scholarly journals Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds

2015 ◽  
Vol 81 (1) ◽  
pp. 137-147 ◽  
Author(s):  
Amit A. Somani ◽  
Kirstin Thelen ◽  
Songmao Zheng ◽  
Mirjam N. Trame ◽  
Katrin Coboeken ◽  
...  
Keyword(s):  
Drug Absorption ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
Class I ◽  
Oral Drug ◽  
Oral Drug Absorption ◽  
Term Neonates ◽  
Biopharmaceutics Classification

scholarly journals Caco-2 Cells, Biopharmaceutics Classification System (BCS) and Biowaiter

2011 ◽  
Vol 54 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Libuše Smetanová ◽  
Věra Štětinová ◽  
Zbyněk Svoboda ◽  
Jaroslav Květina
Keyword(s):  
Drug Absorption ◽  
Classification System ◽  
Drug Transport ◽  
Biopharmaceutics Classification System ◽  
Phenol Red ◽  
Basolateral Side ◽  
Free Transport ◽  
Biopharmaceutics Classification

Almost all orally administered drugs are absorbed across the intestinal mucosa. The Caco-2 monolayers are used as an in vitro model to predict drug absorption in humans and to explore mechanism of drug absorption. The Caco-2 cells are derived from a human colon adenocarcinoma and spontaneously differentiate to form confluent monolayer of polarized cells structurally and functionally resembling the small intestinal epithelium. For studying drug permeability, Caco-2 cells are seeded onto the Transwell inserts with semipermeable membrane and grown to late confluence (21 days). After determination of cell viability, the integrity of monolayer is checked by phenol red permeability and by 14C-mannitol permeability. The transport from apical to basolateral (AP-BL) and basolateral to apical (BL-AP) is studied by adding the diluted drug on the apical or basolateral side and withdrawing the samples from the opposite compartment, respectively, for HPLC analysis or liquid scintillation spectrometry. Ca2+- free transport medium is used to determine paracellular component of the drug transport. On the basis of permeability and solubility, drugs can be categorized into four classes of Biopharmaceutics Classification System (BCS). For certain drugs, the BCS-based biowaiver approach can be used which enables to reduce in vivo bioequivalence studies.

scholarly journals Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System

Pharmaceutics ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 567 ◽  
Author(s):  
Jose-Manuel delMoral-Sanchez ◽  
Isabel Gonzalez-Alvarez ◽  
Marta Gonzalez-Alvarez ◽  
Andres Navarro ◽  
Marival Bermejo
Keyword(s):  
World Health Organization ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
Essential Medicines ◽  
World Health ◽  
Oral Drug ◽  
Essential Medicines List ◽  
The World ◽  
Health Organization ◽  
Biopharmaceutics Classification

The objective was using the Essential Medicines List for children by the World Health Organization (WHO) to create a pediatric biopharmaceutics classification system (pBCS) of the oral drugs included in the Essential Medicines List by the World Health Organization and to compare our results with the BCS for adults (aBCS). Several methods to estimate the oral drug dose in different pediatric groups were used to calculate dose number (Do) and solubility (high/low). The estimation of the gastrointestinal water volume was adapted to each pediatric group. Provisional permeability classification was done by comparison of each drug lipophilicity versus metoprolol as the model drug of high permeability. As a result, 24.5% of the included drugs moved from the favorable to unfavorable class (i.e., from high to low solubility). Observed changes point out potential differences in product performance in pediatrics compared to adults, due to changes in the limiting factors for absorption. BCS Class Changes 1 to 2 or 3 to 4 are indicative of drugs that could be more sensitive to the choice of appropriate excipient in the development process. Validating a pBCS for each age group would provide a valuable tool to apply in specific pediatric formulation design by reducing time and costs and avoiding unnecessary pediatric experiments restricted due to ethical reasons. Additionally, pBCS could minimize the associated risks to the use of adult medicines or pharmaceutical compound formulations.

scholarly journals ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 363
Author(s):  
Claudia Miranda ◽  
Alexis Aceituno ◽  
Mirna Fernández ◽  
Gustavo Mendes ◽  
Yanina Rodríguez ◽  
...  
Keyword(s):  
Latin American ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
In Vitro Dissolution ◽  
Ich Guidelines ◽  
Latin American Region ◽  
Regulatory Guidelines ◽  
Biopharmaceutics Classification

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.

The effect of HPMC—a cholesterol-lowering agent—on oral drug absorption in dogs

1998 ◽  
Vol 19 (8) ◽  
pp. 523-530 ◽  
Author(s):  
C. Reppas ◽  
G. Eleftheriou ◽  
P. Macheras ◽  
M. Symillides ◽  
D. Greenwood ◽  
...  
Keyword(s):  
Drug Absorption ◽  
Oral Drug ◽  
Oral Drug Absorption ◽  
Cholesterol Lowering
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