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Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms

Authorized Users Only
2013
Authors
Petrović, Aleksandra
Petricević, Sasa M.
Ristić, Slavica M.
Ibrić, Svetlana
Simić, Slobodanka
Đurić, Zorica
Popović, Radmila
Article (Published version)
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Abstract
Objective: The suitability of the rabbit as an animal model for the primary screening and selection of the pilot scale batches during the early stages of the formulation development was studied. Materials and methods: Three modified-release formulations of aminophylline consisted of Carbopol (R) 971P/HPMC K4M (F-I), and HPMC K100M (F-II) or HPMC K4M (F-III) were used. Commercial products were Aminofilin retard 350 mg tablets, Srbolek, Serbia (R-I) and Phyllocontin (R) 350, tablets Purdue Frederic, Canada (R-II). Results: Calculated release rate constants and the f2 values between R-I/F-I (84.1) and R-II/F-III (83.4) indicated similar in vitro release while the coefficient n showed presence of different mechanisms of release from Anomalous transport, Fickian diffusion to Case-II transport. Higher T-max, was found in the rabbits, dosed with F-II (12.00 h), F-III (10.50 h), and R-II (15.00 h) formulation. The highest C-max (9.22 mg/L) was obtained with F-II, similar lower values was seen ...for F-I and F-III, while commercial products showed the lowest values R-I (5.58 mg/L) and R-II (4.18 mg/L). Higher AUC values were detected for all three formulations (from 115.90 to 204.06 mgh/L) in relation to commercial products (105.33 and 113.25 mgh/L). Discussion and conclusion: The results demonstrated a good correlation of Level A (r(2) = 0.97) for the two formulations (F-I, F-III) and commercial product (R-I) indicates that there is a reasonable assumption that the rabbit might be use as a model for the preliminary comparison of scale up formulations in the early stages of the product development.

Keywords:
Modified release tablets / aminophylline / in vitro dissolution / rabbit / absorption in vivo / in vitro-in vivo / correlation
Source:
Drug Development and Industrial Pharmacy, 2013, 39, 6, 889-900
Publisher:
  • Informa Healthcare, London

DOI: 10.3109/03639045.2012.713364

ISSN: 0363-9045

PubMed: 22905673

WoS: 000318358300009

Scopus: 2-s2.0-84877010684
[ Google Scholar ]
5
4
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2002
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Petrović, Aleksandra
AU  - Petricević, Sasa M.
AU  - Ristić, Slavica M.
AU  - Ibrić, Svetlana
AU  - Simić, Slobodanka
AU  - Đurić, Zorica
AU  - Popović, Radmila
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2002
AB  - Objective: The suitability of the rabbit as an animal model for the primary screening and selection of the pilot scale batches during the early stages of the formulation development was studied. Materials and methods: Three modified-release formulations of aminophylline consisted of Carbopol (R) 971P/HPMC K4M (F-I), and HPMC K100M (F-II) or HPMC K4M (F-III) were used. Commercial products were Aminofilin retard 350 mg tablets, Srbolek, Serbia (R-I) and Phyllocontin (R) 350, tablets Purdue Frederic, Canada (R-II). Results: Calculated release rate constants and the f2 values between R-I/F-I (84.1) and R-II/F-III (83.4) indicated similar in vitro release while the coefficient n showed presence of different mechanisms of release from Anomalous transport, Fickian diffusion to Case-II transport. Higher T-max, was found in the rabbits, dosed with F-II (12.00 h), F-III (10.50 h), and R-II (15.00 h) formulation. The highest C-max (9.22 mg/L) was obtained with F-II, similar lower values was seen for F-I and F-III, while commercial products showed the lowest values R-I (5.58 mg/L) and R-II (4.18 mg/L). Higher AUC values were detected for all three formulations (from 115.90 to 204.06 mgh/L) in relation to commercial products (105.33 and 113.25 mgh/L). Discussion and conclusion: The results demonstrated a good correlation of Level A (r(2) = 0.97) for the two formulations (F-I, F-III) and commercial product (R-I) indicates that there is a reasonable assumption that the rabbit might be use as a model for the preliminary comparison of scale up formulations in the early stages of the product development.
PB  - Informa Healthcare, London
T2  - Drug Development and Industrial Pharmacy
T1  - Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms
VL  - 39
IS  - 6
SP  - 889
EP  - 900
DO  - 10.3109/03639045.2012.713364
ER  - 
@article{
author = "Petrović, Aleksandra and Petricević, Sasa M. and Ristić, Slavica M. and Ibrić, Svetlana and Simić, Slobodanka and Đurić, Zorica and Popović, Radmila",
year = "2013",
abstract = "Objective: The suitability of the rabbit as an animal model for the primary screening and selection of the pilot scale batches during the early stages of the formulation development was studied. Materials and methods: Three modified-release formulations of aminophylline consisted of Carbopol (R) 971P/HPMC K4M (F-I), and HPMC K100M (F-II) or HPMC K4M (F-III) were used. Commercial products were Aminofilin retard 350 mg tablets, Srbolek, Serbia (R-I) and Phyllocontin (R) 350, tablets Purdue Frederic, Canada (R-II). Results: Calculated release rate constants and the f2 values between R-I/F-I (84.1) and R-II/F-III (83.4) indicated similar in vitro release while the coefficient n showed presence of different mechanisms of release from Anomalous transport, Fickian diffusion to Case-II transport. Higher T-max, was found in the rabbits, dosed with F-II (12.00 h), F-III (10.50 h), and R-II (15.00 h) formulation. The highest C-max (9.22 mg/L) was obtained with F-II, similar lower values was seen for F-I and F-III, while commercial products showed the lowest values R-I (5.58 mg/L) and R-II (4.18 mg/L). Higher AUC values were detected for all three formulations (from 115.90 to 204.06 mgh/L) in relation to commercial products (105.33 and 113.25 mgh/L). Discussion and conclusion: The results demonstrated a good correlation of Level A (r(2) = 0.97) for the two formulations (F-I, F-III) and commercial product (R-I) indicates that there is a reasonable assumption that the rabbit might be use as a model for the preliminary comparison of scale up formulations in the early stages of the product development.",
publisher = "Informa Healthcare, London",
journal = "Drug Development and Industrial Pharmacy",
title = "Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms",
volume = "39",
number = "6",
pages = "889-900",
doi = "10.3109/03639045.2012.713364"
}
Petrović, A., Petricević, S. M., Ristić, S. M., Ibrić, S., Simić, S., Đurić, Z.,& Popović, R.. (2013). Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms. in Drug Development and Industrial Pharmacy
Informa Healthcare, London., 39(6), 889-900.
https://doi.org/10.3109/03639045.2012.713364
Petrović A, Petricević SM, Ristić SM, Ibrić S, Simić S, Đurić Z, Popović R. Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms. in Drug Development and Industrial Pharmacy. 2013;39(6):889-900.
doi:10.3109/03639045.2012.713364 .
Petrović, Aleksandra, Petricević, Sasa M., Ristić, Slavica M., Ibrić, Svetlana, Simić, Slobodanka, Đurić, Zorica, Popović, Radmila, "Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms" in Drug Development and Industrial Pharmacy, 39, no. 6 (2013):889-900,
https://doi.org/10.3109/03639045.2012.713364 . .

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