Skip to content
Free planNo credit card requiredStart writing
AI for Research home
AI for Research home
Dashboard
Sign inGet started

Search 250 million research papers

Read the abstract, see who wrote it and who cites it, and get the citation in APA, MLA, Chicago or Harvard.

About 792 papers for “Biopharmaceutics Classification System”

Biopharmaceutics classification system and biowaivers

Denise Bonamici · LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) · 2009

A absorção oral de um fármaco é fundamentalmente dependente da solubilidade aquosa e da permeabilidade gastrintestinal. Estes são fatores determinantes da biodisponibilidade e, consequentemente, da eficácia clínica de um medicamento. O Sistema de Classificação Biofarmacêutica (SCB), fundamentado nas propriedades de solubilidade e permeabilidade, consolidou-se nos últimos anos como ferramenta de auxílio na predição da biodisponibilidade de fármacos e tem sido empregado no desenvolvimento de formas farmacêuticas, contendo novos fármacos ou não, bem como no registro de medicamentos genéricos. O emprego do SCB para a isenção dos estudos de biodisponibilidade relativa/bioequivalência para algumas classes de fármacos vem sendo adotado e discutido, uma vez que os ensaios de biodisponibilidade apresentam limitações técnicas, econômicas e éticas. Assim, nos últimos anos, Agências Regulatórias têm utilizado o SCB para permitir que testes de dissolução in vitro sejam usados para estabelecer bioequivalência no caso de fármacos altamente solúveis e altamente permeáveis. O presente trabalho tem como objetivos revisar e reunir a literatura relacionada ao SCB com vistas a discutir a possibilidade de isenção dos estudos de biodisponibilidade relativa / bioequivalência para os medicamentos. Com esta proposta, foram pesquisadas as bases de dados Pubmed, Medline, Legislações Brasileiras indexadas no Visalegis e Legislação Internacional. Buscou-se a literatura pertinente publicada no período entre 1980 e o primeiro semestre de 2009. Desde a introdução do SCB existe uma relutância na aplicação das bioisenções para o registro de genéricos uma vez que as indústrias farmacêuticas não querem arriscar uma rejeição à sua solicitação nos países onde esse sistema ainda não é aceito, principalmente devido à falta de harmonização da legislação global. No Brasil, o SCB não é aceito para isenção de estudos de biodisponibilidade relativa/bioequivalência, pois os dados de permeabilidade são escassos na literatura científica para a grande maioria dos fármacos e ainda não existem protocolos validados para os estudos de permeabilidade. Além disto, o país ainda não possui um sistema de registro e controle de qualidade de princípios ativos e excipientes, ou seja, até o momento, não há regulamentação técnica para registro de matérias-primas de produtos farmacêuticos e cosméticos, ao contrário do que existe nos Estados Unidos. Para uma melhor aplicabilidade do SCB nas bioisenções as seguintes questões devem ser destacadas: continuidade do suporte científico para assegurar bioisenções para fármacos da Classe III; suporte científico para as metodologias de determinação de permeabilidade, com o objetivo de determinar a classificação biofarmacêutica dos fármacos; discutir a aplicação da Classificação Biofarmacêutica na fase de pesquisa e desenvolvimento de novas moléculas.

Cited by 0

Biopharmaceutics Classification System: Theory and Practice

Mehul Mehta, Jayabharathi Vaidyanathan, Lawrence X. Yu · 2023

This chapter describes the theory and practice of the biopharmaceutics classification system (BCS). The BCS is the concept that was developed to meet regulatory needs. It resulted in the first Food and Drug Administration (FDA) guidance that was entirely based on the results of regulatory-sponsored research. The FDA issued its first BCS guidance in 2000. However, it took 20 years for its acceptance worldwide, as witnessed by the issuing of M9, the ICH BCS guidance. Over the years, we have witnessed how a scientifically fundamental concept involving basic properties of the drug substance and drug product evolved into regulatory guidance, resulting in approval of hundreds of drug applications. By providing appropriate in vitro methods to replace expensive, time-consuming, and avoidable in vivo bioequivalence (BE) studies, the BCS has facilitated availability of good-quality drug products at reduced cost and at a faster pace for benefit of patients globally.

Cited by 1

Biopharmaceutics Classification System: A Regulatory Approach

B. Basanta Kumar Reddy, A. Karunakar · Dissolution Technologies · 2011

The Biopharmaceutics Classification System (BCS) is the result of continuous efforts in mathematical analysis for the elucidation of the kinetics and dynamics of the drug process in the gastrointestinal tract (GIT) for NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) filings and biowaivers. This step reduces timelines in the new drug development process, both directly and indirectly, reduces unnecessary drug exposure in healthy volunteers, and increases impact for the replacement of certain bioequivalence (BE) studies with in vitro dissolution tests.

Cited by 72Open access

An Overview of the Biopharmaceutics Classification System (BCS)

L. Prasanna Tarivitla, M. Sunitha Reddy · GSC Biological and Pharmaceutical Sciences · 2021

The Biopharmaceutics Classification System (BCS) is an essential tool in pharmaceutical sciences, providing a scientific framework for classifying drugs based on their solubility and permeability characteristics. This system, developed in 1995, helps streamline drug development and regulatory approval processes by predicting in vivo drug performance from in vitro data. This paper reviews the four BCS classes, their solubility and permeability criteria, detailed procedures for determining these characteristics, and suitable formulation strategies for each class. Additionally, it explores the concept of biowaivers, which allows for the waiver of in vivo bioavailability and bioequivalence studies under certain conditions, primarily for BCS Class I drugs. The advantages, challenges, and limitations of biowaivers are discussed, emphasizing the need for global harmonization to fully realize the BCS's potential.

Cited by 2Open access

Biopharmaceutics classification system: importance and inclusion in biowaiver guidance

Lorena Barbosa Arrunátegui, Neila Márcia Silva-Barcellos, Karime Rezende Bellavinha et al. · Figshare · 2022

Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.

Cited by 0Open access

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

Libuše Smetanová, V. Štětinová, Zbyněk Svoboda et al. · Acta Medica (Hradec Kralove Czech Republic) · 2011

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.

Cited by 66Open access

Biowaiver based on biopharmaceutics classification system: Considerations and requirements

Pratik R. Dhake, Smita Kumbhar, Vinod L. Gaikwad · Pharmaceutical Science Advances · 2023

Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the US, Europe, and other developing markets. Only pharmaceutical products that meet the regulatory requirements for solubility, diffusion, and permeability will be granted a biowaiver. Due to high solubility and considerable permeability, BCS class I and class III drugs are highly preferred for biowaiver by regulatory agencies. The World Health Organization recently expanded the scope of the biowaiver acceptance by considering all BCS classes. These techniques can cut down on time and money spent on ineffective bioequivalence studies. In the present article, an attempt has been made to cover the prerequisites and guidelines for biowaiver approval of a generic product, a topical system, oral films, and BCS class II and IV drugs.

Cited by 7Open access

Biopharmaceutics classification system: importance and inclusion in biowaiver guidance

Lorena Barbosa Arrunátegui, Neila Márcia Silva-Barcellos, Karime Rezende Bellavinha et al. · Brazilian Journal of Pharmaceutical Sciences · 2015

Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.

Cited by 18Open access