Once‐a‐Day Controlled‐Release Dosage form of Divalproex Sodium I: Formulation Design and in Vitro/in Vivo Investigations
Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder, and prophylaxis of migraine headaches. The present investigation was undertaken to design an oral dosage form that would provide once‐daily adm...
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| Published in | Journal of pharmaceutical sciences Vol. 92; no. 6; pp. 1166 - 1173 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Elsevier Inc
01.06.2003
Wiley Subscription Services, Inc., A Wiley Company Wiley American Pharmaceutical Association |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-3549 1520-6017 |
| DOI | 10.1002/jps.10385 |
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| Abstract | Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder, and prophylaxis of migraine headaches. The present investigation was undertaken to design an oral dosage form that would provide once‐daily administration with improved therapy and to explore the relationships between in vitro drug release and in vivo absorption. Controlled release hydrophilic matrix formulations of divalproex sodium were designed and evaluated via in vitro and in vivo studies. The release rate of divalproex sodium was modulated by varying different rate‐controlling hydrophilic polymers and measured in vitro using a USP apparatus II dissolution method. Formulations with differing release rates were studied in beagle dogs and in healthy subjects. A selected formulation given once‐daily was further evaluated against the commercial enteric tablet dosed twice‐daily in a multiple dose study, and shown to provide desired nearly constant therapeutic plasma concentrations over the entire 24‐h dosing interval. Preliminary linear relationships between in vitro dissolution and in vivo absorption were observed in both the animal model and in humans. However, the relationships were formulation dependent, indicating a need for further studies. © 2003 Wiley‐Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 92:1166–1173, 2003 |
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| AbstractList | Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder, and prophylaxis of migraine headaches. The present investigation was undertaken to design an oral dosage form that would provide once-daily administration with improved therapy and to explore the relationships between in vitro drug release and in vivo absorption. Controlled release hydrophilic matrix formulations of divalproex sodium were designed and evaluated via in vitro and in vivo studies. The release rate of divalproex sodium was modulated by varying different rate-controlling hydrophilic polymers and measured in vitro using a USP apparatus II dissolution method. Formulations with differing release rates were studied in beagle dogs and in healthy subjects. A selected formulation given once-daily was further evaluated against the commercial enteric tablet dosed twice-daily in a multiple dose study, and shown to provide desired nearly constant therapeutic plasma concentrations over the entire 24-h dosing interval. Preliminary linear relationships between in vitro dissolution and in vivo absorption were observed in both the animal model and in humans. However, the relationships were formulation dependent, indicating a need for further studies.Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder, and prophylaxis of migraine headaches. The present investigation was undertaken to design an oral dosage form that would provide once-daily administration with improved therapy and to explore the relationships between in vitro drug release and in vivo absorption. Controlled release hydrophilic matrix formulations of divalproex sodium were designed and evaluated via in vitro and in vivo studies. The release rate of divalproex sodium was modulated by varying different rate-controlling hydrophilic polymers and measured in vitro using a USP apparatus II dissolution method. Formulations with differing release rates were studied in beagle dogs and in healthy subjects. A selected formulation given once-daily was further evaluated against the commercial enteric tablet dosed twice-daily in a multiple dose study, and shown to provide desired nearly constant therapeutic plasma concentrations over the entire 24-h dosing interval. Preliminary linear relationships between in vitro dissolution and in vivo absorption were observed in both the animal model and in humans. However, the relationships were formulation dependent, indicating a need for further studies. Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder, and prophylaxis of migraine headaches. The present investigation was undertaken to design an oral dosage form that would provide once‐daily administration with improved therapy and to explore the relationships between in vitro drug release and in vivo absorption. Controlled release hydrophilic matrix formulations of divalproex sodium were designed and evaluated via in vitro and in vivo studies. The release rate of divalproex sodium was modulated by varying different rate‐controlling hydrophilic polymers and measured in vitro using a USP apparatus II dissolution method. Formulations with differing release rates were studied in beagle dogs and in healthy subjects. A selected formulation given once‐daily was further evaluated against the commercial enteric tablet dosed twice‐daily in a multiple dose study, and shown to provide desired nearly constant therapeutic plasma concentrations over the entire 24‐h dosing interval. Preliminary linear relationships between in vitro dissolution and in vivo absorption were observed in both the animal model and in humans. However, the relationships were formulation dependent, indicating a need for further studies. © 2003 Wiley‐Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 92:1166–1173, 2003 Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder, and prophylaxis of migraine headaches. The present investigation was undertaken to design an oral dosage form that would provide once-daily administration with improved therapy and to explore the relationships between in vitro drug release and in vivo absorption. Controlled release hydrophilic matrix formulations of divalproex sodium were designed and evaluated via in vitro and in vivo studies. The release rate of divalproex sodium was modulated by varying different rate-controlling hydrophilic polymers and measured in vitro using a USP apparatus II dissolution method. Formulations with differing release rates were studied in beagle dogs and in healthy subjects. A selected formulation given once-daily was further evaluated against the commercial enteric tablet dosed twice-daily in a multiple dose study, and shown to provide desired nearly constant therapeutic plasma concentrations over the entire 24-h dosing interval. Preliminary linear relationships between in vitro dissolution and in vivo absorption were observed in both the animal model and in humans. However, the relationships were formulation dependent, indicating a need for further studies. |
| Author | Qiu, Yihong Cheskin, Howard S. Engh, Kevin R. Poska, Richard P. |
| Author_xml | – sequence: 1 givenname: Yihong surname: Qiu fullname: Qiu, Yihong email: qiu.yihong@abbott.com organization: Formulation Center, Global Pharmaceutical Research and Development, Abbott Laboratories, 1401 N. Sheridan Rd, North Chicago, Illinois 60064 – sequence: 2 givenname: Howard S. surname: Cheskin fullname: Cheskin, Howard S. organization: Formulation Center, Global Pharmaceutical Research and Development, Abbott Laboratories, 1401 N. Sheridan Rd, North Chicago, Illinois 60064 – sequence: 3 givenname: Kevin R. surname: Engh fullname: Engh, Kevin R. organization: Formulation Center, Global Pharmaceutical Research and Development, Abbott Laboratories, 1401 N. Sheridan Rd, North Chicago, Illinois 60064 – sequence: 4 givenname: Richard P. surname: Poska fullname: Poska, Richard P. organization: Formulation Center, Global Pharmaceutical Research and Development, Abbott Laboratories, 1401 N. Sheridan Rd, North Chicago, Illinois 60064 |
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| Cites_doi | 10.1007/BF03257392 10.1016/0378-5173(87)90172-4 10.1016/0378-5173(84)90217-5 10.1016/0378-5173(91)90071-U 10.1016/0168-3659(90)90089-C 10.1016/0378-5173(89)90306-2 10.1002/jps.2600841213 10.1002/bdd.2510050102 |
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| Keywords | controlled release in vitro–in vivo relationship divalproex sodium in vitro release in vivo absorption matrix system Anticonvulsant Multiple dose Absorption Single daily dose Tablet Dog Release Human Fissipedia Carnivora Pharmaceutical technology Controlled release form Single dose Oral administration Valproic acid In vitro In vivo Vertebrata Mammalia Dosage form Active ingredient Pharmacokinetics in vitro-in vivo relationship |
