Biowaiver Monographs for Immediate Release Solid Oral Dosage forms: Metoclopramide Hydrochloride

Stosik, Andrea; Junginger, Hans E.; Kopp, Sabine; Midha, K. K.; Shah, Vinod P.; Stavchansky, Salomon A; Dressman, Jennifer B.; Barends, D. M.

doi:10.1002/jps.21276

Cited by 38 publications

(27 citation statements)

References 30 publications

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“…MET exists as a base, as a monohydrochloride, and as a dihydrochloride (23). Both the European Pharmacopoeia and the United States Pharmacopeia (USP) use the name 'metoclopramide hydrochloride' for the monohydrochloride monohydrate (23).…”

Section: Chemicalsmentioning

confidence: 99%

“…Metoclopramide (MET) is a centrally acting anti-emetic and prokinetic agent widely used for the treatment of ileus, gastro-oesophageal reflux disease, dyspepsia, nausea, and vomiting during migraine or cancer therapy (2,22,23). The recommended dose for MET is 10 mg (hydrochloride, HCl), according to the WHO Model List of Essential Medicines (24).…”

mentioning

confidence: 99%

“…The recommended dose for MET is 10 mg (hydrochloride, HCl), according to the WHO Model List of Essential Medicines (24). In the BCS framework, MET is conservatively assigned to Class 3, or a boundary Class 1/3, depending on the reviewed literature (2,22,23). MET has a biowaiver recommendation if, according to the biowaiver monograph, (a) the test product contains only excipients also present in MET HCl containing IR solid oral drug products approved in ICH or associated countries, (b) in amounts in normal use in IR solid oral dosage forms, and (c) the test product and the comparator both comply with the criteria for 'very rapidly dissolving' (5,23).…”

mentioning

confidence: 99%

“…In the BCS framework, MET is conservatively assigned to Class 3, or a boundary Class 1/3, depending on the reviewed literature (2,22,23). MET has a biowaiver recommendation if, according to the biowaiver monograph, (a) the test product contains only excipients also present in MET HCl containing IR solid oral drug products approved in ICH or associated countries, (b) in amounts in normal use in IR solid oral dosage forms, and (c) the test product and the comparator both comply with the criteria for 'very rapidly dissolving' (5,23). In those cases, the risk to accept a bioinequivalent drug product is extremely low, and if a bioinequivalent product passes the evaluation, the consequences for the patient will not be serious (5,23).…”

mentioning

confidence: 99%

“…MET has a biowaiver recommendation if, according to the biowaiver monograph, (a) the test product contains only excipients also present in MET HCl containing IR solid oral drug products approved in ICH or associated countries, (b) in amounts in normal use in IR solid oral dosage forms, and (c) the test product and the comparator both comply with the criteria for 'very rapidly dissolving' (5,23). In those cases, the risk to accept a bioinequivalent drug product is extremely low, and if a bioinequivalent product passes the evaluation, the consequences for the patient will not be serious (5,23). Moreover, in these cases where 85% of the labeled amount is dissolved within 15 minutes (for the test and reference products in all media), the similarity of dissolution profiles may be accepted as demonstrated without any mathematical evaluation (i.e., f 2 calculation) (4,8,9,25,26).…”

mentioning

confidence: 99%

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Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

Varillas¹,

Brevedan²,

Vidal³

2018

Dissolution Technol.

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Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient (API), in the same dosage form, meet comparable quality standards, and are intended to be administered by the same route. Pharmaceutical equivalents imply therapeutical equivalence when, after administration, their effects are essentially the same; these effects can be demonstrated by bioequivalence studies or, in some cases, by in vitro studies based on the Biopharmaceutics Classification System. In this scheme, biowaivers are recommended for immediate-release solid oral dosage forms containing Class 3 drugs (like Metoclopramide) using dissolution testing as a surrogate for in vivo bioequivalence studies, with special consideration regarding excipient composition. The present work aimed to compare in vitro dissolution characteristics and other critical quality attributes of Metoclopramide tablets purchased in Argentina to establish their pharmaceutical equivalence and similarity. All evaluated products fulfill the pharmaceutical equivalence criteria. Three of the tested products and the reference formulation complied with the criteria for 'very rapidly dissolving,' so they could be described as essentially similar. Nevertheless, it is important to have access to additional information about the excipient composition of these formulations to assure a safe interchangeability process for this Class 3 drug.

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Section: Chemicalsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 3 more Smart Citations

Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

Varillas¹,

Brevedan²,

Vidal³

2018

Dissolution Technol.

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show abstract

Provisional BCS Classification of the Leading Oral Drugs on the Global Market

Dahan

Amidon

2010

Burger's Medicinal Chemistry and Drug Discovery

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In the early 1990s, a collaborative research effort between academia and the U.S. Food and Drug Administration (FDA) was initiated to establish a database of human jejunal permeabilities based on a Biopharmaceutics Classification System (BCS). The BCS broadly allowed the prediction of human absorption, Fraction absorbed ( F abs ) and the rate‐limiting step in the intestinal absorption process of drugs following oral administration. The BCS classified compounds into one of four biopharmaceutical classes according to water solubility and membrane permeability characteristics. Today, the BCS has generated remarkable impact on the global pharmaceutical sciences arena, in drug discovery, development and regulation, and an extensive validation/discussion of the BCS is continuously published in the literature. BCS has been effectively implanted by drug regulatory agencies around the world, and widely practiced by the pharmaceutical industry. The aim of this chapter is to present the BCS and its scientific basis, to describe its impact on regulatory practice of oral drug products, and to access the BCS classification of the top drugs on the global market. Finally, current and future directions in BCS related extensions, and their impact on the pharmaceutical industry, will be discussed.

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Provisional BCS Classification of the Leading Oral Drugs on the Global Market

Dahan

Amidon

2021

Burger's Medicinal Chemistry and Drug Discovery

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In the early 1990s, a collaborative research effort between academia and the U.S. Food and Drug Administration (FDA) was initiated to establish a database of human jejunal permeabilities based on a Biopharmaceutics Classification System (BCS). The BCS broadly allowed the prediction of human absorption, Fraction absorbed ( F abs ) and the rate‐limiting step in the intestinal absorption process of drugs following oral administration. The BCS classified compounds into one of four biopharmaceutical classes according to water solubility and membrane permeability characteristics. Today, the BCS has generated remarkable impact on the global pharmaceutical sciences arena, in drug discovery, development and regulation, and an extensive validation/discussion of the BCS is continuously published in the literature. BCS has been effectively implanted by drug regulatory agencies around the world, and widely practiced by the pharmaceutical industry. The aim of this article is to present the BCS and its scientific basis, to describe its impact on regulatory practice of oral drug products, and to access the BCS classification of the top drugs on the global market. Finally, current and future directions in BCS related extensions, and their impact on the pharmaceutical industry, will be discussed.

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Biowaiver Monographs for Immediate Release Solid Oral Dosage forms: Metoclopramide Hydrochloride

Cited by 38 publications

References 30 publications

Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

Provisional BCS Classification of the Leading Oral Drugs on the Global Market

Provisional BCS Classification of the Leading Oral Drugs on the Global Market

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