Dose-response effect of combination hydrocodone with ibuprofen in patients with moderate to severe postoperative pain

Palangio, Mark; Wideman, Gilder L.; Keffer, Marie; Landau, Craig; Morris, E. W. T.; Doyle, Ralph T.; Jiang, John; Damask, Michael; Padova, Anthony de

doi:10.1016/s0149-2918(00)80070-3

Cited by 3 publications

(1 citation statement)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Historically, Hydrocodone has been used primarily as cough medicine [1,2] and for treating acute post operative pain [3]. Over time, there has been an increasing need for usage of the drug in relation to chronic pain in, among others, cancer, persistent musculoskeletal pain such as osteoarthritis and lower back pain [4].…”

Section: Introductionmentioning

confidence: 99%

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

Hemmingsen¹,

Haahr²,

Gunnergaard³

et al. 2011

Pharmaceutics

View full text Add to dashboard Cite

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.

show abstract