pharmaceutical solids. J. Pharm. Sci. 1983, 72:342-345.
    • (1983) J. Pharm. Sci. , vol.72 , pp. 342-345
    • Danielson, D.W.1    Morehead, W.T.2    Rippie, E.G.3
  • 8
    • 0034044685 scopus 로고    scopus 로고
    • Influence of tabletting forces and lubricant concentration on the adhesion strength in complex layer tablets
    • Dietrich P., Bauer-Brandl A., Schubert R. Influence of tabletting forces and lubricant concentration on the adhesion strength in complex layer tablets. Drug Dev. Ind. Pharm. 2000, 26:745-754.
    • (2000) Drug Dev. Ind. Pharm. , vol.26 , pp. 745-754
    • Dietrich, P.1    Bauer-Brandl, A.2    Schubert, R.3
  • 10
    • 57149131253 scopus 로고    scopus 로고
    • Formulation study and evaluation of matrix and three-layer tablet sustained drug delivery systems based on carbopols with isosorbite mononitrate
    • Efentakis M., Peponaki C. Formulation study and evaluation of matrix and three-layer tablet sustained drug delivery systems based on carbopols with isosorbite mononitrate. AAPS PharmSciTech 2008, 9:917-923.
    • (2008) AAPS PharmSciTech , vol.9 , pp. 917-923
    • Efentakis, M.1    Peponaki, C.2
  • 11
    • 0014785506 scopus 로고
    • Determination of tablet strength by diametrical compression test
    • Fell J.T., Newton J.M. Determination of tablet strength by diametrical compression test. J. Pharm. Sci. 1970, 59:688-691.
    • (1970) J. Pharm. Sci. , vol.59 , pp. 688-691
    • Fell, J.T.1    Newton, J.M.2
  • 12
    • 34249025487 scopus 로고    scopus 로고
    • Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength
    • He X., Secreast P.J., Amidon G.E. Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength. J. Pharm. Sci. 2007, 96:1342-1355.
    • (2007) J. Pharm. Sci. , vol.96 , pp. 1342-1355
    • He, X.1    Secreast, P.J.2    Amidon, G.E.3
  • 13
    • 0000693333 scopus 로고
    • An analysis of powder compaction phenomena
    • Heckel R.W. An analysis of powder compaction phenomena. Trans. Metal. Soc. AIME 1961, 221:1001-1008.
    • (1961) Trans. Metal. Soc. AIME , vol.221 , pp. 1001-1008
    • Heckel, R.W.1
  • 14
    • 0000292691 scopus 로고
    • Density-pressure relationships in powder compaction
    • Heckel R.W. Density-pressure relationships in powder compaction. Trans. Metal. Soc. AIME 1961, 221:671-675.
    • (1961) Trans. Metal. Soc. AIME , vol.221 , pp. 671-675
    • Heckel, R.W.1
  • 15
    • 77956231687 scopus 로고    scopus 로고
    • In determination of the critical stress intensity factor (KIC) for microcrystalline cellulose (MCC) using a developed tensile stress method and its application to double-layer tablets
    • Inman S.J., Briscoe B.J., Pitt K.G. In determination of the critical stress intensity factor (KIC) for microcrystalline cellulose (MCC) using a developed tensile stress method and its application to double-layer tablets. The 5th World Congress on Particle Technology 2006.
    • (2006) The 5th World Congress on Particle Technology
    • Inman, S.J.1    Briscoe, B.J.2    Pitt, K.G.3
  • 17
    • 67649097330 scopus 로고    scopus 로고
    • Development and evaluation of bilayer floating tablets of atenolol and lovastatin for biphasic release profile
    • Kulkarni A., Bhatia M. Development and evaluation of bilayer floating tablets of atenolol and lovastatin for biphasic release profile. Iran. J. Pharm. Res. 2009, 8:15-25.
    • (2009) Iran. J. Pharm. Res. , vol.8 , pp. 15-25
    • Kulkarni, A.1    Bhatia, M.2
  • 18
    • 54049150885 scopus 로고    scopus 로고
    • A randomized, double-blind, parallel-group, multicenter, placebo-controlled study of the safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respiratory infections
    • LaForce C., Gentile D.A., Skoner D.P. A randomized, double-blind, parallel-group, multicenter, placebo-controlled study of the safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respiratory infections. Postgrad. Med. 2008, 120:53-59.
    • (2008) Postgrad. Med. , vol.120 , pp. 53-59
    • LaForce, C.1    Gentile, D.A.2    Skoner, D.P.3
  • 19
    • 15244353516 scopus 로고    scopus 로고
    • Preparation and evaluation of release characteristics of 3TabGum, a novel chewing device
    • Maggi L., Segale L., Conti S., Ochoa Machiste E., Conte U. Preparation and evaluation of release characteristics of 3TabGum, a novel chewing device. Eur. J. Pharm. Sci. 2005, 24:487-493.
    • (2005) Eur. J. Pharm. Sci. , vol.24 , pp. 487-493
    • Maggi, L.1    Segale, L.2    Conti, S.3    Ochoa Machiste, E.4    Conte, U.5
  • 20
  • 22
    • 0038607625 scopus 로고    scopus 로고
    • The relationship between the particle properties, mechanical behavior, and surface roughness of some pharmaceutical excipients compacts
    • Narayan P., Hancock B.C. The relationship between the particle properties, mechanical behavior, and surface roughness of some pharmaceutical excipients compacts. Mater. Sci. Eng. 2003, A355:24-36.
