Lyrica capsules

The protocols used for animal studies were consistent with the National Institutes of Health Policy and Animal Welfare Act and were approved by the Institutional Animal Care and Use Committee at Orient Bio, Inc. (Seongnam, Korea). Briefly, twelve male beagles (Covance Research Products Inc., USA) were fasted for 16 h before the experiment. They were divided into two groups and given 80 g of foodstuff 40 min before the oral administration of the drug formulation. An IR capsule of 75 mg (Lyrica capsules, Pfizer) was administered twice daily to group 1 for reference, while group 2 received a TL1 tablet of 150 mg once daily. Each drug of IR capsule and TL1 tablet was administered with 10 mL of water. Blood samples were then collected from the cephalic vein of each dog at the scheduled times. The IR capsule (pregabalin 75 mg) was given twice a day (0 and 10 h) and blood samples were collected at predetermined time points (0, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 10.5, 11, 11.5, 12, 14, 16, 18, and 24). The TL1 tablet (pregabalin 150 mg) was given once a day and blood samples were withdrawn at predetermined time points (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, and 24 h). Samples were immediately centrifuged and stored at −70°C prior to analysis.

Pregabalin was purchased from MSN Pharmachem (India). PEO (Polyox WSR 303) was purchased from Dow Chemical. Microcrystalline cellulose (MCC, Vivapur^® 12) was purchased from JRS Pharma (Germany), povidone (Kollidon^® 90F) from BASF (Germany), L-tartaric acid from Caviro (Italy), and D-mannitol from Roquette. All other excipients used were of pharmaceutical grade. All reagents used in the analyses were of analytical grade. An IR formulation (Lyrica Capsules, Pfizer) was used as a reference drug for pharmacokinetic studies.