메뉴 건너뛰기




Volumn 75, Issue 2, 2010, Pages 232-237

In vivo evaluation of two new sustained release formulations elaborated by one-step melt granulation: Level A in vitro-in vivo correlation

Author keywords

Binder; IVIVC; Melt granulation; Sustained release; Theophylline

Indexed keywords

ETOFYLLINE; GLYCEROL STEARATE; MACROGOL 6000; THEOPHYLLINE;

EID: 77952952552     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.02.008     Document Type: Article
Times cited : (22)

References (37)
  • 1
    • 0002504636 scopus 로고
    • Fundamentals of controlled release drug delivery
    • Marcel Dekker, New York, J.R. Robinson, V.H.L. Lee (Eds.)
    • Li V.H.K., Robinson J.R. Fundamentals of controlled release drug delivery. Controlled Drug Delivery: Fundamentals and Applications 1987, 3-11. Marcel Dekker, New York. J.R. Robinson, V.H.L. Lee (Eds.).
    • (1987) Controlled Drug Delivery: Fundamentals and Applications , pp. 3-11
    • Li, V.H.K.1    Robinson, J.R.2
  • 2
    • 0034878523 scopus 로고    scopus 로고
    • Excipient-excipient interaction in the design of sustained-release theophylline tablets: in vitro and in vivo evaluation
    • Bayomi M.A., Al-Suwayeh S.A., El-Helw A.R. Excipient-excipient interaction in the design of sustained-release theophylline tablets: in vitro and in vivo evaluation. Drug Dev. Ind. Pharm. 2001, 27:499-506.
    • (2001) Drug Dev. Ind. Pharm. , vol.27 , pp. 499-506
    • Bayomi, M.A.1    Al-Suwayeh, S.A.2    El-Helw, A.R.3
  • 3
    • 34248550987 scopus 로고    scopus 로고
    • Modulation of drug release kinetics from hydroxypropyl methyl cellulose matrix tablets using polyvinyl pyrrolidone
    • Hardy I.J., Windberg-Baarup A., Neri C., Byway P.V., Booth S.W., Fitzpatrick S. Modulation of drug release kinetics from hydroxypropyl methyl cellulose matrix tablets using polyvinyl pyrrolidone. Int. J. Pharm. 2007, 337:246-253.
    • (2007) Int. J. Pharm. , vol.337 , pp. 246-253
    • Hardy, I.J.1    Windberg-Baarup, A.2    Neri, C.3    Byway, P.V.4    Booth, S.W.5    Fitzpatrick, S.6
  • 4
    • 0037168220 scopus 로고    scopus 로고
    • Polymer particle erosion controlling drug release. II. Swelling investigations to clarify the release mechanism
    • Zuleger S., Fassihi R., Lippold B.C. Polymer particle erosion controlling drug release. II. Swelling investigations to clarify the release mechanism. Int. J. Pharm. 2002, 247:23-37.
    • (2002) Int. J. Pharm. , vol.247 , pp. 23-37
    • Zuleger, S.1    Fassihi, R.2    Lippold, B.C.3
  • 5
    • 15944414517 scopus 로고
    • Fundamentals of controlled release drug delivery
    • Marcel Dekker, Inc., New York, J.R. Robinson, V.H.L. Lee (Eds.)
    • Heller J. Fundamentals of controlled release drug delivery. In Controlled Drug Delivery: Fundamentals and Applications 1987, 140-174. Marcel Dekker, Inc., New York. J.R. Robinson, V.H.L. Lee (Eds.).
    • (1987) In Controlled Drug Delivery: Fundamentals and Applications , pp. 140-174
    • Heller, J.1
  • 6
    • 0021879828 scopus 로고
    • Formation of sustained release promethazine hydrochloride tablets using hydroxypropylmethylcellulose matrix
    • Ford J.L., Rubinstein M.H., Hogan J.E. Formation of sustained release promethazine hydrochloride tablets using hydroxypropylmethylcellulose matrix. Int. J. Pharm. 1985, 24:327-338.
    • (1985) Int. J. Pharm. , vol.24 , pp. 327-338
    • Ford, J.L.1    Rubinstein, M.H.2    Hogan, J.E.3
  • 7
    • 0032899389 scopus 로고    scopus 로고
    • Formulation and release characteristics of hydroxypropyl methylcellulose matrix tablet containing melatonin
    • Lee B.J., Riu S.G., Cui S.H. Formulation and release characteristics of hydroxypropyl methylcellulose matrix tablet containing melatonin. Drug Dev. Ind. Pharm. 1999, 25:493-501.
