Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
Cast your vote
You can rate an item by clicking the amount of stars they wish to award to this item.
When enough users have cast their vote on this item, the average rating will also be shown.
Your vote was cast
Thank you for your feedback
Thank you for your feedback
AuthorsHofsäss, Martin A
Souza, Jacqueline de
Silva-Barcellos, Neila M
Bellavinha, Karime R
Groot, D W
Polli, James E
Shah, Vinod P
Mehta, Mehul U
Dressman, Jennifer B
MetadataShow full item record
TitleBiowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
Published inJ Pharm Sci 2017, 106(12):3421-430
PubliekssamenvattingThis work presents a review of literature and experimental data relevant to the possibility of waiving pharmacokinetic bioequivalence studies in human volunteers for approval of immediate-release solid oral pharmaceutical forms containing folic acid as the single active pharmaceutical ingredient. For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble." Small, physiological doses of folic acid (≤320 μg) seem to be absorbed completely via active transport, but permeability data for higher doses of 1-5 mg are inconclusive. Following a conservative approach, folic acid is classified as a Biopharmaceutics Classification System class IV compound until more reliable data become available. Commensurate with its solubility characteristics, the results of dissolution studies indicated that none of the folic acid products evaluated showed rapid dissolution in media at pH 1.2 or 4.5. Therefore, according to the current criteria of the Biopharmaceutics Classification System, the biowaiver approval procedure cannot be recommended for immediate-release solid oral dosage forms containing folic acid.
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate.
- Authors: Thambavita D, Galappatthy P, Mannapperuma U, Jayakody L, Cristofoletti R, Abrahamsson B, Groot DW, Langguth P, Mehta M, Parr A, Polli JE, Shah VP, Dressman J
- Issue date: 2017 Oct
- Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.
- Authors: Plöger GF, Quizon PM, Abrahamsson B, Cristofoletti R, Groot DW, Parr A, Langguth P, Polli JE, Shah VP, Tajiri T, Mehta MU, Dressman J
- Issue date: 2020 Jun
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.
- Authors: Charoo NA, Abdallah DB, Parveen T, Abrahamsson B, Cristofoletti R, Groot DW, Langguth P, Parr A, Polli JE, Mehta M, Shah VP, Tajiri T, Dressman J
- Issue date: 2020 Sep
- Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole.
- Authors: Charoo N, Cristofoletti R, Graham A, Lartey P, Abrahamsson B, Groot DW, Kopp S, Langguth P, Polli J, Shah VP, Dressman J
- Issue date: 2014 Dec
- Biowaiver monographs for immediate release solid oral dosage forms: piroxicam.
- Authors: Shohin IE, Kulinich JI, Ramenskaya GV, Abrahamsson B, Kopp S, Langguth P, Polli JE, Shah VP, Groot DW, Barends DM, Dressman JB
- Issue date: 2014 Feb