Biopharmaceutic Consideration and Assessment for Oral Controlled Release Formulations

Zhang, Hua; Surian, Jean M.

doi:10.1002/9780470640487.ch3

Cited by 6 publications

(4 citation statements)

References 77 publications

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“…It plays a crucial role in comparing the dissolution profiles of different pharmaceutical products prior to starting the bioequivalence studies [ 3 ]. The dissolution test is an essential tool in assessing the quality and stability of a medicinal product [ 1 , 4 , 5 ]. The primary prerequisite for a qualified estimation of an API release is selecting the appropriate dissolution method with distinctive character, which can clearly detect the main differences in the API release from individual dosage forms, ideally under the conditions mimicking those for real drug absorption in the human or animal body [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

et al. 2021

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A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the bioequivalence or stability studies. General recommendations for dissolution profile comparison are mentioned by the EMA and FDA guidelines. However, neither the EMA nor the FDA provides unambiguous instructions for comparing the dissolution curves, except for calculating the similarity factor f2. In agreement with the EMA and FDA strategy for comparing the dissolution profiles, this manuscript provides an overview of suitable statistical methods (CI derivation for f2 based on bootstrap, CI derivation for the difference between reference and test samples, Mahalanobis distance, model-dependent approach and maximum deviation method), their procedures and limitations. However, usage of statistical approaches for the above-described methods can be met with difficulties, especially when combined with the requirement of practice for robust and straightforward techniques for data evaluation. Therefore, the bootstrap to derive the CI for f2 or CI derivation for the difference between reference and test samples was selected as the method of choice.

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Section: Introductionmentioning

confidence: 99%

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

et al. 2021

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“…Because of how they are released, SR formulations are more likely to be exposed to first pass metabolism for a long period of time, suffering the risk of low serum levels. 24 When taken there may be a delay in reaching serum plasma levels, however, to compensate for this some SR formulations have combinations of both the IR and SR put together. 19 Beware of the risk of dose dumping and toxicity if the release mechanism fails or the drug is tampered with.…”

Section: 9mentioning

confidence: 99%

Ghost pill: knowledge and awareness of this phenomenon among health care professionals

Tungaraza¹,

Talapan-Manikoth

Eboka³

et al. 2014

Int J Basic Clin Pharmacol

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Background: Slow release (SR) drug formulations associated with the passage of intact tablet like object in faeces sometimes known as the "ghost pill" have been in the market for many years. Anecdotal evidence suggests that few health care professionals are aware of this phenomenon. Our study aims were to find out what proportion of health care professionals was aware of the ghost pill phenomena and what drug formulations and specific drugs were associated with it. Methods: A survey was conducted among health care professionals at three hospital sights in the West Midlands, UK. The subjects included doctors, nursing staff, pharmacists, and other allied professionals involved in patient care. Results: A total of 321 health care professionals were included in the final analysis. Very few, 12.8% (41) have heard of the ghost pill phenomenon and a further 14 (4.4%) have come across of a patient who has experienced it. Only 13 (4%) correctly associated the phenomenon with SR drug formulations. Conclusion: Our survey has shown that the ghost pill phenomenon, a normal outcome of a novel way of delivering orally taken SR drugs, is not well-known among health care professionals. Lack of awareness of it has implications to trainers, medical and nonmedical prescribers and nursing staff working with patients who are taking these medications. Lack of awareness among health care staff, may result in relevant information not being shared with patients at the time of prescribing or when patients enquires of it.

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“…Como o trato GI apresenta uma elevada complexidade fisiológica, variando desde o estômago até o cólon em termos de composição, estrutura e função, isso afeta diretamente as taxas e extensão da absorção de um fármaco. Sendo assim, ao avaliar a liberação controlada do fármaco, suas propriedades devem ser analisadas em função da posição no trato GI, para os diferentes valores de pH, permeabilidades e estabilidade (ZHANG; SURIAN, 2010). Dentre as propriedades analisadas dos fármacos estão a solubilidade aquosa, pKa, coeficiente de partição, estabilidade, tamanho da molécula e difusividade.…”

Section: Propriedades Físico-químicas De Fármacos Para Sistemas De Li...unclassified

“…A solubilidade aquosa de um fármaco depende de sua estrutura química, propriedades físico-químicas de seus grupos funcionais, variações em sua configuração estereoquímica e propriedades de estado sólido, exercendo importante papel sobre a biodisponibilidade do fármaco (ZHANG; SURIAN, 2010). Para ser absorvido, é necessário que o fármaco se dissolva na fase aquosa do local de administração e depois consiga penetrar a membrana absorvente.…”

Section: Solubilidade E Coeficiente De Partiçãounclassified

Desenvolvimento de partículas a partir da blenda de sericina e alginato para incorporação e liberação modificada de anti-inflamatórios cetoprofeno e naproxeno

Dantas de Freitas

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Biopharmaceutic Consideration and Assessment for Oral Controlled Release Formulations

Cited by 6 publications

References 77 publications

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

Ghost pill: knowledge and awareness of this phenomenon among health care professionals

Desenvolvimento de partículas a partir da blenda de sericina e alginato para incorporação e liberação modificada de anti-inflamatórios cetoprofeno e naproxeno

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