Pregabalin Capsules
【CONTENTS】Pregabalin and Pregabalin Capsules(LYRICA)
【SPECIFICATIONS】150mg, 75mg
【INDICATIONS】 Management of postherpetic neuralgia
【DOSAGE AND ADMINISTRATION】
The recommended dose of LYRICA is 75 to 150 mg two times a day. The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
【REGISTRY CLASSIFICATION】6+6
【INTRODUCTION】
LYRICA was first developed by Pfizer, which was approved by EMA in July 2004 and was approved by FDA in December 2004. Pregabalin Capsules entered the Chinese market in August 2010 and have been used on the treatment of postherpetic neuralgia.
Pregabalin is a new regulator of calcium ion channel -non γ-amino butyric acid (GABA) receptor stimulant or antagonist,which can block the voltage dependent calcium channels and reduce the neurotransmitter release. Pregabalin is widely accepted as a drug for patients with peripheral neuropathy or circumscribed partial onset seizures.In 2007,experts from The International Association for the Study of Pain (IASP) all recommended that Lyrica could be viewed as the first-line drug on the treatment of postherpetic neuralgia.In 2010,British NICE guide recommended only Lyrica could simultaneously relieve central and peripheral neuropathy .
【INTELLECTUAL PROPERTY】
There is no risk of infringement.
【TRANSFER TARGETS】
Process of active pharmaceutical ingredients
Process of tablets production
Data for declaring
【RESEARCH PROGRESS】
Active pharmaceutical ingredients
Enlarge production has completed. The size of enlarge production is 5Kg each batch.
Capsules
Enlarge production has completed. The size of enlarge production is 50 thousand each batch.
Study of test methods has completed.