Report of the workshop on: in vitro and in vivo testing and correlation for oral controlled/modified release dosage forms

Skelly, Jerome P.; Amidon, Gordon L.; Barr, William H.; Benet, Leslie Z.; Carter, James E.; Robinson, Joseph R.; Shah, Vinod P.; Yacobi, Avraham; Aiache, J M; Albert, Kenneth S.; Chinchilli, Vernon M.; Chun, Alexander; Davis, S.S.; DeSante, Karl A.; Dobrinska, Michael R.; Gallo-Torres, Hugo E.; Goldberg, Arthur H.; González, Mario A.; Gundert‐Remy, Ursula; Harter, John G.; Hubert, Barbara; Leeson, Lewis J.; Lipicky, Raymond J.; Mahnowski, Henry J.; Mauger, John W.; Meyer, James H.; Möller, H.; Mooney, Kevin; Nicklasson, A.; Noonan, Patrick K.; Rowland, Malcolm; Shiu, Gerald K.; Viswanathan, C. T.; Welling, Peter G.

doi:10.1016/0378-5173(90)90157-y

Cited by 21 publications

(18 citation statements)

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“…Existem vários estudos objetivando o desenvolvimento de modelos de correlação entre dados obtidos in vitro e o comportamento in vivo de fármacos (CIVIV) (Katori et al, 1995;Eddington et al, 1998;Balan et al, 2001;Rao et al, 2001). Estes estudos visam estabelecer correlações estatisticamente aceitáveis entre o processo de absorção do fármaco e sua liberação da forma farmacêu-tica determinada in vitro (Skelly et al, 1990;Cutler et al, 1997).…”

Section: Métodos In Vitro Para Determinação Da Absorção De Fármacosunclassified

Modelos in vitro para determinação da absorção de fármacos e previsão da relação dissolução/absorção

Souza

Freitas

Storpirtis

2007

Rev. Bras. Cienc. Farm.

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Section: Métodos In Vitro Para Determinação Da Absorção De Fármacosunclassified

Modelos in vitro para determinação da absorção de fármacos e previsão da relação dissolução/absorção

Souza

Freitas

Storpirtis

2007

Rev. Bras. Cienc. Farm.

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“…3 However, it is proposed in guidelines that a good method will employ a dissolution media that is physiologically meaningful or closely mimics in vivo conditions. 4,5 The lack of similarity between compendial methods for in vitro dissolution testing and physiologic conditions is cited as a reason for the inability to predict in vivo dissolution from in vitro data. dissolution performance/discrimination are selected as criteria, particularly for quality control functions.…”

Section: Introductionmentioning

confidence: 99%

“…10 However, there is yet no consensus as to which surfactant(s) or bile salts and what concentrations should be used to emulate in vivo conditions for routine dissolution testing. 4 The dissolution of solid dosage forms (disintegrating) is a complex process and involves multiple steps, as outlined by Carstensen. 11 Each step may be influenced to some degree by the mixture of surface active agents present in the media. Schott et al 12 suggested that release of drugs from tablets would be most influenced by surfactants through the mechanisms of wetting, micellar solubilization, and deflocculation.…”

Section: Introductionmentioning

confidence: 99%

Wetting Properties of Bile Salt Solutions and Dissolution Media

Luner

2000

Journal of Pharmaceutical Sciences

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“…These have also been reviewed extensively in the literature (4)(5)(6). The establishment of point-to-point correlations (level A IVIVC) is seen as the most desirable and most informative correlation.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate

Kesisoglou

Xia

Agrawal³

2015

AAPS J

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Abstract. In vitro-in vivo correlations (IVIVC) are predictive mathematical models describing the relationship between dissolution and plasma concentration for a given drug compound. The traditional deconvolution/convolution-based approach is the most common methodology to establish a level A IVIVC that provides point to point relationship between the in vitro dissolution and the in vivo input rate. The increasing application of absorption physiologically based pharmacokinetic model (PBPK) has provided an alternative IVIVC approach. The current work established and compared two IVIVC models, via the traditional deconvolution/convolution method and via absorption PBPK modeling, for two types of modified release (MR) formulations (matrix and multi-particulate tablets) of MK-0941, a BCS III drug development candidate. Three batches with distinct release rates were studied for each formulation technology. A two-stage linear regression model was used for the deconvolution/convolution approach while optimization of the absorption scaling factors (a model parameter that relates permeability and input rate) in Gastroplus TM Advanced Compartmental Absorption and Transit model was used for the absorption PBPK approach. For both types of IVIVC models established, and for either the matrix or the multiparticulate formulations, the average absolute prediction errors for AUC and C max were below 10% and 15%, respectively. Both the traditional deconvolution/convolution-based and the absorption/PBPK-based level A IVIVC model adequately described the compound pharmacokinetics to guide future formulation development. This case study highlights the potential utility of absorption PBPK model to complement the traditional IVIVC approaches for MR products.

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Report of the workshop on: in vitro and in vivo testing and correlation for oral controlled/modified release dosage forms

Cited by 21 publications

References 0 publications

Modelos in vitro para determinação da absorção de fármacos e previsão da relação dissolução/absorção

Modelos in vitro para determinação da absorção de fármacos e previsão da relação dissolução/absorção

Wetting Properties of Bile Salt Solutions and Dissolution Media

Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate

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