Bicarbonate buffer dissolution test with gentle mechanistic stress for bioequivalence prediction of enteric-coated pellet formulations
This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference formulation (RF); Cymbalta® 30 mg capsule) and four generic test formulations (two capsules (CP) and two orally disi...
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| Published in | European journal of pharmaceutical sciences Vol. 192; p. 106622 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier B.V
01.01.2024
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0928-0987 1879-0720 1879-0720 |
| DOI | 10.1016/j.ejps.2023.106622 |
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| Abstract | This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference formulation (RF); Cymbalta® 30 mg capsule) and four generic test formulations (two capsules (CP) and two orally disintegrating tablets (OD)) were used as model formulations. Clinical BE studies were conducted on 24–47 healthy male subjects under fasting conditions. Dissolution tests were performed using a compendial paddle method (PD) (paddle speed: 50 rpm) and a flow-through cell method (FTC) (flow rate: 4 mL/min). For a further test, cotton balls were added to the vessel to apply gentle mechanistic stress to the formulations, and paddle speed was reduced to 10 rpm (paddle with cotton ball method (PDCB)).All the dissolution tests were conducted with 0.01 M HCl (pH 2.0) for 0.5 h followed by 10 mM bicarbonate buffer solutions (pH 6.5) for 4 h. One each of the two CP and two OD showed BE with RF. PDCB was able to discriminate between BE and non-BE formulations, while this was not possible with PD and FTC. In PDCB, the cotton balls intermittently moved the pellets near the vessel bottom. PDCB is useful for predicting BE during formulation development.
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| AbstractList | This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference formulation (RF); Cymbalta® 30 mg capsule) and four generic test formulations (two capsules (CP) and two orally disintegrating tablets (OD)) were used as model formulations. Clinical BE studies were conducted on 24-47 healthy male subjects under fasting conditions. Dissolution tests were performed using a compendial paddle method (PD) (paddle speed: 50 rpm) and a flow-through cell method (FTC) (flow rate: 4 mL/min). For a further test, cotton balls were added to the vessel to apply gentle mechanistic stress to the formulations, and paddle speed was reduced to 10 rpm (paddle with cotton ball method (PDCB)).All the dissolution tests were conducted with 0.01 M HCl (pH 2.0) for 0.5 h followed by 10 mM bicarbonate buffer solutions (pH 6.5) for 4 h. One each of the two CP and two OD showed BE with RF. PDCB was able to discriminate between BE and non-BE formulations, while this was not possible with PD and FTC. In PDCB, the cotton balls intermittently moved the pellets near the vessel bottom. PDCB is useful for predicting BE during formulation development. This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference formulation (RF); Cymbalta® 30 mg capsule) and four generic test formulations (two capsules (CP) and two orally disintegrating tablets (OD)) were used as model formulations. Clinical BE studies were conducted on 24-47 healthy male subjects under fasting conditions. Dissolution tests were performed using a compendial paddle method (PD) (paddle speed: 50 rpm) and a flow-through cell method (FTC) (flow rate: 4 mL/min). For a further test, cotton balls were added to the vessel to apply gentle mechanistic stress to the formulations, and paddle speed was reduced to 10 rpm (paddle with cotton ball method (PDCB)).All the dissolution tests were conducted with 0.01 M HCl (pH 2.0) for 0.5 h followed by 10 mM bicarbonate buffer solutions (pH 6.5) for 4 h. One each of the two CP and two OD showed BE with RF. PDCB was able to discriminate between BE and non-BE formulations, while this was not possible with PD and FTC. In PDCB, the cotton balls intermittently moved the pellets near the vessel bottom. PDCB is useful for predicting BE during formulation development.This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference formulation (RF); Cymbalta® 30 mg capsule) and four generic test formulations (two capsules (CP) and two orally disintegrating tablets (OD)) were used as model