    • (2003) Mater. Sci. Eng. , vol.A355 , pp. 24-36
    • Narayan, P.1    Hancock, B.C.2
  • 23
    • 0024088293 scopus 로고
    • Effects of particle shape and size on the tensile strengths of powders
    • Nikolakakis I., Pilpel N. Effects of particle shape and size on the tensile strengths of powders. Powder Technol. 1988, 56:95-103.
    • (1988) Powder Technol. , vol.56 , pp. 95-103
    • Nikolakakis, I.1    Pilpel, N.2
  • 24
    • 54349095607 scopus 로고    scopus 로고
    • Bilayer tablets of atorvastatin calcium and nicotinic acid: formulation and evaluation
    • Nirmal J., Saisivam S., Peddanna C., Muralidharan S., Nagarajan M., et al. Bilayer tablets of atorvastatin calcium and nicotinic acid: formulation and evaluation. Chem. Pharm. Bull. 2008, 56:1455-1458.
    • (2008) Chem. Pharm. Bull. , vol.56 , pp. 1455-1458
    • Nirmal, J.1    Saisivam, S.2    Peddanna, C.3    Muralidharan, S.4    Nagarajan, M.5
  • 25
    • 0037177497 scopus 로고    scopus 로고
    • Development and evaluation of a biphasic buccal adhesive tablet for nicotine replacement therapy
    • Park C.R., Munday D.L. Development and evaluation of a biphasic buccal adhesive tablet for nicotine replacement therapy. Int. J. Pharm. 2002, 237:215-226.
    • (2002) Int. J. Pharm. , vol.237 , pp. 215-226
    • Park, C.R.1    Munday, D.L.2
  • 26
    • 51449103824 scopus 로고    scopus 로고
    • Variables influencing drug release from layered matrix system comprising hydroxypropyl methylcellulose
    • Phaechamud T. Variables influencing drug release from layered matrix system comprising hydroxypropyl methylcellulose. AAPS PharmSciTech 2008, 9:668-674.
    • (2008) AAPS PharmSciTech , vol.9 , pp. 668-674
    • Phaechamud, T.1
  • 27
    • 0019981084 scopus 로고
    • The role of surfactants in the release of very slightly soluble drugs from tablets
    • Schott H., Kwan L.C., Feldman S. The role of surfactants in the release of very slightly soluble drugs from tablets. J. Pharm. Sci. 1982, 71:1038-1045.
    • (1982) J. Pharm. Sci. , vol.71 , pp. 1038-1045
    • Schott, H.1    Kwan, L.C.2    Feldman, S.3
  • 28
    • 0032767004 scopus 로고    scopus 로고
    • Relationships between the effective interparticulate contact area and the tensile strength of tablets of amorphous and crystalline lactose of varying particle size
    • Sebhatu T., Alderborn G. Relationships between the effective interparticulate contact area and the tensile strength of tablets of amorphous and crystalline lactose of varying particle size. Eur. J. Pharm. Sci. 1999, 8:235-242.
    • (1999) Eur. J. Pharm. Sci. , vol.8 , pp. 235-242
    • Sebhatu, T.1    Alderborn, G.2
  • 29
    • 61449219791 scopus 로고    scopus 로고
    • Rapid quantitative analysis of magnesium stearate in pharmaceutical powders and solid dosage forms by atomic absorption: method development and application in product manufacturing
    • Sugisawaa K., Kanekob T., Tsuyoshi S., Tomonobu S. Rapid quantitative analysis of magnesium stearate in pharmaceutical powders and solid dosage forms by atomic absorption: method development and application in product manufacturing. J. Pharm. Biomed. Anal. 2009, 858-861.
    • (2009) J. Pharm. Biomed. Anal. , pp. 858-861
    • Sugisawaa, K.1    Kanekob, T.2    Tsuyoshi, S.3    Tomonobu, S.4
  • 30
  • 31
    • 61349117983 scopus 로고    scopus 로고
    • Effects of automated external lubrication on tablet properties and the stability of eprazinone hydrochloride
    • Yamamura T., Ohta T., Taira T., Ogawa Y., Sakai Y., Moribe K., Yamamoto K. Effects of automated external lubrication on tablet properties and the stability of eprazinone hydrochloride. Int. J. Pharm. 2009, 370:1-7.
    • (2009) Int. J. Pharm. , vol.370 , pp. 1-7
    • Yamamura, T.1    Ohta, T.2    Taira, T.3    Ogawa, Y.4    Sakai, Y.5    Moribe, K.6    Yamamoto, K.7
  • 32
    • 0030919390 scopus 로고    scopus 로고
    • Compaction simulator study of a novel triple-layer tablet matrix for industrial tabletting
    • Yang L., Venkatesh G., Fassihi R. Compaction simulator study of a novel triple-layer tablet matrix for industrial tabletting. Int. J. Pharm. 1997, 152:45-52.
    • (1997) Int. J. Pharm. , vol.152 , pp. 45-52
    • Yang, L.1    Venkatesh, G.2    Fassihi, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.