Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride

Charoo, Naseem A.; Abdallah, Daud Baraka; Parveen, Thahera; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D.W.; Langguth, Peter; Parr, Alan; Polli, James E.; Mehta, Mehul; Shah, Vinod P.; Tajiri, Tomokazu; Dressman, Jennifer B.

doi:10.1016/j.xphs.2020.06.007

“…[3][4][5][6] After systematically reviewing the data, it was organized in a format aligned with recently published biowaiver monographs for amoxicillin, fluconazole and moxifloxacin. [7][8][9] The solubility of sitagliptin and its release from the reference product were investigated at Al Ribat University, Khartoum. To determine the solubility, sitagliptin phosphate in an excess quantity was added to a predetermined volume of pH 1.2, 4.5, 5.6, 6.8 and 7.4 buffer solutions, prepared according to the European Pharmacopoeia.…”

Section: Methodsmentioning

confidence: 99%

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

Charoo¹,

Abdallah

²

,

Bakheit

³

et al. 2022

Journal of Pharmaceutical Sciences

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“…Evaluation of the API's physiochemical properties, pharmacokinetics, and interactions with excipients are considered for biowaiver risk-based analysis. Many of the monographs support biowaivers for specific drugs and their corresponding IR dosage formulations, such as metformin, sitagliptin, and moxifloxacin (18)(19)(20). Meanwhile, a smaller number of monographs suggest against biowaivers for specific drugs and their corresponding IR dosage formulations, such as carbamazepine (i.e., due to its narrow therapeutic index) (21).…”

Section: Bcs Classification and Bcs-based Biowaiversmentioning

confidence: 99%

Evaluation of Excipient Risk in BCS Class I and III Biowaivers

Metry

¹

,

Polli

²

2022

AAPS J

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The objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here.

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“…With increased investment in pharmaceutical R&D on a global scale, life-saving drugs could become more widely available and affordable to patients around the world (24). As a result, both the original pharmaceutical company and the copycat pharmaceutical company sometimes submit their products for approval to many regulatory agencies at the same time (25).…”

Section: Comparing Ema Fda and Who Requirements For Bcs Biowaiversmentioning

confidence: 99%

BCS Class II Drug & Its Solubility Enhancement: A Review

Bajpai¹,

Singh²,

Bisht³

et al. 2022

J. Res. Appl. Sci. Biotechnol.

0

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The objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here.

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride

Cited by 10 publications

References 88 publications

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

Evaluation of Excipient Risk in BCS Class I and III Biowaivers

BCS Class II Drug & Its Solubility Enhancement: A Review

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