446
Views
5
CrossRef citations to date
0
Altmetric
Original Research

Formulation and bioequivalence studies of choline alfoscerate tablet comparing with soft gelatin capsule in healthy male volunteers

, , , , &
Pages 1049-1058 | Published online: 05 Apr 2019

References

  • ParnettiLMigniniFTomassoniDTrainiEAmentaFCholinergic precursors in the treatment of cognitive impairment of vascular origin: ineffective approaches or need for re-evaluation?J Neurol Sci20072571–226426917331541
  • De Jesus Moreno MorenoMCognitive improvement in mild to moderate Alzheimer’s dementia after treatment with the acetylcholine precursor choline alfoscerate: a multicenter, double-blind, randomized, placebo-controlled trialClin Ther200325117819312637119
  • GattiGBarzaghiNAcutoGAbbiatiGFossatiTPeruccaEA comparative study of free plasma choline levels following intramuscular administration of L-alpha-glycerylphosphorylcholine and citicoline in normal volunteersInt J Clin Pharmacol Ther Toxicol19923093313351428296
  • KangH-AKimS-MKangS-RBioequivalence of Cholicerin soft capsule to Gliatilin soft capsule (choline Alphoscerate 400 Mg)J Pharm Investig2010402109115
  • ChoiS-UChoS-WFormulation of liquid choline Alphoscerate as a solid dosage formJ Korea Acad Industr Coop Soc2013141263246329
  • HelmisMMohamadBKumpugdee-VollrathMInfluence of several excipients on drug release of tablets containing resveratrolM J Phar20161217
  • TrainiEBramantiVAmentaFCholine alphoscerate (alpha-glycerylphosphoryl-choline) an old choline-containing phospholipid with a still interesting profile as cognition enhancing agentCurr Alzheimer Res201310101070107924156263
  • ZeiselSHPhosphatidylcholine: endogenous precursor of cholineLecithinBoston, MASpringer1987107120
  • EMAGuideline on the investigation of bioequivalence2010 Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev.1. Available from: https://www.ema.europa.eu/investigation-bioequivalenceAccessed November 4, 2018
  • Korea Food & Drug Administration (KFDA)Guideline for management of bioequivalence test (KFDA notification No. 2013-115)2013 Available from: www.bio-core.com/UpFiles/NewsLetter/201308/5.pdfAccessed November 4, 2018
  • AnBNMinMHParkJHTablets containing choline alfoscerate and methods for making the sameKorean patent10-162893720141142018
  • GreenspanLHumadity fixed points of binary saturated aqueous solutionsJ Res Natl Bur Stand19778118996
  • The Korean Pharmacopoeia eleventh editionCholine alfoscerate capsulesP12692014 P1269. Available from: https://nedrug.mfds.go.kr/bbs/5/1/Accessed February 11, 2019
  • World Medical AssociationWMA Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects2008 Available from: https://www.wma.net/wp-content/uploads/2018/07/DoH-Oct2008.pdfAccessed January 4, 2019
  • HolmPIUelandPMKvalheimGLienEADetermination of choline, betaine, and dimethylglycine in plasma by a high-throughput method based on normal-phase chromatography-tandem mass spectrometryClin Chem200349228629412560353
  • FDA GuidanceUpdated draft guidance on progesterone2011 Available from: https://www.fda.gov/downloads/drugs/guidancecompliance-regulatoryinformation/guidances/ucm209294.pdfAccessed December 22, 2018
  • LeeYJKimYGLeeMGAnalysis of bioequivalence study using log-transformed modelYakhakhoeji2000444308314
  • TakkaSSakrAGoldbergADevelopment and validation of an in vitro-in vivo correlation for buspirone hydrochloride extended release tabletsJ Control Release200388114715712586512
  • LeeYJChoiJHSongSHDevelopment of K-BE test, a computer program for the analysis of bioequivalenceJ Kor Pharm Sci199828223229
  • RoweRCSheskeyPJQuinnMEHandbook of Pharmaceutical Excipients6th edLondonPharmaceutical Press2009