Pharmaceutics 2011, 3(1), 73-87; doi:10.3390/pharmaceutics3010073
Article

Development of a New Type of Prolonged Release Hydrocodone Formulation Based on Egalet® ADPREM Technology Using In Vivo–In Vitro Correlation

1 Egalet Denmark, Lejrvej 37-41, DK-3500 Værløse, Denmark 2 Biopharmaceutical Department, ERT-CIDAM, Faculty of Pharmacy, University of Auvergne, 28 Place H. Dunant, BP 38, 63001 Clermont-Ferrand, France
* Author to whom correspondence should be addressed.
Received: 6 February 2011; in revised form: 28 February 2011 / Accepted: 4 March 2011 / Published: 9 March 2011
(This article belongs to the Special Issue Recent Developments and Future Perspectives in Dissolution Testing)
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Abstract: A novel abuse deterrent, prolonged release tablet formulation of Hydrocodone for once-daily dosing has been developed, based on the novel proprietary Egalet® ADPREM technology. The tablet is an injection molded polymer system consisting of an erodible matrix in which the Active Pharmaceutical Ingredient (API), such as Hydrocodone, is dispersed. The matrix is partly covered with a water-impermeable, non-erodible shell which leaves both ends of the cylindrical tablet exposed to erosion by the gastrointestinal (GI) fluid. In vivo–in vitro correlation (IVIVC) was initiated and validated with three formulations. A good internal predictability was observed for the three formulations. How the changing conditions in the GI tract influenced in vivo performance of an erosion based product was discussed. The validated IVIVC could be used to optimize the tablet formulation and to obtain a desired profile. In addition, this technique could help to establish the dissolution limits in which a certainty of bioequivalence is calculated. Based on this validated level A IVIVC, dissolution can be used as surrogate of bioequivalence for development, but also scale up post approval changes.
Keywords: hydrocodone; controlled release; opioid; pain management; IVIVC; dissolution; Abuse Deterrent Erodible Matrix technology; oral solid dosage form

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MDPI and ACS Style

Hemmingsen, P.H.; Haahr, A.-M.; Gunnergaard, C.; Cardot, J.-M. Development of a New Type of Prolonged Release Hydrocodone Formulation Based on Egalet® ADPREM Technology Using In Vivo–In Vitro Correlation. Pharmaceutics 2011, 3, 73-87.

AMA Style

Hemmingsen PH, Haahr A-M, Gunnergaard C, Cardot J-M. Development of a New Type of Prolonged Release Hydrocodone Formulation Based on Egalet® ADPREM Technology Using In Vivo–In Vitro Correlation. Pharmaceutics. 2011; 3(1):73-87.

Chicago/Turabian Style

Hemmingsen, Pernille H.; Haahr, Anne-Mette; Gunnergaard, Christine; Cardot, Jean-Michel. 2011. "Development of a New Type of Prolonged Release Hydrocodone Formulation Based on Egalet® ADPREM Technology Using In Vivo–In Vitro Correlation." Pharmaceutics 3, no. 1: 73-87.

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