Summary workshop report: Biopharmaceutics classification system—implementation challenges and extension opportunities

Polli, James E.; Yu, Lawrence X.; Cook, Jack; Amidon, Gordon L.; Borchardt, Ronald T.; Burnside, Beth; Burton, Philip S.; Chen, Mei‐Ling; Conner, Dale P.; Faustino, Patrick J.; Hawi, Amale; Hussain, Ajaz; Joshi, Hemant; Kwei, Gloria Y.; Lee, Vincent H.L.; Lesko, Lawrence J.; Lipper, Robert A.; Loper, Alice E.; Nerurkar, Shriniwas G.; Polli, Joseph W.; Sanvordeker, Dilip R.; Taneja, Rajneesh; Uppoor, Ramana; Vattikonda, Chandra S.; Wilding, Ian R.; Zhang, Guo Hua

doi:10.1002/jps.20064

Cited by 106 publications

(99 citation statements)

References 1 publication

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“…However, extensions of the present requirements to BCS Class III APIs have received increasing attention. [90][91][92][93] Formulation effects giving rises to differences in the extent of absorption, i.e., to differences between the AUC of the test product and the AUC of the reference product, are not known and can be further minimized if the test product is formulated with excipients used in those drug products already having an MA. Comparative in vitro dissolution testing will provide even greater assurance of BE with respect to at least the extent of absorption.…”

Section: Resultsmentioning

confidence: 99%

Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol)

Kalantzi

Reppas

Dressman

et al. 2006

Journal of Pharmaceutical Sciences

147

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Literature data are reviewed on the properties of acetaminophen (paracetamol) related to the biopharmaceutics classification system (BCS). According to the current BCS criteria, acetaminophen is BCS Class III compound. Differences in composition seldom, if ever, have an effect on the extent of absorption. However, some studies show differences in rate of absorption between brands and formulations. In particular, sodium bicarbonate, present in some drug products, was reported to give an increase in the rate of absorption, probably caused by an effect on gastric emptying. In view of Marketing Authorizations (MAs) given in a number of countries to acetaminophen drug products with rapid onset of action, it is concluded that differences in rate of absorption were considered therapeutically not relevant by the Health Authorities. Moreover, in view of its therapeutic use, its wide therapeutic index and its uncomplicated pharmacokinetic properties, in vitro dissolution data collected according to the relevant Guidances can be safely used for declaring bioequivalence (BE) of two acetaminophen formulations. Therefore, accepting a biowaiver for immediate release (IR) acetaminophen solid oral drug products is considered scientifically justified, if the test product contains only those excipients reported in this paper in their usual amounts and the test product is rapidly dissolving, as well as the test product fulfils the criterion of similarity of dissolution profiles to the reference product.

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Section: Resultsmentioning

confidence: 99%

Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol)

Kalantzi

Reppas

Dressman

et al. 2006

Journal of Pharmaceutical Sciences

147

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“…Similarity between the drug release profiles was determined using similarity factor f 2 (Moore and Flanner, 1996;Polli et al, 2004;Asare-Addo et al 2010).…”

Section: Similarity Factormentioning

confidence: 99%

Starch-free grewia gum matrices: Compaction, swelling, erosion and drug release behaviour

Nep

Asare-Addo

Ghori

et al. 2015

International Journal of Pharmaceutics

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“…Similarity factor: The drug release profiles were compared by using similarity factor f2 as shown in equation 8 (Moore and Flanner, 1996;Polli et al, 2004;Asare-Addo et al 2010).…”

Section: Dissolution Parameters (Dissolution Efficiency (De) and Meanmentioning

confidence: 99%

Evaluation of sesamum gum as an excipient in matrix tablets

Nep

Asare-Addo²,

Ngwuluka

et al. 2016

British Journal of Pharmacy

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In developing countries modern medicines are often beyond the affordability of the majority of the population. This is due to the reliance on expensive imported raw materials despite the abundance of natural resources which could provide an equivalent or even an improved function. The aim of this study was to investigate the potential of sesamum gum (SG) extracted from the leaves of Sesamum radiatum (readily cultivated in sub-Saharan Africa) as a matrix former. Directly compressed matrix tablets were prepared from the extract and compared with similar matrices of HPMC (K4M) using theophylline as a model water soluble drug. The compaction, swelling, erosion and drug release from the matrices were studied in deionized water, 0.1 N HCl (pH 1.2) and phosphate buffer (pH 6.8) using USP apparatus II. The data from the swelling, erosion and drug release studies were also fitted into the respective mathematical models. Results showed that the matrices underwent a combination of swelling and erosion, with the swelling action being controlled by the rate of hydration in the medium. SG also controlled the release of theophylline similar to the HPMC and therefore may have use as an alternative excipient in regions where Sesamum radiatum can be easily cultivated.

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Summary workshop report: Biopharmaceutics classification system—implementation challenges and extension opportunities

Cited by 106 publications

References 1 publication

Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol)

Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol)

Starch-free grewia gum matrices: Compaction, swelling, erosion and drug release behaviour

Evaluation of sesamum gum as an excipient in matrix tablets

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