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| References_xml | – volume: 5 start-page: 1 year: 1984 end-page: 10 ident: bb0080 article-title: Comparative pharmacokinetic analysis of a novel sustained release dosage form of valproic acid in the dogs publication-title: Biopharm Drug Dispos – year: 1996 ident: bb0035 article-title: Overview and summary of the clinical pharamcology of divaloproex sodium controlled‐release tablets – volume: 40 start-page: 223 year: 1987 end-page: 234 ident: bb0055 article-title: Importance of drug type, tablet shape and added diluents on drug relase kinetics from hydroxypropylmethylcellulose matrix tablets publication-title: Int J Pharm – volume: 60 start-page: 110 year: 1985 end-page: 111 ident: bb0045 article-title: Analaysis of Fickian and non‐Fickian drug release from polymers publication-title: Pharm Acta Helv – volume: 57 start-page: 169 year: 1989 end-page: 172 ident: bb0060 article-title: A simple equation for the description of solute release. III. Coupling of diffusion and relaxation publication-title: Int J Pharm – start-page: 465 year: 2000 end-page: 503 ident: bb0040 article-title: Research and development aspects of oral controlled release systems publication-title: Handbook of pharamceutical controlled release technology – year: 1992 ident: bb0025 – reference: Depakote® Tablet,Physicians' Desk Reference,2002. – start-page: 450 year: 1990 end-page: 453 ident: bb0020 article-title: Drugs effective in therapy of the epilepsies publication-title: Goodman and Gilman's the pharmacological basis of therapeutics – start-page: 527 year: 2000 end-page: 549 ident: bb0090 article-title: In vitro/in vivo correlations in the development of solid controlled‐release dosage forms publication-title: Handbook of pharmaceutical controlled releasee technology – volume: 71 start-page: 95 year: 1991 end-page: 104 ident: bb0050 article-title: Mathematical modeling of drug relase from hydroxypropyl‐methylcellulose matrices: Effect of temperature publication-title: Int J Pharm – volume: 84 start-page: 1455 year: 1995 end-page: 1463 ident: bb0070 article-title: Drug release from hydrophilic matrices: (I) New scaling laws for predicting polymer and drug release based on the polymer disentaglement concentration and the diffusion layer publication-title: J Pharm Sci – volume: 12 start-page: 133 year: 1990 end-page: 141 ident: bb0065 article-title: Influence of molecular size and water solubility of the solute on its release from swelling and erosion controlled polymeric matrices publication-title: J Controlled Release – start-page: 235 year: 1991 end-page: 266 ident: bb0085 article-title: Animal models for oral drug absorption publication-title: Pharmaceutical bioequivalence – volume: 7 start-page: 1 year: 1994 end-page: 7 ident: bb0015 article-title: Pharmacokinetics of multiple oral dose divalproex sodium after intravenous loading dose administration in healthy volunteers publication-title: Drug Invest – reference: TDx® Reagent Package Manual. 1992. 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J Controlled Release 12: 133-141. – reference: Ju TCR, Nixon PR, Patel VN. 1995. Drug release from hydrophilic matrices: (I) New scaling laws for predicting polymer and drug release based on the polymer disentaglement concentration and the diffusion layer. J Pharm Sci 84: 1455-1463. – reference: Ford JL, Mitchell K, Rowe P, Armstrong DJ, Elliott PNC, Rostron C, Hogan JE. 1991. Mathematical modeling of drug relase from hydroxypropyl-methylcellulose matrices: Effect of temperature. Int J Pharm 71: 95-104. – reference: Samara E. 1996. Overview and summary of the clinical pharamcology of divaloproex sodium controlled-release tablets. Abbott Park, IL: Abbott Laboratories, Abbott Internal Scientific Report. – reference: Peppas NA, Sahlin JJ. 1989. A simple equation for the description of solute release. III. Coupling of diffusion and relaxation. Int J Pharm 57: 169-172. – reference: Bailer M, Friedman M, Dubrovsky J. 1984. 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III. 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| Snippet | Divalproex sodium is a narrow therapeutic index drug that is widely used for the treatment of epilepsy, the manic episodes associated with bipolar disorder,... |
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| SubjectTerms | Animals Anticonvulsants - administration & dosage Anticonvulsants - blood Anticonvulsants - pharmacokinetics Anticonvulsants. Antiepileptics. Antiparkinson agents Biological and medical sciences Chemistry, Pharmaceutical controlled release Cross-Over Studies Delayed-Action Preparations divalproex sodium Dogs Drug Administration Schedule Drug Compounding Excipients Humans in vitro release In Vitro Techniques in vitro-in vivo relationship in vivo absorption Intestinal Absorption matrix system Medical sciences Methylcellulose Neuropharmacology Pharmacology. Drug treatments Tablets Time Factors Valproic Acid - administration & dosage Valproic Acid - blood Valproic Acid - pharmacokinetics |
| Title | Once‐a‐Day Controlled‐Release Dosage form of Divalproex Sodium I: Formulation Design and in Vitro/in Vivo Investigations |
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