formulations. Clinical BE studies were conducted on 24-47 healthy male subjects under fasting conditions. Dissolution tests were performed using a compendial paddle method (PD) (paddle speed: 50 rpm) and a flow-through cell method (FTC) (flow rate: 4 mL/min). For a further test, cotton balls were added to the vessel to apply gentle mechanistic stress to the formulations, and paddle speed was reduced to 10 rpm (paddle with cotton ball method (PDCB)).All the dissolution tests were conducted with 0.01 M HCl (pH 2.0) for 0.5 h followed by 10 mM bicarbonate buffer solutions (pH 6.5) for 4 h. One each of the two CP and two OD showed BE with RF. PDCB was able to discriminate between BE and non-BE formulations, while this was not possible with PD and FTC. In PDCB, the cotton balls intermittently moved the pellets near the vessel bottom. PDCB is useful for predicting BE during formulation development. This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference formulation (RF); Cymbalta® 30 mg capsule) and four generic test formulations (two capsules (CP) and two orally disintegrating tablets (OD)) were used as model formulations. Clinical BE studies were conducted on 24–47 healthy male subjects under fasting conditions. Dissolution tests were performed using a compendial paddle method (PD) (paddle speed: 50 rpm) and a flow-through cell method (FTC) (flow rate: 4 mL/min). For a further test, cotton balls were added to the vessel to apply gentle mechanistic stress to the formulations, and paddle speed was reduced to 10 rpm (paddle with cotton ball method (PDCB)).All the dissolution tests were conducted with 0.01 M HCl (pH 2.0) for 0.5 h followed by 10 mM bicarbonate buffer solutions (pH 6.5) for 4 h. One each of the two CP and two OD showed BE with RF. PDCB was able to discriminate between BE and non-BE formulations, while this was not possible with PD and FTC. In PDCB, the cotton balls intermittently moved the pellets near the vessel bottom. PDCB is useful for predicting BE during formulation development. [Display omitted] |
| ArticleNumber | 106622 |
| Author | Nakagawa, Hidetoshi Kai, Toshiya Sugano, Kiyohiko Ikuta, Shotaro |
| Author_xml | – sequence: 1 givenname: Shotaro surname: Ikuta fullname: Ikuta, Shotaro email: ikuta-shotaro@nipro.co.jp organization: Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan – sequence: 2 givenname: Hidetoshi surname: Nakagawa fullname: Nakagawa, Hidetoshi organization: Pharmaceutical Research Laboratories, Pharmaceutical Department, Nipro Corporation, 3023, Noji-Cho, Kusatsu, Shiga 525-0055, Japan – sequence: 3 givenname: Toshiya surname: Kai fullname: Kai, Toshiya organization: Pharmaceutical Research Laboratories, Pharmaceutical Department, Nipro Corporation, 3023, Noji-Cho, Kusatsu, Shiga 525-0055, Japan – sequence: 4 givenname: Kiyohiko surname: Sugano fullname: Sugano, Kiyohiko organization: Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan |
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| Cites_doi | 10.1023/A:1026147620304 10.1021/acs.molpharmaceut.6b01129 10.1016/j.ejps.2022.106326 10.14227/DT120105P11 10.1016/j.jconrel.2020.06.031 10.1136/gut.27.8.886 10.1248/cpb.c20-00247 10.1016/S0168-3659(00)00194-2 10.1016/j.ejpb.2021.09.009 10.1016/S0168-3659(02)00067-6 10.1023/A:1016231010301 10.1111/jphp.12540 10.1081/DDC-120003856 10.1208/s12248-012-9422-x 10.1016/j.ejps.2014.05.007 10.2165/00003088-200847030-00005 10.1016/j.ejpb.2014.01.007 10.1111/j.2042-7158.2012.01477.x 10.1016/j.ejpb.2008.05.029 10.1007/s11095-021-03153-2 10.1016/j.ejpb.2012.07.011 10.1016/j.ijpharm.2010.09.022 10.1016/j.ejpb.2013.09.009 10.1016/j.ijpharm.2022.122531 10.1021/acs.molpharmaceut.5b00076 10.1016/0378-5173(92)90135-O 10.1016/j.ejpb.2011.01.001 10.1021/mp800148u |
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| Keywords | Mechanistic stress Bicarbonate Floating lid Enteric-coated Bioequivalence Dissolution test |
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| SubjectTerms | Bicarbonate Bicarbonates Bioequivalence Dissolution test Duloxetine Hydrochloride Enteric-coated Floating lid Humans Male Mechanistic stress Solubility Tablets Tablets, Enteric-Coated Therapeutic Equivalency |
| Title | Bicarbonate buffer dissolution test with gentle mechanistic stress for bioequivalence prediction of enteric-coated pellet formulations |
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