    • (1999) Drug Dev. Ind. Pharm. , vol.25 , pp. 493-501
    • Lee, B.J.1    Riu, S.G.2    Cui, S.H.3
  • 8
    • 33947201622 scopus 로고    scopus 로고
    • Development and evaluation of new multiple-unit levodopa sustained-release floating dosage forms
    • Goole J., Vanderbist F., Amighi K. Development and evaluation of new multiple-unit levodopa sustained-release floating dosage forms. Int. J. Pharm. 2007, 334:35-41.
    • (2007) Int. J. Pharm. , vol.334 , pp. 35-41
    • Goole, J.1    Vanderbist, F.2    Amighi, K.3
  • 9
    • 0037473463 scopus 로고    scopus 로고
    • Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique
    • Perissutti B., Rubessa F., Moneghini M., Voinovich D. Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique. Int. J. Pharm. 2003, 256:53-63.
    • (2003) Int. J. Pharm. , vol.256 , pp. 53-63
    • Perissutti, B.1    Rubessa, F.2    Moneghini, M.3    Voinovich, D.4
  • 12
    • 0036805133 scopus 로고    scopus 로고
    • Development and evaluation of prolonged release pellets obtained by the melt pelletization process
    • Hamdani J., Moes A.J., Amighi K. Development and evaluation of prolonged release pellets obtained by the melt pelletization process. Int. J. Pharm. 2002, 245:167-177.
    • (2002) Int. J. Pharm. , vol.245 , pp. 167-177
    • Hamdani, J.1    Moes, A.J.2    Amighi, K.3
  • 13
    • 33845619564 scopus 로고    scopus 로고
    • Effect of the melt granulation technique on the dissolution characteristics of griseofulvin
    • Yang D., Kulkarni R., Behme R.J., Kotiyan P.N. Effect of the melt granulation technique on the dissolution characteristics of griseofulvin. Int. J. Pharm. 2007, 329:72-80.
    • (2007) Int. J. Pharm. , vol.329 , pp. 72-80
    • Yang, D.1    Kulkarni, R.2    Behme, R.J.3    Kotiyan, P.N.4
  • 14
    • 37849023418 scopus 로고    scopus 로고
    • New levodopa sustained-release floating minitablets coated with insoluble acrylic polymer
    • Goole J., Deleuze P., Vanderbist F., Amighi K. New levodopa sustained-release floating minitablets coated with insoluble acrylic polymer. Eur. J. Pharm. Biopharm. 2008, 68:310-318.
    • (2008) Eur. J. Pharm. Biopharm. , vol.68 , pp. 310-318
    • Goole, J.1    Deleuze, P.2    Vanderbist, F.3    Amighi, K.4
  • 15
    • 34548049221 scopus 로고    scopus 로고
    • Oral lipid-based formulations
    • Hauss D.J. Oral lipid-based formulations. Adv. Drug Deliv. Rev. 2007, 59:667-676.
    • (2007) Adv. Drug Deliv. Rev. , vol.59 , pp. 667-676
    • Hauss, D.J.1
  • 16
    • 23144460888 scopus 로고    scopus 로고
    • Preparation and evaluation of diltiazem hydrochloride-gelucire 43/01 floating granules prepared by melt granulation
    • Shimpi S., Chauhan B., Mahadik K.R., Paradkar A. Preparation and evaluation of diltiazem hydrochloride-gelucire 43/01 floating granules prepared by melt granulation. AAPS PharmSciTech 2004, 5(3).
    • (2004) AAPS PharmSciTech , vol.5 , Issue.3
    • Shimpi, S.1    Chauhan, B.2    Mahadik, K.R.3    Paradkar, A.4
  • 17
    • 0036200128 scopus 로고    scopus 로고
    • Development and validation of a non-linear IVIVC model for a diltiazem extended release formulation
    • Sirisuth N., Augsburger L.L., Eddington N.D. Development and validation of a non-linear IVIVC model for a diltiazem extended release formulation. Biopharm. Drug Dispos. 2002, 23:1-8.
    • (2002) Biopharm. Drug Dispos. , vol.23 , pp. 1-8
    • Sirisuth, N.1    Augsburger, L.L.2    Eddington, N.D.3
  • 18
    • 0025258954 scopus 로고
    • Release and absorption characteristics of novel theophylline sustained release formulations: in vitro-in vivo correlation
    • Hussein Z., Friedman M. Release and absorption characteristics of novel theophylline sustained release formulations: in vitro-in vivo correlation. Pharm. Res. 1990, 7:1167-1171.
