Diclofenac sodium multisource prolonged release tablets--a comparative study on the dissolution profiles.
The aim of this work was to compare the dissolution behaviour of six diclofenac sodium prolonged release tablets of different brands obtained from the national market. The formulations contain the same amount of drug substance but different types and/or amount of excipients. The influence of these differences in formulation on the release characteristics of the dosage forms was evaluated on the European Pharmacopoeia apparatus 2 (paddle) employing eight different dissolution media in the pH range 1.2-8. Friability and hardness were tested too according to the European Pharmacopoeia. Dissolution profiles obtained from the studied formulations showed that the release characteristics vary considerably among different manufacturers and that even identical formulations show rather dissimilar release profiles in all the studied media. Use of both SIF without pancreatin and SIF without pancreatin containing 1% (w/v) Tween 20 resulted in strong discrimination among products. A correlation between friability and hardness and in vitro dissolution was evidenced for two formulations having identical excipient composition.
Bertocchi
Paola
P
Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena, 299-00161 Rome, Italy.
Antoniella
Eleonora
E
Valvo
Luisa
L
Alimonti
Stefano
S
Memoli
Adriana
A
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000032:analysis*; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000008:administration & dosage* / Q000032:analysis*; D005079:Excipients; D006244:Hardness; D006863:Hydrogen-Ion Concentration; D012995:Solubility; D013501:Surface-Active Agents
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D005079:Excipients; D013501:Surface-Active Agents; D004008:Diclofenac