    • (1990) Pharm. Res. , vol.7 , pp. 1167-1171
    • Hussein, Z.1    Friedman, M.2
  • 19
    • 0033843842 scopus 로고    scopus 로고
    • Biopharmaceutical characterization of oral theophylline and aminophylline tablets. Quantitative correlation between dissolution and bioavailability studies
    • Varshosaz J., Ghafghazi T., Raisi A., Falamarzian M. Biopharmaceutical characterization of oral theophylline and aminophylline tablets. Quantitative correlation between dissolution and bioavailability studies. Eur. J. Pharm. Biopharm. 2000, 50:301-306.
    • (2000) Eur. J. Pharm. Biopharm. , vol.50 , pp. 301-306
    • Varshosaz, J.1    Ghafghazi, T.2    Raisi, A.3    Falamarzian, M.4
  • 20
    • 0025277157 scopus 로고
    • Preliminary evaluation of the correlation between in vitro release and in vivo bioavailability of two aminophylline slow-release tablets
    • Shan-Yang L., Yuh-Horng K., Hsiao-Ning C. Preliminary evaluation of the correlation between in vitro release and in vivo bioavailability of two aminophylline slow-release tablets. J. Pharm. Sci. 1990, 79:326-330.
    • (1990) J. Pharm. Sci. , vol.79 , pp. 326-330
    • Shan-Yang, L.1    Yuh-Horng, K.2    Hsiao-Ning, C.3
  • 21
    • 27244450620 scopus 로고    scopus 로고
    • Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer
    • Ochoa L., Igartua M., Hernandez R.M., Gascon A.R., Pedraz J.L. Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer. J. Pharm. Pharm. Sci. 2005, 8:132-140.
    • (2005) J. Pharm. Pharm. Sci. , vol.8 , pp. 132-140
    • Ochoa, L.1    Igartua, M.2    Hernandez, R.M.3    Gascon, A.R.4    Pedraz, J.L.5
  • 22
    • 0021904208 scopus 로고
    • Analysis of Fickian and non-Fickian drug release from polymers
    • Peppas N.A. Analysis of Fickian and non-Fickian drug release from polymers. Pharm. Acta Helv. 1985, 60:110-111.
    • (1985) Pharm. Acta Helv. , vol.60 , pp. 110-111
    • Peppas, N.A.1
  • 24
    • 77952950951 scopus 로고    scopus 로고
    • Winnolin 4.1, Pharshigt Corporation, Mountain View, California,.
    • Winnolin 4.1, Pharshigt Corporation, Mountain View, California, 2003.
    • (2003)
  • 25
    • 77952954708 scopus 로고    scopus 로고
    • Food and Drug Administration: Guidance for Industry, Bioanalytical Methods Validation for Human Studies, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville, MD,.
    • Food and Drug Administration: Guidance for Industry, Bioanalytical Methods Validation for Human Studies, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville, MD, 1998.
    • (1998)
  • 26
    • 77952950809 scopus 로고
    • ICH, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Q2/R1 Validation of Analytical Procedures. Text and Methodology,.
    • ICH, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Q2/R1 Validation of Analytical Procedures. Text and Methodology, 1995.
    • (1995)
  • 27
    • 0000898845 scopus 로고
    • An analysis of variance test for normality (complete samples)
    • Shapiro S.S., Wilk M.B. An analysis of variance test for normality (complete samples). Biometrika 1965, 52:591-611.
    • (1965) Biometrika , vol.52 , pp. 591-611
    • Shapiro, S.S.1    Wilk, M.B.2
  • 28
    • 0003139708 scopus 로고
    • Robust tests for equality of variances, in: I. Olkin, S.G. Ghurye, W. Hoeffding, W.G. Madow, H.B. Mann (Eds.), Contribution to Probability and Statistics,
    • H. Levene, Robust tests for equality of variances, in: I. Olkin, S.G. Ghurye, W. Hoeffding, W.G. Madow, H.B. Mann (Eds.), Contribution to Probability and Statistics, 1960, pp. 278-292.
    • (1960) , pp. 278-292
    • Levene, H.1
  • 29
    • 0028915087 scopus 로고
    • In vitro-in vivo correlation studies on a novel controlled release theophylline delivery system and on Theo-Dur tablets
    • Munday D.L., Fassihi A.R. In vitro-in vivo correlation studies on a novel controlled release theophylline delivery system and on Theo-Dur tablets. Int. J. Pharm. 1995, 118:251-255.
    • (1995) Int. J. Pharm. , vol.118 , pp. 251-255
    • Munday, D.L.1    Fassihi, A.R.2
  • 30
    • 0038537306 scopus 로고    scopus 로고
    • A reappraisal of drug release laws using Monte Carlo simulations: the prevalence of the Weibull function
    • Kosmidis K., Argyrakis P., Macheras P. A reappraisal of drug release laws using Monte Carlo simulations: the prevalence of the Weibull function. Pharm. Res. 2003, 20:988-995.
    • (2003) Pharm. Res. , vol.20 , pp. 988-995
    • Kosmidis, K.1    Argyrakis, P.2    Macheras, P.3
  • 31
    • 31144453624 scopus 로고    scopus 로고
    • On the use of the Weibull function for the discernment of drug release mechanisms
    • Papadopoulou V., Kosmidis K., Vlachou M., Macheras P. On the use of the Weibull function for the discernment of drug release mechanisms. Int. J. Pharm. 2006, 309:44-50.
    • (2006) Int. J. Pharm. , vol.309 , pp. 44-50
    • Papadopoulou, V.1    Kosmidis, K.2    Vlachou, M.3    Macheras, P.4
  • 32
    • 0036197917 scopus 로고    scopus 로고
    • Understanding and predicting drug delivery from hydrophilic matrix tablets using the " sequential layer" model
    • Siepmann J., Streubel A., Peppas N.A. Understanding and predicting drug delivery from hydrophilic matrix tablets using the " sequential layer" model. Pharm. Res. 2002, 19:306-314.
    • (2002) Pharm. Res. , vol.19 , pp. 306-314
    • Siepmann, J.1    Streubel, A.2    Peppas, N.A.3
  • 33
    • 48149113652 scopus 로고    scopus 로고
    • Design and in vitro/in vivo evaluation of novel nicorandil extended release matrix tablets based on hydrophilic interpolymer complexes and a hydrophobic waxy polymer
    • Abdelbary G.A., Tadros M.I. Design and in vitro/in vivo evaluation of novel nicorandil extended release matrix tablets based on hydrophilic interpolymer complexes and a hydrophobic waxy polymer. Eur. J. Pharm. Biopharm. 2008, 69:1019-1028.
    • (2008) Eur. J. Pharm. Biopharm. , vol.69 , pp. 1019-1028
    • Abdelbary, G.A.1    Tadros, M.I.2
  • 34
    • 33745481304 scopus 로고    scopus 로고
    • Evaluation of melt granulation and ultrasonic spray congealing as techniques to enhance the dissolution of praziquantel
    • Passerini N., Albertini B., Perissutti B., Rodriguez L. Evaluation of melt granulation and ultrasonic spray congealing as techniques to enhance the dissolution of praziquantel. Int. J. Pharm. 2006, 318:92-102.
    • (2006) Int. J. Pharm. , vol.318 , pp. 92-102
    • Passerini, N.1    Albertini, B.2    Perissutti, B.3    Rodriguez, L.4
  • 36
    • 0038283006 scopus 로고    scopus 로고
    • Once-a-day controlled-release dosage form of divalproex sodium I: formulation design and in vitro/in vivo investigations
    • Qiu Y., Cheskin H.S., Engh K.R., Poska R.P. Once-a-day controlled-release dosage form of divalproex sodium I: formulation design and in vitro/in vivo investigations. J. Pharm. Sci. 2003, 92:1166-1173.
    • (2003) J. Pharm. Sci. , vol.92 , pp. 1166-1173
    • Qiu, Y.1    Cheskin, H.S.2    Engh, K.R.3    Poska, R.P.4
  • 37
    • 77952956942 scopus 로고    scopus 로고
    • Food and Drug Administration: Guidance for Industry. Extended Release Solid Oral Dosage Forms. Development, Evaluation and Application of In Vitro/In Vivo Correlations, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville, MD,.
    • Food and Drug Administration: Guidance for Industry. Extended Release Solid Oral Dosage Forms. Development, Evaluation and Application of In Vitro/In Vivo Correlations, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville, MD, 1997.
    • (1997)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.